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The Vasocor™ Vascular Diagnostic Center (Model 300) is a non-invasive medical device that can be used by physicians and other health care professionals to measure blood pressure values (systolic, diastolic and pulse pressure) and the heart pulse rates based on segmental measurement. The Vascular Diagnostic Center (Model 300) also calculates Framingham coronary heart disease, stroke, and peripheral disease risk scores, body mass index (BMI), oolonary Livel index (ABI), and pressure differentials between certain adjacent peripheral limb segments, and provides indications of arterial compliance. The indications of arterial compliance (that is, elasticity indices) can be used to assist in assessing and managing patients that may have (alarti, crasherly including cardiovascular disease, that might require more specific diagnostic evaluations by physicians or other health care providers.

The Vasocor Vascular Diagnostic Center (Model 300) is a vascular laboratory that integrates, into one device, various modules that provide indices of significance to peripheral vascular and cardiovascular function. These modules include Patient Data, Framingham and BMI, ABIgram™ Ankle/Brachial Index, PADogram™ Segmental Pressure Analysis, and Vasogram™ Arterial Compliance Procedure. The Vascular Diagnostic Center (Model 300) also offers administrative capabilities such as creating periodic system usage reports which show test dates, procedures performed, patient names, and physician names.

The provided text describes a 510(k) premarket notification for the Vasocor™ Vascular Diagnostic Center (Model 300), which is a non-invasive blood pressure measurement system. However, it does not contain any information regarding specific acceptance criteria, clinical study results, sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies.

The submission focuses on establishing substantial equivalence to previously cleared devices based on their shared technological characteristics and intended use (non-invasive blood pressure measurement using oscillometric method, calculation of various cardiovascular indices). The FDA's letter confirms this substantial equivalence.

Therefore, I cannot provide the requested information from the given input.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data is presented. The document is a regulatory submission for equivalence, not a performance report.
2. Sample sized used for the test set and the data provenance: No test set or associated sample size is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment experts are mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication process is described.
5. 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 MRMC study or AI assistance is mentioned. The device is a diagnostic tool, not an AI-assisted diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is discussed.
8. The sample size for the training set: No training set or associated sample size is mentioned.
9. How the ground truth for the training set was established: No training set or ground truth establishment is discussed.

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The PVR-100 / Vasogram is a noninvasive medical device used in conjunction with other devices such as: continuous-wave Doppler ultrasound, treadmill testing, and ultrasonic imaging techniques for vascular studies of the limbs and digits. Use of the PVR-100 / Vasogram in this manner allows the physician to noninvasively diagnosis extremity arterial and venous disorders, and receive, record, and produce a visual display of local arterial compliance.

The PVR-100 / Vasogram is a noninvasive medical device.

This looks like a 510(k) submission summary for a medical device (PVR-100/Vasogram II). The provided text does not contain the detailed information required to answer your request about acceptance criteria and a study proving the device meets them.

Specifically, the text is a letter from the FDA acknowledging receipt and review of the 510(k) submission and stating that the device is substantially equivalent to legally marketed predicate devices. It also outlines the intended use of the device.

To answer your request, I would need to find sections of the 510(k) submission itself that describe:

• The specific performance characteristics tested.
• The acceptance criteria for those characteristics.
• Details of the study (clinical or bench) conducted to demonstrate performance.
• The statistical methods used, sample sizes, ground truth establishment, etc.

Therefore, based solely on the provided text, I cannot complete your request.

If you have access to the full 510(k) submission for the PVR-100/Vasogram II, please provide the relevant sections describing the performance data and acceptance criteria.

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The Vasocor PVR-100 (Pulse Volume Recorder) is a non-invasive medical device used in conjunction with other devices such as; continuous-wave Doppler ultrasound, treadmill testing, and ultrasonic imaging techniques for vascular studies of limbs and digits. Use of the PVR in this manner allows the physician to non-invasively diagnosis extremity arterial and venous disorders.

