(77 days)
The Omega R650 QDASM automatic beam limiting device is intended for use in X-ray diagnostic radiographic/fluoroscopic applications.
The Omega R 650 QDASM is an automatic beam limiting device designed for use in diagnostic radiographic/fluoroscopic applications. It includes square field shutters, spectral filters, and an additional lung filter for cardiac application. This device is substantially equivalent to the predicate devices with respect to technological characteristics.
The provided documentation does not contain a study demonstrating the device meets specific acceptance criteria based on performance metrics such as accuracy, sensitivity, or specificity. The submission is a 510(k) for an X-ray beam-limiting device, focusing on substantial equivalence to predicate devices rather than clinical performance studies.
Therefore, many of the requested details such as acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical or performance study are not applicable or not provided in this specific document.
The document primarily states that the device:
- "will comply with the applicable requirements of 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32" (regulations for diagnostic X-ray systems and their components).
- "will comply with the international safety standards IEC 60601-1, IEC 60101-1-2, and IEC 60601-1-3."
- "will comply with CE Marking requirements."
- "will comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90."
These are compliance statements for safety and electrical standards, not performance metrics related to diagnostic accuracy or clinical utility that would require a study with the detailed elements requested.
Summary of available information (and lack thereof based on the request):
| Information Requested | Response |
|---|---|
| 1. Table of acceptance criteria and reported performance | |
| Acceptance Criteria (Compliance Statements): |
- Compliance with 21 CFR 1020.30, 1020.31, 1020.32 (Diagnostic X-ray system regulations)
- Compliance with IEC 60601-1, IEC 60101-1-2, IEC 60601-1-3 (International safety standards)
- Compliance with CE Marking requirements
- Compliance with UL 60601-1 and CAN/USA C22.2 No.601.1-M90 (Safety standards)
Reported Device Performance: The document states: "This device is substantially equivalent to the predicate devices with respect to technological characteristics." No specific performance metrics (e.g., accuracy, sensitivity, specificity, or quantitative benefit) are provided as would be expected for an AI/algorithm-based device's clinical performance. The "performance" here refers to its ability to function as a beam-limiting device in accordance with regulatory and safety standards, similar to the predicate devices.
|
| 2. Sample size and data provenance for test set | Not applicable. The submission for this device (an X-ray beam-limiting collimator, not an AI diagnostic algorithm) does not include a clinical performance study using a test set of images or patient data. The basis for clearance is substantial equivalence to predicate devices based on technological characteristics and compliance with recognized standards. |
| 3. Number/qualifications of experts for ground truth | Not applicable. No clinical performance study was conducted to establish ground truth for a diagnostic task. |
| 4. Adjudication method for test set | Not applicable. |
| 5. MRMC comparative effectiveness study? Effect size? | No. This device is an automatic beam-limiting device (collimator) for X-ray systems, not an AI or imaging analysis software intended to assist human readers in interpretation or diagnosis. Therefore, no MRMC study comparing human readers with and without AI assistance was performed or would be relevant for this device type. |
| 6. Standalone performance study? | No standalone performance study (in the context of an algorithm's diagnostic accuracy) was reported. The device's "performance" is implicitly its ability to meet the stated technical specifications and safety standards as a physical component of an X-ray system. |
| 7. Type of ground truth used | Not applicable. There is no diagnostic ground truth established for this device's function. The "ground truth" relevant to this submission would be the compliance with engineering and safety standards. |
| 8. Sample size for training set | Not applicable. This is not an AI/ML device that requires a training set of data. |
| 9. How training set ground truth was established | Not applicable. |
§ 892.1610 Diagnostic x-ray beam-limiting device.
(a)
Identification. A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.