(115 days)
ViVIX-S with VXvue is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography and/or for fluoroscopy.
ViVIX-S with VXvue is a digital X-ray flat panel detector which has 43x43cm (FXRD-1717SA, FXRD-1717SB) or 35.8x43cm (FXRD-1417SA, FXRD-1417SB) imaging area. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create an electrical signals. After the electrical signals are generated, it is converted to digital value, and the images will be displayed on monitors. This device should be integrated with an operating PC and an X-Ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic. Advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, and sharing of image information on network.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Metric | Predicate Device (K120020) | Proposed Device (ViVIX-S with VXvue) | Acceptance Status |
|---|---|---|---|---|
| Non-Clinical Performance | Detective quantum efficiency (DQE) | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) |
| Quantum limited performance | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Modulation transfer function (MTF) | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Effects of aliasing | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Sensitivity linearity | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Lag (Erasure thoroughness) | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Change in detection sensitivity | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Dose requirement and reciprocity changes | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Stability of device characteristics with time | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Uniformity of device characteristic | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Noise power spectrum (NPS) | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Spatial resolution | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Minimum dose | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Image Acquisition time | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Black level | Not explicitly stated | Performed | Satisfactory (Substantially Equivalent) | |
| Clinical Performance | Concurrence Study (Image Comparison) | K120020 | ViVIX-S with VXvue | No significant differences found |
| Safety and EMC | Electrical safety (IEC 60601-1) | Not explicitly stated | Performed | Satisfactory |
| EMC (IEC 60601-1-2) | Not explicitly stated | Performed | Satisfactory |
Note: The document states that the non-clinical and clinical studies "show that the ViVIX-S with VXvue is substantially equivalent to the predicate devices in the market." For the clinical study, it specifically notes "no significant differences between the images." This implies the acceptance criteria for these metrics were met by demonstrating equivalence or lack of significant difference compared to the predicate. The specific numerical thresholds for "acceptance criteria" are not provided in this document.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): 30 clinical images.
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective. It is implied to be clinical data used for comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document only mentions a "concurrence study" comparing images, but does not detail the methodology for establishing ground truth or who performed the comparison.
4. Adjudication Method for the Test Set
- Not specified. The document simply states "A concurrence study of 30 clinical images was conducted to compare the performance... There were no significant differences." It doesn't describe the adjudication process if multiple reviewers were involved or how disagreements were resolved.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly stated or described. The clinical study was a concurrence study comparing images from the new device to the predicate, not an assessment of human reader performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- While the device itself is a digital X-ray flat panel detector (hardware), and the "VXvue" part is advanced digital imaging process, the study described is a comparison of images produced by the device against a predicate, not an "algorithm-only" performance evaluation in the context of AI. The "advanced digital imaging process" implies software components, but its standalone diagnostic performance is not detailed separately from the hardware's image acquisition.
7. The type of ground truth used
- The implicit "ground truth" for the clinical study was the image quality and diagnostic information provided by the predicate device (K120020). The study aimed to show "no significant differences" between the images of the proposed device and those of the legally marketed predicate. It's a comparison to an established device, rather than an independent expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not applicable/Not specified. This device is a digital X-ray detector, not an AI/ML algorithm that requires a training set in the conventional sense. The "advanced digital imaging process" is mentioned, but there is no indication of a machine learning component requiring a distinct training set. The study focuses on the performance of the imaging hardware and its processing in comparison to the predicate.
9. How the ground truth for the training set was established.
- Not applicable/Not specified, as no training set for an AI/ML algorithm is described in this submission.
§ 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.