(23 days)
The Multimodality Advanced Vessels Analysis (MM AVA) application is intended for visualization, assessment and quantification of vascular datasets.
Philips Medical Systems' Multimodality Advanced Vessels Analysis (MM AVA) application is intended for visualization, assessment, and quantification of vessels in CTA and MRA data with a unified workflow for both modalities. For CTA data, it provides both automatic and manual bone removal and vessels segmentation including extraction of vessel centerlines, lumen contours and vessel contours. For both modalities, it provides tools for extracting and editing centerlines. MM AVA offers inspection views for selected vessels centerlines and local analysis. It allows creating, capturing, and reviewing of basic user selected endovascular measurements (and calculations when applicable), as well as predefined measurements sets and measurements correlations. The physician retains the ultimate responsibility for making the final diagnosis. Philips Medical Systems' MM AVA is launched from Philips Medical Systems' IntelliSpace Portal (ISP) Platform (K162025).
The provided document outlines the substantial equivalence of Philips Medical Systems' Multimodality Advanced Vessel Analysis (MM AVA) application to existing predicate devices. However, this submission does not contain details about specific acceptance criteria, study methodologies (like sample size for test and training sets, data provenance, expert qualifications, or adjudication methods), or performance metrics demonstrating the device meets quantitative acceptance criteria.
The document states:
- "The test results in this 510(k) premarket notification demonstrate that Multimodality Advanced Vessels Analysis (MM AVA) application: ... Meets the acceptance criteria and is adequate for its intended use and specifications." (Page 17)
- It also mentions that "Philips Medical Systems' Multimodality Advanced Vessels Analysis (MM AVA) application was tested in accordance with Philips verification and validation processes. Verification and Validation tests have been performed to address intended use, the technological characteristics, requirement specifications and the risk management results." (Page 17)
However, the specifics of these "acceptance criteria" and the "test results" demonstrating they were met are not provided in the publicly available sections of this 510(k) summary. This summary focuses on establishing substantial equivalence based on features, intended use, and existing standards rather than detailed performance study results against predefined objective metrics.
Therefore, I cannot populate the requested table or answer the specific questions about the study design that proves the device meets the acceptance criteria, as that information is not present in the provided text.
Based on the available text, here's what can be stated:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (e.g., Specificity, Sensitivity, Accuracy, etc.) | Reported Device Performance |
|---|---|
| Not specified in the provided document. | Not specified in the provided document. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified in the provided document.
- Qualifications of Experts: Not specified in the provided document.
4. Adjudication method for the test set:
- Adjudication Method: Not specified in the provided document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study Done: Not specified whether an MRMC study was performed in the context of human-in-the-loop performance. The document focuses on the software's features and its substantial equivalence to predicate devices, not on human reader improvement with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: The document states "Non-clinical performance tests has been performed on Multimodality Advanced Vessels Analysis (MM AVA) application" and "Philips Medical Systems Multimodality Advanced Vessels Analysis (MM AVA) application was tested in accordance with Philips verification and validation processes." This implies standalone testing, but specific performance metrics (e.g., accuracy of automatic measurements) are not detailed.
7. The type of ground truth used:
- Type of Ground Truth: Not specified in the provided document.
8. The sample size for the training set:
- Sample Size for Training Set: Not specified in the provided document.
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not specified in the provided document.
In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through feature comparison and compliance with general standards and internal validation processes, rather than presenting detailed performance study results that would typically include the requested information.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.