(90 days)
The GR10X Digital X-ray Imaging System is intended for use in generating radiographic images of human anatomy. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. This system is not intended for mammographic applications.
This device consists of X-ray control, high-voltage generator, X-ray tube support, irradiation equipment, detectors, patient photography stand, digital imaging device, viewer SW, etc. The detectors and the viewer SW are cleared under the following 510ks.
- VIVIX-S VW(K200418) . Model Names: FXRD-2530VW, FXRD-2530VW PLUS, FXRD-3643VW, FXRD-3643VW PLUS, FXRD-4343VW, FXRD-4343VW PLUS, with imaging areas of 25cm x 30cm, 36cm x 43cm, 43cm x 43cm, respectively.
A high frequency inverter (Inverter) X-sensor voltage device designed to generate X-rays by combination of tube voltage, tube current, irradiation time, etc. so that it can be filmed at various angles for diagnosis of the patient's skeletal, respiratory, and urinary systems. The digital imaging system is used to obtain the images taken by the X-ray unit as radiation from the X-ray unit passes through the human body and is transmitted by the detector 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, VXvue, acquires and processes the data values from the detector. The resulting digital images will be displayed on monitors.
The provided text describes a 510(k) premarket notification for the GR10X Digital X-ray Imaging System (Models GR10X-40K, GR10X-50K). The submission aims to demonstrate substantial equivalence to a predicate device (Ysio, K081722).
Based on the document, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative format for the clinical study. Instead, the "acceptance criteria" for the clinical study is an overarching statement that the device "provides images of equivalent diagnostic capability to the predicate devices."
The reported device performance from the clinical study is:
- "the study confirmed that the GR10X Digital X-ray Imaging System provides images of equivalent diagnostic capability to the predicate devices, the Yiso and its results demonstrate substantial equivalence."
For non-clinical performance (technical specifications), here's a table comparing the subject device's detectors (VIVIX-S VW Series, VIVIX-S 1717V) to the predicate's detector (Trixell Pixium 4343RCE):
| Technical Specifications | Predicate Device (Trixell Pixium 4343RCE) | Subject Device (VIVIX-S VW Series, VIVIX-S 1717V) Reported Performance | Acceptance Criteria (Implicit) | Comparison Result |
|---|---|---|---|---|
| Dimensions | 423.3mm x 425.4 mm | VIVIX-S 4343VW: 460 mm x 460 mm | ||
| VIVIX-S 3643VW: 384mm × 460mm | ||||
| VIVIX-S 2530VW: 287mm x 350mm | ||||
| VIVIX-S 1717V: 460mm x 460mm | Substantially Equivalent | Substantially Equivalent | ||
| Resolution | 2860 x 2874 pixels | VIVIX-S 4343VW: 3072 x 3072 pixels | ||
| VIVIX-S 3643VW: 2560 x 3072 pixels | ||||
| VIVIX-S 2530VW: 2048 x 2560 pixels | ||||
| VIVIX-S 1717V: 3072 x 3072 pixels | Substantially Equivalent | Substantially Equivalent | ||
| Pixel size | 148 µm | VIVIX-S 4343VW: 140µm | ||
| VIVIX-S 3643VW: 140µm | ||||
| VIVIX-S 2530VW: 124µm | ||||
| VIVIX-S 1717V: 140µm | Substantially Equivalent | Substantially Equivalent | ||
| Semiconductor Material | Amorphous silicon, a-Si | Amorphous silicon, a-Si | Substantially Equivalent | Substantially Equivalent |
| Scintillator | Cesium iodide (CsI) | Cesium iodide (CsI), Gadolinium Oxide (Gadox) | Substantially Equivalent | Substantially Equivalent |
| Acquisition Depth | 16 bit | 16 bit | Substantially Equivalent | Substantially Equivalent |
| DQE @ 0.05 lp/mm (2 µGy) | 67% | FXRD-4343VAW: 47% | ||
| FXRD-4343VAW PLUS: 62% | ||||
| FXRD-3643VAW: 45.5% | ||||
| FXRD-3643VAW PLUS: 61% | ||||
| FXRD-2530VAW: 49% | ||||
| FXRD-2530VAW PLUS: 61% | ||||
| FXRD-1717NAW: 50% | ||||
| FXRD-1717NBW: 27% | Substantially Equivalent | Substantially Equivalent | ||
| MTF @ 1 lp/mm | 62% | FXRD-4343VAW: 76% | ||
| FXRD-4343VAW PLUS: 60% | ||||
| FXRD-3643VAW: 74% | ||||
| FXRD-3643VAW PLUS: 61% | ||||
| FXRD-2530VAW: 76% | ||||
| FXRD-2530VAW PLUS: 60% | ||||
| FXRD-1717NAW: 66% | ||||
| FXRD-1717NBW: (value cut off) | Substantially Equivalent | Substantially 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 mentions a "single-blinded concurrence study" as a "clinical test" but does not provide any specific quantitative details regarding the sample size of the test set, or the provenance (country of origin, retrospective/prospective nature) of the data used in this clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not specify the number of experts used or their qualifications for establishing ground truth in the clinical study. It only refers to a "single-blinded concurrence study."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document states "a single-blinded concurrence study was conducted." It does not provide details on the specific adjudication method used (e.g., 2+1, 3+1, or if it was based on individual expert assessment without formal adjudication). The term "concurrence" implies agreement among readings, but the method for achieving or resolving discrepancies is not described.
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
The document describes a "single-blinded concurrence study" comparing the GR10X system to predicate devices. This study aims to confirm "equivalent diagnostic capability." It is not explicitly described as a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving AI assistance for human readers. The device is an X-ray imaging system, not an AI-powered diagnostic aid for human readers. Therefore, no effect size of human readers improving with AI vs without AI assistance is reported or relevant based on the information provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an X-ray imaging system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply in the context of this device's evaluation. The evaluation is focused on the image quality and diagnostic capability of the imaging system itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions a "single-blinded concurrence study" to confirm "equivalent diagnostic capability." While this implies expert interpretation, it does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The phrase "concurrence study" suggests that the comparison was based on human expert interpretations of images from both the subject and predicate devices.
8. The sample size for the training set
The document describes a clinical study for product clearance and does not mention any "training set." This type of submission (510k for a general X-ray system) typically involves demonstrating performance against a predicate device, and not machine learning model training. Therefore, there is no information on a training set sample size.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of a machine learning model, this question is not applicable based on the provided text.
§ 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.