(206 days)
VIVIX-S 1751S series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film/ screen systems. The VIVIX-S 1751S series is not intended for mammography applications.
The VIVIX-S 1751S, available in models FXRD-1751SA and FXRD-1751SB, features a 17x51 inch imaging area. This device intercepts x-ray photons and uses a scintillator to emit visible spectrum photons. The FXRD-1751SA model uses a Csl:Tl (Thallium doped Caesium lodide) scintillator, while the FXRD-1751SB model uses a Gadox (Gadolinium Oxysulfide) scintillator. These photons illuminate an array of photo (a-SI) detectors, creating electrical signals are then converted to digital values, which are processed by software to produce digital images displayed on monitors. The VIVIX-S 1751S must be integrated with an operating PC and an X-ray generator, and it can communicate with the generator via cable. It is designed for capturing and transferring digital x-ray images for radiography diagnosis. Note that the X-ray generator and imaging software are not included with the VIVIX-S 1751S.
The document describes a 510(k) submission for the VIVIX-S 1751S digital X-ray detector. The acceptance criteria and the study proving the device meets these criteria are primarily demonstrated through a comparison to a predicate device (K190611) and performance testing based on established standards.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device in terms of technological characteristics and performance metrics, as well as compliance with recognized standards. The "performance" column shows the subject device's reported values relative to the predicate device.
| Parameter | Acceptance Criteria (Predicate Device K190611, FXRD-1751SB) | Reported Device Performance (Subject Device K241125, FXRD-1751SA) | Equivalence |
|---|---|---|---|
| Technological Characteristics | Same as Predicate device | Same as Predicate device | Substantially Equivalent |
| Intended Use | VIVIX-S 1751S series is used for general-purpose diagnostic procedures, and to replace radiographic film/screen systems. Not for mammography. | VIVIX-S 1751S series is used for general-purpose diagnostic procedures, and to replace radiographic film/screen systems. Not for mammography. | Equivalent |
| Operating Principle | Same as Predicate device | Same as Predicate device | Equivalent |
| Design Features | Same as Predicate device | Same as Predicate device | Equivalent |
| Communication Method | Same as Predicate device | Same as Predicate device | Equivalent |
| Resolution | Same as Predicate device | Same as Predicate device | Equivalent |
| Scintillator Type | Gadox | CsI (FXRD-1751SA), Gadox (FXRD-1751SB) | Different scintillator for FXRD-1751SA model, but performance shown to be comparable. FXRD-1751SB is identical. |
| Performance (Optical / Imaging) | |||
| MTF (0.5 lp/mm) | ≥ 81 | ≥ 83 | Similar |
| MTF (1 lp/mm) | ≥ 56 | ≥ 63 | Similar |
| MTF (2 lp/mm) | ≥ 22 | ≥ 30 | Similar |
| MTF (3 lp/mm) | ≥ 9 | ≥ 14 | Similar |
| DQE (0.5 lp/mm) | ≥ 29 | ≥ 38 | Similar |
| DQE (1 lp/mm) | ≥ 22 | ≥ 33 | Similar |
| DQE (2 lp/mm) | ≥ 11 | ≥ 23 | Similar |
| DQE (3 lp/mm) | ≥ 4 | ≥ 14 | Similar |
| Compliance with Standards | Compliance with 21CFR1020.30, 21CFR1020.31, IEC 60601-1, CAN/CSA-C22.2 No. 60601-1, ANSI/AAMI ES60601-1, IEC 60601-1-2 | Complies with all listed standards | Compliant |
| Diagnostic Capability | Equivalent to predicate device | Demonstrated equivalent diagnostic capability | Equivalent |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "A-Qualified Expert Evaluation study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted..." However, it does not specify the sample size of cases/images used in this clinical evaluation study.
The data provenance (country of origin, retrospective/prospective) is not explicitly stated in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions an "Expert Evaluation study" but does not specify the number of experts or their exact qualifications (e.g., "radiologist with 10 years of experience"). It only indicates that it was a "Qualified Expert Evaluation study."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe the adjudication method used for the expert evaluation study.
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
A multi-reader multi-case (MRMC) study was conducted as part of the "Qualified Expert Evaluation study." The primary goal of this study was to confirm that the subject device (VIVIX-S 1751S - FXRD-1751SA) provides images of equivalent diagnostic capability to the predicate device (VIVIX-S 1751S - FXRD-1751SB).
The document does not mention the involvement of AI in this study, nor does it quantify any improvement of human readers with AI assistance. The study described is a comparison of two different X-ray detector technologies, not an AI-assisted reading study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is an X-ray detector, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance without a human-in-the-loop is not applicable in the same way it would be for an AI diagnostic software. The performance metrics reported (MTF, DQE) are physical image quality parameters of the detector itself, which could be considered "standalone" in this context as they characterize the device's inherent imaging capability.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the "clinical test" (Expert Evaluation study) was established by "Qualified Expert Evaluation" to assess "equivalent diagnostic capability" of the images. This suggests a form of expert consensus or individual expert readings to determine the diagnostic quality of the images produced by the subject device compared to the predicate. It does not mention pathology or outcomes data as the primary ground truth.
8. The sample size for the training set
The document does not mention a training set in the context of this device because it is a hardware device (X-ray detector), not an AI algorithm that requires a training phase.
9. How the ground truth for the training set was established
Since there is no mention of a training set for an AI algorithm, the question of how its ground truth was established is not applicable to 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.