(55 days)
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
| Acceptance Criteria | Reported Device Performance (Digora PCT or Digipod) |
|---|---|
| Dose required to produce equal pixel value of a known object (compared to predicate device Fuji FCR 9000HQ) | Substantially equal to Fuji FCR 9000HQ |
| Spatial Resolution (compared to predicate device Fuji FCR 9000HQ) | Substantially identical, specifically 4 - 5 lp/mm |
| Diagnostic Capability (compared to predicate device Fuji FCR 9000HQ) | Substantially equivalent diagnostic capability |
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.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.