(336 days)
Rotograph Prime and I-MAX are extra-oral dental panoramic X-ray units to radiograph teeth, jaw and oral structures.
The devices are operated and used by dentists, radiologists and other legally qualified health care professionals.
They can be used with both pediatric and adult patients.
Rotograph Prime (and I-MAX under trade mark Owandy Radiology) is a complete panoramic X-ray system. The basic version performs:
- -Panoramic adult or child exams, with 3 sizes and 3 tvpes of biting for a total of 18 combinations with automatic parameter selection; with manual selection, it is possible to select a high voltage between 60kV and 70kV, in 2kV steps and anodic current from 2 mA to 7.1 mA in the R20 scale steps.
- -Sinus mode to take exams of the paranasal sinuses with front projection (postero/anterior);
- -TMJ (closed/open mouth) exams in lateral projection.
XP (Extended Projection Package) optional function allows to carry out the following additional exams:
- -Right or left half-panoramic, to be used when the patient is known to have a problem only on one side of the arch, in order to reduce radiation;
- -Low dose Panoramic, which reduces the dose radiated by excluding the TMJ's ascending rami from the radiograph;
- Frontal dentition, for a radiograph of the front part (roughly from canine to canine); -
- -Ortho Rad Panoramic which reduces teeth overlap, thereby improving the diagnosis of interproximal decay:
- Bitewing left or right for lateral dentition (generally from eighth to fourth) with a trajectory that reduces teeth overlap;
- -Bilateral Bitewing (left and right), which sequentially performs both bitewings, showing them on the same image.
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). In particular, Rotograph Prime is equipped with a PAN sensor: it is suitable for Panoramic-type imaging, all Panoramic, i.e. all images with about 14cm-high field; all Panoramic. TMJ, and Sinus images belong to this type.
This document describes the Rotograph Prime and I-MAX extra-oral dental panoramic X-ray units and compares them to a predicate device, the Rotograph EVO D, to demonstrate substantial equivalence for FDA 510(k) clearance.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a quantitative sense for image quality or clinical performance metrics. Instead, it relies on the comparison to a predicate device (Rotograph EVO D) and conformance with recognized international standards for safety and performance. The primary acceptance criterion for the premarket notification appears to be demonstrating substantial equivalence to the predicate device, meaning the new device is as safe and effective.
The provided tables mainly focus on comparing technical specifications and features. The key "performance" aspect is image quality, which is addressed through a comparative study.
| Acceptance Criterion (Implicit) | Reported Device Performance (as per document) |
|---|---|
| Image Quality Equivalence to Predicate Device | "The equivalence of the image quality of panoramic radiographies of the subject device has been assessed with image comparison tests." (Specific metrics or results not detailed in this summary, but a separate annex titled "7_Image_Quality_Comparison" is mentioned as having been supplied) |
| Conformance with International Standards for Safety and Essential Performance (examples of key standards) | Conforms to: |
- IEC 60601-1: General requirements for basic safety and essential performance
- IEC 60601-1-2: Electromagnetic compatibility
- IEC 60601-1-3: Radiation Protection in Diagnostic X-Ray Equipment
- IEC 60601-2-63: Particular requirements for dental extra-oral X-ray equipment
- IEC 62304: Medical device software
- ANSI/AAMI ES60601-1: General Requirements
- CAN/CSA-C22.2 No. 60601-1: General requirements for basic safety and essential performance
- IEC 60601-1-6: Usability
- IEC 62366: Usability engineering
- ISO 10993: Biological evaluation of medical devices (Parts 2, 5, 10, 12) |
| Software Validation (Moderate Level of Concern) | "The software validation activities were performed in accordance with the FDA Guidance, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' (May 11, 2005)." Device software is classified as "Moderate Level of Concern." |
| Device not introducing new questions of safety or effectiveness (based on technological differences) | "The review of the technological differences...shows that they are due only to technological evolution and removal of not needed functions and/or version so they do not raise any new questions regarding safety or effectiveness..." |
| Biocompatibility of patient-contacting components | "All parts in contact with patient have been assessed according to ISO 10993." |
| Electrical safety, EMC/EMI, and Performance Testing (general categories) | "Electrical safety, EMC/EMI testing, biocompatibility consideration, performance and image quality testing, verification and validation testing were performed to support the substantial equivalence determination." (Specific results not detailed in this summary but mentioned as provided in test reports). |
| Total Filtration compliance | "Due to the reduced kV range, the total filtration has been reduced maintaining the compliance with 21CFR 1020.30." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions "image comparison tests" and refers to "annex 7_Image_Quality_Comparison" for details. However, it does not explicitly state the number of images or cases used in these image comparison tests within the provided text.
- Data Provenance: Not explicitly stated. Given the manufacturer is based in Italy (Villa Sistemi Medicali S.p.A.), and the predicate device is also from the same manufacturer, it's highly probable the data was generated in Europe, possibly Italy. The document indicates it's a premarket submission for a new device, implying it would involve newly acquired images for testing, making it somewhat "prospective" in the context of comparing a new device against an existing one, although the images themselves might be taken from a test phantom or patient data collected specifically for the comparison. It is not explicitly stated whether it uses patient data or phantom data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. The document refers to "image comparison tests" but does not detail how ground truth was established, who participated, or their qualifications.
4. Adjudication Method for the Test Set
This information is 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
- MRMC Study: No, this document describes an X-ray imaging device, not an AI software. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.
- Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this document describes an X-ray imaging device, which is a physical hardware product. Therefore, a standalone algorithm-only performance study is not applicable. The image quality comparison is likely testing the device's ability to produce diagnostically equivalent images to the predicate, irrespective of an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "image comparison tests" to assess "equivalence of the image quality." It does not specify the type of ground truth used for these images. It's common in such comparisons for technical performance (e.g., resolution, contrast, artifact levels) to be assessed against expected values or by visual comparison by experts. It is possible a gold standard phantom or reference images were used, but this is not explicitly stated.
8. The Sample Size for the Training Set
This information is not applicable as the device is an X-ray hardware system, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
§ 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.