(27 days)
1012WCC and 1012WGC Digital Flat Panel X-Ray Detector are indicated for digital imaging solution designed for human anatomy including head, neck, cervical spine, arm, leg and peripheral (foot, hand, wrist, fingers, etc.). They are intended to replace film based radio diagnostic systems and provide a case diagnosis and treatment planning for physicians and other health care professionals. Not to be used for mammography.
1012WCC / 1012WGC is a wired/wireless digital solid state X-ray detector that is based on flat-panel technology. The wireless LAN(IEEE 802.11a/g/n/ac) communication signals images captured to the system and improves the user operability through high-speed processing. This radiographic image detector and processing unit consists of a scintillator coupled to an a-Si TFT sensor. This device needs to be integrated with a radiographic imaging system. It can be utilized to capture and digitalize X-ray images for radiographic diagnosis. The RAW files can be further processed as a DICOM compatible image file by a separate console SW program (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a diagnostic analysis.
The provided text describes the 510(k) premarket notification for the Rayence Co., Ltd.'s 1012WCC and 1012WGC Digital Flat Panel X-Ray Detectors. The document focuses on demonstrating substantial equivalence to a predicate device (1012WCA) and a reference device (1210SGA), rather than establishing novel acceptance criteria for a new device type.
Therefore, the acceptance criteria are implicitly defined by demonstrating equivalence to the performance of the predicate and reference devices. The "study" here refers to the performance testing conducted to prove this equivalence.
Here's an analysis of the provided information, framed to address your questions about acceptance criteria and the supporting study:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds to be met, but rather as demonstrating substantial equivalence to the predicate (1012WCA) and reference (1210SGA) devices in key performance metrics. These metrics are:
| Metric | Acceptance Criteria (Implied: Equivalent/Superior to Predicate/Reference) | Reported Device Performance (1012WCC vs 1012WCA) | Reported Device Performance (1012WGC vs 1210SGA) |
|---|---|---|---|
| Modulation Transfer Function (MTF) | Equivalent to predicate/reference at various spatial frequencies. | 1012WCC shows similar/slightly higher MTF than 1012WCA, especially at higher frequencies (e.g., 3.93 lp/mm). | 1012WGC MTF performance "almost same" as 1210SGA. |
| Detective Quantum Efficiency (DQE) | Equivalent to predicate/reference, particularly DQE(0). | 1012WCC DQE(0) = 0.778 (vs. 1012WCA DQE(0) = 0.753). "1012WCC has higher DQE performance at high spatial frequencies, especially from 2.5 lp/mm to 4 lp/mm, compared with 1012WCA." | 1012WGC DQE(0) = 0.437 (vs. 1210SGA DQE(0) = 0.470). Performance results "almost same". |
| Noise Power Spectrum (NPS) | Equivalent to predicate/reference. | Tested (results not explicitly detailed, but implied as satisfactory). | Tested (results not explicitly detailed, but implied as satisfactory). |
| Clinical Image Quality | Diagnostic image quality equivalent/superior to predicate/reference. | "images obtained with the 1012WCC/1012WGC were superior to the same view obtained from a similar patient with the 1012WCA/1210SGA, respectively." Specifically, "both the spatial and soft tissue contrast resolution are superior using the 1012WCC/1012WGC." | "images obtained with the 1012WCC/1012WGC were superior to the same view obtained from a similar patient with the 1012WCA/1210SGA, respectively." Specifically, "soft tissues on extremity films were seen with better clarity." |
| Safety and Performance (Electrical, Mechanical, Environmental) | Conform to IEC 60601-1:2005 and IEC 60601-1-2:2007 standards. | All test results satisfactory. | All test results satisfactory. |
Study Information (Performance Testing)
The document describes "non-clinical test" and "clinical consideration test" to demonstrate substantial equivalence.
-
Sample sizes used for the test set and the data provenance:
- Clinical Consideration Test: The document states "sample radiographs of similar age groups and anatomical structures." It does not specify the exact number of images or patients (sample size) in the clinical test set.
- Data Provenance: Not explicitly stated regarding the origin (e.g., country) of the clinical data. It is a "clinical consideration test," meaning it's likely a small comparative review rather than a large clinical trial. The images are "taken from both subject devices" (1012WCC/WGC) and compared to images from the predicate/reference devices (1012WCA/1210SGA). This suggests a prospective collection of comparison images, not necessarily a large retrospective dataset.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Only one expert was used: "a licensed US radiologist."
- Qualifications: "a licensed US radiologist." No further details on years of experience or subspecialty.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- There was no formal adjudication method described. The review was conducted by a single "licensed US radiologist" who rendered an "expert opinion." This falls into the "none" category for a multi-expert adjudication process.
-
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:
- No MRMC study was done. This study solely focuses on the image quality of the device itself (hardware) compared to predicate devices, not on the interaction of human readers with AI assistance. The devices are flat-panel X-ray detectors, not AI algorithms for interpretation.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone technical performance was done. The non-clinical tests (MTF, DQE, NPS) are standalone evaluations of the device's image quality metrics, independent of human interpretation.
- The "clinical consideration test" is a standalone evaluation of the image quality from the devices by an expert, focusing on diagnostic utility, rather than an "algorithm only" performance. The device itself is the "algorithm" in terms of image generation.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests (MTF, DQE, NPS): The ground truth is based on physical measurements and established international standards (IEC 62220-1) for image performance.
- For the clinical consideration test: The ground truth for image quality assessment was the expert opinion/review of a single licensed US radiologist. There's no mention of pathology or outcomes data to establish clinical ground truth.
-
The sample size for the training set:
- Not applicable / Not explicitly mentioned. The document describes a comparison between new devices and predicate devices, demonstrating substantial equivalence for hardware. It does not describe a machine learning model that would require a "training set." The closest analogy might be the development data used for the original predicate devices, but that's not detailed here.
-
How the ground truth for the training set was established:
- Not applicable. As there's no mention of a machine learning model or training set, this question is not addressed.
§ 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.