The Omega R 605FACS is an automatic collimator designed for use in diagnostic Trie Offically of tool AOO is an adtomatio continues round field shutters and an additional lung filter for cardiac application.

AI/ML Overview

This submission is a 510(k) premarket notification for the Omega R605 FACS automatic collimator. The document describes the device and its intended use, and states that it is substantially equivalent to predicate devices. However, it does not contain the detailed study information typically required to prove a device meets specific acceptance criteria based on performance metrics.

Here's a breakdown of the requested information, highlighting what is missing from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Missing	Missing

Explanation: The document states that the Omega R605 FACS collimator will comply with various safety standards (21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.32, IEC 60601-1, IEC 60101-1-2, IEC 60601-1-3, UL 60601-1, and CAN/USA C22.2 No.601.1-M90) and CE Marking requirements. However, it does not provide specific numerical acceptance criteria for performance parameters (e.g., accuracy of beam limiting, illumination levels, alignment tolerances) or data demonstrating the device actually met these criteria. This is a common characteristic of 510(k) summaries where compliance with recognized standards is stated, but the detailed test results are not included in the public-facing summary.

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not provided. The document does not describe a clinical or technical performance study with a specific test set.
Data Provenance: Not applicable. No study data is presented.

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

Not applicable. No study data is presented, and thus no ground truth establishment by experts is described.

4. Adjudication method for the test set:

Not applicable. No study data is presented.

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:

No. This device is an automatic collimator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with human readers improving with AI assistance is not relevant to this device.

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

Not explicitly described as a standalone algorithm study. The device itself is an automatic collimator, implying its function is standalone in terms of beam limiting. The document states it will comply with technical performance standards, which implies standalone technical testing was performed to demonstrate compliance. However, no specific details of such tests (e.g., methodology, results) are provided in this summary.

7. The type of ground truth used:

Not applicable / Implied by standards compliance. For a physical device like a collimator, "ground truth" would relate to the objective, measurable accuracy of its physical functions (e.g., how precisely it limits the X-ray field compared to a known standard or reference measurement). The document implies that compliance with recognized safety and performance standards (like 21 CFR 1020.30, 1020.31, 1020.32, IEC 60601-1, etc.) serves as the basis for establishing that the device performs as intended. These standards specify physical requirements and testing methodologies.

8. The sample size for the training set:

Not applicable. This is a physical medical device (automatic collimator), not a machine learning or AI algorithm that requires a training set of data.

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

Not applicable. As above, this is not an AI/ML device requiring a training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Based on the Provided Text):

The provided 510(k) summary does not detail a specific performance study with a test set, ground truth, or expert review in the way one would describe for a diagnostic imaging algorithm. Instead, the submission for the Omega R605 FACS automatic collimator relies on declaration of compliance with established regulatory and international standards to demonstrate its safety and effectiveness and its substantial equivalence to predicate devices.

The document states that the device "will comply" with:

21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32: These are U.S. FDA regulations pertaining to diagnostic X-ray systems and their components, specifically addressing performance standards for diagnostic X-ray sources, protective shields, and beam-limiting devices.
IEC 60601-1, IEC 60101-1-2, and IEC 60601-1-3: These are international safety standards for medical electrical equipment, including general requirements, electromagnetic compatibility, and requirements for diagnostic X-ray equipment.
CE Marking requirements: European conformity mark, indicating compliance with relevant EU directives.
UL 60601-1 and CAN/USA C22.2 No.601.1-M90: Safety standards for medical electrical equipment for the U.S. and Canada, respectively.

Conclusion from the document: The manufacturer asserts that the Omega R605 FACS collimator "does not introduce any new indications for use" and is "substantially equivalent with the predicate devices." This substantial equivalence, coupled with the declared compliance to established safety and performance standards, is the basis of the 510(k) clearance, rather than a detailed performance study like those conducted for AI/ML devices. The FDA's letter confirms they determined the device to be substantially equivalent based on the information provided in the 510(k) premarket notification.

Summary

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OMEGA MEDICAL IMAGING, INC.

K050092

510(k) SUMMARY

JAN 3 1 2005

Company Name:	Omega Medical Imaging, Inc
Address:	675 Hickman CircleSanford, FL 32771
Telephone No:	407-323-9400
Registration No.:	1052701
Contact person:	James A. Princehorn
Date Prepared	3 January 2005
Device (trade) name:	Automatic Beam-limiting Device Model R605FACS
Classification name:	Diagnostic X-Ray Beam-Limiting Device (21 CFR 892.1610)Class II (Procode: 90 IZW)
Common/usual name:	Automatic Radiographic/fluoroscopic Collimator

Predicate device:

Dunlee automatic "FORMAT A" collimator manufactured by Philips Medical Systems legally . marketed under number K031597.
marketed under number Roo roof :
Advantech Model R600/800 series collimators manufactured by RALCO S.R.L. legally marketed . under number K904182

Device description:

Device desoription:
The Omega R 605FACS is an automatic collimator designed for use in diagnostic Trie Offically of tool AOO is an adtomatio continues round field shutters and an additional lung filter for cardiac application.

Intended use:

The Omega R605 FACS automatic collimator is intended for use in diagnostic . radiographic/fluoroscopic applications.

Safety information:

mornation.
The Omega R605 FACS collimator will comply with the applicable requirements of 21 CFR . 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32.
The Omega R605 FACS collimator will comply with the international safety standards IEC . 60601-1, IEC 60101-1-2, and IEC 60601-1-3.
The Omega R605 FACS will comply with CE Marking requirements. .
The Omega R605 FACS will comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90 .

Conclusion:

Oonega R605 FACS collimator does not introduce any new indications for use, nor does the use of The Omoga Rood Proo Considers the R605 FACS collimator the R605 FACS collimator to be substantially equivalent with the predicate devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or body. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 1 2005

Mr. James A. Princehorn President Omega Medical Imaging, Inc. 675 Hickman Circle SANFORD FL 32771

Re: K050092 Trade/Device Name: Omega R605 FACS automatic collimator Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray Beam-limiting device Regulatory Class: II Product Code: 90 IZW Dated: January 5, 2005 Received: January 14, 2005

Dear Mr. Princehorn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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 (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmam.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Omega Medical Imaging, Inc.

K050092

Omega R605 FACS Collimator

Indications for Use:

The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

Prescription Use

David G. Ingram

Regulation Number and Section

§ 892.1610 Diagnostic x-ray beam-limiting device.

(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.