(205 days)
OSCAR 15 is a mobile fluoroscopy system is 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, cardiac and critical care.
The system may be used for other imaging applications at the physician's discretion.
OSCAR 15 is consist of X-ray Tube, X-ray tube assembly, x-ray controller, detector and accessories. There is no wireless function in this device.
The OSCAR 15, 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 or medical 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 is a 510(k) summary for the OSCAR 15 mobile fluoroscopy system. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study proving the device meets specific acceptance criteria in the context of AI/ML performance.
Therefore, most of the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document as it pertains to AI/ML device validation.
Here's what can be extracted and a general explanation for the missing information:
1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria in terms of numerical performance metrics for an AI/ML component. Instead, it focuses on demonstrating substantial equivalence to a predicate device (ZEN-7000) based on design features, indications for use, and compliance with industry standards for safety and electrical performance.
The reported device performance is primarily in relation to physical and technical specifications, and safety/EMC compliance.
| Criterion Category | Acceptance Metric (Implicit from Substantial Equivalence and Standards) | Reported Device Performance (OSCAR 15) | Predicate Device (ZEN-7000) |
|---|---|---|---|
| Indications for Use | Same as predicate device | Mobile fluoroscopy for diagnostic, surgical, interventional procedures (cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care). Physician's discretion for other applications. | Mobile fluoroscopy for diagnostic, surgical, interventional procedures (cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care, emergency room procedures). Physician's discretion for other applications. |
| Generator | High Frequency Inverter | High Frequency Inverter | High Frequency Inverter |
| Max. output power | Similar to predicate (15 kW) | 15 kW | 5 kW (15 kW Optional) |
| X-ray Tube | Rotating tube, same focal spots | Rotating tube, Large: 0.6 mm, Small: 0.3 mm | Rotating tube, Large: 0.6 mm, Small: 0.3 mm |
| Fluoroscopy kV/mA | Similar range to predicate | 40-120 kV / 0.2-6.0 mA | 40-120 kV / 0.2-6.0 mA |
| Pulsed Fluoroscopy mA | Similar or improved range to predicate | 1 mA to 48 mA | 1 mA to 20 mA (5kW), 1 mA to 48 mA (15kW) |
| Radiography kV/mAs | Similar range to predicate | 40-120 kV / 0.4-100 mAs | 40-120 kV / 1-100 mAs |
| Detector Type | Different from predicate, but superior performance shown (DQE, image quality) | Flat panel detector (CMOS) | Image Intensifier |
| Detector Active Image Area | Specified | 260 x 256 mm | 9" or 12" |
| Detector Central Resolution | Specified | 4.6 lp/mm | 2.2 lp/mm (9"), 1.6 lp/mm (12") - at monitor |
| Detector Contrast Ratio | Specified | 30:1 | Not explicitly stated, implied by DQE |
| Detector Resolution | Specified | 2600 x 2560 | Not explicitly stated |
| Detector Pixel Sampling Resolution | Specified | 14 bits | Not explicitly stated |
| Detector Pixel Pitch | Specified | 100 µm | Not explicitly stated |
| Detector MTF | Specified | 56% | Not explicitly stated |
| Detector DQE | Superior to effective DQE of predicate | 59% | 65% (typical Image Intensifier DQE), but effective DQE of complete predicate device is 51% |
| Safety, EMC, Performance | Compliance with relevant IEC standards and CFR regulations | Complies with IEC 60601-1 Series, 60601-1-3, 60601-2-28, 60601-2-43, 60601-2-54, 60601-1-2. Meets EPRC standards (21 CFR 1020.30, 31, 32). Followed FDA guidance for SSXI devices, software, and cybersecurity. | Complies with similar standards (implied by K140041 substantial equivalence) |
| Physical Dimensions (SID, Rotation, Travel) | Similar to predicate | SID: 1000 mm, Panning: ±12.5°, Orbital: 155°, Vert. Travel: 500 mm, Horiz. Travel: 200 mm | SID: 1000 mm, Panning: ±12.5°, Orbital: 135°, Vert. Travel: 500 mm, Horiz. Travel: 200 mm |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document describes a medical imaging device (C-arm fluoroscopy system), not an AI/ML algorithm. Therefore, there is no "test set" in the context of an AI/ML model. The evaluation is based on engineering tests, compliance with standards, and comparison of specifications with a predicate device. "Bench and clinical evaluation" is mentioned, suggesting some testing with human interaction, but no details on sample size or data provenance for such evaluations are provided.
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 this is not an AI/ML device requiring expert-labeled ground truth for model validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI/ML device.
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 a fluoroscopy system, which provides images directly to the physician. It does not include an AI assistance component whose effectiveness would be measured in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device with an "algorithm only" performance to evaluate. The device itself is the standalone product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as the evaluation is based on technical specifications, safety standards compliance, and image quality metrics (DQE, resolution, etc.), not the diagnostic accuracy of an AI/ML model against a clinical ground truth.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 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.