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The Digora PCT or Digipod imaging system is indicated for capturing, digitization and processing of extraoral, maxillofacial, cephalometric and podiatric X-ray images stored in imaging plate recording media.

A digital radiography system for imaging plates located in cassettes. The system may be used with x-ray equipment utilizing film or similar cassettes. The image is recorded on reusable imaging plate which substitutes for conventional x-ray film. The x-ray energy absorbed in the imaging plate remains stored as a latent image. When fed to the device the stored energy is released as an optical emission proportional to the stored energy when the imaging plate is stimulated pixel by pixel by a scanning laser. An optical system collects the emission for photoelectronic system, which converts the emission to digital electronic signals. These signals are processed in a computer system which formats and stores the signals.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Digora PCT or Digipod device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The study described is a comparison study against a predicate device, focusing on technical performance parameters rather than a clinical trial with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for a test set. The evaluation primarily focuses on direct technical comparisons of objective metrics (dose, spatial resolution) and a general statement about diagnostic capability, rather than an assessment of diagnostic accuracy by human readers.

4. Adjudication Method for the Test Set

No adjudication method is mentioned as there is no indication of human expert review being part of the test set evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on direct technical comparisons between the device and its predicate, not on the improvement of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance evaluation was done. The "Performance data" section describes a comparison of the Digora PCT or Digipod directly against the predicate device (Fuji FCR 9000HQ) in terms of dose requirements and spatial resolution. This is an evaluation of the device's inherent technical capabilities, independent of human interpretation.

7. The Type of Ground Truth Used

The ground truth for the technical performance study appears to be objective physical measurements rather than clinical ground truth like pathology or outcomes data.

• For dose comparison, the ground truth was a "known object" and the "equal pixel value" it produced.
• For spatial resolution, the ground truth was the objective measure of line pairs per millimeter (lp/mm).

8. The Sample Size for the Training Set

The document does not mention a training set. The device described is an imaging plate reader, not an AI or machine learning algorithm that requires a training set. The "processing" mentioned refers to conventional image processing, not AI model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set for an AI/machine learning model.

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