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extra oral source X-ray system for dental radiographic examination and diagnosis of diseases of the teeth.

extra oral source X-ray system for dental radiographic examination of the teeth

The provided text is a 510(k) summary for a medical device called ENDOS DC, which is an extraoral source X-ray system for dental radiographic examination. It compares the ENDOS DC to a predicate device, the GENDEX DENTSPLY model 765DC.

Based on the information provided, here's an analysis of the acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state "acceptance criteria" in a typical quantitative performance metric sense (e.g., sensitivity, specificity, accuracy) for a medical imaging device's diagnostic capability. Instead, it focuses on technical specifications and safety features to demonstrate substantial equivalence to a predicate device.

The premise of this 510(k) is that if ENDOS DC meets or performs comparably to the predicate device in these technical areas, it is considered safe and effective for its intended use. Therefore, the "acceptance criteria" are implied to be the specifications of the predicate device.

Note on Differences: While many specifications are comparable, there are a few differences (e.g., tube current, focal spot size, anode inclination, X-ray exposure timing). The FDA's substantial equivalence determination implies these differences do not raise new questions of safety or effectiveness. For example, a larger focal spot size (0.7mm vs 0.4mm) generally results in slightly less sharp images but is still within acceptable limits for dental radiography, and the lower tube current (4-5 mA vs 7 mA) means potentially longer exposure times or lower quality images (if not compensated by other factors), but the FDA still found it substantially equivalent.

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

The document does not describe a clinical study with a "test set" in the context of diagnostic image analysis. This 510(k) submission is for a conventional X-ray generator, not an AI or image analysis device that would be evaluated for diagnostic accuracy on a dataset of images. Therefore, the concepts of "sample size used for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable to the type of information presented. The "test" here refers to engineering and performance testing against its own specifications and comparison to a predicate device's specifications.

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

This information is not applicable as there is no diagnostic "test set" or "ground truth" derived from expert interpretation described in this submission. The device is an X-ray generator, and its performance is evaluated based on physical measurements of its output (e.g., kVp, mA, leakage radiation) and adherence to engineering standards.

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

This is not applicable for the same reason mentioned in point 3. There is no diagnostic test set requiring adjudication of expert interpretations.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI or new imaging techniques on human reader diagnostic performance. The ENDOS DC is an X-ray generator, not an AI or image analysis system.

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

No, a standalone performance study was not done. This concept applies to AI algorithms whose performance can be measured independently of human interpretation. The ENDOS DC is a hardware device.

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

No "ground truth" in the diagnostic sense is described or used. The "proof" for this device's performance primarily relies on:

• Engineering specifications and measurements: Demonstrating the device outputs X-rays within specified parameters (e.g., kVp, mA, filtration, leakage).
• Compliance with recognized standards: The document mentions IEC 336 for focal spot size, implying adherence to international standards for X-ray equipment.
• Substantial equivalence to a predicate device: The fundamental "proof" is that the device's technical specifications and intended use are similar enough to a legally marketed predicate device such that it raises no new questions of safety or effectiveness.

8. The sample size for the training set

Not applicable. This device is an X-ray generator and does not involve machine learning or AI models that require a "training set."

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

Not applicable. As there is no training set for an AI/ML model, there is no ground truth to establish for it.

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