(34 days)
The Gendex 765DC Intraoral Dental X-Ray System is to be used as an extraoral source of x-rays in Dental Radiography.
The Dentsply/Gendex 765DC Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral images in dental radiography. The system is comprised of the following main components: X-ray tubehead, Yoke with user interface capabilities, Articulation arm, Horizontal arm, Electronic control unit (which my be mounted remotely), Wall mount, 8" or 20cm cone. Optional components include: 8 ft. coil cord with exposure switch, 55" and 65" reach option, Optional cone lengths and shapes. The power supply is regulated to provide a fixed 65kVp, and the x-ray target current is fixed at 7ma. Predefined exposure times may be selected directly through the control or yoke switchpads. The range of exposure time is 0.02 through 2.00 seconds.
The provided text describes a 510(k) premarket notification for the Gendex 765DC Intraoral Dental X-Ray System, focusing on its substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving performance against those criteria. As such, the information required for a comprehensive answer to your request is largely absent in the document.
However, I can extract and infer some information based on the typical requirements for such submissions and what is explicitly stated.
Acceptance Criteria and Device Performance Study (Based on Submitted Document)
The document does not explicitly state numerical acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or AUC that are typical for AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance.
The "study" described is a regulatory submission process rather than a standalone clinical trial with quantifiable acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (From K992610) |
|---|---|
| Safety: | Device is safe when used as labeled. |
| - Meets product specifications | Performance testing to meet product specifications was conducted. |
| - Software validated | Software testing validated software design/performance. |
| - Hazard analysis completed | Hazard analysis including risk level and solution completed. |
| Effectiveness: | Device is effective when used as labeled. |
| - Produces effective clinical images | Effective clinical image exposures were demonstrated. |
| - Similar indications for use as predicates | Shares the same indications for use as predicate devices. |
| - Similar materials, design, operational, and functional features as predicates | Shares similar materials, design, operational, and functional features as predicate devices. |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document refers to "Performance testing to meet product specifications" and "Effective clinical image exposures" but does not detail the size of any test sets used in these evaluations.
- Data Provenance: Not specified. It's likely that any performance testing or clinical image evaluations would have been conducted internally by the manufacturer (Gendex Dental X-Ray Division of Dentsply International, Inc.) or contracted labs. The document does not indicate country of origin for data or if it was retrospective/prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document mentions "Effective clinical image exposures," implying evaluation by dental or radiology professionals, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of a 510(k) for an X-ray system (which focuses on device safety and performance characteristics rather than diagnostic interpretation by an AI), a formal adjudication method for a test set of interpretations is unlikely to be discussed in this document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, the document does not mention an MRMC study. This type of study is typically done for diagnostic AI devices where human performance changes with AI assistance. The Gendex 765DC is an X-ray imaging system, not an AI diagnostic tool.
- Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was reported and the device is not an AI diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
- Was a standalone study done? Not explicitly in the sense of an "algorithm only" performance. The device is a hardware system (X-ray machine). The "Software testing to validate software design / performance" would be similar to a standalone evaluation of the device's internal software functions, but not an independent diagnostic algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: The document refers to "Effective clinical image exposures." For an X-ray system, the ground truth would typically relate to:
- Image Quality Metrics: Resolution, contrast, signal-to-noise ratio, dose-to-image quality relationship, absence of artifacts.
- Compliance with Standards: Meeting electrical, radiation safety, and performance standards.
- Clinical Efficacy (Inferential): The ability to produce images suitable for diagnostic tasks, as judged by experts (though not explicitly detailed here).
No specific "pathology" or "outcomes data" ground truth is mentioned in relation to proving the device's utility, as it is a foundational imaging tool.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is an X-ray system, not an AI model that undergoes a "training" phase with a dataset. Any internal software development would not use a "training set" in the AI sense.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for an AI model.
§ 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.