(29 days)
REXTAR X is a portable X-ray system to be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray lmages using intraoral image receptors. It is intended for both adult and pediatric subjects.
The REXTAR X consists of an X-ray tube, X-Ray tube assembly, X-Ray Controller built into a hand held camera-like device. The Rextar model contains additional accessories. The REXTAR X is an extraoral source x-ray system with a DC-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, X-ray camera, is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.
The provided text does not contain detailed information about specific acceptance criteria, a scientific study with performance metrics, or the methodologies for establishing ground truth, as would be expected for an AI/ML device.
This document describes a conventional X-ray device, the REXTAR X, and its substantial equivalence to a predicate device (REXTAR LCD) for FDA 510(k) clearance. The comparison focuses on technical and operational specifications rather than AI/ML performance.
Therefore, many of the requested sections about acceptance criteria, study details, human reader improvement, and ground truth establishment cannot be answered from the provided input.
However, based on the information available, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for this device appear to be primarily based on demonstrating substantial equivalence to a predicate device (REXTAR LCD) and compliance with relevant safety and performance standards for X-ray systems.
| Parameter (Criterion) | REXTAR X Performance (Reported Device Performance) | REXTAR LCD Performance (Predicate Device Performance) |
|---|---|---|
| Intended Use | Matches predicate device | To be used by trained dentists and dental technicians as a mobile, extraoral x-ray source for producing diagnostic x-ray images using intraoral image receptors. It is intended for both adult and pediatric subjects. |
| Indications | Matches predicate device | X-ray system designed to provide images of the patients undergoing dental procedures. Clinical uses include Bite wing, periapical, occlusal and panoramic images. |
| Dentist/dental assistant Involvement | Supervision | Supervision |
| X-ray Generator | High-Frequency | High-Frequency |
| Tube Power | 70kV /2mA | 70kV /2mA |
| Tube Type | Stationary | Stationary |
| Tube Focal Spot | 0.4mm | 0.4mm |
| Target Angle | 12° | 12° |
| Exposure Time | 0.01 ~ 1.30 (sec) (43 steps) | 0.01 ~ 1.3 (sec) (43 Steps) |
| Power Requirement | DC 11.1 V | DC 11.1 V |
| Picture Quality | Good | Good |
| Battery Type | Rechargeable | Rechargeable |
| Display | LCD Panel Display (3.5 Inch, BTN LCD, 1/4Duty, 1/3BIAS) | LCD Panel Display (4 Digits, 0.5 Inch Character Height) |
| Size | 146×155×139mm | 404× 234× 198mm |
| Weight (kg) | 2 | 1.88 |
| Compliance with Standards | UL/IEC 60601-1, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32, EN/IEC 60601-1-2 | (Implied compliance for predicate, not explicitly listed as acceptance criteria for REXTAR X in the table) |
The "study" that proves the device meets "acceptance criteria" is essentially the comparison table demonstrating substantial equivalence and the EMC testing results. The conclusion states: "Based on comparison with the predicate devices and the results of testing Metabiomed believes its REXTAR and REXTAR LCD devices are substantially equivalent" (Section 13).
2. Sample size used for the test set and the data provenance
Not applicable for this type of submission. The performance assessment is based on technical specifications and comparison to a predicate device, not a diagnostic accuracy study with a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.
4. Adjudication method for the test set
Not applicable.
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. This is a conventional X-ray device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used
Not applicable. The "ground truth" for this submission concerned the technical specifications and safety compliance of the device itself, rather than diagnostic accuracy against a clinical gold standard.
8. The sample size for the training set
Not applicable. No AI/ML component.
9. How the ground truth for the training set was established
Not applicable. No AI/ML component.
§ 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.