(18 days)
QLV-CMS provides quantitative information regarding the calculated dimensions and calculated performance characteristics of the left ventricle of the heart, imaged during angiographic x-ray procedures typically performed in cardiac cath labs. This information is suitable for use by physicians and scientists in the following applications:
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Scientific and research studies, assessing the angiographic condition of patients and the results of device and drug therapies,
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Review and analysis of patient angiographic imaging records, providing additional information to physicians and administrators.
QLV-CMS performs quantitative analysis of angiograms (specific to the left ventricle) that are input to the system in formats that include digitized video (from 35 mm cinefilm) and DICOM-file standard formats. The analysis results of the OLV-CMS operation may be printed or archived in files for export to a general-purpose database.
The provided text does not contain a study that describes acceptance criteria or proves the device meets those criteria. The document is a 510(k) summary for a medical device (Quantitative Analysis of Left Ventricular Angiograms - QLV-CMS) seeking substantial equivalence to a predicate device.
It primarily details:
- Device Description and Intended Use: What the QLV-CMS does (quantitative analysis of left ventricular angiograms).
- Substantial Equivalence: How it compares to its predicate device (Cardiovascular Measurement System - CMS), noting technical standards and algorithms are the same, but the operating system and modularity have changed.
- Safety and Effectiveness Opinion: MEDIS Medical Imaging Systems' opinion that the device is safe and effective, supported by a risk management plan, verification and validation tests, and evaluations by hospitals. This is a statement of opinion, not a description of a specific study with acceptance criteria.
- FDA Approval Letter: The FDA's determination of substantial equivalence, allowing the device to be marketed.
Therefore, I cannot provide the requested information from the provided text as the study details, acceptance criteria, test set, training set, expert qualifications, adjudication methods, MRMC studies, or standalone performance studies are not present.
§ 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.