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Model R 72B Manual X-RAY Collimator is intended for use in diagnostic radiographic or fluoroscopic applications fluoroscopic applications.

This is a compact collimator with an external cover in ABS plastic. It is a single-layer, square field radiological collimator. Its light weight and compact size allow cass. positioning and make it ideal for mobile and portable units. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator and by o yead disc near the x-ray focus to reduce scattered radiation. An indexed scale provides information on the field set with the knobs.

This 510(k) summary describes a manual X-ray collimator (Model R 72B) and primarily focuses on demonstrating its substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense for algorithm-based devices.

Here's an analysis based on the provided text, addressing the points where information is available or noting where it's not applicable for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Summary of Device Performance: The device (Model R 72B Manual X-Ray Collimator) was determined to be substantially equivalent to the predicate device (Ralco Model R72, K030487) based on bench, safety, and laboratory testing. It is reported to be identical in components and specifications, conforms to US Performance Standards, is CSA Listed, has few technological differences, and shares identical indications for use.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable in the context of this 510(k) submission. This submission is for a physical medical device (an X-ray collimator) and focuses on engineering specifications, safety testing (bench, electrical, mechanical), and comparison to a predicate device. It does not involve a "test set" of clinical data to evaluate an algorithm's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable. Since there is no "test set" in the context of a clinical performance study involving image interpretation by experts, there is no ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This submission is for a physical X-ray collimator, not an AI or imaging software device that would typically undergo an MRMC study to evaluate human reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

No. This device is a manual X-ray collimator; there is no embedded algorithm to evaluate in a standalone capacity.

7. The Type of Ground Truth Used

The "ground truth" for this device relates to its engineering specifications, safety features, and performance as a physical component in an X-ray system. This would be established through:

• Engineering specifications and drawings: Defining the design, materials, and dimensions.
• Bench testing: Verifying mechanical function, field size accuracy, light field/X-ray field congruence, leakage radiation, etc.
• Safety testing: Ensuring electrical safety, radiation safety (e.g., leakage radiation limits), and compliance with relevant standards (e.g., CSA listing).
• Comparison to predicate device: Direct comparison of features and performance characteristics to the legally marketed predicate.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an AI or algorithm development for this physical device.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the reasons stated above.

In summary: K093596 is a 510(k) for a manual X-ray collimator. The approval is based on demonstrating substantial equivalence to a predicate device (Ralco Model R72, K030487) through bench, safety, and laboratory testing, confirming identical components, specifications, and indications for use, and adherence to relevant performance and safety standards. The concepts of clinical test sets, ground truth by experts, and AI performance evaluations are not relevant to this type of device submission.

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