Search Results

The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected area of interest to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, 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. This software runs on the Philips Medical Systems Brilliance TM Workspace of a CT System.

The Brain Perfusion Option is used in a Philips Medical Systems Brilliance ™ Workspace of a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace. It is intended to assist the user-selected area of interest to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, 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. This software runs on the Philips Medical Systems Brilliance TM Workspace of a CT System.

The Brain Perfusion Option is used in a Philips Medical Systems Brilliance ™ Workspace of a Computed Tomography X-Ray System intended to produce crosssectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.

The Philips Medical Systems CT Brain Perfusion Option is intended to assist the user by providing a diagnostic patient imaging tool to be included on a CT workspace to generate qualitative and quantitative information about changes in image intensity over time. It supports the analysis of dynamic/serial CT after injection of contrast, by calculating the parameters related to brain perfusion and displays the results as composite images.

Based on the provided text, the submission does not contain a detailed study with specific acceptance criteria and performance metrics. Instead, the focus is on establishing substantial equivalence to previously marketed predicate devices (Image Processing Function on the Select CT/SP in CDRH Document Control No K961464 and K012009, and the Mx8000IDT).

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The provided text does not include a table of acceptance criteria or reported device performance metrics for the Brain Perfusion Option. The submission relies on demonstrating substantial equivalence to predicate devices rather than presenting a performance study against predefined criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. No specific test set or data provenance is mentioned as there isn't a stand-alone performance study described.

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)

This information is not provided in the document. Since there is no described test set or ground truth establishment process, details about experts are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. No adjudication method is mentioned as there is no described test set.

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

There is no mention of an MRMC comparative effectiveness study in the provided text. The document focuses on the device's functional capabilities and substantial equivalence, not on human reader improvement with AI assistance. The device is referred to as "intended to assist the user," but no study is presented to quantify this assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study of the algorithm is not explicitly described in the document. The submission emphasizes the device's functional specifications and how it "assists the user," suggesting a human-in-the-loop context, but no specific performance metrics are offered for the algorithm itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. As no performance study with a test set is outlined, the type of ground truth used is not specified.

8. The sample size for the training set

This information is not provided in the document. Details about algorithm training are not included.

9. How the ground truth for the training set was established

This information is not provided in the document. The process of establishing ground truth for any potential training set is not detailed.

Summary of the Study (as inferred from the document):

The "study" described in the provided text is primarily a substantial equivalence review rather than a performance study. Philips Medical Systems (Cleveland), Inc. asserts that the Brain Perfusion Option is "of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely the Image Processing Function on the Select CT/SP in CDRH Document Control No K961464 and K012009 and the Mx8000IDT."

The basis for this claim is that the devices "comply with the same or equivalent standards and have the same or equivalent intended uses." The document highlights the functional specifications and operator's instructions (Appendices "B" and "C", which are not provided) to support this comparison. It also states that the device adheres to FDA GMPs, 21 CFR 1020.30-33, and voluntary standards for safety/effectiveness (UL 2601) to minimize hazards.

Therefore, the "study" that proves the device meets the acceptance criteria is an argument for substantial equivalence based on comparable intended use, technology, and adherence to regulatory and safety standards, rather than a clinical performance trial with predefined acceptance criteria and measured outcomes against a ground truth.

Ask a specific question about this device