(122 days)
ViVIX-S 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 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. It can do 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, sharing of image information on network.
Here's a breakdown of the acceptance criteria and the study details for the ViVIX-S device, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The document describes both non-clinical and clinical studies conducted to demonstrate substantial equivalence to predicate devices. The acceptance criteria are implicitly met by showing "no significant differences" in the clinical study and "satisfactory" results and "substantially equivalent" characteristics in the non-clinical studies.
| Acceptance Criteria Category | Reported Device Performance (ViVIX-S) |
|---|---|
| Non-clinical Performance | |
| Detective Quantum Efficiency (DQE) | Substantially equivalent to predicate device |
| Quantum Limited Performance | Substantially equivalent to predicate device |
| Modulation Transfer Function (MTF) | Substantially equivalent to predicate device |
| Effects of Aliasing | Substantially equivalent to predicate device |
| Sensitivity Linearity | Substantially equivalent to predicate device |
| Lag (Erasure Thoroughness) | Substantially equivalent to predicate device |
| Change in Detection Sensitivity | Substantially equivalent to predicate device |
| Dose Requirement & Reciprocity | Substantially equivalent to predicate device |
| Stability of Device Characteristics with Time | Substantially equivalent to predicate device |
| Uniformity of Device Characteristic | Substantially equivalent to predicate device |
| Noise Power Spectrum (NPS) | Substantially equivalent to predicate device |
| Spatial Resolution | Substantially equivalent to predicate device |
| Minimum Dose | Substantially equivalent to predicate device |
| Image Acquisition Time | Substantially equivalent to predicate device |
| Black Level | Substantially equivalent to predicate device |
| Clinical Performance | |
| Image Concurrence Study | No significant differences compared to predicate device images |
| Electrical Safety & EMC | |
| IEC 60601-1 (Electrical Safety) | All test results were satisfactory |
| IEC 60601-1-2 (EMC Testing) | All test results were satisfactory |
Study Details
Here's the detailed information about the studies conducted:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: 30 clinical images.
- Data Provenance: Not explicitly stated, but given the manufacturer is based in South Korea, it is likely the data was collected there. The study is described as a "concurrence study," which often implies prospective collection for the purpose of the study, though it's not explicitly stated as retrospective or prospective.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number of experts used or their qualifications for the clinical image concurrence study. It only states a "concurrence study of 30 clinical images was conducted to compare the performance of the ViVIX-S to the predicate device."
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Adjudication method for the test set:
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical image concurrence study. It implies a comparison without detailing the consensus process.
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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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not done. This study solely compared the image quality of the new device to a predicate device. The device is a "Digital Flat Panel X-ray Detector," not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The clinical study was a "concurrence study" of images. While not explicitly stated as "standalone algorithm performance," the nature of comparing image quality to a predicate device implies an assessment of the device's output (the image) rather than a human reading process. The non-clinical studies (DQE, MTF, NPS, etc.) are inherently standalone assessments of the device's physical performance characteristics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical study, the "ground truth" was implicitly established by the images from the predicate device (K090742) being the standard against which the ViVIX-S images were compared. The statement "There were no significant differences between the images of the ViVIX-S and the predicate device images" indicates the predicate device's image quality was the benchmark. There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for diagnostic accuracy.
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The sample size for the training set:
- The document does not mention a training set or any machine learning/AI components that would require one. The ViVIX-S is a hardware device (a digital X-ray detector).
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How the ground truth for the training set was established:
- As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.
§ 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.