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The HemoSonic™ 200 is intended for use in patients with surgical, medical, or anesthetic risk to provide a non-invasive, continuous, real-time composite hemodynamic profile that indicates and monitors cardiovascular status by assessing contractility, flow, and resistance parameters.

The HemoSonic™ 200 is a monitoring device that non-invasively measures real-time descending aortic blood flow and other hemodynamic parameters during anesthesia and intensive care. The HemoSonic™ 200 system is composed of a monitor, a transesophageal probe assembly and probe holder

The provided text describes the HemoSonic™ 200 Hemodynamic Monitor and its 510(k) summary, but it does not contain information related to acceptance criteria, device performance metrics, or clinical study details as requested in your prompt.

Specifically, the document focuses on:

• Substantial equivalence to a predicate device (Sometec - Dynemo 3000).
• Device description and intended use.
• Technological characteristics (stated as unchanged from the predicate).
• A list of performance tests conducted, which are primarily related to safety, electrical standards, and some comparative engineering tests (round trip insertion loss, pulsatile flow loop test). These are not clinical performance acceptance criteria in the sense of accuracy, sensitivity, specificity, or agreement with a reference standard.
• The FDA's classification and clearance letter.
• An "Indications for Use" form for diagnostic ultrasound, which specifies the clinical applications and modes of operation but does not list performance metrics.

Therefore, for your specific request:

1. A table of acceptance criteria and the reported device performance: This information is not available in the provided text. The document lists engineering/safety tests but not performance metrics related to the accuracy of hemodynamic parameter measurements.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned, as no clinical performance study is detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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: Not applicable, as this is a hemodynamic monitor, not an AI-assisted diagnostic imaging device requiring human reader interpretation in the context of MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of typical AI device performance, but the engineering tests listed are standalone device tests. However, no clinical "performance" in terms of accuracy is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned, as no clinical performance study is detailed. The "ground truth" for the listed engineering tests would be the established standards or predicate device's characteristics.
8. The sample size for the training set: Not applicable, as no AI/machine learning model is described in the context of "training data."
9. How the ground truth for the training set was established: Not applicable.

In summary, the document details the regulatory clearance process for a hemodynamic monitor based on substantial equivalence and engineering/safety testing, but it does not provide clinical performance data or acceptance criteria in the way you've outlined for diagnostic tools.

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