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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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A diagnostic x-ray beam-limiting device intended to restrict the dimension of a diagnostic x-ray field by limiting the size of the primary x-ray beam coming from x-ray system.

Collimator (manual drive) – a beam limiting device

This document is an FDA 510(k) clearance letter for a Collimator (manual drive) and does not contain information about acceptance criteria or a study proving its performance. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text.

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Model R72 is intended to be used as an X-Ray beam limitation device on portable and mobile diagnostic X-Ray units.

R72 X-Ray Collimator: External cover in abs plastic Single-layer, square field radiological collimator. Focus/mounting flange plane distance is 70mm. The X-ray field size is limited by two pairs of lead shutters controlled by two knobs located on the sides of the collimator, a lead cone situated near the x-ray anode reduces the off-focus radiation. Its light weight and compact size allow easy positioning and make it ideal for portable units. A table on the front panel allows the operator to read field dimensions set with the knobs.

Here's a breakdown of the acceptance criteria and study information for the Ralco Model R72 X-Ray Collimator, based on the provided 510(k) summary:

This device (Ralco Model R72 X-Ray Collimator) is not an AI-powered device, therefore, many of the requested sections (sample sizes for test/training sets, expert details, MRMC studies, standalone performance) are not applicable as they relate to studies typically performed for AI/ML medical devices. The submission focuses on demonstrating substantial equivalence to a predicate device through bench and user testing.

Acceptance Criteria and Device Performance

Study Proving Device Meets Acceptance Criteria

The study described is a comparison to a legally marketed predicate device (Ralco Model R302, K946320) to demonstrate substantial equivalence. The device is an X-Ray Collimator, a hardware component, not an AI/ML device.

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

   • Test Set: Not explicitly quantifiable in terms of "samples" or "data" as would be for an AI model. The testing involved "bench and user testing." The document does not provide the number of units tested or the specific conditions of "user testing."
   • Data Provenance: Not specified, but implied to be from testing conducted by Ralco srl (Italy). The nature of "bench and user testing" suggests prospective testing rather than retrospective data analysis.

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

   • Not applicable as this is a hardware device submission, not an AI/ML device requiring expert ground truth for classification or interpretation. Testing would involve adherence to technical specifications and safety standards.

3. Adjudication method for the test set:

   • Not applicable for this type of submission. The evaluation is based on technical specifications and functional equivalence.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. This type of study is relevant for AI/ML devices that assist human readers in image interpretation.

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

   • Not applicable. This device is a passive hardware component, not an algorithm. Its function is to limit the X-ray beam, and its performance is inherent in its design and physical characteristics, not in an interpretive algorithm.

6. The type of ground truth used:

   • The "ground truth" for this device's performance would be derived from engineering specifications, direct measurements (bench testing), and compliance with recognized standards (e.g., 21 CFR 1020.30, UL 2601, IEC 60601-1). For functional aspects like timer accuracy or beam coverage, the ground truth would be the expected performance based on design and physical measurement.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/ML device.

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

   • Not applicable, as there is no training set.

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