(15 days)
The QwikSIM Virtual Simulation System may be used by radiation oncologists, medical physicists, and medical dosimetrists for patient localization, image import and review, tumor and normal tissue delineation, and virtual simulation of treatment unit setup during the treatment planning process of external beam radiotherapy treatment. This information may then be exported to a treatment planning system for dose calculation.
The QwikSIM Virtual Simulation System provides fast and accurate visualization, contouring and beam definition to streamline the radiation therapy planning process. QwikSIM imports image data, and provides an array of tools to straining and adjusting images. Manual and automatic contouring tools allow for anatomical and tumor contour definition. Beam placement and visualization tools facilitate treatment port definition, isocenter placement and laser center placement. The resulting plan data can then be used with laser positioning systems for patient marking and exported to therapy planning systems for dose calculation.
The provided document is a 510(k) Premarket Notification summary for the QwikSIM Virtual Simulation System (Version 2.00). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria. As such, the document does not contain specific acceptance criteria or a study designed to prove the device meets those criteria in the way a clinical trial for novel devices would.
Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices. Here's what can be extracted and what is not present based on your request:
Acceptance Criteria and Reported Device Performance
The document states that "Clinical performance data is not required for determination of substantial equivalence for this type and class of device." Therefore, there are no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or corresponding reported device performance metrics in the submission summary. The acceptance criteria for this submission are based on demonstrating that the intended use and technological characteristics are substantially equivalent to predicate devices, and that any differences do not raise new safety or effectiveness concerns.
The closest analogue to "reported device performance" is the statement "The testing demonstrated that the functionality of QwikSIM was successfully implemented." This is a qualitative statement about successful implementation rather than a quantitative performance metric.
Remaining Information Based on Document's Content:
Due to the nature of a 510(k) submission for a virtual simulation system, many of the requested details about clinical studies, expert-established ground truth, and training data are not included or applicable.
| Information Requested | Presence in Document | Details from Document (if available) |
|---|---|---|
| 1. Table of Acceptance Criteria & Reported Device Performance | No | As stated above, clinical performance data with specific acceptance criteria (e.g., sensitivity, specificity) and corresponding reported performance metrics are not required or provided for this type of 510(k) submission focused on substantial equivalence. The document asserts that "The testing demonstrated that the functionality of QwikSIM was successfully implemented." |
| 2. Sample size for the test set and data provenance (country, retrospective/prospective) | Not Applicable | No clinical test set data (e.g., patient cases) is mentioned or used for performance evaluation in this 510(k) summary. The "test set" refers to internal engineering verification and validation. |
| 3. Number of experts used to establish ground truth for the test set and their qualifications | Not Applicable | Not applicable as no clinical test set requiring expert ground truth is described. The "ground truth" for internal testing was based on design specifications and expected functionality. |
| 4. Adjudication method for the test set | Not Applicable | Not applicable as no clinical test set requiring adjudication is described. |
| 5. Multi-reader multi-case (MRMC) comparative effectiveness study, and effect size. | No | No MRMC study was conducted or reported. The submission does not claim human improvement with AI assistance, as it's a virtual simulation system for treatment planning, not an AI diagnostic tool. |
| 6. Standalone (algorithm only) performance study. | No, but internal | "IMPAC's Quality Engineering department has completed all product operation and hazard mitigation testing and has certified passing test results. Engineering testing was also performed to ensure that the QwikSIM product functions as intended and specified, according to design specifications and customer labeling." This describes internal functional testing, not a standalone clinical performance study. The device is a "Virtual Simulation System," which is by its nature a standalone software application. |
| 7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) | System Specifications | For the internal verification and validation, the "ground truth" was established by the device's own design specifications, requirements, and expected operational functionality. |
| 8. Sample size for the training set. | Not Applicable | No "training set" in the context of machine learning or AI algorithm training is mentioned or relevant for this type of device. The QwikSIM System was developed using a standard software development lifecycle (SDLC) governed by the IMPAC Software Design Control Procedure (SDCP). |
| 9. How the ground truth for the training set was established. | Not Applicable | Not applicable as there is no mention of a training set for machine learning/AI. The "ground truth" for the overall development and testing process was adherence to established quality systems, design specifications, and regulatory standards (21 CFR 820, ISO 9001:1994, ISO 13485:1996, 93/42/EEC, EN 46001:1997, EN 601-1-4:1996). "A Traceability Matrix has been created... to ensure the completion of the specification, implementation, and testing of all requirements." |
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.