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The Trophy Radiologie digital imaging kit is now designed for use with the following panoramic X-ray units : OP100, manufacturer Instrumentarium, K912893 ; OrthoSlice OS1000, manufacturer ASAHI, K991455 pending ; Panoura Ultra, manufacturer YOSHIDA, K number unknown to us ; X-Caliber, manufacturer ASAHI, K number unknown to us. The image generated is displayed on a computer monitor and can replace the conventional film for primary diagnostic purpose. The image can then be archived through computer storage and archival means. Referal copies of the image can be obtained with optional hard copy systems.

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The provided text is a 510(k) clearance letter from the FDA for the DIGIPAN Digital Kit for Panoramic X-Ray and its Indications for Use. It does not contain specific details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA's decision was based on a comparison to existing devices, not necessarily on a de novo study proving specific performance metrics against pre-defined acceptance criteria.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated from the document, with the understanding that most of the requested information regarding a detailed study is not present:

1. Table of acceptance criteria and the reported device performance

• Cannot be provided from the text. The document does not define specific acceptance criteria or report performance metrics (e.g., sensitivity, specificity, spatial resolution, contrast resolution). The clearance is based on substantial equivalence to predicate devices, implying that its performance is considered comparable enough for its intended use.

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

• Not mentioned. The document does not describe a test set or its provenance.

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

• Not mentioned. The document does not indicate that a ground truth was established by experts for a test set.

4. Adjudication method for the test set

• Not mentioned. No adjudication method is described.

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. This device is a "Digital Kit for Panoramic X-Ray," which digitizes existing panoramic X-Ray units to replace conventional film. It is not an AI-based diagnostic tool, and therefore an MRMC study comparing human readers with and without AI assistance is not applicable or discussed.

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

• Not applicable/Not mentioned. As noted above, this is a digital imaging kit, not an AI algorithm. No standalone algorithm performance is discussed.

7. The type of ground truth used

• Not mentioned. No specific ground truth methodology is described. The basis for clearance is substantial equivalence to predicate radiography devices, implying that the diagnostic capability of the images produced is considered equivalent to those from conventional film.

8. The sample size for the training set

• Not mentioned. The document describes a "digital imaging kit," not a machine learning algorithm that requires a training set.

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

• Not applicable/Not mentioned. No training set or ground truth establishment for a training set is discussed.

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