(107 days)
The XGEO GC80 Digital X-ray Imaging System is intended for use in generating radiographic images of human analomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
The XGEO GC80 digital X-ray imaging system is to be used to take and store image for diagnosis of patients. It consists of the High voltage generator (HVG), Ceiling suspension, Detector, X-ray tube, Patient table, Wall stand, Collimator and etc.
The provided text is a 510(k) Premarket Notification for the SAMSUNG XGEO GC80 Digital Diagnostic X-ray System. It primarily focuses on demonstrating substantial equivalence to a predicate device (also XGEO GC80, K123098) by highlighting similarities and minor differences in new detector components.
Unfortunately, this submission does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria for diagnostic performance, a detailed study proving the device meets those criteria, or information on ground truth establishment, expert involvement, and sample sizes for diagnostic performance evaluation.
Here's a breakdown of what can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Safety Testing | Satisfactory | Standard electrical, mechanical, environmental safety, and EMC testing were conducted according to IEC standards (60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32, 60601-1-2(2001)). |
| Substantial Equivalence | Stated to be substantially equivalent to predicate device K123098. | This is the primary claim of the submission. Differences in resolution, pixel pitch, and communication methods for new detectors were noted but deemed to have minor impacts on safety and performance and not introduce new safety risks. |
| Image Quality (Detectors) | Changes in resolution and pixel pitch were acknowledged for new detectors (S4335-W, S4343-W) compared to cleared detectors (SDX-4336CP, SDX-4343CS), but "affect image quality but has not an effect on safety." No specific quantitative image quality metrics or acceptance criteria are provided. | The submission implies that the image quality is acceptable for its intended use, likely by qualitative comparison or internal testing against the predicate's performance, but no details are given. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for performance evaluation. The document focuses on technical specifications and safety standards rather than clinical performance data with a specific test set.
- Data Provenance: The company is SAMSUNG ELECTRONICS Co., Ltd., based in the Republic of Korea. The testing mentioned (safety, EMC) would likely have been conducted internally or by accredited labs within Korea or globally, but specific provenance for "test set data" in a diagnostic context is not available. The submission implies these are technical tests, not a clinical study on diagnostic accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The submission does not detail any studies involving expert readers or ground truth establishment for diagnostic accuracy.
4. Adjudication Method for the Test Set
- This information is not provided in the document, as no specific diagnostic performance test set or adjudication process is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) submission. This submission focuses on hardware and safety equivalence, not a clinical comparison of diagnostic effectiveness with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study is not mentioned or described. The device is a "Digital Diagnostic X-ray System," implying human operation for image acquisition and interpretation. There is no indication of an AI algorithm or standalone performance being evaluated.
7. The Type of Ground Truth Used
- For the safety and performance claims made, the "ground truth" seems to be adherence to international standards (IEC 60601 series for safety and EMC). For the image quality aspect, it's implied that the new detectors produce diagnostically acceptable images, likely confirmed through internal testing or comparison, but no explicit ground truth (e.g., pathology, clinical outcomes) is detailed.
8. The Sample Size for the Training Set
- This information is not applicable and not provided. The device is an X-ray imaging system, not an AI or machine learning algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable and not provided, as there is no "training set" described for this 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.