(22 days)
The Centrion 500 C-Arm System is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic and surgical procedures. Clinical applications include, but are not limited to, general surgery, gastro-intestinal, urologic, orthopedic, neurologic, vascular, and emergency room procedures. The system may also be used for other imaging applications at the physician's discretion.
The Centrion 500 C-Arm System. Is a digital C-Arm-type fluoroscopic system. It includes nearly every feature that exists on currently marketed System: "It interacts noany, while enclosing those features in a products, nact system, and adding a Real-Time Pulsed Fluoroscopy more offical by John Pulsed Fluoroscopy mode can significantly reduce the dose to the patient, without compromising image quality. Dose reductions of up to 85% are possible.
This 510(k) summary for the Centrion 500 C-Arm System focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and adherence to performance standards for X-ray devices. It does not contain information about a study that would typically establish acceptance criteria and device performance in the manner of an AI/software device.
Here's an analysis based on the provided text, highlighting what is and is not present given the request's scope for an AI/software device:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Technological Equivalence | Similar technological characteristics to predicate device. | Both proposed and predicate devices use digital image receptors and standard image manipulation software. | This is the primary "performance" metric implied by the 510(k) process for this type of device. The system is considered equivalent if its core functions match the predicate. |
| Safety and Performance Standards | Compliance with relevant X-ray device standards (e.g., IEC-60601 series, 21 CFR 1020). | "Testing to the requirements of consensus standards was carried out to assure equivalence." (Specific test results or performance metrics against these standards are not detailed in the summary). | General statement of compliance; no quantitative performance metrics. |
| Dose Reduction | N/A (No specific quantifiable acceptance criteria provided for dose reduction). | "Real-Time Pulsed Fluoroscopy mode can significantly reduce the dose to the patient, without compromising image quality. Dose reductions of up to 85% are possible." | This is a claimed capability and potential benefit, not an explicit acceptance criterion with a specific threshold that was "met" with documented evidence in this summary. The summary states it's possible, not that it was definitively demonstrated as an acceptance criterion for this submission. |
| Image Quality | N/A (No specific quantifiable acceptance criteria provided for image quality). | "without compromising image quality" (in relation to dose reduction). | This is a qualitative claim. No objective metrics or studies on image quality preservation are detailed in the submitted summary as acceptance criteria. |
| Intended Use | Device can provide fluoroscopic and spot-film imaging for specified clinical applications. | Device is "designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic and surgical procedures." (Clinical applications listed). | This is an assertion of functionality and purpose, assumed to be met by virtue of the device's design and technological characteristics being similar to the predicate. |
Based on the provided K050866 510(k) summary, the following information is either not applicable, not detailed, or not explicitly stated as per your request, which seems more tailored to a software/AI device performance study.
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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):
- Not applicable/Not provided. This 510(k) summary primarily demonstrates substantial equivalence through technological comparison and compliance with electrical/radiation safety standards for an imaging hardware device. It does not describe a clinical performance study with a "test set" of images or patient data in the way an AI/software device would. The "testing" mentioned refers to compliance with device standards, not a diagnostic accuracy study.
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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/Not provided. No "ground truth" establishment by experts for a test set is described.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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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/Not provided. This is a hardware imaging system, not an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable/Not provided. This is not an algorithm-only device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided.
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The sample size for the training set:
- Not applicable/Not provided. This device is a C-arm system, not an AI model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary of the 510(k) approach:
This 510(k) submission for the Centrion 500 C-Arm System does not describe a performance study with a test set, ground truth, or expert review in the context of an AI/software medical device. Instead, it demonstrates "substantial equivalence" based on:
- Comparison to a Legally Marketed Predicate Device: The Centrion 500 C-Arm System is presented as substantially equivalent to the General Electric OEC FLEXIVIEW 8800 Digital Mobile Imaging System (K003837).
- Similar Technological Characteristics: Both devices utilize a digital image receptor and standard image manipulation software for real-time digital fluoroscopic images.
- Compliance with Recognized Standards: The device was tested against several IEC and CFR standards pertaining to X-ray devices (e.g., IEC-60601-1-3, IEC-60601-2-7, IEC-60601-2-28, IEC-60601-2-32, 21 CFR 1020). The fulfillment of these standards serves as the "study" proving its safety and basic performance characteristics relative to established norms for such devices, rather than a clinical accuracy study.
- Identical Intended Use: The intended uses for diagnostic and surgical fluoroscopic/spot-film imaging are identical to the predicate.
The "acceptance criteria" in this context are primarily the successful demonstration of substantial equivalence by meeting regulatory requirements, technological similarity to the predicate, and adherence to relevant safety and performance standards for X-ray equipment. There are no clinical performance metrics or studies involving patient data or expert interpretation detailed in this summary.
§ 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.