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The Cranex Basex D and Cranex Excel D dental panoramic equipments are indicated for dental radiographic examinations by producing digital radiographs of dentition, TM-joints and other oral structures.

Cranex Basex D and Cranex Excel D are panoramic extraoral source dental x-ray systems, which produce digital images of dentition. They are modified from the existing Soredex dental panoramic x-ray systems (K880982) by substantially replacing the film image receptor with a digital receptor(CCD). The technique factor settings are constant for the x-ray tube anode voltage (65kV) and current (6 mA DC),

The provided text is a 510(k) summary for the Cranex Basex D and Cranex Excel D dental panoramic x-ray equipment. It states that "Verification and validation testing was successfully performed to confirm that Cranex Basex D and Cranex Excel D correspond with the intended use." However, it does not contain specific details on acceptance criteria, reported performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria: Not specified in the document.
   • Reported Device Performance: Not specified in the document beyond a general statement that "Verification and validation testing was successfully performed."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Not specified in the document.

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

   • Not specified in the document.

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

   • The document describes a standalone device (dental panoramic x-ray equipment) that produces digital images; it does not mention any AI component or MRMC comparative effectiveness study involving human readers.

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

   • This is a standalone medical device (x-ray equipment). Its performance is inherently "standalone" in the sense that it acquires images. The document does not describe an algorithm with standalone performance; it describes the performance of the imaging system itself.

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

   • Not specified in the document.

8. The sample size for the training set

   • Not specified in the document. (This device is not an AI algorithm that would typically have a "training set" in the machine learning sense).

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

   • Not applicable/Not specified in the document. (As above, this is an imaging device, not an AI algorithm requiring a training set with ground truth in the usual sense).

Summary of available information:

The 510(k) summary for the Cranex Basex D and Cranex Excel D dental panoramic x-ray equipment states that "Verification and validation testing was successfully performed to confirm that Cranex Basex D and Cranex Excel D correspond with the intended use." However, it does not provide any specific details regarding acceptance criteria, performance metrics, study design, sample sizes, ground truth establishment, or any comparative effectiveness studies.

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