(128 days)
1417PGA 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.
The 1417PGA is a portable digital X-ray flat panel detector that can generate images of any part of the body. This X-ray imaging system consists of a scintillator directly coupled to an a-Si TFT sensor. It makes high-resolution, high-sensitive digital images. 1417PGA is designed specifically to be integrated with an operating PC and a X-ray generator to digitalize X-ray images into RAW files. The RAW files can be made to DICOM compatible image files for a radiographic diagnosis and analysis by console SW.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: 1417PGA Digital Flat Panel X-ray Detector
Predicate Device: SDX-4336CP by Samsung Mobile Display Co., Ltd. (K102321)
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating substantial equivalence to the predicate device, rather than defining explicit "acceptance criteria" against a fixed benchmark. The performance is compared directly against the predicate device. The primary performance metrics mentioned are Modulated Transfer Function (MTF) and Detective Quantum Efficiency (DQE).
| Metric | Acceptance Criteria (Compared to Predicate Device SDX-4336CP) | Reported Device Performance (1417PGA) |
|---|---|---|
| MTF (Modulated Transfer Function) | Equivalent or better resolution performance and sharpness | Performed better than SDX-4336CP at 0-2.2 lp/mm due to smaller pixel size (127 µm vs 143 µm) and new bonding mechanism. |
| DQE (Detective Quantum Efficiency) | Equivalent or better ability to visualize object details of a certain size and contrast; higher Signal-to-Noise Ratio (SNR) transfer | Demonstrated better DQE performance than SDX-4336CP at various spatial frequencies. Zero-frequency DQE values: 1417PGA (0.761) > SDX-4336CP (0.740). |
| NPS (Noise Power Spectrum) | (Implied better image quality through reduced noise) | Exhibited NPS which has lower performance than SDX-4336CP, indicating reduced noise and improved image accuracy. |
| Diagnostic Image Quality (Clinical) | Equivalent or "better diagnostic image quality" in expert review | Clinical images reviewed by a licensed US radiologist found equivalent or better diagnostic image quality compared to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Non-clinical (MTF, DQE, NPS) Test Set: The sample size is not explicitly stated. The report mentions "the MTF, DQE and NPS test results of 1417PGA and SDX-4336CP by using the identical test equipment and same analysis method described by IEC 62220-1." This suggests controlled laboratory measurements, not a patient-based dataset.
- Clinical Test Set: The sample size for clinical images is not explicitly stated. It mentions that "clinical images are taken from both devices."
- Data Provenance: The submission is from Rayence Co., Ltd. in Korea. The "non-clinical test report and clinical consideration report were prepared and submitted to FDA separately." The clinical images for the expert review were compared "according to age group and anatomical structures." The country of origin for the clinical data is not specified, but the expert reviewer is a "licensed US radiologist."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Non-clinical: Ground truth was established through physical measurements and standard analysis methods (IEC 62220-1). No human experts were involved in establishing ground truth for these objective metrics.
- Clinical: "a licensed US radiologist" was used for the expert opinion on clinical images. The specific qualifications beyond "licensed US radiologist" (e.g., years of experience, subspecialty) are not provided. The number of experts was one.
4. Adjudication Method for the Test Set
- Non-clinical: Not applicable, as ground truth was established by objective measurements based on standards like IEC 62220-1.
- Clinical: Not applicable. The expert review was a single reader's opinion. There is no mention of multiple readers or an adjudication process. The phrasing "a licensed US radiologist to render an expert opinion" suggests a single-reviewer assessment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not explicitly stated or described. The clinical assessment involved a single radiologist reviewing images from both devices. There is no mention of measuring how much human readers improve with AI vs. without AI assistance, as this device itself is a digital X-ray detector, not an AI-powered diagnostic tool. The comparison is between two different hardware detectors.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Yes, the non-clinical performance testing (MTF, DQE, NPS) represents standalone performance of the detector hardware without human interpretation. These are objective measurements of the device's image quality characteristics. The device itself is a digital X-ray panel, not an algorithm that outputs a diagnostic decision; its "standalone" performance is its ability to acquire high-quality images.
7. The Type of Ground Truth Used
- Non-clinical (MTF, DQE, NPS): The ground truth was established through physical measurements and standardized testing procedures (IEC 62220-1).
- Clinical: The "ground truth" for the clinical comparison was essentially the expert opinion of a single licensed US radiologist comparing the diagnostic image quality of images produced by both the proposed and predicate devices. This is a form of expert consensus, albeit from a single expert.
8. The Sample Size for the Training Set
Not applicable. This device is a digital X-ray detector (hardware), not an AI algorithm that requires a training set. The submission is for a medical imaging device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this hardware 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.