(157 days)
This product is intended primarily for on-line or remote viewing of cardiac catheterization angiography studies communicated by network, or transported by CD-R interchage media. The CD-R media may also be used as a full resolution digital image archive of complete cath lab studies, to replace cine film. The ARS2 can optionally be used with other digital imaging modalities, such as R/F, nuclear and ultrasound. The ARS2 provides the capability to write and read CD-R optical discs which are produced in accordance with the ACC/NEMA DICOM standard.
Digital image recording and display system for use in cardiac catheterization, radiography/fluoroscopy, ultrasound, or other digital imaging modalities.
This 510(k) summary for the Camtronics Analytical Review Station (ARS2) does not contain the information needed to answer your questions regarding acceptance criteria and a study proving the device meets those criteria.
Here's a breakdown of why based on the provided text:
- No Acceptance Criteria or Performance Study: The document explicitly states:
- "Performance data: Not required for determination of substantial equivalence for this class of device."
- "Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device."
This means that for the purpose of this 510(k) submission, the FDA did not require the manufacturer to provide specific performance acceptance criteria or a study demonstrating the device met such criteria. The submission focuses on demonstrating substantial equivalence to predicate devices based on specifications and intended use, not on a detailed performance evaluation with acceptance metrics.
Therefore, I cannot populate the table or provide information on sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established from the provided text.
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.