(38 days)
The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation provides the physician with fluoroscopic images during diagnostic, surgical and interventional procedures. The surgical navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may be benefit from the use of stereotactic surgery and which provides a reference to ridged anatomical structures such as sinus, cranial, long bone or vertebra visible on fluoroscopic images.
The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation is a fluoroscopic system with integrated surgical navigation capabilities.
The OEC Olympus Mobile Fluoroscopy System with Integrated Navigation is an image intensified fluoroscopic system consisting of a mobile C-arm and OEC Workstation. The C-arm supports the high-voltage generator, x-ray tube, x-ray controls, and image intensifier. The C-arm is designed to perform linear and rotational motions that allow the user to position the x-ray imaging components at various angles and distances with respect to the patient. The OEC workstation is a mobile platform that supports image display monitors, image processing and recording devices.
The integrated surgical navigation system allows the surgeon to view reconstructed two-dimensional images of the patient's anatomy in response to an electromagnetically tracked surgical instrument. This indicates the position of the tracked surgical instrument with regard to the patient's anatomy based on preoperative medical images.
The provided text is a 510(k) summary for the GE OEC Olympus Mobile Fluoroscopy System with Integrated Navigation. This document focuses on establishing substantial equivalence to previously marketed devices and compliance with safety standards rather than presenting a performance study with acceptance criteria in the typical sense for a new diagnostic device.
Therefore, many of the requested categories (acceptance criteria table, sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth specifics for studies) are not present in this type of regulatory submission.
The document states that the device is "substantially equivalent to the OEC FluoroTrak 9800 Plus (K022069) and the OEC 9800 E/CV+ Digital Mobile System (K024012)." This statement implies that the device inherently meets the performance established by these predicate devices. The study proving this substantial equivalence would primarily involve demonstrating that its technical characteristics and indications for use are similar, and that it adheres to relevant safety and performance standards.
Here's a breakdown of what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly provided in the 510(k) summary as a set of acceptance criteria for a new performance study. The core of this submission is demonstrating substantial equivalence to predicate devices rather than proving performance against novel performance metrics. The "performance" is implicitly considered equivalent to the predicate devices.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. There is no mention of a specific test set or data provenance in the context of a new performance study.
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)
This information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided.
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
An MRMC study was not mentioned or described. The device is a fluoroscopy system with integrated navigation, not an AI-assisted diagnostic tool that would typically undergo MRMC studies to evaluate reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not mentioned or described. The device is a system with human-in-the-loop (surgeon using navigation aid).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided.
8. The sample size for the training set
This information is not provided.
9. How the ground truth for the training set was established
This information is not provided.
Summary based on the 510(k) document:
The regulatory submission for the "OEC Olympus Mobile Fluoroscopy System with Integrated Navigation" focuses on demonstrating substantial equivalence to pre-existing devices (OEC FluoroTrak 9800 Plus (K022069) and OEC 9800 E/CV+ Digital Mobile System (K024012)) and adherence to various product safety and performance standards (e.g., 21 CFR 1020.30-32, ANSI/NFPA 70 & 99, UL 60601, IEC series). It does not present a de novo performance study with explicit acceptance criteria, test sets, or ground truth establishment as would be expected for a novel diagnostic algorithm. The "study" proving the device meets criteria is implicitly the demonstration of its technical specifications aligning with predicate devices and compliance with established industry and regulatory safety standards.
§ 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.