(448 days)
The MINE is intended to be used by trained dental technicians as extra-oral x-ray source for producing diagnostic x-ray images using intra-oral image receptors or film. Its use is intended for both adult and pediatric subjects.
MINE, a portable dental X-ray system, operates on 11.1V DC supplied by a rechargeable LiPolymer battery pack, The X-ray tube head, controls and power source are assembled into a single hand-held enclosure. The package includes a battery charger.
The portable X-ray system. MINE, being composed of X-ray generator, controller, and beam limiting device is designed to diagnose tooth and jaw through generated and controlled X-ray. The operating principle of MINE starts from the generation of X-ray by high voltage electricity, which in turn penetrates tooth and jaw area after flowing through X-ray tube and produces X-ray images on X-ray receptors (i.e. chemical film or digital sensor)
This device contains a high frequency inverter that converts direct to alternating current, X-ray tube head, electrical protective devices, and other elements. The MINE produces sharp and clear images and prevents patients and dentists from radiation exposure with utilizing small dose of radiation.
The provided text is a 510(k) summary for the medical device "MINE," an extra-oral x-ray system. This document focuses on demonstrating substantial equivalence to a predicate device ("EXARO") rather than presenting a clinical study with detailed acceptance criteria and performance data for AI/human reader studies.
Therefore, the information requested in the prompt regarding acceptance criteria, study design for AI/human reader performance, sample sizes, expert qualifications, and ground truth establishment for such studies is not available in the provided text. The document explicitly mentions non-clinical testing and phantom images to demonstrate performance.
Here's a breakdown of what is available in relation to your prompt:
1. A table of acceptance criteria and the reported device performance:
The document does not provide a table of acceptance criteria for a clinical performance study with defined metrics (e.g., sensitivity, specificity, AUC) for an AI or human reader outcome. Instead, it focuses on demonstrating compliance with safety and performance standards relevant to an X-ray device itself.
The "reported device performance" is primarily about the device's technical specifications and adherence to standards:
| Characteristic | MINE Performance (subject device) | Predicate Device (EXARO) |
|---|---|---|
| Anode current | 2mA | 2mA Fixed |
| Expose time | 0.01~1.3sec | 0.01~2.0 seconds, 0.01 increments |
| Time Accuracy | ±(10%+1ms) | ±(10%+1ms) |
| Heat Capacity | 4300J (6 KHU) | 8.5 KHU |
| Power Output | 100W | 100W |
| mA | 2mA Fixed | 2mA Fixed |
| kVp | 60kV Fixed | 60kV Fixed |
| Focal Spot | 0.4mm | 0.8mm |
| Wave Form | Constant Potential (DC) | Constant Potential (DC) |
| Safety, EMC and Performance (Standards) | IEC/EN 60601-1, IEC/ EN 60601-1-3, IEC/EN 60601-2-28, IEC 60601-2-65 (also compliance with 21 CFR 1020) | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-7, IEC 60601-2-28 |
| Source to skin Distance | 20cm | 20cm |
| Cone Diameter | 6cm | 6cm |
The document notes that "Phantom images were provided to demonstrate the overall performance of the device as part of a complete intraoral x-ray imaging chain." This suggests a technical performance evaluation, not a clinical efficacy study involving diagnostic accuracy.
2. Sample size used for the test set and the data provenance:
- Not applicable / not provided. The document describes a technical device and its compliance with performance standards, primarily through non-clinical testing and phantom images. There is no mention of a "test set" for a clinical study involving diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / not provided. As there is no clinical test set described, there's no information on experts establishing ground truth for diagnostic purposes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / not provided.
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. This device is an X-ray source, not an AI-powered diagnostic tool. The submission is for a traditional medical device, demonstrating substantial equivalence to another X-ray device based on technical specifications and safety standards.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / not provided. The device's performance was assessed through phantom images and compliance with electrical/radiation safety standards, not clinical ground truth.
8. The sample size for the training set:
- Not applicable / not provided. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable / not provided.
In summary: The provided document is a 510(k) summary for an X-ray device, focusing on its technical specifications, safety, and substantial equivalence to a predicate device. It does not contain information about acceptance criteria or study results for AI performance, human reader studies, or associated ground truth establishment, as it's not relevant to the type of device being cleared.
§ 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.