(28 days)
OSCAR is a mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, and stone localization.
OSCAR Prime and OSCAR Classic are classified according to the option of image acquisition parts. Flat panel detector is OSCAR Prime, and Image intensifier is OSCAR Classic. And they are called OSCAR as the brand name.
OSCAR is consist of X-ray Tube, X-ray tube assembly, x-ray controller, image receptor and some accessories. There is no wireless function in this device.
The OSCAR, C-Arm Mobile is the device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This device is used for providing fluoroscopic and radiographic images of patient anatomy, especially during the special procedures in a hospital clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time without the need to develop individual films.
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner requested (e.g., a detailed clinical trial or performance study with metrics, sample sizes, and ground truth establishment).
This document is a 510(k) Premarket Notification from the FDA, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific detailed acceptance criteria through a dedicated performance study.
Here's what can be extracted from the document, organized as per your request, with explicit notes about missing information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific quantitative thresholds that a study then verifies. Instead, the "performance" is discussed in terms of technical specifications and compliance with industry standards.
| Feature/Standard | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| General | Safe and Effective (equivalent to predicate) | "OSCAR is safe and effective as predicate device, and has no new indication for use. Therefore, OSCAR is substantially equivalent to predicate device." |
| Safety | Compliance with relevant IEC standards and CFR | "OSCAR complies with industry standards such as IEC 60601-1 Series and 21 CFR 1020.30, 21 CFR 1020.31 and 21 CFR 1020.32 to minimize electrical, mechanical and radiation hazards." |
| "Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54 and IEC 62366 were performed." | ||
| EMC | Compliance with IEC 60601-1-2 | "EMC testing was conducted in accordance with standard IEC 60601-1-2." |
| EPRC | Compliance with 21 CFR 1020.30, 31, 32 | "OSCAR meets the EPRC standards (21 CFR 1020.30, 31, 32)." |
| Software | Compliance with FDA guidance, changes do not affect safety/effectiveness | "FDA guidance 'guidance for SSXI devices', and 'guidance for the Content of Premarket Submissions for Software Contained in Medical devices', was performed for OSCAR." |
| "Changes to the predicate device software were tested and they do not affect the device safety and effectiveness. Also, the device software is moderate level of concern." | ||
| DQE | For OSCAR Prime: More effective and safe than predicate's DQE | For OSCAR Prime (Flat panel): Mentioned DQE: 59% (Option A) and 45% (Option B). Compared to predicate's DQE (image intensifier + CCD camera) of 51%. "the DQE of the OSCAR Prime is more effective and safety than predicate device." (This is a qualitative statement of comparison rather than a specific numeric acceptance criterion being met). Other technical specifications (e.g., resolution, kV, mA ranges) are listed but not presented with explicit acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The document refers to "bench and clinical evaluation" but does not detail the size or nature of these evaluations for the purpose of a test set for performance.
- Data Provenance: Not specified. The document does not indicate the country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- This information is not provided in the document. The document refers to "bench and clinical evaluation" but does not detail how ground truth was established by experts.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. No effect size of human reader improvement with AI vs. without AI assistance is present, primarily because the device described is a fluoroscopy system, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This information is not applicable as the device is a medical imaging system (fluoroscopy system), not an AI algorithm designed to operate without human intervention. The performance mentioned relates to the technical specifications of the imaging equipment.
7. Type of Ground Truth Used
- The document does not explicitly state the type of ground truth used for any performance evaluation. It mentions "bench and clinical evaluation," which generally implies a comparison against existing clinical standards or established benchmarks for image quality and safety. However, specific types like expert consensus, pathology, or outcomes data are not cited.
8. Sample Size for the Training Set
- This information is not provided and is not applicable in the context of this device, as it is a fluoroscopy system and not an AI/machine learning algorithm requiring a separate training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided and is not applicable, as the device described is a fluoroscopy system, not an AI/machine learning algorithm with a training set.
§ 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.