(128 days)
KMC-650 Surgical Mobile Fluoroscopic X-ray System is indicated for use in generating fluoroscopic / radioscopic images of human anatomy. This device is not intended for interventional guided procedure & mammographic applications.
The KMC-650 Surgical Mobile Fluoroscopic X-rav System consists of a high voltage (HV) inverter generator. a tube support unit, an X-ray beam limiting device, mobile cart, a detector, operating software, and a tube, and is primarily used in a hospital for diagnosis of diseases in skeletal, respiratory and urinary systems such as the skull, spinal column, chest, abdomen, extremities, and other body parts. Not to be used for mammography.
KMC-650 is a solution to produce radiological images of patient during medical operations. This inverter control X-ray unit visualizes the anatomical structure on screen, which is obtained by X-ray fluoroscopy and the image intensifier. This system can be applied in emergency room, operation room, cast room or etc. of hospital.
This document is a 510(k) Summary for a medical device called the KMC-650 Surgical Mobile Fluoroscopic X-ray System. It asserts substantial equivalence to a predicate device (KMC-950) rather than providing a performance study against specific acceptance criteria for a novel device. Therefore, many of the requested elements for a detailed AI/model performance description are not applicable or cannot be extracted directly from this document.
However, I can extract information related to the device's technical specifications and safety/effectiveness concerns addressed to establish substantial equivalence.
Here's an attempt to answer your questions based on the provided text, noting where the information is not present or relevant to this type of submission:
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A table of acceptance criteria and the reported device performance
This document does not present "acceptance criteria" in the typical sense of a novel device's performance targets (e.g., sensitivity, specificity for a diagnostic algorithm) and then report performance against those. Instead, it argues for "substantial equivalence" to a predicate device (KMC-950). The performance characteristics are compared to the predicate device.
Characteristic Predicate Device (KMC-950) Proposed Device (KMC-650) Acceptance Criteria (Implicit for Substantial Equivalence) Reported Performance (KMC-650) X-ray Tube Varian (RAD-99) Toshiba (DF-151SBR) Functionally equivalent; safe and effective Different manufacturer and model, but no new safety/effectiveness concerns raised. Anode Type Rotating Stationary Functionally equivalent; safe and effective Stationary Heat Capacity 300,000 HU 45,000 HU Sufficient for intended use (1 kW or less fluoro) 45,000 HU. Stated as sufficient as typical fluoroscopy mode requires 1 kW or less. Anode Heat Cooling 70 kHU/min 47 kHU/min Sufficient for intended use 47 kHU/min Focal Size 0.3mm / 0.6mm 0.5mm / 1.5mm Appropriately sized for imaging 0.5mm / 1.5mm X-ray Generator POSKOM (HTC-120) POSKOM (C-650) Functionally equivalent; safe and effective Different model, but high frequency/inverter type for both. Power Output 12.5 kW 2.2 kW Sufficient for intended use (1 kW or less fluoro) 2.2 kW. Stated as sufficient as typical fluoroscopy mode requires 1 kW or less. Fluoro kV range 40 to 125 kV 40 to 110 kV Within clinically acceptable range 40 to 110 kV Fluoro mA range 0.5 to 5 mA 0.5 to 4 mA Within clinically acceptable range 0.5 to 4 mA Pulse Fluoro Yes Yes Present Yes ABS function Yes Yes Present Yes Snap Shot 8.0 mA shot available 8.0 mA shot available Present 8.0 mA shot available Boost Shot 20.0 mA shot available 20.0 mA shot available Present 20.0 mA shot available Image Intensifier Size 9" 9" Same size 9" Magnification 9" / 6" / 4.5" 9" / 6" / 4.5" Same options 9" / 6" / 4.5" Camera Type 1/2" CCD 1/2" CCD CCD CCD Active pixels 512 x 512 1,024 x 1,024 Equivalent or improved (higher resolution shown) 1,024 x 1,024 SID 950mm 1000mm Within acceptable range 1000mm Range of C-arm Rail Rotation 115° (90° / 25°) 135° (90° / 45°) Clinically acceptable 135° (90° / 45°) Image Storage Capacity Digital Digital Digital storage Digital Image Matrix Size 5,000 images 5,000 images Adequate storage 5,000 images Monitor Size 17" 19" Adequate for display (larger shown) 19" Note: The "acceptance criteria" here are implicitly that the proposed device is either equivalent to the predicate or that any differences do not raise new questions of safety or effectiveness. The device "performance" is the technical specification of the KMC-650.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a 510(k) submission for a fluoroscopic X-ray system, which is hardware. It does not mention any "test set" in the context of evaluation of an AI or algorithm. The "studies" referenced are non-clinical engineering and compliance tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/algorithm submission that requires expert-established ground truth for a test set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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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
Not applicable. This device is an X-ray system, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The ground truth for this device's performance validation would be based on physical measurements of radiation output, image quality metrics (resolution, contrast, noise), electrical safety, EMC compliance, etc., according to recognized standards.
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The sample size for the training set
Not applicable. There is no training set for this hardware device.
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How the ground truth for the training set was established
Not applicable.
Summary of Device Safety and Effectiveness from the Document:
The document primarily focuses on establishing Substantial Equivalence between the KMC-650 and its predicate device, KMC-950. The safety and effectiveness of the KMC-650 are asserted through:
- Comparison of technological characteristics: A detailed table comparing specifications like X-ray tube, generator, fluoroscopic modes, image intensifier, camera, and C-arm mechanics. Differences (e.g., tube's heat capacity, power output, kV/mA ranges, camera active pixels) are addressed by explaining that the proposed device's lower specifications are still sufficient for typical fluoroscopy modes (e.g., 1 kW or less) or that higher specifications (e.g., camera resolution) represent an improvement.
- Compliance with recognized standards: The device adheres to a robust set of international and FDA recognized standards, including:
- IEC 60601-1:2005 (General requirements for basic safety and essential performance)
- IEC 60601-1-2:2007 (Electromagnetic compatibility)
- IEC 60601-1-3:2008 (Radiation protection in diagnostic X-ray equipment)
- IEC 60601-2-28:2010 (Medical diagnostic X-ray equipment for radiography and radioscopy)
- IEC 60601-2-43:2010 (X-ray equipment for interventional procedures)
- IEC 60601-2-54:2009 (X-ray equipment for radiography and radioscopy)
- NEMA PS 3.1-3.20 (DICOM standard)
- ISO 14971:2012 (Application of risk management for medical devices)
- 21 CFR 1020.32 (Electronic product radiation control)
- Verification and Validation Activities: Stated that "Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks."
- Instructions for Use: Labeling includes information for safe and effective operation.
The conclusion is that despite some differences in components and specifications, these differences "do not raise any new questions of safety and effectiveness."
§ 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.