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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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