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The Diffuser Panel is designed to diffuse the light source in Radiographic Film Illuminators.

The Diffuser Panel consists of layers of light diffusing and brightness enhancer films, plus a clear polycarbonate panel that is coated with a scratch guard to protect the surface of the brightness enhancer from scratching.

The provided text describes a 510(k) premarket notification for a "Diffuser Panel" used in a Radiographic Film Illuminator. It's important to note that this is a very basic accessory device, not an AI or advanced medical imaging device. Therefore, many of the requested categories for acceptance criteria and study details (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of device.

This document focuses on establishing substantial equivalence to a predicate device for a relatively simple component. The acceptance criteria would primarily revolve around basic functional performance (light diffusion, brightness, evenness) rather than complex clinical accuracy.

Here's an attempt to extract and infer the information based on the provided text, with clear indications where information is not available or not applicable.

Acceptance Criteria and Device Performance

Explanation: The document does not provide specific numerical acceptance criteria (e.g., "brightness uniformity less than X%") or quantitative performance metrics. The "performance" is implicitly stated through the device's design and intended function, claiming equivalence to a predicate device.

Study Details

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

   • Not Applicable / Not Provided. This is a device component (diffuser panel) where "test sets" of patient data in the clinical sense are not relevant. Testing would likely involve optical measurements or comparisons with the predicate, not clinical data.

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

   • Not Applicable / Not Provided. Ground truth (in the context of clinical accuracy) is not established for this type of device. The evaluation would be engineering/performance-based, not clinical interpretation.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable / Not Provided. Adjudication methods are relevant for clinical interpretations, not for a diffuser panel.

4. 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:

   • Not Applicable. This is not an AI device, and an MRMC study is completely irrelevant for a radiographic film illuminator component.

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

   • Not Applicable. This is not an algorithm or an AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Applicable. Ground truth, in the clinical sense, is not relevant for this device. The "ground truth" would be the engineering specifications and performance of the predicate device.

7. The sample size for the training set:

   • Not Applicable / Not Provided. This is not a machine learning or AI device that requires a "training set."

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

   • Not Applicable / Not Provided. (See point 7)

Summary for this specific 510(k) document:

The provided 510(k) is for a simple component (a diffuser panel) of a medical device (radiographic film illuminator). The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device based on material composition, intended use, and functional characteristics (light diffusion, evenness, brightness, scratch resistance). The detailed clinical study data, expert consensus, and AI-related metrics requested are not applicable to this type of device submission.

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