(58 days)
The Rotograph Plus as manufactured by Villa Sistemi Medicali S.p.A of Milan, Italy is intended to be used as an extra oral radiological device for the examination of the human dentition and related anatomy as well as craniostatic examinations. They are to be used for Panoramic and Cephalometric Radiology as it is applied to dental diagnosis in dentistry.
This product is manufactured by the Villa Sistemi Medicali company of Milan, Italy and is classified as a class II device. It is intended to be used as a dental extra oral x-ray device for the panoramic and cephalometric examination of the human anatomy as it applies to dentistry.
The provided text is a 510(k) summary for the ROTOGRAPH PLUS dental extra oral x-ray device. It states that the device is "substantially equivalent" to a predicate device (Belmont X-Caliber unit).
However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, or how ground truth was established.
The document only states:
- Product Name: ROTOGRAPH PLUS
- Manufacturer: Villa Sistemi Medicali S.p.A. (Milan, Italy)
- Intended Use: Dental extra oral x-ray device for panoramic and cephalometric examination of human anatomy as it applies to dentistry, including human dentition, related anatomy, and craniostatic examinations.
- Regulatory Class: Class II (procode 90 EHD)
- Standards: Manufactured under guidelines of FDA/DHHS performance standards for radiation emitting devices, 21 CFR Subchapter J, and International Standard IEC 601.1 and 601.2.7.
- Substantial Equivalence: Deemed substantially equivalent to the Belmont X-Caliber unit.
- Safety and Effectiveness: "The manufacturer further warrants that this device is safe and effective for its intended use."
Since the document is a 510(k) summary claiming substantial equivalence, it typically relies on the predicate device's performance demonstration rather than providing new, detailed performance study data for the new device. A 510(k) often focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring a full, standalone clinical trial with specific performance metrics as might be seen for a PMA.
Therefore, for the information requested:
- A table of acceptance criteria and the reported device performance: Not provided in the document. The document primarily focuses on regulatory compliance and substantial equivalence to a predicate device.
- Sample size used for the test set and the data provenance: Not provided in the document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
- Adjudication method for the test set: Not provided in the document.
- 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. This device is an X-ray machine, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an X-ray machine, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the document.
- The sample size for the training set: Not applicable. This device is an X-ray machine, not an AI model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.