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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:

1. A specific table of acceptance criteria and reported device performance for the Venus 2000 from a clinical study.
2. Sample sizes used for a clinical test set for the Venus 2000.
3. Data provenance (country, retrospective/prospective) for a clinical test set for the Venus 2000.
4. Number of experts and their qualifications used to establish ground truth for a clinical test set for the Venus 2000.
5. Adjudication method for a clinical test set for the Venus 2000.
6. Multi-reader multi-case (MRMC) comparative effectiveness study results.
7. Standalone (algorithm only) performance study results. The device is a physical system for measuring CVP, not an AI algorithm.
8. Type of ground truth used from a clinical study for the Venus 2000.
9. Sample size for the training set (not applicable as this is a physical measurement device, not an AI model).
10. 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.

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Mespere Venus 1000 is intended to be used by healthcare professionals for assessment of central venous blood pressure (CVP) of adult individuals.

The Mespere LifeSciences Inc. Mespere Venus 1000 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 main components of the Mespere Venus 1000 System include: a handheld display unit, a pressure sensor cable unit, neck patch adhesive liners, an adhesive reference patch, and a docking station for calibration and charging. The handheld unit displays the CVP value at a refresh rate of one second and the plethysmographic waveform.

The provided text describes two clinical studies: "Clinical Verification" and "Clinical Validation." The "Clinical Verification" study focused on usability, accuracy, and correlation of the device with CVP obtained by physicians, while the "Clinical Validation" study compared the device to the Edwards Swan-Ganz right heart catheter (RHC) for accuracy.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets (e.g., "accuracy must be X%"). Instead, the studies aim to demonstrate "claimed accuracy and appropriate usability" and "equivalence in performance."

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Verification:
  • Sample Size: "a mix of healthy volunteers and patients." The exact number is not specified.
  • Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The text does not provide country of origin.
• Clinical Validation:
  • Sample Size: "acute and chronic heart failure patients already receiving RHC as part of their usual care." The exact number is not specified.
  • Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The text does not provide country of origin.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Clinical Verification:
  • Number of Experts: Unspecified, but ground truth was "CVP obtained by physicians." This implies multiple physicians, but the exact number isn't given.
  • Qualifications: "physicians." No specific qualifications (e.g., "radiologist with 10 years of experience") are provided.
• Clinical Validation:
  • Number of Experts: Not applicable, as the ground truth was the "Edwards Swan-Ganz right heart catheter (RHC)," which is a device, not human experts.

4. Adjudication Method for the Test Set

• The text does not mention any adjudication method (e.g., 2+1, 3+1, none) for either the clinical verification or the clinical validation studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was explicitly described. The clinical validation study compared the device to a reference standard (RHC), but it did not involve human readers comparing the AI-assisted vs. non-AI assisted approaches. The "Clinical Verification" mentions "physicians" obtaining CVP, but doesn't describe a formal MRMC study design for improving human performance with AI.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Yes, a standalone performance study was done. Both the "Clinical Verification" and "Clinical Validation" studies assessed the performance of the Mespere Venus 1000 System independently (i.e., the algorithm/device's output) against a reference standard or physician assessment. There is no mention of a "human-in-the-loop" component in these performance evaluations.

7. Type of Ground Truth Used

• Clinical Verification: Expert consensus (implicitly, "CVP obtained by physicians" suggesting their clinical judgment)
• Clinical Validation: Device-based reference standard ("Edwards Swan-Ganz right heart catheter (RHC)")

8. Sample Size for the Training Set

• Not provided. The document focuses on the clinical verification and validation studies, which typically refer to the test set. Information about the training set size or how the algorithm was developed is not included.

9. How the Ground Truth for the Training Set Was Established

• Not provided. As the training set information is absent, the method for establishing its ground truth is also not mentioned.

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