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PaX-P&P is a digital x-ray system that uses a high resolution CCD detector for real time digital image acquisition. The system allows lower radiation dose, simple user interface, and produces high quality images. It is intended for producing diagnostic x-ray radiographic images of skull, dentition, and oral structures. The device is operated and used by physicians, dentists, and x-ray technologists.

Vatech Model PaX-P&P is a digital panoramic dental imaging system. It uses high resolution CCD detector for real time digital image acquisition. It has lower radiation dose results, simple user interface and high quality producing capability.

The provided 510(k) summary for the Vatech PaX-P&P Digital X-Ray Imaging System does not contain the detailed information requested regarding specific acceptance criteria, a comprehensive study proving device performance against those criteria, or the methodology for establishing ground truth for training and test sets.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices rather than a standalone clinical performance study with defined acceptance criteria. The approval is based on the device having similar use, capability, design, and performance characteristics to previously cleared devices.

However, I can extract what is stated and highlight what is missing based on your request.

Acceptance Criteria and Reported Device Performance

The 510(k) summary does not provide a table of specific numerical acceptance criteria (e.g., sensitivity, specificity, spatial resolution, contrast-to-noise ratio values) that the device was tested against. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to predicate devices, meaning the device performs equivalently well for its intended use.

The document states:

• "The Vatech system is technologically equivalent in concept, function and performance to the predicate devices."
• "Evaluations have proven that the system is safe and effective for the intended use."

Without specific numerical criteria, I cannot construct the requested table. The "reported device performance" is essentially a qualitative claim of equivalence and safety/effectiveness for its intended use, rather than quantified performance metrics.

Study Details (Information Not Provided in the Document)

The document does not describe a specific clinical study with a test set, ground truth, or a multi-reader multi-case comparison in the way requested. The 510(k) pathway for this device, being for a new digital X-ray imaging system, primarily relies on:

1. Technical comparison: Demonstrating that the device's technical specifications and characteristics are similar to predicate devices.
2. Safety and Effectiveness Claims: Asserting that the device is safe and effective through comparison and compliance with applicable standards, rather than through a detailed independent clinical performance study with quantifiable results.

Therefore, the following information is not available in the provided text:

• Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No dedicated test set described.
• 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): No ground truth for a test set described.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no such test set is described.
• 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 is an imaging device, not an AI-assisted diagnostic tool for interpretation.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an imaging device, not an algorithm being evaluated without human interaction.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): No specific ground truth methodology for a performance study is described.
• The sample size for the training set: Not applicable, as this is hardware, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

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