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510(k) Data Aggregation
(34 days)
1417WGC Digital Flat Panel X-Ray Detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.
1417WGC 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) 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 DICOM compatible image files by separate console SW (not part of this 510k submission) for a radiographic diagnosis and analysis.
The provided 510(k) submission describes the Rayence 1417WGC Digital Flat Panel X-ray Detector. This device is a modification of a previously cleared device, the 1417WGA. The submission focuses on demonstrating substantial equivalence to the predicate device rather than presenting acceptance criteria against a specific benchmark or a comprehensive study proving new clinical efficacy. Instead, the "acceptance criteria" are implicitly the performance of the predicate device, 1417WGA, and the "study that proves the device meets the acceptance criteria" is a comparative performance evaluation.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Criteria (Predicate: 1417WGA Performance) | Reported Device Performance (1417WGC) |
|---|---|---|
| Image Quality - MTF | Performance of 1417WGA | "almost same with 1417WGA" |
| Image Quality - DQE | Performance of 1417WGA (e.g., 46% at lowest SF) | Higher than 1417WGA at various spatial frequencies (e.g., 49% at lowest SF); "provides almost same Signal to Noise Ratio (SNR) transfer from the input to the output of a detector as a function of frequency." |
| Image Quality - NPS | Performance of 1417WGA | "almost same performance with 1417WGA" |
| A/D Conversion | 14 bit | 14 / 16 bit (improved capability) |
| Physical Dimensions | 460 x 417 x 15.9 mm | 460 x 384 x 15.4 mm (thinner and lighter) |
| Weight | 3.9 kg | 3.1 kg (lighter) |
| Wireless Specifications (Standard) | 802.11a/g/n compliance | 802.11a/g/n compliance (same) |
| Wireless Specifications (Peak Rate) | 300Mbps | 300Mbps (same) |
| Wireless Specifications (Frequency) | 2.4 GHz / 5 GHz | 2.4 GHz / 5 GHz (same) |
| Wireless Specifications (Bandwidth) | 20MHz/40MHz | 20MHz/40MHz (same) |
| Wireless Specifications (MIMO) | 2x2 | 2x2 (same) |
| Safety (Electrical, Mechanical, Environmental) | Compliance with IEC 60601-1:2005 + CORR.1(2006) + CORR(2007) and IEC 60601-1-2:2007 | "All test results were satisfactory." (Implies compliance with the same standards) |
| Clinical Readability | Acceptable image quality for diagnostic procedures by a licensed US radiologist based on 1417WGA. | "comparable or superior to the same view obtained from a similar patient with the 1417WGA," with "superior" spatial resolution and soft tissue contrast on 1417WGC. "No difficulty in evaluating a wide range of anatomic structures necessary to provide a correct conclusion." (Expert opinion after review of clinical images). |
2. Sample Size Used for the Test Set and Data Provenance
- Non-clinical Test Set (MTF, DQE, NPS): Sample sizes are not explicitly stated for these tests, but they were conducted using "identical test equipment and same analysis method described by IEC 6220-1." These are laboratory measurements on the devices themselves.
- Clinical Test Set: Sample size is not explicitly stated. The text mentions "taking sample radiographs of similar age groups and anatomical structures."
- Data Provenance: Not explicitly stated, but given the manufacturer (Rayence Co., Ltd.) is from Korea, and the clinical review was performed by a "licensed US radiologist," it's likely the non-clinical tests were conducted in Korea, and the clinical images could have been acquired there or elsewhere, then reviewed by a US radiologist for the submission. The study is retrospective in the sense that images were "taken" and then "reviewed" for comparative analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: One ("a licensed US radiologist").
- Qualifications: "licensed US radiologist." No specific experience level (e.g., "10 years of experience") is mentioned.
4. Adjudication Method for the Test Set
The adjudication method used for the clinical image review was none, as only one expert reviewed the images from both devices. The expert provided a direct comparative opinion.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted or reported. The clinical evaluation involved a single licensed US radiologist comparing images from the two devices. There is no mention of human readers improving with AI vs. without AI assistance, as this is a comparison between two digital X-ray detectors, not an AI-assisted diagnostic system.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable in the context of this submission. The 1417WGC is a digital X-ray detector, a hardware device that captures images. It does not incorporate an AI algorithm for diagnostic interpretation in a standalone capacity. The performance metrics (MTF, DQE, NPS) are standalone evaluations of the detector's physical image quality characteristics.
7. Type of Ground Truth Used (for the comparative study)
The "ground truth" for the clinical comparison was the expert opinion (expert consensus of one radiologist) on the diagnostic image quality of the radiographs. The goal was to establish "substantial equivalency" in terms of image quality for diagnostic procedures, not to detect specific pathologies.
8. Sample Size for the Training Set
This concept is not applicable here as the device is a hardware X-ray detector, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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