(172 days)
The RAYSCAN α- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
RAYSCAN a- Expert is designed for panoramic scanning of teeth, jaw and oral cavity, used to create and control the X-ray beam. And as a dental digital panoramic X-ray system with X-ray located on outer part of the oral cavity, includes the Cephalometric scanning function, as an option, for acquiring images of the head. RAYSCAN a- Expert offers digital imaging with or without the optional cephalometric attachment. The system includes processing, and archiving "SMARTDent "software(Optional)
The provided document K122918 describes the RAYSCAN α-Expert Dental X-Ray System. However, it does not explicitly detail acceptance criteria or a specific study proving the device meets those criteria in the way typically found for an AI/CADe device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Orthophos XGPlus DS/Ceph K033073) and compliance with electrical, mechanical, environmental, and EMC safety and performance standards.
The closest information regarding performance acceptance criteria and study is within the "Safety and Effectiveness Information" section, which states: "Non-clinical & Clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed. All test results were satisfactory." This is a general statement and does not provide specific performance metrics, sample sizes, or ground truth establishment relevant to an AI/CADe system.
Therefore, many of the requested details for an AI/CADe device cannot be extracted from this document, as the RAYSCAN α-Expert is an X-ray imaging system, not an AI-powered diagnostic tool in the sense of the prompt's implied context (e.g., for detecting specific pathologies). The focus is on the safety and effectiveness of the imaging system itself to produce X-rays for examination and diagnosis by a human, not on automated analysis or improved human reading through AI assistance.
Based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific quantitative acceptance criteria or reported device performance metrics in the way one would expect for an AI/CADe device (e.g., sensitivity, specificity, AUC for a diagnostic task). The performance assessment is qualitative, focusing on compliance with safety and effectiveness standards, and substantial equivalence to a predicate device in terms of technical specifications.
| Acceptance Criteria Category | Specific Criteria (Implicit from document) | Reported Device Performance (Implicit from document) |
|---|---|---|
| Safety | Compliance with IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, and IEC 60601-1-2 (EMC) | "All test results were satisfactory." |
| Effectiveness | Ability to produce X-rays for dental radiographic examination and diagnosis. Substantial equivalence to predicate device (Orthophos XGPlus DS/Ceph K033073) in intended use, indications, construction materials, principle of operation, features, and technical data. | "the RAYSCAN α-Expert system is safe and effective to perform its intended use as well as substantially equivalent to the Predicate device." |
| Image Quality | Not directly specified with metrics, but implied through substantial equivalence to predicate device's image modality (Digital only) and detector types. | Not specified with metrics. |
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. The document primarily discusses non-clinical and clinical considerations for the imaging device itself, not a test set for an AI algorithm's diagnostic performance. There is no mention of a "test set" in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This concerns an AI/CADe system's diagnostic accuracy, which is not the focus of this document for an X-ray imaging system.
4. Adjudication method for the test set
Not applicable/Not provided.
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
Not applicable/Not provided. The device is an X-ray system, not an AI assistance tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not provided. The device is not an AI algorithm.
7. The type of ground truth used
Not applicable/Not provided.
8. The sample size for the training set
Not applicable/Not provided. The device is an X-ray system, not an AI algorithm that undergoes training.
9. How the ground truth for the training set was established
Not applicable/Not provided.
§ 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.