(25 days)
1717SCC 127um and 1717SCC 140um are 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.
While 1717SCC 127um is identical to 1717SCC (K122173), both 1717SCC 127 um and 1717SCC 140um are digital solid state X-ray detectors based on flat-panel technology. These radiographic image detectors and processing unit consist of a scintillator coupled to an a-Si TFT sensor. Both devices are connected to the user PC via wired LAN (ethernet cable) and need to be integrated with a radiographic imaging system. Both devices do not operate as an X-ray generator controller but can be utilized to convert X-ray to light and light to electrical signals for image data digitization.
The RAW files can be further processed as DICOM compatible image files by separate console SW (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.
The provided document describes the 510(k) premarket notification for the Rayence Co., Ltd. 1717SCC 127um and 1717SCC 140um digital flat panel X-ray detectors. It claims substantial equivalence to predicate devices (1717SGN / 1717SCN, K150150 and 1717SCC, K122173). The document focuses on demonstrating that the new devices do not raise new concerns for safety and effectiveness compared to the predicates, rather than establishing specific acceptance criteria and providing a detailed study proving the device meets those criteria.
Therefore, the information below is extracted from the document to infer acceptance criteria and describe the studies conducted in the context of demonstrating substantial equivalence, rather than a direct presentation of pre-defined acceptance criteria met by a single study.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criterion (Inferred from Predicate Equivalence) | Reported Device Performance (1717SCC 140um vs. 1717SCN) |
|---|---|---|
| Intended Use | Same as predicate (general radiographic system, not mammography) | Same |
| Material/Form Factor | Same as predicate | Same |
| Safety Characteristics | Same as predicate (conformance to IEC standards) | Conforms to IEC 60601-1:2005 and IEC 60601-1-2:2007 |
| Performance Characteristics (Overall) | Not to raise new concerns for safety and effectiveness compared to predicate | Performance is "almost same and slightly better" for MTF and DQE at high spatial frequencies; clinical images are "superior" in spatial and soft tissue contrast resolution. |
| MTF (Modulation Transfer Function) | Comparable to or better than predicate | Performed better than 1717SCN, especially from 2 lp/mm. |
| DQE (Detective Quantum Efficiency) | Comparable to or better than predicate | Performed better than 1717SCN, especially from 2 lp/mm. |
| NPS (Noise Power Spectrum) | Comparable to predicate | Testing performed, no explicit comparison statement provided, but implied to be satisfactory given overall claims. |
| Image Quality (Clinical Review) | Diagnostic image quality equivalent to or better than predicate | Clinical images "superior" in spatial and soft tissue contrast resolution; "little difficulty in evaluating a wide range of anatomic structures." |
| Pixel Pitch (140um model) | Does not raise new concerns for safety and effectiveness compared to predicate (139um) | Minor difference, considered not to raise new concerns. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Consideration Report for 1717SCC 140um): The document states "sample radiographs of similar age group and anatomical structures." It does not specify an exact number of cases or images.
- Data Provenance: Not explicitly stated, but the submission is from Rayence Co., Ltd. in Korea. The "clinical consideration report" implies human subjects were involved. The exact country of origin for the clinical data is not specified. It is implied to be prospective for the clinical images used for comparison, as they were "taken from both subject devices" for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: "a licensed physician" is mentioned. This suggests one expert.
- Qualifications of Experts: Identified as "a licensed physician." Specific specializations (e.g., radiologist) or years of experience are not provided.
4. Adjudication Method for the Test Set
- The document states, "reviewed by a licensed physician to render an expert opinion" and "outcome of a comparative review by an expert for both devices." This suggests a single expert review without formal adjudication by multiple experts.
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
- No, an MRMC comparative effectiveness study was not done. The device itself is an X-ray detector, not an AI-assisted diagnostic tool. The document describes a comparison of the image quality produced by the new detectors versus predicate devices, reviewed by a physician. There is no mention of AI assistance or human reader improvement with/without AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was conducted for the device's technical specifications. The non-clinical test report contains MTF, DQE, and NPS test results of 1717SCC_140µm by using the identical test equipment and same analysis method described by IEC 62220-1. This is a technical performance evaluation of the device itself, independent of a human observer's interpretation of images.
7. The Type of Ground Truth Used
- For standalone performance (MTF, DQE, NPS): These are objective physical measurements against established industry standards (IEC 62220-1). The "ground truth" here is the physical performance of the detector under controlled conditions.
- For clinical consideration (image quality review): The "ground truth" was expert opinion/consensus by a licensed physician on the diagnostic image quality and clarity of anatomical structures.
8. The Sample Size for the Training Set
- Not Applicable. The document describes a medical device (an X-ray detector), not a machine learning or AI algorithm that requires a training set. The device itself is characterized by its physical performance and image output, not by a trained model.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As per point 8, there is no training set for this type of device.
§ 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.