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The Portable X-ray System is used as a portable, extra oral x-ray source for producing diagnostic x-ray images using conventional film, PSP (phosphor plates) or digital sensors. It is intended for adult and pediatric patients. This equipment is available only to trained and qualified dentist or dental technician.

The portable X-Ray system, Canis014D07, is intended to be used by trained dentists and dental technicians as an extra-oral x-ray source for producing diagnostic x-ray images using intraoral image receptors. The images presented in the product screen are for preview purposes only, not for imaging diagnosis. It also includes accessories, which are battery, recharging unit and hand switch.

The provided text describes a 510(k) premarket notification for a Portable X-ray System (Canis014D07). It outlines the device's indications for use, its technological characteristics compared to predicate and reference devices, and a summary of non-clinical testing conducted to demonstrate safety and effectiveness.

However, the document does not contain information related to specific acceptance criteria for diagnostic performance, a study evaluating device performance against such criteria, sample sizes for test or training sets, data provenance, number or qualifications of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Summary of Performance Testing" section states that the performance test for the device and predicate are "identical in the indications for use, patient population, intended operation environment, and electrical safety." It also mentions "Validation was performed for overall operation by taking and reviewing test images" and that "the test images were reviewed by a professional with adequate qualifications, and that the images were of diagnostic quality." This suggests a qualitative assessment of image quality rather than a quantitative study with pre-defined diagnostic performance metrics.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, or details about the study that proves acceptance criteria are met, as this information is not present in the provided text.

Based on the available text, here's what can be extracted with respect to your request, noting the missing information:

Acceptance Criteria and Study Details (Based on Available Information)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document mentions "test images were reviewed," but the number of images is not provided.
• Data Provenance: Not specified.

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

• Number of Experts: "a professional" (singular)
• Qualifications of Experts: "a professional with adequate qualifications" (No specific details like "radiologist with 10 years of experience" are provided).

4. Adjudication method for the test set:

• Adjudication Method: Not specified. It appears a single professional reviewed the images for diagnostic quality.

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:

• MRMC Study: No, an MRMC study was not described. The device is an X-ray system, not an AI algorithm for image interpretation.

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

• Standalone Performance: Not applicable. This device is an X-ray imaging system, not an AI algorithm. Its performance refers to its ability to produce diagnostic images, not to interpret them. The document explicitly states, "The images presented in the product screen are for preview purposes only, not for imaging diagnosis."

7. The type of ground truth used:

• Type of Ground Truth: Expert opinion on "diagnostic quality" of the images produced by the device.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/not specified. The device is a hardware X-ray system, not an AI algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

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