(10 days)
The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment during radiographic and fluoroscopic procedures. It is designed to be adapted to various x-ray systems.
The Collimare "Collimator Family" and/or variations is used to control the x-ray beam for use on diagnostic imaging equipment. The intended usage is all portable/fixed, manual and automatic, Radiographic, Fluoroscopic, rectangular, square and/or circular shuttering. It can encompass a light simulation, spectral filters, wedge filters, input port shuttering, dose measurement, laser alignment indicating lines and/or mechanical or digital SID measurement.
The provided text describes a 510(k) premarket notification for the Collimare "Collimator Family" device, which is an X-ray beam limiting device. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, device performance, sample sizes, ground truth establishment, or any details related to AI/human reader studies.
The document primarily focuses on:
- Submission details: Submitter, contact, common/trade/classification names, predicate devices.
- Device description and intended use: Control of X-ray beams for diagnostic imaging.
- Performance standards / Safety Information: References existing regulatory standards (21 CFR Section 1020.30, .31 & .32; UL 60601-1; IEC 60825-1).
- FDA correspondence: The FDA's determination of substantial equivalence to predicate devices.
- Indications for Use statement.
Therefore, I cannot provide the requested information in the table or answer the specific questions as the input text does not contain it. This type of document, a 510(k) summary and FDA decision letter, typically attests to compliance with established safety and performance standards rather than presenting novel clinical study data with specific acceptance criteria as you might see for a diagnostic AI device.
In summary, none of the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth, or MRMC/standalone studies is present in the provided text.
§ 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.