(126 days)
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."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Usability of the device for measuring CVP | The clinical verification demonstrated "appropriate usability" of the Mespere Venus 1000 System. |
| Accuracy of the device for measuring CVP (compared to physical examination) | The clinical verification demonstrated the "claimed accuracy" of the Mespere Venus 1000 System. (No specific numerical accuracy is provided). |
| Accuracy of the device for measuring CVP (compared to RHC) | The clinical validation study demonstrated that the Mespere Venus 1000 System is "equivalent in performance" to the Edwards Lifesciences Swan-Ganz catheter with respect to measuring CVP. (No specific numerical equivalence metric is provided). |
| Safety (Adverse Events) | "No adverse events were reported" in both the clinical verification and clinical validation studies. |
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.
§ 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).