(31 days)
The OEC Everview 7500 is a mobile digital C-arm designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical, critical-care and emergency room procedures. Examples of clinical application may include, but are not limited to cholangiography, endoscopy, urology, vascular, orthopedic, neurology and cardiac procedures. It is anticipated that this product will be used on a daily basis by such users, as prescribed by the physician. The system may be used for other imaging applications at the physician's discretion.
The OEC Everview 7500 is an image intensified fluoroscopic mobile C-arm system. It consists of a C-arm that supports a high-voltage generator, x-ray tube, x-ray controls, image intensifier, and CRT monitors. It is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles with respect to the patient, and supports image processing and recording devices.
The provided text refers to a 510(k) Notification for the GE OEC Everview 7500, a mobile digital C-arm. This document is a premarket notification for demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study designed to establish new performance criteria. Therefore, the information requested in points 1-9, which typically relate to clinical performance studies for novel devices or significant modifications, is not fully present or directly applicable in this 510(k) summary.
Here's a breakdown of the available information in relation to your questions:
1. A table of acceptance criteria and the reported device performance:
This document does not contain a table of acceptance criteria in the context of clinical performance or specific reported device performance metrics. Instead, it lists product standards that the device is designed in accordance with. These standards primarily cover safety, electrical, and radiation protection requirements, and not clinical performance metrics like sensitivity or specificity.
| Document / Standard | Description |
|---|---|
| Title 21 CFR, Subchapter J, Parts 807, 1020.30 through 1020.32 | U.S. requirements for 510(k) submissions, U.S. Federal Performance Standard for Diagnostic X-ray Systems, U.S. |
| Canadian Food & Drug Act SOR/98-292 7 May 2004 | Health Canada- Canadian Medical Device Regulation |
| ANSI/NFPA 70 and 99 | US National Electric Code/Electrical Equipment, Health Care Facilities |
| UL 60601-1: 2003: 1st Edition | Medical Electrical Equipment, Part 1: General Requirements for Safety including any Collateral Std (601-1-x) and Particular Std (601-2-x), as adopted. |
| CSA-C22.2 No. 601.1-M90 | Medical Electrical Equipment, Part 1: General Requirements for Safety including any Collateral Std (601.1.x) and Particular Std (601.2.x), as adopted. |
| EN 60601-1 (IEC 60601-1:1988 + A1 & A2) | Medical Electrical Equipment, Part 1: General Requirements for Safety |
| IEC 60601-1-1:2000: 2nd edition | Collateral Std: Safety of Medical Electrical Systems |
| IEC 60601-1-2:2001: 2nd edition | Collateral Std: Electromagnetic Compatibility |
| IEC 60601-1-3:1994: 1st edition | Collateral Std: Radiation Protection in Diagnostic X-ray Equipment |
| IEC 60601-1-4:2000: 1.1 edition (+A1) | Collateral Std: Safety of Programmable Medical Systems |
| IEC 60601-2-7:1998: 2nd edition | Particular Std: Safety of H.V. Diagnostic X-ray Generators |
| IEC 60601-2-28:1993: 1st edition | Particular Std: Safety of X-ray Tube and X-ray Source Assemblies |
| IEC 60601-2-32:1994: 1st edition | Particular Std: Safety of Associated Equipment of X-ray Equipment |
| 93/42/EEC, Annex I (Essential Requirements) | Council Directive Concerning Medical Devices (European Union) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No information is provided regarding a test set sample size or data provenance related to clinical performance. This type of information is not typically part of a 510(k) summary for a substantial equivalence determination of a C-arm. The focus is on technical specifications and comparison to predicate devices.
3. 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. As no clinical performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication method is described.
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:
Not applicable. This device is an image-intensified fluoroscopic x-ray system, and the document does not mention any AI components or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. No algorithm-only performance study is mentioned for this imaging system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no external ground truth for clinical performance is described. The "ground truth" for this 510(k) is the substantial equivalence to the predicate devices, meaning it performs as intended and is as safe and effective as those existing devices based on technical specifications and design.
8. The sample size for the training set:
Not applicable. This document does not describe a machine learning model or a training set.
9. How the ground truth for the training set was established:
Not applicable, as no machine learning model or training set is described.
In summary, the provided 510(k) notification for the GE OEC Everview 7500 focuses on demonstrating substantial equivalence to previously cleared predicate devices based on design, technical specifications, and adherence to relevant product safety and performance standards. It does not contain information about clinical performance studies, test sets, or ground truth establishment in the manner typically associated with studies for novel devices or AI-powered systems.
§ 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.