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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.

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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 related to brain perfusion are calculated: Cerebral Blood Flow (CBF), Cerebral Blood Volume (CBV), local bolus timing (Time to Peak (TTP)) and Mean Transit Time (MTT) and supports processing and visualization of Permeability maps.

The provided document describes the Philips Medical Systems' Brain Perfusion (BP) application, a post-processing software for CT brain perfusion images. It aims to assist in evaluating areas of interest and generating qualitative and quantitative information about changes in image intensity over time, particularly for cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), time to peak (TTP), and permeability maps.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance evaluation of the device as follows:

Note: The document does not provide specific numerical thresholds or detailed statistical results for the "pre-set acceptance criteria" or "correlation and agreement according to regression analysis characteristics" beyond stating that the criteria were met.

2. Sample Size Used for the Test Set and Data Provenance

• Perfusion Parameters (Comparison with Predicate): The test set for perfusion parameters involved a synthetic phantom. The sample size (number of phantom simulations or data points generated) is not specified. The data provenance is synthetic/simulated.
• Permeability Maps (Pre-clinical Validation): The test set involved rats imaged during occlusion and after reperfusion. The number of rats or cases is not specified. The data provenance is described as "in-vivo" (animal model).
• User Validation: "Physicians evaluated..." The number of physicians and cases used for this evaluation is not specified. Data provenance is implied to be from their evaluation of the device's features and workflows.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Perfusion Parameters (Synthetic Phantom): The ground truth for the synthetic phantom is inherent in its design and the known parameters it simulates. No external experts are mentioned for establishing ground truth for this segment.
• Permeability Maps (Pre-clinical Validation): Histology was used to determine the ground truth for the status of brain tissue and BBB permeability in rats. The number of experts interpreting the histology, or their qualifications, are not specified.
• User Validation: The ground truth is effectively the "user needs" and "intended use" as evaluated by "physicians." The number of physicians is not specified, nor are their specific qualifications (e.g., number of years of experience in radiology/neurology).

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1, 3+1, etc.) for any of the test sets.

• For the perfusion parameters, it was a comparison against data from a synthetic phantom and the predicate device.
• For permeability maps, it was a comparison against histology as ground truth.
• For user validation, it was based on scores provided by physicians.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study to assess the improvement of human readers with AI vs. without AI assistance. The performance evaluation focused on the device's standalone output and its comparison with a predicate device and ground truth.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done.

• The "Performance evaluation testing was conducted in order to validate the proper function of the perfusion and permeability parametric maps."
• "The subject device's perfusion parameters performance was evaluated in comparison with the predicate device according to pre-set acceptance criteria (assessment of correlation and agreement according to regression analysis characteristics). The perfusion parameters values were generated by utilizing a synthetic phantom." This assesses the algorithm's performance in generating perfusion maps.
• "Internal performance evaluation of the Permeability maps calculation was conducted in two phases. In the technical validation, a quantitative validation using synthetic simulated data was performed... The implemented permeability method has successfully identified regions of increased permeability that correspond to ground truth permeability markers on histology." This assesses the algorithm's ability to calculate and identify permeability.

These evaluations focus on the algorithm's outputs and their accuracy against known values or ground truth, without a human-in-the-loop component.

7. Type of Ground Truth Used

• Perfusion Parameters: The ground truth was based on the known parameters of a synthetic phantom and comparison with the outputs of a predicate device.
• Permeability Maps: The ground truth was established using histology from rats.
• User Validation: The ground truth was implicit in the user needs and intended use, assessed by physicians' evaluations.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set. It primarily discusses the validation and verification processes.

9. How the Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for any potential training set was established. It focuses on the evaluation of the final product.

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