(28 days)
Star-X is intra-oral X-ray system for dental diagnosis that can radiate X-ray images by irradiating X-rays generated by high voltage to an anode in an X-ray tube and reacting with the receptor (film, sensor).
Star-X is a dental X-ray equipment (extra-oral source system) intended for use by qualified dentist or dental technician for both adult and pediatric patient for producing diagnostic dental radiographs for treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
The Star-X is an X-ray generator for dental intra-oral X-ray imaging and intended to be used for producing diagnostic dental radiographs for treatment of disease of teeth, jaw and oral structures. The Star-X is consisted of X-ray generator, beam limiting device (cone), control panel, mechanical arm, support device, chair and backrest. The control panel allows for accurate exposure control and adjustable arm provide for convenient patient positioning.
The provided text is a 510(k) summary for the Star-X Intraoral X-ray System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for a new AI/CAD device. Therefore, much of the requested information regarding acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, ground truth establishment, and expert qualifications for performance evaluation is not present in the given document.
The document primarily addresses the safety and technical characteristics of the X-ray system itself, comparing it to existing X-ray units. It does not describe a study to prove meeting acceptance criteria in the context of an AI/CAD system for image analysis.
Here's a breakdown of what can be extracted and what is missing based on your specific request:
Acceptance Criteria and Reported Device Performance
The document describes compliance with various electrical safety, electromagnetic compatibility, and radiation protection standards for an X-ray system. It does not present acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/CAD system.
The "device performance" reported here is about the technical specifications of the X-ray unit, not an AI's diagnostic capabilities.
| Acceptance Criterion Type (as implied for an X-ray system) | Reported Device Performance (Star-X) |
|---|---|
| Electrical Safety | Complies with ES60601-1 |
| Electromagnetic Compatibility | Complies with IEC 60601-1-2 |
| Radiation Protection | Complies with IEC 60601-1-3 |
| Dental Intra-Oral X-Ray Equipment Requirements | Complies with 60601-2-65 |
| Rated mains voltage | 100-120/200-240 VAC |
| Tube Voltage | 65 kV |
| Tube Current | 3 or 6 mA |
| Exposure Time | 0.01-3.2 s (in 0.01 step) |
| Inherent Filtration | 0.8 mm Al |
| Total Filtration | > 1.8 mm Al |
| Focal Spot Size | 0.8 mm |
| Anode Material | Tungsten |
| Compatible with Digital Imaging | Applicable |
| Duty Cycle | 1:60 |
| Software Validation | Designed, developed, verified, and validated according to FDA guidance (Moderate level of concern) |
| Cybersecurity | Complies with FDA guidance |
Missing Information for AI/CAD System Evaluation:
The following information cannot be provided from the given document as it pertains to the regulatory submission for an X-ray imaging device, not an AI/CAD diagnostic software.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is an X-ray hardware device, not an AI/CAD system being evaluated for diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable (for AI model training). The software mentioned is for the control and operation of the X-ray machine.
- How the ground truth for the training set was established: Not applicable.
Summary of the Document's Content:
The provided document is a 510(k) premarket notification for the "Star-X, Intraoral X-ray System." It seeks to establish substantial equivalence to existing predicate X-ray devices. The "study" referenced in the document is a series of non-clinical tests demonstrating compliance with electrical safety, EMC, radiation protection, and performance standards relevant to X-ray hardware. It also mentions software validation for the control software of the X-ray system, confirming it was designed, developed, verified, and validated for a moderate level of concern, and that cybersecurity information was provided. This is not a diagnostic performance study of an AI algorithm on medical images.
§ 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.