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As a part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography.

The Philips XD-S is a workstation (computer, keyboard, display, mouse), combined with a flat solid state X-ray detector. It is used by the operator to preset examination data, and to generate, process and handle digital X-ray images. As a part of a radiographic system, the Philips XD-S is intended to acquire, process, store, display, and export digital radiographic images. The Philips XD-S is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography. The complete X-ray system would further include other subsystems and components, like patient table, X-ray control(s), X-ray high voltage generator, X-ray tube(s), collimator(s), accessories, etc. There is a standalone version with minimal integration into the X-ray system. With the fully integrated version, the workstation screen also provides displays area and controls for X-ray generator control. The workstation computer can also host parts of the system control software.

The provided text is a 510(k) summary for the Philips XD-S Direct Radiography Workstation/Package. It primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to safety and performance standards. It does not contain information about acceptance criteria or a specific study proving the device meets those criteria based on clinical performance metrics (e.g., sensitivity, specificity, accuracy).

The "Performance Standards" section refers to compliance with federal X-Ray performance standards, electrical safety standards, electromagnetic compatibility standards, and DICOM. These are regulatory and technical standards, not clinical performance acceptance criteria in the sense of a medical diagnostic device.

Therefore, I cannot populate the table or answer most of your specific questions related to clinical performance studies, as this information is not present in the provided document.

Here's what can be extracted based on your request, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Information Not Provided: The document does not describe a clinical performance test set, its sample size, or the provenance of any data used for such a test. The evaluation here is based on substantial equivalence and compliance with technical standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Information Not Provided: As no clinical performance study or test set is described, there is no mention of experts or ground truth establishment in this context.

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

• Information Not Provided: No test set is described.

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

• Information Not Provided: This device is a digital image acquisition workstation, not an AI-powered diagnostic assist tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission and not mentioned.

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

• Information Not Provided: This device is a workstation for acquiring, processing, storing, and displaying images. It does not contain an autonomous algorithm whose standalone performance would typically be evaluated in this context. Its "standalone version" refers to its integration level with other X-ray system components, not an AI algorithm.

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

• Information Not Provided: No clinical performance study requiring ground truth is described.

8. The sample size for the training set

• Information Not Provided: This document does not describe a machine learning model that would require a training set.

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

• Information Not Provided: Not applicable, as no training set is described.

Summary of Device Evaluation in the 510(k) Summary:

The Philips XD-S Direct Radiography Workstation/Package obtained clearance through the 510(k) pathway by demonstrating substantial equivalence to previously cleared predicate devices (Philips Digital Diagnost and Philips Computed Radiography). The evaluation also focused on:

• Compliance with federal X-ray performance standards and various international electrical safety and electromagnetic compatibility standards.
• Adherence to the DICOM standard for digital imaging communication.
• The use of mature technology and software deemed to have a MINOR level of concern.
• Implementation of product risk management according to ISO 14971, with all risks reduced to an acceptable level.

The 510(k) process for this type of device (a digital image acquisition workstation) at the time (2007) typically focused on safety, fundamental performance, and equivalence to existing devices, rather than detailed clinical performance metrics like sensitivity and specificity derived from a dedicated clinical study against a defined ground truth.

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