(252 days)
The KMC-950 is intended to provided fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures. The system may be used for other RF imaging application at physician's discretion.
The KMC-950 is a C-arm X-ray mobile systems consisting of a C-arm stand base and monitor trolley. The C-arm mobile stand holds the high-frequency X-Ray generator, X-ray tube assembly, X-ray controls, image intensifier and CCD camera. Monitor trolley supports the image display TV monitors, image processing and recording devices. KMC-950 are providing a dynamic motion images on the TV monitor in such principles of lower dosage, better image quality and digital manipulation, workflow enhancement, operator and patient comfort and versatility. A general radiographic stationary images are able to produce on x-ray film. Therefore a cassette holder is provided with the mobile system.
The provided text describes a 510(k) submission for the KMC-950 C-arm Mobile X-ray Unit. This submission is for a medical device that generates X-ray images, and its acceptance and evaluation are based on conformance to established performance standards for X-ray systems, not on an "AI algorithm" or "device performance" in terms of classification metrics like AUC, sensitivity, or specificity. Therefore, many of the requested categories in your prompt related to AI model evaluation are not applicable to this document.
However, I can extract and present the information that is relevant from the provided text according to your request categories:
1. Table of Acceptance Criteria and Reported Device Performance
For the KMC-950 C-arm Mobile X-ray Unit, "acceptance criteria" and "reported device performance" are defined by compliance with a set of national and international safety and performance standards for medical electrical equipment and diagnostic X-ray systems. The document states that the device conforms to these standards.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| 21 CFR 1020.30-32: Federal Performance Standard for Diagnostic X-ray Systems | Conformance to all applicable performance standards promulgated by FDA for these systems. |
| IEC 60601-1-1: Medical Electrical Equipment - Part 1. General Requirements for Safety 1 & 2 | Conformance during performance and compliance testing at manufacturing facility and independent test organization. |
| IEC 60601-1-2: Medical Electrical Equipment Part 1. General Requirements for Safety - 2 (Collateral Standard / Electromagnetic Compatibility - Requirements & Test) | Conformance during performance and compliance testing at manufacturing facility and independent test organization. |
| IEC 60601-1-3: Medical Electrical Equipment - Part 1 (Collateral Standard / General requirement - For radiation protection in diagnostic x-ray equipment) | Conformance during performance and compliance testing at manufacturing facility and independent test organization. |
| IEC 60601-2-7: Medical Electrical Equipment - Part 2, Particular Requirements for the safety of high voltage of diagnostic x-ray generators | Conformance during performance and compliance testing at manufacturing facility and independent test organization. |
| IEC 60601-2-28: Medical Electrical Equipment, X-ray tubes and X-ray Source Assemblies | Conformance during performance and compliance testing at manufacturing facility and independent test organization. |
| IEC 60601-2-32: Medical Electrical Equipment, Part 2 Particular Requirements for the Safety of associated devices of X-ray equipment | Conformance during performance and compliance testing at manufacturing facility and independent test organization. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of X-ray system performance standards. The testing is on the device's adherence to regulatory specifications, not on a dataset for diagnostic accuracy.
- Data Provenance: Not applicable. The testing described is on the physical device and its operational parameters, not on clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth for these standards is established by the technical specifications and requirements of the standards themselves, not by expert consensus on images.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The testing involves objective measurements against established technical standards.
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, this is an X-ray imaging device. This type of study is not relevant for its regulatory clearance.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This document describes an X-ray imaging system, not an AI algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for proving the device meets acceptance criteria is defined by the technical specifications and requirements outlined in the cited national and international performance standards (e.g., 21 CFR 1020.30-32, IEC 60601 series). These standards cover aspects like radiation output, image quality parameters, electrical safety, electromagnetic compatibility, and mechanical integrity, rather than diagnostic accuracy against pathology or outcomes data.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no AI algorithm training described for this device.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable.
§ 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.