(148 days)
1417WGA 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.
1417WGA is a wired/wireless digital X-ray flat panel detector that can acquire radiographic images of human anatomy when used with existing radiographic x-ray systems. 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 X-ray imaging detector consists of a scintillator directly coupled to an a-Si TFT sensor. 1417WGA is designed specifically to be integrated with a console PC system and X-Ray generator to digitalize x-ray images into RAW files. The RAW files can be made to DICOM compatible image files which can be viewed by console SW for a radiographic image diagnosis and analysis.
This submission is for a digital flat panel X-ray detector, 1417WGA, which is very similar to a previously cleared device, 1417PGA. The study conducted to demonstrate substantial equivalence primarily relied on comparing the new device against the predicate device.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantified table format for the new device (1417WGA). Instead, the performance of the 1417WGA is compared directly to the predicate device (1417PGA), with the implication that performing "almost same" as the predicate device meets the acceptance criteria for substantial equivalence.
| Characteristic | Acceptance Criteria (Implied: "almost same as 1417PGA") | Reported Device Performance (1417WGA) | Predicate Device Performance (1417PGA) |
|---|---|---|---|
| Image Quality (MTF) | "almost same" as 1417PGA | "performed almost same with 1417PGA" | - |
| Image Quality (DQE) | "almost same" as 1417PGA | "demonstrated almost same DQE performance" | 42% (at lowest spatial frequency) |
| DQE (at lowest spatial freq.) | "almost same" as 1417PGA | 41% | 42% |
| Image Quality (NPS) | "almost same" as 1417PGA | "exhibited NPS which has almost same performance" | - |
| SNR Transfer | "almost same" as 1417PGA | "provides almost same Signal-to Noise Ratio (SNR) transfer" | - |
| Clinical Image Review | Images from 1417WGA are comparable to 1417PGA by expert opinion | Clinical images reviewed by a licensed US radiologist, expert opinion supports substantial equivalency | - |
| Safety & EMC | Compliance with IEC 60601-1, IEC 60601-1-2, FCC Rule part(s) 47CFR PART 15.107(B) / 47CFR PART 15.109(G) CLASSB | All test results were satisfactory for these standards | - |
2. Sample Size Used for the Test Set and Data Provenance:
- Non-clinical Test Set: The document does not specify a quantitative sample size for the non-clinical tests (MTF, DQE, NPS). It states that both 1417WGA and 1417PGA were tested using identical equipment and analysis methods.
- Clinical Test Set: The document simply states "clinical images are taken from both devices" (1417WGA and 1417PGA). A specific number of images or patients is not provided.
- Data Provenance: Not explicitly stated, but the company is based in South Korea. The U.S. Designated agent is in Houston, TX. No specific country of origin for the data is mentioned. The study is retrospective as it compares the new device to a predicate device that was already cleared and presumably has a history of use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: "a licensed US radiologist" (singular).
- Qualifications of Experts: "a licensed US radiologist." No further details on years of experience or specialization are provided.
4. Adjudication Method for the Test Set:
- The document implies a "none" adjudication method in the traditional sense of multiple readers coming to an agreement. It states that "clinical images are taken from both devices and reviewed by a licensed US radiologist to render an expert opinion." This suggests a single expert's opinion was sufficient for the comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not explicitly conducted or reported. The clinical evaluation was based on a single expert's review of images from both devices, not a study comparing human reader performance with and without AI assistance. The device itself is a detector, not an AI interpretation tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the non-clinical performance tests (MTF, DQE, NPS) are considered standalone (algorithm/device-only) evaluations as they measure the intrinsic physical performance of the detector. The device itself is a detector, not an "algorithm" in the sense of AI.
7. Type of Ground Truth Used:
- Non-clinical Tests: Ground truth is established by standardized physical measurements (e.g., MTF, DQE, NPS measurements according to IEC 6220-1).
- Clinical Review: Ground truth is established by expert opinion/consensus from a licensed US radiologist comparing images from the two devices according to established diagnostic radiography evaluation procedures.
8. Sample Size for the Training Set:
- This information is not applicable/not provided. The device is an X-ray detector, not a machine learning algorithm that requires a "training set" for its operation. The performance is based on its physical and electronic characteristics.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as 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.