Search Results

The CDR PanX Model 4792 is indicated for individuals requiring extra-oral dental exams. It exposes and acquires radiographic images at the dento-maxillofacial region.

The CDR PanX Model 4792 is a digital panoramic device. A high voltage power supply charges an x-ray tube that emits a pulse which is attenuated by the patient's head. An FDA approved digital receptor receives the resultant image and transmits the data to a computer. The receptor and x-ray source both revolve on a motion stage such that multiple projections may be generated thereby resulting in a panoramic view of the skull. The computer processes and displays the image data on a monitor.

Here's a breakdown of the acceptance criteria and study information based on the provided text, though it's important to note that this 510(k) summary (K031291) from 2003 offers limited detail on performance criteria and specific study methodologies typical of more modern submissions for AI/software devices. The device described is a traditional X-ray system, not an AI/software device.

Acceptance Criteria and Reported Device Performance

Study Information

Given this is a K031291 (approved in 2003) for a digital X-ray machine (not an AI/software device), the depth of information regarding "acceptance criteria" and "study" in the context of performance metrics (like sensitivity, specificity, etc.) is very limited compared to what would be found in a modern AI/software device submission. The "study" here primarily refers to comparative testing against a predicate device to establish substantial equivalence.

1. Sample size used for the test set and the data provenance: Not explicitly stated. The submission mentions "a radiation survey" and "careful analysis and validation studies," but does not provide details on the number of patients, images, or the origin (country, retrospective/prospective) of any data used for these comparisons.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not stated. Ground truth, in the context of an X-ray machine demonstrating "similar radiation" or "conforming to electrical standards," would likely refer to engineering measurements and comparisons rather than expert interpretation of images for diagnostic accuracy.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not stated.

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 device is a traditional digital X-ray machine, not an AI-powered diagnostic tool. Therefore, no MRMC study for AI assistance would have been performed or relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the stated criteria (radiation and electrical safety), the ground truth would be based on engineering measurements and established regulatory standards. For the image quality aspect (implied by substantial equivalence to a device producing panoramic radiographs), the ground truth would likely be the visual and diagnostic quality of images produced by the predicate device. Specifics are not provided.

7. The sample size for the training set: Not applicable. This is a hardware device; there is no mention of a "training set" in the context of machine learning.

8. How the ground truth for the training set was established: Not applicable. As above, this is a hardware device.

Ask a specific question about this device