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The Philips OmniDiagnost is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.

The OmniDiagnost is a multifunctional, universal, overtable X-Ray system offering fluoroscopic, radiographic, angiographic and interventional techniques in a wide variety of applications. The OmniDiagnost employs a scanning concept, whereby the column with X-Ray tube and Image Intensifier moves while the table remains fixed.

The basic system is composed of the OmniDiagnost stand, X-Ray generator, X-Ray tube and collimator, II-TV subsystem and monitors, Control Desks, Digital Acquisition System (DSI (K920793)), and Easy Vision (initially introduced under K920950).

This document describes a 510(k) submission for the Philips OmniDiagnost, a remote-controlled radiographic/fluoroscopic system. As such, the information you've requested regarding acceptance criteria and a study proving the device meets those criteria is not typically present in this type of regulatory submission.

510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device already legally marketed. This means the new device has the same intended use, technological characteristics, and safety and effectiveness as a predicate device, or if there are differences, those differences do not raise new questions of safety and effectiveness.

Therefore, the sections you've requested like "acceptance criteria" and details of a "study that proves the device meets the acceptance criteria" in terms of performance metrics (sensitivity, specificity, etc., with sample sizes, ground truth, expert qualifications) are not applicable to this 510(k) document.

Here's why and what information is provided:

• Acceptance Criteria & Reported Device Performance: This type of information is generally for devices with quantifiable performance metrics, often software algorithms or diagnostic tests. For an X-ray system, the "acceptance criteria" revolve around demonstrating that the image quality, radiation dose, and functional capabilities are at least as good as, and do not introduce new risks compared to, the predicate device. The document does not specify quantified acceptance criteria or performance metrics in this format.

• Study Details (Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone): These are all relevant to clinical performance studies, especially for AI/algorithm-driven devices for diagnosis or screening. The Philips OmniDiagnost is a hardware system; its performance is assessed against established X-ray system standards and by demonstrating equivalence to a known predicate device. There is no mention of a human-in-the-loop study, standalone algorithm performance, or a test set with expert-established ground truth because these concepts don't directly apply to the regulatory approval process presented here for a radiographic/fluoroscopic system.

• Training Set Sample Size & Ground Truth: Similarly, these are for machine learning models. The OmniDiagnost doesn't describe an AI component that would require a "training set."

What the document does provide in relation to regulatory approval:

1. Device Name: Philips OmniDiagnost
2. Product Code: 90 JAA
3. Classification Name: Fluoroscopic X-Ray System, 21 CFR 892.1680
4. Intended Use: Diagnostic imaging for radiographic, fluoroscopic, angiographic, and interventional applications.
5. Predicate Device: Philips Diagnost 96 (FDA ref. K912470)
6. Substantial Equivalence Claim: The OmniDiagnost is described as a "modification of, and substantially equivalent to the Philips Diagnost 96 system."
7. Safety Information: Complies with applicable portions of 21 CFR parts 1020.30/.31/.32 and voluntary safety standards, such as UL 2601.

In summary, because this is a 510(k) submission for an X-ray imaging system rather than a diagnostic algorithm or software, the detailed performance study information you've requested is not found in the provided text. The "study" for this type of device involves demonstrating that its technical specifications, image quality, and safety features are equivalent to those of a pre-existing, legally marketed device (the predicate).

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