(87 days)
The Omega Medical Imaging, LLC CS-series-FP with 3030+ Option systems are intended for use in radiographic/fluoroscopic application including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging.
The Omega Medical Imaging, LLC. CS-series-FP systems currently incorporate a 19.8cm x 19.8cm solid-state flat-panel detector (FPD) as an option. This 510(k) submission adds a larger format (29.8cm x 29.8cm) flat-panel detector as an additional option. The CS-series-FP fluoroscopy single and dual plane x-ray imaging systems are configured with a floor mounted C-arm and a patient table. The dual plane systems incorporate a ceiling suspended C-arm into the system. The flat-panel image detector utilizes a cesium iodide scintillator coupled to an amorphous silicon TFT panel. The captured digital image is processed by the acquisition system which includes image processing, viewing functions, local storage, and DICOM compatibility.
The provided text is a 510(k) summary for the Omega Medical Imaging, LLC CS-series-FP with 3030+ Option radiographic/fluoroscopy system. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a traditional clinical study with defined acceptance criteria and performance metrics against a gold standard in the way an AI/ML device might.
Therefore, the requested information elements related to acceptance criteria, ground truth, expert review, and statistical analyses of clinical performance are largely not applicable in this context. The "study" described is a non-clinical performance testing to show the new device meets the same performance standards as its predicate.
Here's an attempt to interpret and answer your questions based on the provided text, highlighting where the information is not available or not relevant for this type of submission:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from Substantial Equivalence Claim) | Reported Device Performance (Summary) |
|---|---|
| Equivalence to Predicate Device: | The CS-series-FP with 3030+ Option (larger FPD) utilizes |
| - Low-contrast object visibility comparable to predicate | identical technology and image processing to the predicate. |
| - Spatial and temporal resolution comparable to predicate | Performance data was compared with the existing system |
| - Dynamic range comparable to predicate | utilizing the smaller FPD. These tests used commercially |
| - Compliance with safety and regulatory standards | available Test Objects to assess low-contrast objects, |
| spatial/temporal resolution, and dynamic range. | |
| The manufacturer's opinion is that the larger FPD system | |
| is essentially equivalent to the cleared smaller FPD system. | |
| Regulatory Compliance: | The device complies with applicable requirements of |
| - 21 CFR 1020.30, 1020.31, 1020.32 | 21 CFR 1020.30, 1020.31, 1020.32. |
| - IEC 60601-1, -1-2, -1-3, -2-7, -2-28, -2-32, -2-43 | |
| - UL 60601-1, CAN/USA C22.2 No.601.1-M90 |
Explanation of "Acceptance Criteria" in this context: For a 510(k) submission, the primary acceptance criterion is substantial equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device. The "acceptance criteria" here are therefore the performance characteristics of the predicate device, which the new device aims to match or exceed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the traditional sense of patient data. The "test set" consisted of "commercially available Test Objects" (phantoms). The number and specific types of these test objects are not detailed, but they are not human or animal subjects.
- Data Provenance: Not applicable. The "data" comes from non-clinical performance testing using phantoms, not patient data from a specific country or collected retrospectively/prospectively.
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. Ground truth as typically understood for clinical studies involving expert interpretation of images or diagnoses is not relevant here. The "ground truth" for non-clinical performance testing is inherent in the design specifications of the test objects themselves (e.g., a known number of low-contrast objects, a specific spatial resolution pattern). Performance is measured objectively by the system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no human adjudication of results for the non-clinical performance tests. Measurements are objective and quantitative (e.g., measuring line pairs per millimeter, contrast-to-noise ratio).
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
- No. An MRMC study was not performed. This submission is for an imaging system (hardware), not an AI/ML diagnostic tool. There is no AI component or human-in-the-loop performance measurement described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is an imaging system, not an algorithm, so "standalone (algorithm only)" is not applicable. The performance tests evaluate the physical and technical capabilities of the X-ray system and its detector.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical testing was based on the known characteristics and specifications of the commercially available test objects (phantoms). These phantoms are designed to have specific, measurable properties (e.g., specific sizes of low-contrast objects, known spatial frequencies).
8. The sample size for the training set
- Not applicable. As this is not an AI/ML device, there is no "training set" in the machine learning sense. The device is a conventional X-ray imaging system.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.