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510(k) Data Aggregation
(26 days)
The indications for use of the Progeny Vantage Extra-Oral Panoramic X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
The Progeny Vantage Panoramic X-ray System is an extraoral radiographic imaging system for producing digital radiographs in a panoramic view of the teeth, jaw, and oral structure. The Progeny Vantage Panoramic Extraoral Radiographic Imaging System consists of the following main components: X-ray tubehead with integrated collimation. Digital Image Receptor Rotating C-Arm for tubehead and image receptor mounting Overhead arm Elevating Column Patient Positioning Table Electronic Control Unit Computer Display Workstation 8 ft. coil cord with exposure switch
The provided 510(k) summary for the Progeny Vantage Panoramic X-Ray System primarily focuses on demonstrating substantial equivalence to predicate devices through comparison of technical specifications and indications for use. It does not contain information about specific acceptance criteria related to device performance in terms of diagnostic effectiveness that would typically be evaluated in a study with a ground truth, human readers, or quantitative performance metrics like sensitivity and specificity.
Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment cannot be extracted from this document, as they are not present.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to predicate devices by matching their characteristics. The "reported device performance" in this context refers to the device's technical specifications.
| Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Progeny Vantage) |
|---|---|---|
| kVp | 60-84 kVp (within range of predicates) | 60-84 kVp |
| mA | 1-16 mA (within range of predicates) | 4-10 mA |
| Digital Sensor | Yes | Yes |
| Image Pixel size | 66 µm - 96 µm (within range of predicates) | 96 µm |
| Exposure Time | 2-17s (within range of predicates) | 8-10s |
| Image Profiles | Pan, TMJ, Ortho (matching predicates) | Pan, TMJ, Ortho |
| Operator Exposure Control | Deadman Switch | Deadman Switch |
| User Interface | Color Touch Screen / Keypad & LED Display | Color Touch Screen |
| X-Ray tube focal spot | 0.4mm² - 0.5mm² (within range of predicates) | 0.5mm² |
| Magnification | 1.2 - 1.3 (within range of predicates) | 1.2 |
| Column | Telescoping / Fixed | Telescoping |
| Construction | Aluminum castings/extrusions with plastic/metal | Aluminum castings with plastic/metal covers |
| Indications For Use | To provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures (matching predicates) | To provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures |
| Safety & Effectiveness (General) | Performance testing, software testing, hazard analysis, same indications as predicates | Performance testing and verification to meet product specifications, Software testing to validate software design and performance, Hazard analysis and risk level assessment, Same indications for use as predicate devices |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly provided in the document. The filing mentions "Performance testing and verification to meet product specifications" and "Software testing to validate software design and performance" but does not detail the size or nature of the test sets used for these evaluations, nor their provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The application focuses on technical equivalence rather than a clinical study requiring expert assessment of ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is 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
This type of study was not done, nor is it applicable, as the device is a panoramic x-ray system, not an AI-powered diagnostic tool for interpretation. Its function is to produce images, not to analyze them with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided, and it is not applicable given the nature of the device as an imaging system rather than an algorithm for standalone diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided. For an imaging device like this, ground truth for image quality assessments would typically involve objective measurements (e.g., spatial resolution, contrast-to-noise ratio) and potentially subjective evaluation by clinicians to confirm diagnostic utility. However, the document does not elaborate on how these were established.
8. The sample size for the training set
This information is not provided. There is no mention of a "training set" as the device is an imaging system, not a machine learning model requiring a training phase for its core function.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons mentioned above.
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