(76 days)
The ORCA is a small image intensibled fluoroscopic C-Arm, for imaging extremities in orthopedic applications. The ORCA Operator's manual contains the following statement: "CAUTION: Federal Law (USA) restricts this device to sale and use by or on the order of a physician."
The ORCA is a small image intensified fluoroscopic C-Arm, for imaging extremities in orthopedic applications.
The provided text is a 510(k) summary for a medical device called ORCA, an image-intensified fluoroscopic C-Arm. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in the provided text.
The document focuses on comparing the technical characteristics of the ORCA to a predicate device (OEC Medical Systems Inc. Series 6600 Digital Mobile C-Arm) to establish substantial equivalence.
Here's a breakdown of what is available from the text and why the requested information is absent:
- A table of acceptance criteria and the reported device performance:
- Acceptance Criteria/Performance: The document presents a "Summary of Technical Characteristics" table comparing features of the ORCA to its predicate device. This table effectively is the "performance" data used to argue for substantial equivalence, rather than a separate set of acceptance criteria based on clinical outcomes. For example, it compares X-Ray source specifications (e.g., 0.3mm focal spot vs. 0.25mm), image intensifier size (6 inch vs. 4 or 6 inch), and scatter radiation to operator (
§ 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.