(23 days)
The detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications.
The detector functions by intercepting X-ray photons. Then the scintillator emits visible spectrum photons that illuminate an array of photo detectors (a-Si) that create electrical signals. The electrical signals are then digitally converted to display an image on the monitor.
The detector should be connected to a computer and X-ray generator for transfer of diagnostic images (the x-ray generator and the computer are not part of the submission). The functions of the YosemiteView 4343W/ YosemiteView 3643W are supported by software and the software is of Moderate level of concern. The main function of software is image acquisition and transfer. The detectors can be used for dynamic imaging (fluoroscopy) that is same as Predicate Device.
The provided document is a 510(k) Summary for the CareRay Digital Medical Technology Co., Ltd. YosemiteView 4343W/YosemiteView 3643W X-ray Flat Panel Detectors. It aims to demonstrate substantial equivalence to a predicate device, the EverestView 4343X.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a table format with performance targets. Instead, it provides a "Comparison with the predicate device" table that lists technical specifications for both the proposed device and the predicate device. The implied acceptance is that the proposed device's performance is, at least, equivalent to or better than the predicate device.
| Item | Proposed Device: YosemiteView 4343W/3643W | Predicate Device: EverestView 4343X | Comparison and Implied Acceptance |
|---|---|---|---|
| Intended Use | The detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications. | The detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. This product is not intended for mammography applications. | Identical |
| Classification Name | Stationary X-ray system | Stationary X-ray system | Identical |
| Product Code | MQB, JAA | MQB, JAA | Identical |
| Regulation Number | 892.1680 | 892.1680 | Identical |
| Panel | Radiology | Radiology | Identical |
| Class | II | II | Identical |
| X-ray Absorber | CsI Scintillator | CsI Scintillator | Identical |
| Installation Type | Wireless, Wired, Cassette (Proposed device adds Wireless capability) | Wired, Cassette | Proposed is enhanced |
| Readout Mechanism | Thin Film Transistor | Thin Film Transistor | Identical |
| Image Matrix Size | YosemiteView 4343W: 4352×4352 pixels | ||
| YosemiteView 3643W: 3584×4352 pixels | EverestView 4343X: 4302 ×4302 pixels | Proposed has larger for 4343W | |
| Pixel Pitch | 100 µm | 100 µm | Identical |
| Effective Imaging Area | YosemiteView 4343W: 430 mm × 430 mm | ||
| YosemiteView 3643W: 430 mm × 356 mm | EverestView 4343X: 430 mm × 430 mm | Proposed matches or is smaller | |
| Grayscale | 16 bit, 65536 grayscale | 16 bit, 65536 grayscale | Identical |
| Spatial Resolution | 5.0 line pair/mm | 5.0 line pair/mm | Identical |
| MTF | ≥65 (@ 1lp/mm) | ||
| ≥35 (@ 2lp/mm) | |||
| ≥20 (@ 3lp/mm) | ≥65 (@ 1lp/mm) | ||
| ≥20 (@ 3lp/mm) | |||
| ≥7 (@ 5lp/mm) | Proposed is better or similar* | ||
| DQE | (@RQA5, 10µGy) | ||
| ≥50 (@ 1lp/mm) | |||
| ≥30 (@ 3lp/mm) | (@RQA5, 2µGy) | ||
| ≥62 (@ 0lp/mm) | |||
| ≥30 (@ 3lp/mm) | |||
| ≥11 (@ 5lp/mm) | Proposed is similar for 3lp/mm, but tested at higher dose; difficult to directly compare 0lp/mm and 1lp/mm given different doses. | ||
| Pixel matrix | 100μm: 4352×4352 (1x1 binning); | ||
| 200μm: 2176x2176 (2x2 binning) (for 4343W) | |||
| 100µm: 3584×4352 (1x1 binning); | |||
| 200µm: 1792x2176 (2x2) (for 3643W) | 100μm: 4302×4302 (1x1 binning); | ||
| 200μm: 2150x2150 (2x2 binning) | |||
| 400 μm: 1074x1074 (3x3 binning) | Proposed matches or is finer binning, 400µm binning not present. |
*Note on MTF: The proposed device reports MTF at 2lp/mm (≥35) which the predicate does not. For 1lp/mm, both are ≥65. For 3lp/mm, the proposed is ≥20 while the predicate is also ≥20. The predicate reports 5lp/mm (≥7) which the proposed does not. Based on available comparable points, the proposed device meets or exceeds the predicate's reported MTF.
2. Sample size used for the test set and the data provenance
The document states "Nonclinical and clinical considerations A: The proposed devices and predicate device share most of primary product specifications including intended use, technology, material, and imaging principle, power supply method etc. The only difference is the wireless function and dimension. The difference of wireless function and dimension don't affect the technological parameters and clinical images."
This statement, coupled with the lack of details on a separate clinical image test set, suggests that a dedicated clinical image test set for comparing performance (e.g., diagnostic accuracy) was likely not used for the substantial equivalence demonstration, beyond confirming the effect of the new features (wireless function and dimension) on "technological parameters and clinical images." The report focuses heavily on technical specifications and electrical safety.
Therefore, information on sample size, country of origin, or retrospective/prospective nature of a clinical test set is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Given the lack of details on a dedicated clinical image test set (as discussed in point 2), there is no information provided about the number or qualifications of experts used to establish ground truth for such a set. The submission relies on "Nonclinical and clinical considerations" that attribute no significant impact from the changes.
4. Adjudication method for the test set
Similarly, because details of a clinical image test set are absent, the adjudication method is not mentioned.
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 the device as an X-ray Flat Panel Detector, which captures images. There is no mention of an AI component or a multi-reader multi-case (MRMC) comparative effectiveness study. The device's function is "image acquisition and transfer" (page 5).
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is an imaging hardware component; it is not an algorithm that performs standalone diagnostic tasks. Therefore, a standalone algorithm performance study was not applicable and not performed/reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As noted in point 2, a specific clinical image test set with established ground truth types (expert consensus, pathology, outcomes data) is not detailed in this document. The submission relies on demonstrating substantial equivalence based on technical specifications and the assertion that differences in wireless function and dimension do not affect technological parameters or clinical images.
8. The sample size for the training set
The device is a hardware component (X-ray Flat Panel Detector), not an AI algorithm requiring a training set in the conventional sense. While there might have been internal testing and calibration data, the document does not refer to a "training set" in the context of machine learning, nor does it provide a sample size for such.
9. How the ground truth for the training set was established
As there is no mention of an AI training set, this information is not applicable or provided.
§ 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.