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The VO200 - NeurOs Cerebral Oximetry is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood in the brain tissue beneath the sensor. The prospective clinical value of data from the VO200 - NeurOs Cerebral Oximetry has not been demonstrated in disease states. The VO200 - NeurOs Cerebral Oximetry should not be used as the sole basis for diagnosis or therapy.

The Mesepre VO 200 - NeurOs Cerebral Oximetry System is based on the same optical operating principles of multi-distance diffuse reflectance spectroscopy as the predicate device. It measures oxygenated and de-oxygenated hemoglobin content underneath the sensor probe and allows clinicians to monitor the blood oxygenation level of cerebral tissue. The VO 200 - NeurOs Cerebral Oximetry System consists of a reusable sensor, a single use disposable adhesive, and a display software. The sensor uses two wavelengths within the range from 660nm to 905nm to measure light absorption of tissue, with one wavelength is more sensitive to deoxygenated hemoglobin, the other is more sensitive to oxygenated hemoglobin. Regional cerebral tissue oxygen saturation is calculated through the ratio of tissue absorption to the two wavelengths and validated aqainst blood sample testing through the blood gas analyzer. Sensors are sized to provide desired depth and area coverage for the measurement. The sensor consists of LEDs, photo detectors, pre-amplifier, analogue to digital convertor, and a CUP for controlling the light emission and detection sequence, auto power adjustment for LED, gain adjustment for photo detectors to ensure optimized signal to noise ratio, and data processing and calculations. It also has an isolator between the monitor and the sensor to ensure the electric safety of the sensor. The enclosure of the sensor is made of medical grade ABS. The single use sensor adhesive is made of a soft foam with medical grade adhesives. The Mespere Display Software can be loaded to a tablet, laptop, or stationary PC. The sensor is then connected through a standard USB connector. It displays the measurement through the computer user interface at a refresh rate of approximately one second. Screenshots of the measurement can be saved to a user specified file and can be exported through USB ports or the internet.

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria for the VO200 - NeurOs Cerebral Oximetry System, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size used for the test set and the data provenance:

   • Sample Size: 12 healthy subjects. A total of 284 paired venous and arterial blood sample readings and 284 VO200 - NeurOs Cerebral Oximetry system readings were used for comparison and statistical analysis.
   • Data Provenance: Prospective clinical study conducted at the University of California San Francisco (UCSF) Hypoxia Labs, San Francisco, California, USA. The subjects were healthy, non-smoking individuals aged 21-49 years old.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not explicitly state the number or qualifications of experts involved in establishing the ground truth measurements. The ground truth was established through invasive blood samples analyzed by a Co-Oximeter, which implies highly trained medical and laboratory professionals were involved in the process, but their specific roles or qualifications are not detailed.

3. Adjudication method for the test set:
   The document does not mention an explicit adjudication method (e.g., 2+1, 3+1). The ground truth was established by simultaneously drawing invasive blood samples (from jugular bulb and radial artery) and immediately analyzing them with a Co-Oximeter. This suggests a direct measurement approach rather than an expert consensus/adjudication process on interpretations.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   No. This was not an MRMC comparative effectiveness study involving human readers and AI assistance. The study focused on validating the accuracy of the device against direct physiological measurements.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Yes, a standalone performance study was done for the device. The clinical study aimed to validate the accuracy of the VO200 - NeurOs Cerebral Oximetry system's measurements directly against invasive blood samples, without human interpretation of the device's output to determine the primary outcome.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth was established through invasive physiological measurements (venous jugular bulb and radial arterial blood samples) directly analyzed by a Co-Oximeter.

7. The sample size for the training set:
   The document does not provide information about a separate training set. The descriptions focus on the clinical validation study (test set). For medical devices, particularly those based on established physiological principles like oximetry, the "training" (calibration) might be integrated into the device's design and manufacturing process rather than through a distinct, large-scale clinical training dataset as would be common for AI/ML algorithms.

8. How the ground truth for the training set was established:
   As no separate training set is explicitly mentioned, the method for establishing ground truth for a training set is not provided. The accuracy and trending accuracy (which could be considered performance, not training data) values were derived from the validation study described above, where ground truth was established by Co-Oximeter analysis of invasive blood samples.

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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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