(15 days)
The O-Arm™ Imaging System is designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-Arm™ Imaging System is compatible with certain Image Guided Surgery Systems.
The O-Arm™ Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging. The system consists of two parts: the x-ray O-Arm™ Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitors).
Here's an analysis of the O-Arm™ Imaging System's acceptance criteria and study, based on the provided 510(k) summary:
O-Arm™ Imaging System Performance Analysis
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Diagnostic Equivalence | For all image pairs (3-D and fluoroscopic), images from the O-Arm™ and the predicate device (Siemens ISO-C C-Arm Imaging System) were determined to be of equivalent diagnostic capability. |
2. Sample Size and Data Provenance
- Test Set Sample Size: 31 pairs of images (including both 3-D and fluoroscopic images). A "pair" refers to an image from the O-Arm and a corresponding image from the predicate device of the same anatomical structure.
- Data Provenance: The study was conducted using a cadaver. This suggests the data was from a controlled, experimental setting rather than a clinical environment. The country of origin is not explicitly stated, but the submission is to the US FDA. The study appears to be prospective as it was conducted specifically for the 510(k) submission.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: One (1) radiologist.
- Qualifications of Experts: The document simply states "A radiologist." No further details on experience or specialization are provided beyond their profession.
4. Adjudication Method
- The document implies a single-reader evaluation by the radiologist. There is no mention of multiple reviewers or an adjudication process like 2+1 or 3+1. The radiologist "determined" the equivalence independently.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described. The study involved a single radiologist making a determination of equivalence between the O-Arm and a predicate device. There is no assessment of human readers improving with AI assistance, as this is a device comparison study (equivalence) rather than an AI-assisted diagnostic study.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone study was implicitly done. The "device" in this context is the entire imaging system. The radiologist evaluated the images produced by the O-Arm itself (standalone, without human-in-the-loop assistance for image interpretation) and compared them to those from the predicate device.
7. Type of Ground Truth Used
- The ground truth was established through expert consensus/opinion by a single radiologist, comparing images from the investigational device to images from a legally marketed predicate device. The underlying "true status" of the anatomical structures was not explicitly determined by pathology or outcomes data, but rather by the radiologist's assessment of diagnostic capability equivalence between the two imaging systems.
8. Sample Size for the Training Set
- The document does not provide any information regarding a training set. This is not an AI/algorithm training study, but rather a device equivalence study. The O-Arm is an imaging system, not an AI software.
9. How Ground Truth for the Training Set was Established
- As no training set is mentioned or relevant to this type of device submission, this information is not applicable.
§ 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.