(84 days)
The Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation, with an optional cephalometric capability, and a digital imaging capability for taking both panoramic and cephalometric images.
The Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function is an extraoral source X-ray unit that is used for dental radiographic examination and diagnosis of teeth, jaw, and oral structure by exposing an X-ray image receptor to ionizing radiation, with an optional cephalometric capability, and a digital imaging capability for taking both panoramic and cephalometric images.
The provided text describes the 510(k) summary for the "J. Morita Manufacturing Corporation's Veraviewepocs Panoramic/Cephalometric X-ray Unit With Digital Image Function". However, this document does not contain specific acceptance criteria, performance data, or details of a study that directly proves the device meets acceptance criteria.
Instead, the document focuses on:
- Substantial Equivalence: It claims substantial equivalence to previously cleared predicate devices based on intended use, principle of operation, and technological characteristics.
- Compliance with Standards: It states that the device was tested and complied with UL2601-1 and IEC 60601-1, and will comply with 21 C.F.R. Subchapter J and successfully passed image quality testing.
- Software Validation: It mentions a software validation report describing development processes, requirements, hazard analysis, and certification of adherence to procedures.
- Biocompatibility: It addresses the use of biocompatible materials.
This 510(k) summary is a regulatory submission demonstrating substantial equivalence, not a detailed study report for meeting specific performance acceptance criteria. Therefore, most of the requested information cannot be extracted directly from the provided text.
Here is what can be inferred or stated based on the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document implies acceptance criteria are related to compliance with safety standards (UL2601-1, IEC 60601-1, 21 C.F.R. Subchapter J), successful software validation, and image quality testing. However, specific quantitative acceptance criteria (e.g., minimum resolution, SNR, DQE values, tolerance for geometric distortion) are not provided.
- Reported Device Performance: The document states the device "complied with the applicable requirements" for safety standards and "passed the image quality testing." No specific performance metrics or values are reported.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with UL2601-1 and IEC 60601-1 (electrical, thermal, mechanical safety) | Device "complied with the applicable requirements." |
| Compliance with 21 C.F.R. Subchapter J (radiation control provisions) | Device "will comply with the applicable requirements... prior to marketing." |
| Software Validation | Software "successfully validated by Morita." |
| Image Quality | Device "passed the image quality testing." |
| Biocompatibility | Uses "biocompatible metals and plastics" widely used in medical applications. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not provided. The document states "The modified Veraviewepocs was tested" and "passed the image quality testing," but gives no details about the sample size (e.g., number of images, number of patients, number of components tested) or the provenance of any data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not provided. The document does not mention the use of experts for establishing ground truth, as it is primarily focused on technical compliance and substantial equivalence rather than diagnostic performance evaluation by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not provided. This information is typically relevant for studies involving human interpretation and consensus, which is not described here.
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
- No, an MRMC comparative effectiveness study was not done or reported. This device is an X-ray unit, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Irrelevant/Not applicable. This device is an imaging hardware unit, not a standalone algorithm. The software mentioned is for controlling the device and processing the images, not for automated diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided/Implicit through compliance standards. For "image quality testing," the ground truth would likely be defined by objective metrics and technical specifications (e.g., MTF, spatial resolution, contrast-to-noise ratio measured against phantoms or reference images) rather than medical interpretations like expert consensus or pathology. No details are given.
8. The sample size for the training set
- Not applicable. This device is a hardware X-ray unit with associated operational software, not a machine learning model that requires a "training set" in the conventional sense. The "software validation" refers to verifying that the software meets its specified requirements and functions correctly, not to training an AI model.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 872.1830 Cephalometer.
(a)
Identification. A cephalometer is a device used in dentistry during x-ray procedures. The device is intended to place and to hold a patient's head in a standard position during dental x-rays.(b)
Classification. Class II.