(17 days)
The Omega R605 FACS automatic collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
The Omega R 605FACS is an automatic collimator designed for use in diagnostic Trie Offically of tool AOO is an adtomatio continues round field shutters and an additional lung filter for cardiac application.
This submission is a 510(k) premarket notification for the Omega R605 FACS automatic collimator. The document describes the device and its intended use, and states that it is substantially equivalent to predicate devices. However, it does not contain the detailed study information typically required to prove a device meets specific acceptance criteria based on performance metrics.
Here's a breakdown of the requested information, highlighting what is missing from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Missing | Missing |
- Explanation: The document states that the Omega R605 FACS collimator will comply with various safety standards (21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.32, IEC 60601-1, IEC 60101-1-2, IEC 60601-1-3, UL 60601-1, and CAN/USA C22.2 No.601.1-M90) and CE Marking requirements. However, it does not provide specific numerical acceptance criteria for performance parameters (e.g., accuracy of beam limiting, illumination levels, alignment tolerances) or data demonstrating the device actually met these criteria. This is a common characteristic of 510(k) summaries where compliance with recognized standards is stated, but the detailed test results are not included in the public-facing summary.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not provided. The document does not describe a clinical or technical performance study with a specific test set.
- Data Provenance: Not applicable. No study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No study data is presented, and thus no ground truth establishment by experts is described.
4. Adjudication method for the test set:
- Not applicable. No study data is presented.
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. This device is an automatic collimator, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study with human readers improving with AI assistance is not relevant to this device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not explicitly described as a standalone algorithm study. The device itself is an automatic collimator, implying its function is standalone in terms of beam limiting. The document states it will comply with technical performance standards, which implies standalone technical testing was performed to demonstrate compliance. However, no specific details of such tests (e.g., methodology, results) are provided in this summary.
7. The type of ground truth used:
- Not applicable / Implied by standards compliance. For a physical device like a collimator, "ground truth" would relate to the objective, measurable accuracy of its physical functions (e.g., how precisely it limits the X-ray field compared to a known standard or reference measurement). The document implies that compliance with recognized safety and performance standards (like 21 CFR 1020.30, 1020.31, 1020.32, IEC 60601-1, etc.) serves as the basis for establishing that the device performs as intended. These standards specify physical requirements and testing methodologies.
8. The sample size for the training set:
- Not applicable. This is a physical medical device (automatic collimator), not a machine learning or AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable. As above, this is not an AI/ML device requiring a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria (Based on the Provided Text):
The provided 510(k) summary does not detail a specific performance study with a test set, ground truth, or expert review in the way one would describe for a diagnostic imaging algorithm. Instead, the submission for the Omega R605 FACS automatic collimator relies on declaration of compliance with established regulatory and international standards to demonstrate its safety and effectiveness and its substantial equivalence to predicate devices.
The document states that the device "will comply" with:
- 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32: These are U.S. FDA regulations pertaining to diagnostic X-ray systems and their components, specifically addressing performance standards for diagnostic X-ray sources, protective shields, and beam-limiting devices.
- IEC 60601-1, IEC 60101-1-2, and IEC 60601-1-3: These are international safety standards for medical electrical equipment, including general requirements, electromagnetic compatibility, and requirements for diagnostic X-ray equipment.
- CE Marking requirements: European conformity mark, indicating compliance with relevant EU directives.
- UL 60601-1 and CAN/USA C22.2 No.601.1-M90: Safety standards for medical electrical equipment for the U.S. and Canada, respectively.
Conclusion from the document: The manufacturer asserts that the Omega R605 FACS collimator "does not introduce any new indications for use" and is "substantially equivalent with the predicate devices." This substantial equivalence, coupled with the declared compliance to established safety and performance standards, is the basis of the 510(k) clearance, rather than a detailed performance study like those conducted for AI/ML devices. The FDA's letter confirms they determined the device to be substantially equivalent based on the information provided in the 510(k) premarket notification.
§ 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.