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510(k) Data Aggregation
(149 days)
Sensus TPS Workstation
Sensus TPS Workstation is a software system intended for treatment planning and analysis of intraoperative radiation therapy administered with the Sensus IORT System, a device suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.
The intended users of Sensus TPS Workstation shall be clinically qualified radiation therapy staff trained in using the system.
The Sensus TPS Workstation is a multi-functional, integrated software suite that forms a comprehensive electronic oncology management system for radiation oncology facilities. For radiation oncology users, the TPS Workstation provides image-enabled electronic patient charting and record management. For radiation oncology users, it also includes the ability to import and export radiation treatment plan information, beam geometry planning, treatment plan review, and verification and record treatment setup and delivery. The Sensus Healthcare TPS Workstation is dedicated for use with the Sensus Healthcare IORT System only. The software is not a general-use product compatible with other IORT systems.
The Sensus TPS Workstation is a software system intended for treatment planning and analysis of intraoperative radiation therapy administered with the Sensus IORT System. The software has undergone design verification and validation testing to ensure it functions according to its design parameters and meets safety and performance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the acceptance criteria in terms of the successful completion of various verification and validation tests. The reported device performance is that the device passed all these tests.
| Acceptance Criteria (Test Protocol Name) | Reported Device Performance (Results) |
|---|---|
| TPS Software Verification Validation Test Plan (6-2-7380-0000) | Pass |
| TPS Software System Integration Testing (6-2-7381-0000) | Pass |
| Static Analysis Report Summary (6-2-7390-0000) | Pass |
| Unit Testing Report Summary (6-2-7391-0000) | Pass |
| Comparison of the measured dose and the dose calculated by the radiation treatment planning system (SEN18940_RPT) | Proved accurate and consistent beam/dose output |
| IEC 62304 (Medical device software – Software life cycle processes) | Compliance |
| ISO 14971 (Medical devices -- Application of risk management to medical devices) | Compliance |
| FDA Guidance for Management of Cybersecurity in Medical Devices | Compliance |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size (e.g., number of patient cases or specific test data points) used for each listed test protocol. It mentions "several test treatment plans" were generated for the treatment plan-to-beam generation fidelity testing, but no specific number is provided.
The data provenance is not explicitly mentioned as country of origin; however, the testing was performed internally by Sensus Healthcare as part of their design and development process for regulatory submission. The testing appears to be based on an internal bench testing paradigm rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. The "ground truth" for the performance testing appears to be based on established engineering benchmarks, system requirements, and the expected output of a radiation treatment planning system, rather than expert clinical interpretation of patient data. For the "Comparison of the measured dose and the dose calculated by the radiation treatment planning system," the truth was against "measured dose."
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The tests appear to be pass/fail based on predetermined criteria outlined in the test protocols and system requirements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned in the provided document. The study focuses on the standalone performance and safety of the Sensus TPS Workstation itself and its equivalence to a predicate device, rather than the improvement of human readers with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The described "Non-Clinical Performance Testing" and "Non-clinical Safety Tests" are essentially standalone evaluations of the Sensus TPS Workstation software. The system functionality, dose calculation engine, and various software modules were tested to ensure they performed according to their specifications and produced accurate and consistent results independently. The "treatment plan-to-beam generation fidelity testing" directly evaluates the algorithm's output against actual physical measurements.
7. Type of Ground Truth Used
The ground truth used for testing includes:
- System Requirements Specifications (SRS): The tests were executed to ensure the system functioned "in accordance with its design parameters" and passed "all of the requirements determined in the testing procedures."
- Measured Dose and Beam Output: For the treatment plan-to-beam generation fidelity testing, the "ground truth" was established by measuring the actual beam output and yield from the Sensus IORT System's x-ray source and comparing it with the computational engine output and results.
- Predicate Device Performance: Performance testing demonstrated that the Sensus TPS Workstation "provided the same technical capabilities as the predicate device," implying the predicate device's established performance served as a benchmark for equivalence.
8. Sample Size for the Training Set
The document does not mention a training set, as this device is a treatment planning software system, not a machine learning or AI model that typically requires a training set in the conventional sense. The "pre-calculated Monte Carlo simulations" for the Sensus IORT System described under "Calculation for photons" could be considered analogous to a foundational data set used by the algorithm, but it's not a "training set" in the context of supervised learning for image analysis, for example.
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no mention of a traditional "training set" for a machine learning model. For the pre-calculated Monte Carlo simulations (which could be seen as foundational data), the document states: "A set of Monte Carlo simulations has been performed to predict the dose distribution produced by each operating point of the Sensus IORT device with high accuracy." This implies that the ground truth for these simulations would be based on established physics principles and validated simulation methods, likely compared against physical measurements of dose distribution for the IORT system, though the specific validation of the Monte Carlo simulations themselves is not detailed here.
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