(30 days)
The Sonoclot Coagulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.
The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.
The Sonoclot Analyzer System generates a qualitative graph, known a the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.
The Sonoclot Coaqulation & Platelet Function Analyzer System is an in vitro diagnostic device for measuring coagulation and platelet function. This system has two configurations. The historic configuration is a Sonoclot Analyzer connected to a thermal graphics printer. The standard configuration is a Sonoclot Analyzer connected to a computer running Sonoclot Viewer data collection software.
The Sonoclot Analyzer System rapidly provides information on the entire hemostasis process including coagulation, fibrin gel formation, clot retraction (platelet function) and fibrinolysis.
The Sonoclot Analyzer System generates a qualitative graph, known as the Sonoclot Signature, and quantitative results on the clot formation time (Activated Clotting Time-Onset), the rate of fibrin polymerization (Clot Rate), and clot retraction (Platelet Function). This information can be used to identify numerous coagulopathies including platelet dysfunction, factor deficiencies, anticoagulant effect, hypercoagulable tendencies and hyperfibrinolysis. Different disposable tests are available for use with the Sonoclot Analyzer System for different applications.
Sonoclot Viewer is a data collection, storage, and retrieval program for use with Sonoclot Analyzers. Sonoclot Viewer collects serial data from one or more Sonoclot Analyzers. This data is compressed, processed for certain performance results, displayed, and stored as data files.
Sonoclot Viewer enables users to assign patient, operator, and reagent information to a test, manage patient test results and analyzer/reagent quality control data, communicate with the hospital information system, and create reports to meet billing or regulatory compliance requirements.
I am unable to provide a description of the acceptance criteria and the study that proves the device meets them because the provided text does not contain this information. The text is a 510(k) summary for the Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a study proving their fulfillment.
Instead, the document highlights:
- Device Name & Classification
- Legally Marketed Predicate Devices
- Device Description Summary
- Intended Use/Indications for Use
- Comparison of Indications for Use and Technology
- Non-Clinical and/or Clinical Test Summary & Conclusions for Software Reengineering
The "Non-Clinical and/or Clinical Test Summary & Conclusions" section mentions validation of reengineered software (Sonoclot Viewer) against the predicate software (Signature Viewer) to ensure equivalent calculated results. However, it does not define specific acceptance criteria for performance metrics (like accuracy, precision, sensitivity, specificity, etc.) nor does it describe a study design with sample sizes, expert involvement, or ground truth establishment in the way requested for a typical AI/device performance study.
Without this specific information regarding acceptance criteria and a detailed study report, I cannot fulfill your request.
§ 864.7140 Activated whole blood clotting time tests.
(a)
Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.(b)
Classification. Class II (performance standards).