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The Philips BV300 Series Release 2.1 systems are Mobile C-Arm X-Ray Systems offering Radiographic and Fluoroscopic techniques in a wide variety of applications. The series has been designed primarily for use in the operating theater.

The Philips BV300 Series Release 2.1 systems are intended for the same applications as the BV300 Series Release 1, i.e. surgical interventions. needing X-ray imaging and/or guidance and interventions inside and outside the Operating Room.

This includes cerebral, thoracic, abdominal, peripheral, orthopedic and vascular procedures. The systems are also suited as a back-up for a fixed vascular X-ray system.

The Philips BV300 Series Release 2.1 is a Mobile C-Arm X-Ray System offering Radiographic and Fluoroscopic techniques in a wide variety of applications. It has been designed primarily for use in the operating theater. All BV300 systems consist of a mobile C-arm stand with image intensifier and X-Ray unit, and a mobile View station with image processor, monitors and optionally archiving devices.

This document is a 510(k) summary for the Philips BV300 Series Release 2.1, a Mobile C-Arm Fluoroscopic System. It states that the device is substantially equivalent to its predicate device, the Philips BV300 Series (Release 1). This type of submission, a 510(k), is for demonstrating substantial equivalence to an already legally marketed device, not for proving novel safety or effectiveness criteria through extensive clinical studies.

Therefore, the provided document does not contain the information requested regarding acceptance criteria, specific device performance metrics, detailed study designs (sample sizes, data provenance, expert qualification, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, or ground truth establishment relevant to the device's functional performance as would be found in a study proving device meets acceptance criteria.

The document primarily focuses on:

• Substantial Equivalence: It explicitly states that the BV300 Series Release 2.1 is a "modification of, and substantially equivalent to, the BV300 Series Release 1, 510(k) No. K953910." This means its performance is considered equivalent to a device already on the market.
• Intended Use: It clarifies the intended use is for "surgical interventions needing X-ray imaging and/or guidance and interventions inside and outside the Operating Room."
• Safety Information: It notes compliance with applicable portions of 21 CFR parts 1020.30/.31/.32 and voluntary safety standards like UL 2601.

In summary, there is no information in the provided text to fulfill the request for a table of acceptance criteria, reported device performance, or details of a study proving the device meets specific acceptance criteria related to its imaging efficacy or diagnostic accuracy. The 510(k) process for this device relies on demonstrating equivalence rather than establishing new performance benchmarks through a dedicated study as implied by your questions.

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