This x-ray collimator Multilayer, square-field, automatic collimation system. Stepper motors control the movements of shutters and the additional filter. There is a mounting plane at 80 mm (3.15") from the focus. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The field dimensions may be decreased and increased to the set value by two knobs placed on the collimator front panel.

AI/ML Overview

The provided text describes a submission for a 510(k) premarket notification for the RALCO Model R225 ACS Automatic X-RAY Collimator. This device is a collimator, which is a component of an X-ray system, and therefore, the assessment criteria and study design are different from those for AI-powered diagnostic devices.

The submission focuses on establishing substantial equivalence to a predicate device (K072780, Ralco Model R302DACS Automatic Collimator) rather than demonstrating a specific performance metric against a "ground truth" in the way an AI diagnostic algorithm would.

Based on the provided text, here's a breakdown of the requested information:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Safety and Effectiveness Equivalence to Predicate Device: The new device must be as safe and effective as the predicate device (K072780, Ralco Model R302DACS Automatic Collimator).	"The results of bench, safety test, and laboratory testing indicates that the new device is as safe and effective as the predicate device."
Conforms to US Performance Standards: The device must meet applicable US performance standards.	"The new device conforms to US Performance Standards."
CSA Listed to US Standards for safety for medical devices: The device must be listed by CSA to US safety standards.	"and is CSA Listed to US Standards for safety for medical devices."
Identical Indications for Use: The new device must have the same indications for use as the predicate device.	"and has identical indications for use" (Indications for Use: Intended for use in diagnostic/fluoroscopic applications.)
Technological Differences: Differences should be minimal and not raise new questions of safety or effectiveness.	"has few technological differences" (The primary described difference is that the predicate employs a round field, similar to the new device, but the new device also features "Multilayer, square-field, automatic collimation system" which suggests an enhancement over the predicate's possibly singular "round field" description; however, the conclusion emphasizes "few technological differences.")

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

Test Set Sample Size: Not applicable in the context of this submission. The submission relies on "bench, safety test, and laboratory testing" rather than a clinical dataset with a specific "test set" for performance evaluation against a diagnostic ground truth.
Data Provenance: Not explicitly stated as clinical data from specific countries or retrospective/prospective studies. The testing is described as "bench, safety test, and laboratory testing," which typically refers to engineering and quality assurance activities conducted by the manufacturer (RALCO srl in Biassono, Italy).

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

Not applicable. This is not a study requiring expert consensus for a diagnostic "ground truth." The evaluation focuses on the engineering performance and safety of the collimator itself, which are assessed through engineering tests and adherence to standards.

4. Adjudication method for the test set:

Not applicable. There is no specific "test set" requiring adjudication in the context of this submission.

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 MRMC comparative effectiveness study was done. This device is a hardware component (an X-ray collimator), not an AI algorithm intended to assist human readers.

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

Not applicable. This is a hardware device, not an algorithm.

7. The type of ground truth used:

Not applicable in the sense of clinical diagnostic ground truth (e.g., pathology, patient outcomes). The "ground truth" here is adherence to engineering specifications, safety standards (e.g., CSA Listed to US Standards), and functional equivalence to the predicate device as demonstrated through "bench, safety test, and laboratory testing."

8. The sample size for the training set:

Not applicable. This is a manufactured hardware device, not a machine learning model that requires a training set.

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

Not applicable. As noted above, this device does not involve a training set or associated ground truth in the context of machine learning.

Summary

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RALCO srl Via dei Tigli 13/G 20046 Biassono (mi) Italy Tel. +39.039.249.7925 Fax: +39.039.249.7799 email: ralco@ralco.it Date prepared: May 18, 2009 Contact person: Vincenzo Velardi, President and CEO

1. Identification of the Device:

Proprietary-Trade Name: Model R225 ACS Automatic X-RAY Collimator Classification Name: collimator, automatic, radiographic, Product Code IZW Common/Usual Name: Automatic X-Ray Collimator.

Equivalent legally marketed devices: K072780, Ralco Model R302DACS Automatic Collimator. 2.
Indications for Use (intended use): Intended for use in diagnostic/fluoroscopic applications. 3.
Description of the Device: This x-ray collimator Multilayer, square-field, automatic collimation 4. system. Stepper motors control the movements of shutters and the additional filter. There is a mounting plane at 80 mm (3.15") from the focus. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The field dimensions may be decreased and increased to the set value by two knobs placed on the collimator front panel.
Safety and Effectiveness, comparison to predicate device. The results of bench, safety test, and 5. laboratory testing indicates that the new device is as safe and effective as the predicate device. The predicate employs a round field, same as our new device. The new device conforms to US Performance Standards and is CSA Listed to US Standards for safety for medical devices.
Conclusion: After analyzing both bench and safety testing data, it is the conclusion of Ralco that the . 6. Model R225 ACS is as safe and effective as the predicate device, has few technological differences, and has identical indications for use, thus rendering it substantially equivalent to the predicate device.

Image /page/0/Figure/10 description: The image shows two different devices, labeled "Predicate" and "R225 ACS". Both devices are cube-shaped with control panels on the front. The "Predicate" device has a keypad and knobs, while the "R225 ACS" device has a display screen, buttons, and knobs.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUI 1 4 2009

RALCO, srl % Mr. Daniel Kamm Principal Consultant Kamm & Associates 333 Milford Rd. DEERFIELD IL 60015

Re: K091517

Trade/Device Name: Model R225 ACS Automatic Collimator Regulation Number: 21 CFR 892.1610 Regulation Name: Diagnostic x-ray beam-limiting device Regulatory Class: II Product Code: IZW Dated: May 20, 2009 Received: June 02, 2009

Dear Mr. Kamm:

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 (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to hitp://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K09 / S17

Model R225 ACS Automatic Collimator Device Name:

Indications For Use:

Model R225 ACS Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Reever

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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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.