(28 days)
1417WCC 127um and 1417WCC 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 1417WCC 127um digital X-ray detector is identical to 1417WCC (K141566), both 1417WCC 127 um and 1417WCC 140 um are wired/wireless digital solid state X-ray detectors that are 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. These radiographic image detectors and processing unit consist of a scintillator coupled to an a-Si TFT sensor. These devices 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 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 (K160579 / Xmaru View V1 and Xmaru PACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.
The provided text describes Rayence Co., Ltd.'s 510(k) summary for their 1417WCC_127µm and 1417WCC_140µm digital flat panel X-ray detectors. The primary goal of the submission is to demonstrate substantial equivalence to predicate devices, namely 1417WCA (K130935) and 1417WCC (K141566).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific thresholds for performance metrics. Instead, it relies on demonstrating "similar" or "superior" performance compared to predicate devices, especially regarding MTF and DQE.
However, based on the provided text, we can infer the performance comparisons made:
| Characteristic | Acceptance Criteria (Implied: Similar to/Better than Predicate) | Reported Device Performance (1417WCC_127µm & 1417WCC_140µm) |
|---|---|---|
| Intended Use | Same as predicate (General radiography, not mammography) | Same as predicate |
| Detector Type | Same as predicate (Amorphous Silicon, TFT) | Amorphous Silicon, TFT |
| Scintillator | Same as predicate (CsI:Tl) | CsI:Tl |
| Imaging Area | Same as predicate (14 x 17 inches) | 14 x 17 inches |
| Pixel Matrix | Similar to predicate | 127: 3328 X 2816; 140: 3052 X 2500 (Different from predicate 127µm but deemed similar) |
| Pixel Pitch | Similar to/Same as predicate | 127 µm, 140 µm (Predicate was 127 µm, so 127 µm is same, 140 µm is different but considered acceptable) |
| Resolution | Same as predicate (3.9 lp/mm) | 3.9 lp/mm |
| A/D Conversion | Similar to predicate | 14 bit for 127 µm / 16 bit for 140 µm (Predicate was 14 bit) |
| Preview Time | Similar to predicate | ≤2 seconds (wired / wireless) (Predicate was 2 |
| Data Output | Same as predicate (RAW, convertible to DICOM 3.0) | RAW, convertible to DICOM 3.0 |
| Dimensions | Similar to predicate | 460 × 384 × 15 mm (Predicate was 460 × 417 × 15.9 mm, so similar/slight improvement for 140µm) |
| Weight | Similar to predicate | 3.0 kg (incl. battery) (Predicate was 3.9 kg, so lighter/superior for 140µm) |
| MTF Performance (from 2 lp/mm to 3.5 lp/mm) | Similar to predicate (1417WCA) | "similar MTF performance" |
| DQE Performance (from 2 lp/mm to 3.5 lp/mm) | Similar to predicate (1417WCA) | "similar DQE performance" |
| Diagnostic Image Quality (Clinical Evaluation) | Diagnostically acceptable and comparable to predicate, ideally superior. | "superior to the same view obtained from a similar patient with the predicate devices, 1417WCA." and "little difficulty in evaluating a wide range of anatomic structures necessary to provide a diagnostic review." |
| Safety and Effectiveness Concerns | No new concerns compared to predicate | "differences do not raise new concerns for the safety and effectiveness" |
| Electrical, Mechanical, Environmental Safety | Compliance with IEC 60601-1:2005 and IEC 60601-1-2: 2007 | Satisfactory results |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: Not explicitly stated. The text mentions "sample radiographs of similar age groups and anatomical structures" but does not quantify the number of images or patients.
- Data Provenance: Not explicitly stated. The origin (e.g., country) of the clinical images is not provided. It is not stated whether the study was retrospective or prospective, though the description of taking "sample radiographs" suggests it was likely a prospective acquisition for the purpose of the comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: "a licensed US doctor" is mentioned, implying a single expert.
- Qualifications of Experts: "a licensed US doctor" is the only qualification provided. No specialty (e.g., radiologist) or years of experience are specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The evaluation was performed by a single licensed US doctor, so there was no need for adjudication for consensus among multiple readers.
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
- MRMC Study: No. The study described is a comparison of two devices by a single expert, not an MRMC study comparing human readers with and without AI assistance. The device itself is a digital X-ray detector, not an AI-powered diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of an AI algorithm. The device is a hardware detector. However, non-clinical performance (MTF, DQE, NPS) was evaluated for the device itself. This can be considered a "standalone" evaluation of the detector's physical performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the clinical evaluation, the "ground truth" was established by the expert opinion of a licensed US doctor based on the visual assessment of diagnostic image quality from sample radiographs. There is no mention of pathology or outcomes data as ground truth. For the technical performance, physical measurements (MTF, DQE) against established standards (IEC 62220-1) served as the ground truth.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. The devices are digital X-ray detectors, not AI algorithms that require training sets.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set for these hardware devices.
Summary of Studies and Evidence:
The submission relies on a combination of technical performance testing and a clinical evaluation to demonstrate substantial equivalence:
-
Technical Performance Testing:
- Standards: IEC 62220-1 for MTF, DQE, and NPS tests.
- Measurements: MTF and DQE were measured for the 1417WCC_140µm detector and compared to the predicate 1417WCA. The results indicated "similar MTF and DQE performance."
- Other Tests: Electrical, mechanical, and environmental safety and performance testing according to IEC 60601-1:2005 and IEC 60601-1-2: 2007, which yielded "satisfactory results."
- Risk Management: FMEA method was used to analyze risks, and identified hazards were reportedly mitigated.
-
Clinical Evaluation:
- Methodology: Sample radiographs of "similar age groups and anatomical structures" were taken using both the 1417WCC_140µm and the predicate 1417WCA device.
- Assessment: A "licensed US doctor" reviewed the images and rendered an "expert opinion."
- Findings: The expert found images from the 1417WCC_140µm to be "superior to the same view obtained from a similar patient with the predicate devices," specifically noting better clarity in soft tissues and "little difficulty in evaluating a wide range of anatomic structures necessary to provide a diagnostic review."
The overall conclusion is that based on these non-clinical and clinical considerations, the subject devices are substantially equivalent to the predicate devices in terms of diagnostic image quality, safety, and effectiveness.
§ 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.