(149 days)
VIVIX-S 1717N (FXRD-1717NA, FXRD-1717NB, FXRD-1717NAW and FXRD-1717NBW) 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.
Models FXRD-1717NA, FXRD-1717NB, FXRD-1717NAW and FXRD-1717NBW intercept 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, these are converted to a digital value, and an image will be displayed on the monitor.
These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.
Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, and image information sharing on the network.
Models XRD-1717NA, FXRD-1717NB, FXRD-1717NAW and FXRD-1717NBW are digital X-ray flat panel detectors, and each model has a 10 x 12 inch imaging area.
FXRD-1717NA and FXRD-1717NB communicate by using a wired communication feature (Gigabit Ethernet communication method by connecting to a tether cable), while FXRD-1717NAW and FXRD-1717NBW communicate by using a wireless communication feature (IEEE 602.lla/b/g/n).
The scintillator used in FXRD-1717NA and FXRD-1717NAW is Csl. Gadox was used for FXRD-1717NB and FXRD-1717NBW.
The FXRD-1717N series is designed to be used with any certified X-ray generators that features DR Trigger mode and is marketed legally. When the DR Trigger mode is not desired, then the connection with the generator can be maintained with AED mode. FXRD-1717N is not designed to function as an X-ray control. The AED mode does not require integration procedure since there is no connection requirement between the X-ray System and the detector. The subject device can receive any types of x-ray signals without SW.
For the DR Trigger mode, the generator interface cable connects the SCU and the X-ray generator. The head of the cable is connected with one of the port (EXT-INF) of the SCU, and the other end of the cable (which is stripped) is connected to the generator's socket.
This document (K152894) describes a 510(k) premarket notification for the VIVIX-S 1717N digital flat panel X-ray detector. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a specific clinical acceptance criterion with a novel AI device. Therefore, much of the requested information about AI performance, multi-reader multi-case studies, and detailed ground truth for training data is not applicable or available in this document.
However, I can extract and infer information about the acceptance criteria for a medical imaging device's performance through comparison to a predicate device, as well as the study conducted to demonstrate this equivalence.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" for quantitative clinical performance metrics of the device in a table format as one might expect for a new AI diagnostic device. Instead, it demonstrates substantial equivalence to predicate devices based on technological characteristics and image quality assessments. The "acceptance criteria" are implicitly met if the device's performance metrics are comparable to or better than the predicate's.
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| DQE (Gadox) | 0.5 lp/mm: 37, 1 lp/mm: 31, 2 lp/mm: 20, 3 lp/mm: 11 | "Similar performance characteristics" to predicate. Implicitly, meets or exceeds these values. Values shown for predicate: 0.5 lp/mm: 37, 1 lp/mm: 31, 2 lp/mm: 20, 3 lp/mm: 9 (Reference), 3 lp/mm: 11 (Primary Predicate). The table for the subject device is blank under DQE, implying it is substantially equivalent to these. |
| DQE (CsI) | 0.5 lp/mm: 60, 1 lp/mm: 54, 2 lp/mm: 45, 3 lp/mm: 31 | "Similar performance characteristics" to predicate. Implicitly, meets or exceeds these values. Values shown for predicate: 0.5 lp/mm: 59, 1 lp/mm: 53, 2 lp/mm: 45, 3 lp/mm: 27 (Reference), 3 lp/mm: 31 (Primary Predicate). The table for the subject device is blank under DQE, implying it is substantially equivalent to these. |
| MTF (Gadox) | 0.5 lp/mm: 80, 1 lp/mm: 58, 2 lp/mm: 25, 3 lp/mm: 11 | "Similar performance characteristics" to predicate. Implicitly, meets or exceeds these values. Values shown for predicate: 0.5 lp/mm: 80, 1 lp/mm: 56, 2 lp/mm: 24, 3 lp/mm: 10 (Reference), 3 lp/mm: 11 (Primary Predicate). The table for the subject device is blank under MTF, implying it is substantially equivalent to these. |
| MTF (CsI) | 0.5 lp/mm: 88, 1 lp/mm: 72, 2 lp/mm: 44, 3 lp/mm: 25 | "Similar performance characteristics" to predicate. Implicitly, meets or exceeds these values. Values shown for predicate: 0.5 lp/mm: 81, 1 lp/mm: 58, 2 lp/mm: 28, 3 lp/mm: 15 (Reference) / 0.5 lp/mm: 88, 1 lp/mm: 72, 2 lp/mm: 44, 3 lp/mm: 25 (Primary Predicate). The table for the subject device is blank under MTF, implying it is substantially equivalent to these. |
| Spatial Resolution | 3.5 lp/mm (Predicate) | 3.5 lp/mm (implicitly assumed to be achieved as it's not listed as a difference) |
| Diagnostic Capability | Equivalent to K122865 (ViVIX-S wireless) | "The new x-ray detectors FXRD-1717NA, FXRD-1717NB, FXRD-1717NAW and FXRD-1717NBW provide images of equivalent diagnostic capability to the predicate device (K122865)." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated in terms of number of images or patients. The document only mentions "a single-blinded concurrence study."
- Data Provenance: Not specified in the document (e.g., country of origin). The study is described as a "clinical test, which complied with the requirements specified in the CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices." This suggests a prospective or retrospective collection of images for the comparison, but details are not provided. The study confirms "equivalent diagnostic capability" of the new detectors to the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The study is referred to as a "single-blinded concurrence study," which implies some form of assessment by experts, but the exact method of combining opinions or establishing ground truth isn't detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? The document describes a "single-blinded concurrence study" to assess "equivalent diagnostic capability." While this involves readers and cases, the text does not indicate it was designed as a comparative effectiveness study comparing human readers with AI vs. without AI assistance. The device itself is an X-ray detector, not an AI interpretation algorithm.
- Effect Size of Human Readers with AI vs. without AI assistance: Not applicable, as this is a device for image acquisition, not AI for image interpretation.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
- Was a standalone study done? Not applicable in the context of an AI algorithm. This device is an X-ray detector. Its performance was evaluated based on physical detector characteristics (DQE, MTF, spatial resolution) and a "concurrence study" of its images against a predicate, implying human interpretation of the images produced by the detector.
7. Type of Ground Truth Used for the Test Set
- Type of Ground Truth: The "single-blinded concurrence study" evaluated "equivalent diagnostic capability." This implies that the ground truth for image quality was established through expert assessment of the diagnostic content of the images produced by the subject device compared to the predicate device. It is a form of expert consensus on image diagnosticity, rather than pathology or long-term outcomes data primarily.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document describes a medical imaging device (X-ray detector), not an AI algorithm that requires a training set. The performance data relates to the physical characteristics of the detector and the quality of the images it produces.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as this is a medical imaging device, not an AI algorithm.
§ 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.