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The Scan300fp / Retropan (VDC) Digital X-ray Conversion Kit is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films.

The Scan300fp sensor produces instant digital images. The Scan300fp allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software, #K012439, which gives post processing capabilities to enhance images.

lt is faster to obtain images with the Scan300fp / Retrofit (VDC) than with conventional film since no chemical nor any other type of processing is required.

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This document is a 510(k) clearance letter from the FDA for the Scan300fp/Retropan (VDC) Digital X-ray Conversion Kit. It primarily focuses on the regulatory approval and indications for use, rather than a detailed study report describing acceptance criteria and device performance. As such, most of the requested information cannot be extracted directly from the provided text.

Here is what can be inferred or stated from the document:

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

This information is not provided in the document. The letter states that the device is "substantially equivalent" to legally marketed predicate devices, which is the primary criterion for 510(k) clearance. However, specific performance metrics or acceptance criteria for that substantial equivalence are not detailed.

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

This information is not provided 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)

This information is not provided in the document.

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

This information is not provided 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

This information is not provided in the document. The device is a digital X-ray conversion kit, not an AI-assisted diagnostic tool.

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

This information is not explicitly stated, but the device is a hardware component (conversion kit) that integrates with software. Its performance would be evaluated in the context of producing images for human interpretation, not as a standalone diagnostic algorithm.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary from the provided text:

The provided document is a regulatory clearance letter. It confirms that the Scan300fp/Retropan (VDC) Digital X-ray Conversion Kit has been deemed substantially equivalent to predicate devices for its intended use.

Indications for Use:
The device is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films. It produces instant digital images, allowing for less exposure time than conventional films, thereby lowering patient dose. The sensor connects to DentalEye software, #K012439, which provides post-processing capabilities to enhance images. The device is faster than conventional film because no chemical or other type of processing is required.

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