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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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