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510(k) Data Aggregation
(34 days)
PREVA, 76IN ARM, 66IN ARM, 56IN ARM, MODELS P7017, P7016, P7015
The intended use of the Progeny PREVA Extra-Oral X-Ray system is to act as a diagnostic source for radiographic dental imaging.
The Progeny, Inc. PREVA Intraoral Dental X-Ray System is an extraoral source of x-rays for intraoral radiographs in dental diagnostic radiography. The system consists of the following main components: X-ray tubehead, Rotating yoke for tubehead mounting, Articulation arm, Horizontal extension arm, Electronic control unit, Wall mount, 8 inch cone. Optional Components include a 12 inch cone and an 8 ft. coil cord with exposure switch. The Power supply is regulated to provide a selectable 60, 65, or 70 kVp at a selectable tube current of 4, 6, or 8 mA. Predefined exposure times may be selected via the operator control panel. The range of exposure times is 0.01 to 2.00 seconds.
The provided 510(k) summary for the Progeny, Inc. PREVA Intraoral Dental X-Ray System describes a device for generating X-rays for dental imaging. However, it does not include acceptance criteria related to diagnostic performance (e.g., sensitivity, specificity, accuracy) or detailed study results demonstrating such performance.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Gendex Gx-770 and Gendex 765DC) based on shared indications for use, materials, design, and operational/functional features. The safety and effectiveness are supported by:
- Performance testing and verification to meet product specifications (general statement, no specifics provided).
- Software testing to validate software design and performance (general statement, no specifics provided).
- Hazard analysis and risk level assessment (general statement, no specifics provided).
- The fact that it shares the same indications for use as predicate devices.
Therefore, many of the requested elements for describing specific acceptance criteria and a study proving their achievement cannot be extracted from this document, as the submission relies on substantial equivalence for a device generating X-rays, rather than presenting a comparative diagnostic performance study against a ground truth.
Here's an attempt to answer the questions based on the available information, noting where information is absent:
1. Table of acceptance criteria and the reported device performance
Based on the provided document, specific quantitative acceptance criteria for diagnostic imaging performance (e.g., image quality, diagnostic accuracy measures like sensitivity, specificity, or AUC) are not defined or reported. The "acceptance criteria" presented are implicit in the comparison to predicate devices, focusing on key physical and operational characteristics to demonstrate substantial equivalence, rather than a quantifiable measure of diagnostic utility.
| Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (PREVA) |
|---|---|---|
| Kv (Kilovoltage Peak) | Comparable to predicate devices (fixed 70 kVp, fixed 65 kVp) | 60, 65, 70 kVp, selected |
| mA (Milliampere) | Comparable to predicate devices (7.0 mA, 7.5 mA) | 4, 6, 8mA, selected |
| Operator Technique Selection | Exposure Duration Only (as in predicate devices) | kV, mA, Exposure Duration |
| Suspension | Articulated Arm (as in predicate devices) | Articulated Arm |
| X-Ray Field Size | Within range of predicate devices (6.5 cm diameter, 6.0 cm diameter) | 6.5 cm diameter |
| Focal Distance | Comparable to predicate devices (8 in. cone, 12 in. cone) | 8 in. cone, 12 in. cone |
| Operator Exposure Control | Deadman Switch (as in predicate devices) | Deadman Switch |
| Safety and Effectiveness | Demonstrated by performance testing, software testing, hazard analysis, and similar indications for use as predicate devices. | Meets the above criteria (no specific performance metrics given). |
2. Sample size used for the test set and the data provenance
Not applicable. The document does not describe a test set or data from a diagnostic performance study to establish clinical effectiveness or accuracy. The evaluation is based on technical specifications and substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No expert ground truth establishment for a diagnostic test set is detailed in this document.
4. Adjudication method for the test set
Not applicable. No test set or related adjudication method is described.
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 document pertains to an X-ray hardware system (the generator of the X-rays), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an X-ray generator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The document describes a medical device (X-ray system), not an interpretative algorithm, thus, no "ground truth" for diagnostic performance is discussed. The ground truth for the technical performance data would be the physical measurements of the device's output (e.g., kVp, mA, exposure time).
8. The sample size for the training set
Not applicable. This is an X-ray hardware system, not a software algorithm that requires a training set in the AI/machine learning sense.
9. How the ground truth for the training set was established
Not applicable. As above, this is an X-ray hardware system.
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