(432 days)
The Philips Medical Systems' Brain Perfusion is a post processing software application intended to assist with the evaluation of an area of interest, to generate qualitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast agent, by calculating the parameters related to brain perfusion and displays the results as a composite (single image that is calculated from a set of time course images at a single location) images.
The Philips Medical Systems' Brain Perfusion (BP) application is a post processing software to be used as an advanced visualization application of CT brain perfusion images. The BP application is used to support the analysis of dynamic and/or serial CT brain images after injection of contrast. The BP application is intended to assist with the evaluation of an area of interest, and to generate qualitative and quantitative information about changes in image intensity over time. The BP application presents the results as a composite (single image that is calculated from a set of time course images at a single location) images and provides perfusion parameters maps. The following parameters relate to brain perfusion are calculated: Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), local bolus timing (Time to Peak (TTP)/Time to Maximum (Tmax)) and Mean Transit Time (MTT) and supports processing and visualization of Permeability maps. The physician retains the ultimate responsibility for making the final diagnosis.
The provided document is a 510(k) summary for the Philips Medical Systems' Brain Perfusion (BP) application. It explicitly states that "Brain Perfusion (BP) application did not require clinical studies to support equivalence." Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance.
The document discusses non-clinical tests to demonstrate compliance with international and FDA-recognized consensus standards and internal Philips verification and validation processes. However, it does not provide specific acceptance criteria or detailed results of a study (clinical or non-clinical) proving device performance against such criteria.
Therefore, most of the requested information cannot be extracted from this document, as it focuses on demonstrating substantial equivalence through comparison to a predicate device and adherence to general engineering and quality standards, rather than direct performance metrics from a comparative or standalone study.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria for device performance or report specific performance metrics for the Brain Perfusion (BP) application. It states that "The test results in this 510(k) premarket notification demonstrates that Brain Perfusion (BP) application... Meets the acceptance criteria and is adequate for its intended use and specifications," but does not elaborate on what those criteria or results are.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. No clinical test set or data provenance is mentioned as no clinical studies were performed. Non-clinical tests are mentioned, but details on the "test set" (e.g., number of test cases, type of data used for verification) are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided. No clinical studies or use of experts for ground truth establishment are detailed in this document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No details on clinical test sets or adjudication methods are present.
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
- Cannot be provided. The document explicitly states that clinical studies were not required. Therefore, no MRMC study, or any information on human reader improvement with or without AI assistance, is included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. While "non-clinical performance testing" and "verification and validation processes" are mentioned for the software, the document does not detail specific "standalone" performance studies, or quantify the algorithm's performance on its own.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. As no clinical studies or ground truth establishment process is described for evaluating the device's performance against medical conditions.
8. The sample size for the training set
- Cannot be provided. The document describes a post-processing software application but does not mention any machine learning components that would require a "training set."
9. How the ground truth for the training set was established
- Cannot be provided. As no training set is mentioned.
Summary from the provided document:
The Philips Medical Systems' Brain Perfusion (BP) application is a post-processing software intended to assist with the evaluation of an area of interest by calculating parameters related to brain perfusion from dynamic/serial CT scans.
Key takeaway regarding performance studies:
The document explicitly states: "The subject of this premarket submission, Brain Perfusion (BP) application did not require clinical studies to support equivalence."
Instead of clinical studies, the submission relies on:
- Substantial equivalence to a predicate device (Philips Medical Systems' Brain Perfusion Application, K182716).
- Non-clinical performance testing to demonstrate compliance with international and FDA-recognized consensus standards (ISO 14971, IEC 62304, NEMA PS 3.1-3.20, IEC 62366-1) and internal Philips verification and validation processes. The document asserts that these tests demonstrated the device "Meets the acceptance criteria and is adequate for its intended use and specifications," and "meets all defined functionality requirements and performance claims." However, specific criteria and quantitative results are not provided in this summary.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).