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The Philips Thoravision is intended for use in general radiographic applications wherever conventional screen-film systems may be used.

The Philips Thoravision was submitted as a radiographic system dedicated to chest imaging in 1993. It is now recognized that the system can also be used equally well for examinations of other anatomical areas. This extension to other anatomical areas has required only minor adjustments to the system, primarily in providing APRs addressing those new anatomical areas. As such, the screen layout of the user interface display has changed somewhat. No change has been made to the hardware.

This Philips Thoravision 510(k) submission describes an extension to the intended use of an existing device, not a new device requiring detailed performance studies against specific acceptance criteria. Therefore, the provided text does not contain the requested information regarding acceptance criteria, device performance, or detailed study methodology.

The submission focuses on establishing substantial equivalence for the expanded intended use of an existing system (Philips Thoravision, cleared under K931071) to include all general-purpose radiographic examinations, beyond its original limitation to chest examinations.

Here's what can be extracted and why the other details are missing:

1. Acceptance Criteria and Reported Device Performance

The document does not specify new acceptance criteria or report performance metrics for the device for its expanded intended use. This is because the submission is for a modification of an already cleared device, primarily through software adjustments (APRs - Anatomically Programmed Radiography) and user interface changes, with no hardware modifications. The substantial equivalence argument relies on the existing device's safety and effectiveness.

Missing Information: A table with acceptance criteria and reported device performance is not provided as this type of submission typically defers to the original clearance for such details.

2. Sample Size for Test Set and Data Provenance

Missing Information: The document does not describe a test set or any specific performance studies for the extended indications. It relies on the substantial equivalence to a predicate device (the previously cleared Philips Thoravision chest system). Therefore, sample size and data provenance are not applicable to this particular submission as presented.

3. Number of Experts and Qualifications for Ground Truth

Missing Information: No information is provided regarding experts or ground truth establishment for a test set, as no new performance study data is presented for review in this 510(k) summary.

4. Adjudication Method

Missing Information: No adjudication method is mentioned as there is no new test set or study described in this document.

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

Missing Information: No MRMC study is mentioned. This type of study would typically be performed for new AI-powered diagnostic tools or significant changes in image interpretation, which is not the subject of this 510(k) extension.

6. Standalone Performance (Algorithm Only)

Missing Information: No standalone performance study is mentioned. The device is a radiographic system, not an independent algorithm for diagnostic interpretation.

7. Type of Ground Truth Used

Missing Information: Since no new performance studies are detailed, the type of ground truth used is not specified.

8. Sample Size for Training Set

Missing Information: The document does not describe a training set. The changes primarily involve software adjustments (APRs) for different anatomical areas, not the development of a new image processing algorithm that would require a training set in the AI sense.

9. How Ground Truth for Training Set Was Established

Missing Information: As no training set is mentioned, the method for establishing its ground truth is also not provided.

In summary, this 510(k) submission is for a minor modification (extension of intended use) of an already cleared medical device, the Philips Thoravision. The core argument for clearance is substantial equivalence to the previously cleared version, rather than presenting new performance data against specific acceptance criteria. Therefore, most of the requested detailed information regarding performance studies and data is not present in this document.

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