(59 days)
Rotograph EVO and Rotograph EVO D, panoramic x-ray imaging system with cephalostat, are extraoral source x-ray system, which are intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry.
Rotograph EVO and Rotograph EVO D are conventional panoramic x-ray system utilizing either films and cassettes (Rotograph EVO) or digital imaging (Rotograph EVO D). Both models can be equipped with a cephalostat. The device can be equipped with accessories to fulfil different diagnostic needs. In digital configuration (Rotograph EVO D) the images are acquired by a CCD sensor and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device).
The provided text is a 510(k) summary for the Rotograph EVO and Rotograph EVO D dental panoramic and cephalometric units. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the specific information required to complete a table of acceptance criteria, reported device performance, or details of a study proving the device meets acceptance criteria.
The document states:
- Safety and Effectiveness Information: "The software development for this device follows documented processes for software design, verification and validation testing, Final device validation (see Appendix C) and risk assessment has been conducted, to identify potential design hazards that could cause an error or injury based on the use of this device."
- Conclusion: "Rotograph EVO and Rotograph EVO D perform the same functions in the same environment as the predicate devices. They share the same technology as the predicate devices. They are based on well known technology. They are as safe and effective as the predicate devices. We believe they do not introduce any new potential safety risks and are substantially equivalent to the predicate devices."
This indicates that a validation study was conducted, likely assessing the device's technical performance against a set of predetermined criteria, but the details of these criteria, the study's methodology, results (acceptance criteria met), sample sizes, ground truth establishment, or expert involvement are not included in this 510(k) summary. The summary focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study.
Therefore, I cannot provide most of the requested information based solely on the provided text.
Here's what can be inferred or explicitly stated from the document, with many fields left as "Not provided in the document":
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document (Likely technical specifications related to image quality, radiation dose, mechanical performance, software reliability, and safety standards like IEC 60601-1) | Not provided in the document (Stated to be "as safe and effective as the predicate devices" and that validation testing was conducted) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not provided in the document.
- Data provenance: Not provided in the document. (The device is manufactured in Italy, so testing data might originate there, but this is not specified.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided in the document.
4. Adjudication method for the test set
- Not provided in the document.
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 imaging system, not an AI-powered diagnostic aid for human readers. The document refers to "software development" and "validation testing" but does not mention AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is an X-ray imaging device, not purely an algorithm. Its performance typically refers to the quality and consistency of the images it produces.
7. The type of ground truth used
- Not explicitly stated. For an imaging device, ground truth for performance validation typically involves comparing images against established quality metrics, phantom studies, or potentially clinical correlation, but this is not detailed.
8. The sample size for the training set
- Not applicable/Not provided. The document describes a "software development" and "validation testing" process, suggesting traditional software engineering and testing for device functionality rather than an AI model requiring a training set.
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.