The Vasocor PVR-100 provides Pulse Volume Recording (PVR) made possible through air plethysmography. The PVR-100 device, which is based on a PC platform, includes various standard blood pressure cuff sizes that allow use of the PVR measurement on various limb and digit extremities, a pneumatic circuit that allows for internal calibration as well as inflation cuff pressure, and a user interface that includes various menus and screens for inputting patient demographic data, performing tests, displaying and entering results, and printing reports. The PVR tracing is accomplished by attaching a standard blood pressure cuff on various areas of the extremities. Once atmospheric air is injected into the cuff to provide skin contact, a pressure transducer records the pressure change in the PVR cuff secondary to change in volume of the extremity segment under the cuff during repeated cardiac cycles. PVR measurement is accomplished by calculating the volume change in the extremity segment under evaluation, where the PVR tracing shows the change in pressure of the same segment during the cardiac cycle.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vasocor PVR-100 device:

Vasocor PVR-100: Acceptance Criteria and Study Details

The provided document describes the Vasocor PVR-100, a Pulse Volume Recorder (PVR) that utilizes air plethysmography for non-invasive vascular studies. The submission aims to establish substantial equivalence to a predicate device, the Life Sciences Pulse Volume Recorder.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the traditional sense (e.g., target specificity, sensitivity, or amplitude correlation coefficient). Instead, the non-clinical and clinical testing sections describe a comparison methodology to demonstrate equivalence to the predicate device. The primary "acceptance criteria" can be inferred as: producing PVR amplitude measurements and contours that are comparable to those produced by the predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Non-clinical (In-vitro): Not explicitly stated how many distinct "tests" or parameter variations were run on the hemodynamic model, but the model itself served as the synthetic "test set."
  • Clinical: Six subjects (3 normal, 3 with known peripheral vascular disease).
• Data Provenance: The document does not specify the country of origin for the clinical subjects. Given the submitter's address (Miami, Florida), it's highly probable the clinical data was collected in the USA.
• Retrospective or Prospective:
  • Non-clinical: The hemodynamic model was "developed specifically for the Vasocor PVR," suggesting a controlled, prospective experimental setup.
  • Clinical: The six subjects were "evaluated using the new Vasocor PVR-100 subject to this 510(k) and the predicate device," indicating a prospective comparative study.

3. Number of Experts and Qualifications for Ground Truth

• Non-clinical: The ground truth for the in-vitro model was based on its design to "produce Pressure and Volume contours that mimic the normal human circulation in lower extremities." This effectively means the model itself is the ground truth based on established hemodynamic principles. No external experts are mentioned for this part.
• Clinical: The document mentions "known peripheral vascular disease" for three subjects, implying a pre-existing clinical diagnosis by qualified medical professionals (e.g., vascular specialists, radiologists). The "visual analysis" of PVR contours is stated as a "method used clinically," implying interpretation by clinical experts. However, the exact number and qualifications of experts involved in establishing the ground truth for the study itself (e.g., confirming the disease status of the patients, or interpreting the PVR tracings for comparison) are not explicitly stated.

4. Adjudication Method

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The comparison of PVR amplitude and contour was made between the Vasocor PVR-100 and the predicate device. "Amplitudes were measured in millimeters to the nearest 0.5mm." "Contour analysis were made by visual analysis (method used clinically)." This suggests a direct comparison, likely by the study investigators or a designated clinical expert, rather than a multi-reviewer adjudication process.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done. The study's focus was on the substantial equivalence of the device's output (PVR tracings) compared to a predicate device, not on how human readers' diagnostic performance might improve with or without AI assistance. This device is an output-generating tool, not an AI-assisted diagnostic aid for human interpretation.

6. Standalone Performance Study

Yes, a standalone performance essentially was done for the device itself. The PVR-100's ability to generate PVR tracings and measurements was evaluated directly, both in a hemodynamic model and on human subjects, in comparison to the predicate device. The performance being measured is the device's output, independent of human interpretation for diagnostic purposes, though the output is intended for human interpretation.

7. Type of Ground Truth Used

• Non-clinical: Hemodynamic model (designed to mimic normal human circulation) and its controlled variations.
• Clinical:
  • For subject selection: Pre-existing clinical diagnosis (e.g., "known peripheral vascular disease").
  • For performance comparison: The output of the predicate device (Life Sciences Pulse Volume Recorder) was used as the reference against which the Vasocor PVR-100's output was compared. This implies the predicate device's output is considered the "ground truth" for what a functional PVR tracing should look like.

8. Sample Size for the Training Set

Not applicable. The document describes a 510(k) submission for a medical device that produces physiological measurements (PVR tracings), not a machine learning or AI model. Therefore, there is no "training set" in the context of AI model development. The device's operation is based on pneumatic and pressure transducer technology, not learned patterns from data.

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

Not applicable, as no training set was used/described.

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