(150 days)
The Minray dental x-ray system is intended to be used for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intraoral digital or film image receptor media.
The Minray dental x-ray system is indicated for dental radiographic examinations by producing radiographs of dentition, jaws and other oral structures on intra oral film or digital image receptor media.
Minray is an extraoral source dental x-ray system, which produces dental images on intraoral digital or film image receptors. The x-ray generator operates on high frequency and has an DC output. There are two selectable anode voltages 60 kV and 70 kV. Anode current is constant 7 mA. Exposure time can be selected from 20 ms to 3.2 s.
The provided text is a 510(k) summary for the Minray Dental X-ray System. It describes the device, its intended use, and states that "Verification and validation testing was successfully performed to confirm that Minrav corresponds with the intended use."
However, this document does not contain the detailed performance data, acceptance criteria, sample sizes, ground truth establishment methods, or information about expert involvement that your request asks for. The document is a regulatory submission summary, not a study report.
Therefore, I cannot fulfill your request with the information provided because:
- Acceptance Criteria and Reported Device Performance: No specific acceptance criteria or quantitative performance metrics (like sensitivity, specificity, accuracy) are mentioned in the document. It only states that verification and validation were "successfully performed."
- Sample Size and Data Provenance: No sample size for test sets or data provenance (country, retrospective/prospective) is provided.
- Number and Qualifications of Experts: There is no mention of experts being used to establish ground truth.
- Adjudication Method: No adjudication method is described.
- MRMC Comparative Effectiveness Study: There is no indication of an MRMC study or an effect size for human readers.
- Standalone Performance: While the device is an X-ray system, the document doesn't present an "algorithm only" standalone performance if AI were involved. It's a hardware device.
- Type of Ground Truth: The document does not specify the type of ground truth used for any testing.
- Training Set Sample Size and Ground Truth Establishment: No information on a training set or how its ground truth was established is provided, as this device is an X-ray generator, not an AI/ML algorithm.
To answer your questions, I would need a different type of document, such as a detailed study report or clinical trial results, which are not present in this 510(k) summary.
§ 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.