(30 days)
Edge is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general purpose diagnostic procedures. Not to be used for mammography.
Edge digital flat panel X-ray detector is based on flat-panel technology. 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 (K160579 / XmaruView V1 and XmaruPACS/ Rayence Co.,Ltd.) for a radiographic diagnosis and analysis.
The provided text describes the 510(k) submission for the "Edge Digital Flat Panel X-ray Detector" and its substantial equivalence to a predicate device, the "1717SCC_140µm". The performance testing described primarily focuses on demonstrating this equivalence through non-clinical (bench) testing and a clinical consideration report.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for the device's performance in the typical sense of a target value that must be met for approval. Instead, the acceptance criteria for the study proving substantial equivalence appears to be based on the similarity of performance characteristics to the predicate device.
The performance characteristics used for comparison are:
| Characteristic | Acceptance Criteria (Implicit: Similar/Not Inferior to Predicate) | Reported Device Performance (Edge) | Predicate Device Performance (1717SCC_140µm) | Remarks |
|---|---|---|---|---|
| Intended Use | Same | Digital imaging solution for general radiographic system for human anatomy; replace film or screen-based systems; not for mammography. | Digital imaging solution for general radiographic system for human anatomy; replace film or screen-based systems; not for mammography. | Same |
| Detector Type | Same | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Same |
| Scintillator | Same | CsI:Tl | CsI:Tl | Same |
| Imaging Area | Same | 17 x 17 inches (3072 x 3072 matrix) | 140 type : 3072 x 3072 | Same |
| Pixel Matrix | Same | 3072 x 3072 | 3072 x 3072 | Same |
| Pixel Pitch | Same | 140 µm | 140 µm | Same |
| Resolution | Similar | 3.9 lp/mm | 3.9 lp/mm | Same |
| A/D conversion | Same | 14 / 16 bit | 14 / 16 bit | Same |
| Preview Time | Same or better | ≤2 | ≤2 | Same |
| MTF (@1 lp/mm) | Similar / Not inferior | 59.1 (%) | 58.2 (%) | Similar (Edge marginally better) |
| DQE | Similar / Not inferior | 76 (%) | 74 (%) | Similar (Edge marginally better) |
| Data Output | Same | RAW (convertible to DICOM 3.0) | RAW (convertible to DICOM 3.0) | Same |
| Imaging Software | Same | Xmaru View 1 / Xmaru PACS (Version 2.0.0) | Xmaru View 1 / Xmaru PACS (Version 2.0.0) | Same |
| Dimensions | Same | 460 x 460 x 15.5 mm | 460 x 460 x 15.5 mm | Same |
| Weight | Same | 4 kg | 4 kg | Same |
| Application | Same | General Radiology system or Portable system | General Radiology system or Portable system | Same |
| Clinical Image Quality | Superior or equivalent to predicate | Superior to predicate in spatial and soft tissue contrast resolution. | - | Clinical consideration by expert |
2. Sample size used for the test set and the data provenance
The document states: "To further demonstrate the substantial equivalency of two devices, clinical images are taken from both subject devices and reviewed by a licensed US radiologist to render an expert opinion."
- Sample Size: Not explicitly stated as a number of images or patients. It mentions "sample radiographs of similar age group and anatomical structures". This suggests a limited sample size rather than a large clinical trial.
- Data Provenance:
- Country of Origin: US (implied by "licensed US radiologist").
- Retrospective or Prospective: Not explicitly stated, but the description "clinical images are taken from both subject devices and reviewed" and "sample radiographs... taken" suggests these were specifically acquired for this comparison, implying a prospective data collection for the purpose of the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: "a licensed US radiologist" - One (1) expert.
- Qualifications: "licensed US radiologist". No specific years of experience or subspecialty are provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: None mentioned. The single radiologist's opinion appears to be the sole basis for the clinical image quality assessment ("reviewed by a licensed US radiologist to render an expert opinion").
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, an MRMC study was not conducted. This study's purpose was to demonstrate substantial equivalence between two X-ray detectors, not to evaluate AI assistance for human readers. The device itself is an X-ray detector, not an AI algorithm for improving reader performance.
- Effect Size: Not applicable as no such study was performed or needed for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The device is an X-ray detector. Its performance is standalone in terms of image acquisition (MTF, DQE, etc.). The "clinical consideration" involved human review of the images produced by the device, but this was to compare the image quality of the device to its predicate, not to assess an AI's diagnostic performance without a human. The non-clinical tests (MTF, DQE) are indeed "standalone" measures of the detector's physical performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The term "ground truth" isn't explicitly used in the context of diagnostic findings. For the non-clinical tests (MTF, DQE), the "ground truth" is established by adherence to IEC 62220-1 standards for objective physical performance measurements.
- For the "clinical consideration" part, the "ground truth" for image quality comparison was the expert opinion of a single licensed US radiologist. This is a subjective assessment of image characteristics ("spatial and soft tissue contrast resolution are superior"). There's no mention of a diagnostic "ground truth" (e.g., presence/absence of disease confirmed by pathology or other means) being established for the clinical images used for review. The focus was on comparing the quality of the images produced by the devices, not on the diagnostic accuracy of those images for specific conditions.
8. The sample size for the training set
- This information is not applicable and not provided. The "Edge Digital Flat Panel X-ray Detector" is an imaging hardware device, not an AI algorithm that requires a training set. The clinical consideration involved comparing images produced by two hardware devices.
9. How the ground truth for the training set was established
- This information is not applicable and not provided as the device is not an AI algorithm requiring a training set.
§ 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.