(228 days)
VIVIX-S 4386W is indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography. It is intended for both adult and pediatric populations.
VIVIX-S 4386W, a flat panel detector model named; FXRD-4386WB with imaging areas of 43cm x 86cm. The device intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create electrical signals. After the electrical signals are generated, it is converted to digital value, and the Software which acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors. These devices should be integrated with an operating PC and an X-Ray generator. It can be utilized to digitalize x-ray images and transfer for radiography diagnostic.
Here's a breakdown of the acceptance criteria and study information for the VIVIX-S 4386W device, based on the provided text:
Acceptance Criteria and Reported Device Performance
The provided text focuses on demonstrating substantial equivalence to a predicate device (VIVIX-S 1717V, K181003) rather than defining specific acceptance criteria for de novo performance. The acceptance criteria implicitly are that the device performs as well as or better than the predicate device for relevant metrics, and that any differences do not raise new safety or effectiveness concerns.
The comparison table below highlights the performance metrics reported and their relationship to the predicate device.
| Parameter | Predicate Device (VIVIX-S 1717V) | Subject Device (VIVIX-S 4386W) | Equivalence Assessment (from text) |
|---|---|---|---|
| MTF (1lp/mm) | FXRD-1717VA: Horizontal 66, Vertical 67; FXRD-1717VB: Horizontal 58, Vertical 58 | 62 | Substantially Equivalent (Stated "higher than the one of the predicate device models" for FXRD-1717VB, which is consistent with 62 vs 58) |
| DQE (1lp/mm) | FXRD-1717VA: Horizontal 53, Vertical 54; FXRD-1717VB: Horizontal 29, Vertical 29 | 28 | Substantially Equivalent (Stated "little lower" than the predicate device FXRD-1717VB, explicitly noting "not significant (just one 1)p/mm value difference)") |
| Resolution | 3.5 lp/mm | 3.5 lp/mm | Equivalent |
| Spatial Resolution | 3.5 lp/mm | Min. 3.5 lp/mm | Equivalent |
| Field of View | 17 x 17 inch | 17 x 34 inch | Similar (Larger) |
| Pixel Pitch | 0.14mm | 0.14mm | Equivalent |
| Weight | 4.5kg | 8kg (With two battery packs) | Equivalent (Though numerically different, likely considered within acceptable range for a larger form factor) |
| Materials Scintillator | Csl: TI, Gd2O2S:Tb | Gd2O2S:Tb | Substantially Equivalent |
| Communication Method | Wired | Wired / Wireless | Substantially Equivalent (Added Wireless capability) |
| Image Acquisition Time (Wired) | 1.5 sec | Max. 5 sec. (Exposure time is set to 500ms, Excluding exposure time) | Similar (Longer, but likely deemed acceptable given overall performance) |
| Active Area | 430.08 x 430.08 (mm) | 430.08 mm × 860.16 mm; 430.08 mm × 430.08 mm | Substantially Equivalent (Larger option available) |
| Active Array | 3072 x 3072 pixels | 3072 x 6144 pixels; 3072 x 3072 pixels | Substantially Equivalent (Larger option available) |
| Method of Generator Interface | DR Trigger (External Line Trigger); AED (Auto Exposure Detection); Passive Trigger (External Line Trigger) | DR Trigger (External Line Trigger); AED (Auto Exposure Detection); Software Trigger | Substantially Equivalent (Added Software Trigger) |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not explicitly state the number of images or cases used in the clinical study. It only mentions that "a single-blinded concurrence study was conducted."
- Data Provenance: Not specified (e.g., country of origin). The study is described as a "concurrence clinical study," implying prospective data collection for the purpose of the study, but this is not definitively stated.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified (e.g., radiologist with 10 years of experience).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not specified. The study is described as "single-blinded concurrence study," which suggests readers were evaluating images without knowing if they were from the subject or predicate device, but the method for reconciling disagreements or establishing a consensus ground truth is not detailed.
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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:
- MRMC Study: Yes, a "single-blinded concurrence study" was conducted comparing the subject device with the predicate. This is a form of comparative effectiveness study.
- Effect Size (AI Assistance): Not applicable. This study evaluates a digital X-ray detector (hardware plus basic image processing software), not an AI-assisted diagnostic tool. The study aims to show equivalence between the subject device and the predicate device in terms of diagnostic capability, not to demonstrate improvement with AI assistance. The document states, "the study confirmed that the new VIVIX-S 4386W provides images of equivalent diagnostic capability to the predicate devices."
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, non-clinical performance evaluations (MTF, DQE, spatial resolution) were conducted in a standalone manner to assess the physical performance characteristics of the device. However, the "clinical study" aspect would inherently involve human readers to assess "diagnostic capability." The term "standalone" in the context of diagnostic algorithms typically refers to the algorithm making a direct diagnostic output without human review, which is not what this device does. This device is a diagnostic imaging system component, and its images are intended for human interpretation.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for the clinical study is based on expert assessment of diagnostic capability via comparison of images from the subject device to those from the predicate device. The document states "provides images of equivalent diagnostic capability." It does not specify if an independent "ground truth" (e.g., pathology reports, follow-up outcomes) was established for the cases themselves, but rather the relative diagnostic utility of the images produced by the two devices.
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The sample size for the training set:
- Training Set Sample Size: Not applicable. This document describes a medical device (digital X-ray detector) and its associated image acquisition and processing software. It is not an AI/ML algorithm that typically requires a large, annotated training set in the conventional sense for learning specific diagnostic tasks. The "training" for such a system involves engineering and calibration to produce high-quality images.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable for the reasons mentioned above. The development of the VIVIX-S 4386W involves engineering design, physical measurements, and quality control, rather than machine learning training with labeled data.
§ 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.