(42 days)
CVP-VENUS-2000 is intended to be used by healthcare professionals for assessment of central venous blood pressure (CVP) of adult individuals.
The Mespere LifeSciences Inc. CVP-VENUS-2000 Central Venous Pressure System is used to indicate right heart pressure at the superior vena cava, which is clinically referred to as central venous pressure (CVP). The Venus 2000 is a modified version of Venus 1000 which has been cleared by FDA. The modification is to improve the detection sensitivity, data managements, and usability. The main improvements are moving the analog to digital conversion chip from the handheld to the sensor head to reduce cable noise and enhance the sensitivity; using a tablet/laptop instead of the handheld unit for faster speed of signal processing and easier data management; and using lighter sensor cable and smaller sensor head to enhance usability. The Venus 2000 system has the same fundamental scientific technology and intended use as the predicate device, the Venus 1000 System.
This document, a 510(k) premarket notification for the Mespere Venus 2000 Central Venous Pressure System, describes the device and its equivalence to a predicate device (Venus 1000). While it details the device's technical modifications and compliance with various standards, it does not contain the specific information required to complete your request for acceptance criteria and a study proving the device meets those criteria.
The document states:
- "There are no further clinical tests required for the Venus 2000. The clinical performance of the Venus 1000 System has been verified and validated. The Venus 2000 system was a device modification. It continues to meet the requirements to patient safety and effectiveness."
- "The Venus 2000 System was subjected to extensive safety testing, performance testing, verification, and validation testing."
- "The bench top test verified that the Venus 2000 System has the same performance as Venus 1000 System and the Venus 2000 System met the design requirements in an ideal non-clinical environment."
This indicates that the manufacturer relies on the clinical data and validation of its predicate device (Venus 1000) and describes bench-top testing for the Venus 2000 to show equivalent performance, rather than a new standalone clinical study for the Venus 2000.
Therefore, I cannot provide the requested information in the format you specified, as the document does not contain:
- A specific table of acceptance criteria and reported device performance for the Venus 2000 from a clinical study.
- Sample sizes used for a clinical test set for the Venus 2000.
- Data provenance (country, retrospective/prospective) for a clinical test set for the Venus 2000.
- Number of experts and their qualifications used to establish ground truth for a clinical test set for the Venus 2000.
- Adjudication method for a clinical test set for the Venus 2000.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance study results. The device is a physical system for measuring CVP, not an AI algorithm.
- Type of ground truth used from a clinical study for the Venus 2000.
- Sample size for the training set (not applicable as this is a physical measurement device, not an AI model).
- How ground truth for the training set was established (not applicable).
The document is a regulatory filing for a medical device that highlights its substantial equivalence to a previously cleared device, not a detailed scientific paper on a new clinical trial.
§ 870.1140 Venous blood pressure manometer.
(a)
Identification. A venous blood pressure manometer is a device attached to a venous catheter to indicate manometrically the central or peripheral venous pressure.(b)
Classification. Class II (performance standards).