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As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Wireless Portable Detector FD-W17 is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Detector is combined with a Philips XD-S workstation (K063781) which consists of a computer, keyboard, display, mouse. The complete X-ray system would further include other Philips subsystems and components, like patient table, X-ray control(s), X-ray high voltage generator, X-ray tube(s), collimator(s), accessories, etc. The XD-S workstation and the complete X-ray systems are not changed other than by replacing an Xray receptor with the Wireless Portable Detector FD-W17.

The provided text describes a 510(k) submission for the "Wireless Portable Detector FD-W17." However, it does not contain any information about acceptance criteria, device performance metrics, sample sizes for test sets or training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, or standalone performance studies.

The submission focuses on:

• Device Identification: Manufacturer, submitter, product names, classification.
• Compliance with Standards: Federal X-Ray performance standards (CFR 1020.30, .31), electrical safety (UL 60601-1, IEC 60601-1), radiation protection (IEC 60601-1-3), Electromagnetic Compatibility (IEC-60601-1-2), and risk management (ISO 14971).
• System Description: How the detector integrates into a larger X-ray system.
• Intended Use: Acquiring digital radiographic images for routine, intensive care, trauma, and pediatric exams, excluding fluoroscopy, angiography, and mammography.
• Equivalence Information: Demonstrating substantial equivalence to a predicate device (Pixium 4600) and other existing Philips components for the workstation and pre-processing.
• Safety Information: Mature technology, compliance with standards, wireless transmission evaluation, and risk management.
• Conclusion: Stating substantial equivalence based on similar indications for use, technological characteristics, and no new hazards.
• FDA Clearance Letter: Confirming substantial equivalence based on the provided indications for use.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and performance studies based on the provided text. The document is a regulatory submission for substantial equivalence, not a detailed performance study report.

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