(59 days)
Model R302DACS/A Automatic X-RAY Collimator is intended for use in diagnostic radiographic/fluoroscopic applications.
Model R302DACS/A Automatic X-RAY Collimator is an Automatic X-ray beam-limiting system with a multilayer square field collimator. Stepper motors drive shutter movements as well as additional filters and the round field if these two features are mounted. A microprocessor circuit controls the stepper motors and provides the stepless adjustment of the square field dimensions at variable FFD (SID). The two stepper motors that provide shutter control may also be manually adjusted by the two knobs or by the pushbuttons located on the front panel. Two boards built into the collimator allow direct control of the system via CAN-Bus protocol.
The provided text is a 510(k) summary for the RALCO srl Model R302DACS/A Automatic X-RAY Collimator. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or reported device performance metrics that would allow for the comprehensive completion of the requested table and study information.
The document primarily focuses on establishing substantial equivalence based on safety and effectiveness compared to predicate devices, rather than presenting a performance study with defined acceptance criteria and quantitative results for the new device.
Therefore, I cannot populate the table or provide the requested study details as the information is not present in the provided text.
Here is an explanation of why the requested information cannot be extracted:
- Acceptance Criteria and Reported Device Performance: The document states, "The results of bench, safety test laboratory and user testing indicates that the new device is as safe and effective as the predicate device." It also mentions "analyzing both bench and safety testing data." However, it does not define what these "results" or "data" actually are, what specific performance metrics were measured (e.g., accuracy of collimation, field size precision), nor what the predefined "acceptance criteria" for these metrics were.
- Sample Size, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone, Training Set Details: None of this information is available in the provided text. The submission focuses on regulatory compliance and comparison to predicate devices, not on a detailed clinical or technical performance study with these elements.
- Type of Ground Truth: While it mentions "bench, safety test laboratory and user testing," it doesn't specify if this involved expert consensus, pathology, or other forms of "ground truth" as typically understood in a performance study for AI/diagnostic devices. For an X-ray collimator, ground truth would likely relate to the actual dimensions and alignment of the X-ray field versus the device's output, but this is not detailed.
In summary, the provided 510(k) pertains to a hardware device (X-ray collimator) and emphasizes regulatory equivalence based on general safety and effectiveness. It does not include the type of detailed performance study data, acceptance criteria, or ground truth establishment typically found for AI/software-based diagnostic devices.
§ 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.