(13 days)
The Hitachi CB MercuRay system is an x-ray imaging device that uses a cone beam with a 360°rotational sequence, providing two-dimensional images and three-dimensional volume reconstructions. The system specifically images the head and neck areas, which includes ENT and dentomaxillofacial areas, for use in planning and diagnostic support.
The CB MercuRay system is an x-ray device that uses a cone beam with a 360°rotational sequence, providing twodimensional images and three-dimensional volume reconstructions for ENT and dentomaxillofacial applications. The system consists of two main components; scanner and console. The scanner contains a U-arm with an x-ray generator with a 9" or 12" Image Intensifier and a 100M pixel CCD camera horizontally facing each other. The Uarm rotates horizontally around the patient's head. Data acquisition is performed with the patient in an upright, seated position. Images can be printed or exported on standard computer media.
The provided text is a 510(k) Summary for the "CB MercuRay Dental Cone-Beam X-Ray System." It is a regulatory document submitted to the FDA to demonstrate substantial equivalence to a predicate device. This type of document does not typically contain detailed acceptance criteria, specific study designs, or performance metrics in the way a clinical study report would. It focuses on demonstrating that the new device is as safe and effective as a legally marketed device.
Therefore, much of the requested information cannot be extracted from this document, specifically:
- A table of acceptance criteria and reported device performance: This document does not specify detailed performance metrics or acceptance criteria for a clinical study comparing the AI device against a defined standard. It mentions "Testing has proven that the CB MercuRay system is safe and effective for the indicated use" but provides no data.
- Sample size used for the test set and data provenance: Not mentioned.
- Number of experts used to establish ground truth and qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size: Not mentioned, as this is an imaging device, not an AI-assisted diagnostic tool in the sense of comparing human reader performance.
- Standalone performance study: Not detailed. The device itself is a standalone imaging system, but "standalone performance" in the context of AI usually refers to the algorithm's performance without human intervention, which is not applicable here.
- Type of ground truth used: Not explicitly stated beyond "Testing has proven..." which implies some form of validation, but the method is not described.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Information that can be extracted or inferred:
- Device Type: Extraoral source x-ray system (specifically, a cone-beam CT system for dental and ENT applications).
- Purpose of the Submission: To demonstrate substantial equivalence to a predicate device (NewTom QR-DVT 9000, 510(k) K003787). The primary argument for equivalence is based on similar scientific concepts (cone-beam technology), function (2D and 3D imaging), and performance.
- Key Differences from Predicate Device:
- Patient Positioning: CB MercuRay positions the patient upright and seated, while the predicate device requires the patient to lie down.
- Features: CB MercuRay offers increased options like four different fields of view and enhanced 3D features in the viewing software.
- Implicit "Acceptance Criteria" (Substantial Equivalence Basis):
- The device generates 2D and 3D images of the head and neck.
- These images are suitable for planning and diagnostic support in ENT and dentomaxillofacial areas.
- The device is safe, as assessed through risk and hazard analysis, with no new safety issues compared to the predicate.
- The technological characteristics are equivalent to the predicate device in concept, function, and performance.
In summary, this document is a regulatory filing for an imaging device, not a detailed scientific or clinical study report for an AI algorithm. Therefore, it does not contain the specific information requested about acceptance criteria, study design, ground truth, or expert involvement in the context of evaluating an AI's diagnostic performance.
§ 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.