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).

AI/ML Overview

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:

Device Name: Philips OmniDiagnost
Product Code: 90 JAA
Classification Name: Fluoroscopic X-Ray System, 21 CFR 892.1680
Intended Use: Diagnostic imaging for radiographic, fluoroscopic, angiographic, and interventional applications.
Predicate Device: Philips Diagnost 96 (FDA ref. K912470)
Substantial Equivalence Claim: The OmniDiagnost is described as a "modification of, and substantially equivalent to the Philips Diagnost 96 system."
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).

Summary

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SEP 2 9 1999

Image /page/0/Picture/1 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in a sans-serif font above a circular emblem. The emblem contains two wavy lines representing water, with a four-pointed star above and below the wavy lines. The logo is black and white.

Philips Medical Systems

510(k) Summary

Company name:	Philips Medical Systems North America Company
Address:	710 Bridgeport Avenue, Shelton, CT 06484
Contact person:	Peter Altman
Telephone number:	203-926-7031
Prepared:	August 25, 1998
Device name:	Philips OmniDiagnost
Classification name:	Fluoroscopic X-Ray System, 90JAA, 21 CFR 892.1680
Common/Usual name:	Remote-controlled Radiographic/Fluoroscopic System
Predicate Device(s):	Philips Diagnost 96

Intended use:

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

System description:

Substantial equivalence Information

The OmniDiagnost is a modification of, and substantially equivalent to the Philips Diagnost 96 system (FDA ref. K912470).

Safety Information

The Philips OmniDiagnost complies with the applicable portions of 21 CFR parts 1020.30/.31/.32 and voluntary safety standards, such as UL 2601. The Information for Users contains comprehensive information to insure safe and effective use.

Philips Medical Systems
North America Company
710 Bridgeport Avenue
P.O. Box 860
Shelton, Connecticut 06484-0917
Tel: (203) 926-7674
Fax: (203) 929-6099

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Peter Altman Director of Regulatory Affairs Phillips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917 Re:

K982993 Philips OmniDiagnost Dated: August 26, 1998 Received: August 27, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 JAA

Dear Mr. Altman:

29 19

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Pederal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdch/dsmald.html".

Sincerely yours,

Kilian Yi

Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ______________ Unknown

Philips OmniDiagnost Device Name : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Indications For Use :

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Gamil A. Siyoum

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devic

510(k) Number K982493

Prescription Use
(Per 21 CFR 801.109

............

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.