For device manufacturers: how to evaluate PIL
PIL provides image-analysis software that device manufacturers build into their treatment systems. The information you need is laid out in order.
Deployment steps
STEP 01
Consultation / NDA
Target system and requirements
STEP 02
Technical study / PoC
Accuracy and speed evaluated on your system's images (1–3 months)
STEP 03
Implementation / documentation
Interface implementation; IEC 62304-compliant design documents
STEP 04
Regulatory / delivery / maintenance
Support for change applications; remote maintenance and software updates
How to introduce PIL products
An overview of inputs, outputs, supported platforms and the introduction process for putting PIL software on your treatment machine. Detailed interface and performance specifications are provided individually under NDA.
Supported platforms
| Treatment machines | Photon (linac), proton and carbon-ion therapy, independent of manufacturer; implemented to each delivery specification |
|---|---|
| Deployment | Both of the following are supported. 1. Replacement: functions the treatment machine already has (patient positioning, CBCT reconstruction, etc.) are replaced with PIL products 2. New function: functions the machine does not yet have (markerless tumor tracking, etc.) are added as PIL products In both cases the software can be installed on new machines or retrofitted to systems already in clinical use |
| Interfaces | The interfaces between PIL products and other equipment and systems (treatment machine, imaging system, respiratory gating device, treatment planning system, etc.) are customizable and implemented to your delivery specification (communication method, data format, timing) |
Operating environment and quality
| Computing | GPU workstation (Windows). Recommended configuration (GPU / memory / storage) is provided individually depending on the target machine and functions |
|---|---|
| Development process | Development and documentation in accordance with IEC 62304 (medical device software life cycle), ISO 13485, ISO 14971, IEC 62366-1, IEC 81001-5-1 and IEC 82304-1 |
| Regulatory | PIL prepares product documentation and supports the manufacturer’s partial-change submission, applying the approach established with a Japanese device manufacturer |
| Maintenance and updates | Remote maintenance with first-line response via the manufacturer; improvements to tracking algorithms and AI modules delivered as software updates |
* Input/output specifications and processing times are representative values and vary with the target machine, image size and computing configuration. Items clarified in the evaluation agreement: target machine, installation site and network conditions / installation responsibility / handling of evaluation data / ownership and publication of results / governing law.
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