Search Results

The Acumen™ IQ finger cuff is indicated for patients over 18 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with the HemoSphere advanced monitoring platform.

The Acumen IQ finger cuff is intended to noninvasively measure blood pressure and use the information to derive hemodynamic parameters when connected to an Edwards' HemoSphere Advanced Monitoring platform.

The provided text describes a 510(k) premarket notification for the Acumen IQ finger cuff, which is a modified version of a previously cleared device (K190130). The modification involves expanding the finger circumference size range and removing a finger sizing aid. The submission states that the device is identical to the predicate device in terms of design, intended use, and technology.

The document mentions that usability testing was conducted in accordance with ANSI/AAMI HE75 and that clinical performance testing was completed to ensure the finger cuffs perform as intended, and that the Acumen IQ finger cuff has successfully passed all testing. However, the actual acceptance criteria and device performance results from these studies are not explicitly provided in the given text. The text only broadly states that the device "successfully passed all testing."

Without the specific details of the clinical performance testing, a comprehensive table of acceptance criteria and reported device performance cannot be generated. Similarly, concrete information regarding sample sizes, data provenance, ground truth establishment, MRMC studies, or standalone performance is not available in the provided document.

Therefore,Based on the provided text, a complete answer to your request is not possible. The document states that clinical performance testing was completed and successfully passed, but it does not provide the specific acceptance criteria or the numerical results of this performance testing.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and the Reported Device Performance: This information is not provided in the document. The text only states that "clinical performance testing was completed to ensure the finger cuffs perform as intended" and that the device "has successfully passed all testing." No specific criteria (e.g., accuracy, precision) or numerical performance values are given.

2. Sample size used for the test set and the data provenance: This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided in the document.

4. Adjudication method for the test set: This information is not provided in the document.

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: This information is not provided in the document. The device is a "noninvasive blood pressure measurement system," not an AI diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is a measurement device. Its "performance" would inherently be standalone in its measurement capability once the cuff is applied. However, specific methodology (e.g., comparison to invasive measurements) and results are not provided.

7. The type of ground truth used: Given that the device non-invasively measures blood pressure, the ground truth for clinical performance testing would typically be established using a reference method for blood pressure measurement, such as invasive arterial line measurements or a highly accurate non-invasive oscillometric device that meets specific standards (e.g., ISO or BHS protocols). However, this is not explicitly stated in the document.

8. The sample size for the training set: This information is not provided in the document. (Note: For a device like a blood pressure monitor, there might not be a "training set" in the same sense as an AI algorithm that learns from data. It's more about calibration and validation against ground truth.)

9. How the ground truth for the training set was established: This information is not provided in the document.

In summary, the provided FDA clearance letter and 510(k) summary confirm that usability and clinical performance testing were conducted and passed, but they do not detail the specific acceptance criteria, performance results, or methodologies of those studies.

Ask a specific question about this device