(30 days)
Vidar Vision 3000 and Vidar Vision 4000 X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. The Vidar Vision 3000 and Vidar Vision 4000 is not indicated for diagnostic X-ray mammography.
The VIDAR VISION 3000 Digital Radiography system is an affordable DR (Digital Radiographic) solution designed for smaller radiography environments, including imaging centers, orthopedic practices, small hospitals, and outpatient areas of hospitals. The VIDAR VISION 3000 is the first truly affordable, full-featured DR system. providing a total solution for all digital radiographic examinations. The VIDAR VISION 3000 features high image quality, rapid image acquisition, improved productivity, and ease of use. The flexible system features a 3K detector for the high-resolution imaging needs of busy radiology centers, orthopedic practices, and hospitals. VIDAR's new VISION DR product line also includes the VISION 4000 system, with a 4K detector that is ideal for higher volume settings.
The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in a quantitative manner. Therefore, much of the requested information (such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) is not available in the provided document.
However, based on the provided text, we can infer some details related to the evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are implicitly related to demonstrating "substantial equivalence" to the predicate device, meaning the new device is as safe and effective and has no new indications for use. The performance is reported in terms of functional equivalence and technological specifications.
| Characteristic | Acceptance Criteria (Implied by Predicate Device K042876) | Reported Device Performance (Vidar Vision 3000/4000) |
|---|---|---|
| Intended Use | General purpose diagnostic X-ray unit | SAME (General purpose diagnostic X-ray unit, not for mammography) |
| Safety and Effectiveness | As safe and effective as predicate | "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." (Conclusion) |
| User Interface | Depends on Control console option, mainly dedicated touch controls | Software Driven Touch Panel LCD, + remote control unit + remote console |
| Maximum Output | 30 kW to 64 kW | 50, 64, and 80 kW |
| Image Acquisition | Digital: CANON CXDI-50G (K031447) | Digital: Vidar Digital Radiographic Detector (K070563) |
| Digital Panel Size | Up to 14" x 17" active area | Vision 3000/4000: Active image size: 16 x 16 inches (40cm x 40cm) |
| Digital Resolution | 160 x 160 microns pixel pitch, approx. 6 million pixels | Vision 3000: 160 Micron, 3056 x 3056 (9 megapixels) |
| Vision 4000: 120 Micron, 4096 x 4096 (16 megapixels) | ||
| Method of Control | Dedicated push button Controls | Software Driven Touch Panel LCD |
| Collimator | Manual R302/A | Balco B302I/A DHHS |
2. Sample size used for the test set and the data provenance
The document states "bench, user, and standards testing" were conducted. However, no specific sample sizes or details about data provenance (e.g., country of origin, retrospective/prospective) are provided in the given text for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. The testing appears to be primarily focused on technical specifications and functionality as compared to the predicate device, rather than diagnostic accuracy against a ground truth assessed by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. As there's no mention of expert evaluation of diagnostic images for ground truth, adjudication methods are not relevant here.
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 device is an X-ray system, not an AI-powered diagnostic tool. Thus, MRMC studies and AI-assisted improvements are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an X-ray system, not an algorithm. Standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided. The "ground truth" in this context is the performance and safety established for the predicate device, against which the new device's technical specifications and functional capabilities are compared. This is a comparison of device characteristics, not a diagnostic accuracy study requiring a clinical ground truth.
8. The sample size for the training set
Not applicable/Not provided. This is a hardware device (X-ray system), not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable/Not provided. As above, this is a hardware device.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.