(83 days)
The Garion is intended to be used and operated by: adequately trained, qualified and authorized health care professionals who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except neonates (birth to one month), within the limits of the device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.
GARION is mobile fluoroscopy system is designed to provdie fluoroscopic and spot-film images of thepatient during diagnostic, surgical procedures. This device is a digital X-ray radiographic equipment that consists of high voltage generator, X-ray control unit, X-ray tube unit, Collimator, image processing unit. The image processing unit consists of medical image detector, power supply, medical image collecting unit and relevant software.
The provided text describes a 510(k) premarket notification for a medical device called "Garion", an image-intensified fluoroscopic x-ray system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device, "Zenition 70".
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document focuses on demonstrating substantial equivalence to a predicate device rather than defining specific performance acceptance criteria for the Garion device against a set of quantitative metrics. The "performance" is implicitly assessed through a comparison of technical characteristics to the predicate.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Comparison to Predicate: Zenition 70 K183040) |
|---|---|
| Indications for Use | Same as predicate |
| X-ray Tube Anode Type | Rotating Anode (Same as predicate) |
| X-ray Tube Anode Target Angle | 10° (Same as predicate) |
| X-ray Tube Focal Size | 0.3/0.6 (Same as predicate) |
| Fluoroscopic Mode kV range | 40-125 kV (Similar, slightly higher peak kVp than predicate's 40-120 kV) |
| Fluoroscopic Mode mA range | 0.1-100 mA (Similar, slightly higher mA than predicate's 0.5-60 mA) |
| Pulse Fluoro | YES (Same as predicate) |
| ABS function | YES (Same as predicate) |
| FPD Scintillator | Cesium Iodide (Same as predicate) |
| FPD Detector type | Amorphous silicon detector (Same as predicate) |
| FPD Active detector size | 228.6 mm x 228.6 mm (Similar, slightly larger image than predicate's 207x207 mm) |
| FPD Total pixel matrix | 1024x1024 (Similar to predicate's 1344x1344) |
| FPD Pixel pitch | 205 μm (Similar to predicate's 154 μm) |
| FPD A/D Conversion | 16 bit (Same as predicate) |
| FPD MTF (1.0 lp/mm) | 0.64 (Similar, slightly better than predicate's 0.59) |
| FPD DQE (0 lp/mm) | 0.77 (Same as predicate) |
| SID | 980mm (Similar to predicate's 993mm) |
| C-arm Rail Rotation Range | ±180° (Similar to predicate's ±200°) |
| Linear FR-arm Movement Range | 200mm (Same as predicate) |
| Linear T-arm Movement Range | 400mm (Similar to predicate's 490 mm) |
| Swing-arm Rotation Range | ±15° (Similar, slightly better than predicate's ±10°) |
| Collimator Control | Motor control / rotation (Same as predicate) |
The acceptance criterion, in this context, is that the Garion device's technological characteristics are substantially equivalent to the predicate device, implying similar safety and effectiveness. The reported performance is the direct comparison of these characteristics.
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly states: "9. Summary of clinical testing: Not required for a finding of substantial equivalene." This indicates that no clinical test set was used to evaluate the device's performance against specific acceptance criteria. The evaluation relies on comparing the technical specifications of the new device to the predicate device and adherence to relevant IEC standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Since no clinical test set was used, there were no experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The document states that clinical testing was not required for substantial equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The "Garion" is an X-ray system, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in the same way as it would be for a pure software device. The evaluation is of the hardware and integrated software for image acquisition and display.
7. The Type of Ground Truth Used:
The "ground truth" for the substantial equivalence claim is effectively the established safety and effectiveness of the legally marketed predicate device (Zenition 70), supported by the device's compliance with applicable performance standards (IEC and FDA Radiation Safety Performance Standard). The comparison of technical specifications aims to show that the Garion device is sufficiently similar to the predicate to assume similar safety and effectiveness.
8. The Sample Size for the Training Set:
The concept of a "training set" is typically associated with machine learning or AI algorithms. Since this submission is for an X-ray system and does not mention any AI components requiring supervised learning, there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set or AI algorithms requiring ground truth establishment.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.