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The AESCULON®, AESCULON® CHF Clinic™, AESCULON® Hypertension Clinic® and AESCULON® Pacemaker Clinic Fare intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments.

The AESCULON® Version C2, including the models CHF Clinic™, Hypertension Clinic™ and Pacemaker Clinic™, is a noninvasive comprehensive cardiovascular monitor, also known as a hemodynamic monitor. By application of an array of adhesive ECG type surface electrode to the body, the AESCULON® measures thoracic electrical bioimpedance (TEB) and in particular the changes of bioimpedance related to the cardiac cycle. The AESCULON® determines hemodynamic parameters with respect to blood flow, vascular system (if the NIBP option is incorporated), contractility and fluid status.

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets those criteria:

1. Acceptance Criteria and Reported Device Performance:

The 510(k) summary for the AESCULON® Version C2 does not explicitly state quantitative acceptance criteria or typical device performance metrics in a table format. Instead, it focuses on demonstrating substantial equivalence to a predicate device (AESCULON® Version C1.1). The core of the claim is that the new device "is as safe, as effective, and performs as well as the predicate device."

Therefore, the "acceptance criteria" are implicitly tied to the performance of the predicate device, which is considered to meet established safety and effectiveness standards for impedance plethysmographs. The "reported device performance" is framed as being equivalent to the predicate.

2. Sample Size and Data Provenance for the Test Set:

• Sample Size: Not applicable.
• Data Provenance: Not applicable.

The submission explicitly states: "Summary Clinical testing not part of this submission." This indicates that no new clinical test set was used to directly evaluate the AESCULON® Version C2. The demonstration of substantial equivalence was based on non-clinical performance data and the similarity to the predicate device.

3. Number of Experts and Qualifications for Ground Truth:

• Number of experts: Not applicable.
• Qualifications of experts: Not applicable.

Since no clinical testing was performed for this submission, there was no need for experts to establish ground truth for a new test set.

4. Adjudication Method:

• Adjudication method: Not applicable.

As no clinical testing was performed, there was no need for an adjudication method for a test set.

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

• MRMC study: No.

The submission does not mention any MRMC study. The device is a monitor, not an image interpretation or diagnostic aid that typically involves human readers.

6. Standalone (Algorithm Only) Performance Study:

• Standalone study: Yes, implicitly.

The statement "demonstration of substantial equivalence between the AESCULON® Version C2 (new device) and the Version C1.1 (predicate device) was based on an assessment of non-clinical performance data" implies that the new device's core algorithms and engineering performance were evaluated in comparison to the predicate. While not a "standalone performance study" in the sense of a new clinical trial, the assessment of "non-clinical performance data" confirms the algorithm's behavior is consistent with the established predicate's performance characteristics. This is a form of demonstrating algorithmic functionality without human intervention in the loop of the assessment itself.

7. Type of Ground Truth Used:

• Ground Truth: For the purpose of this 510(k) submission, the "ground truth" for the new device's acceptable performance is its substantial equivalence to the predicate device (AESCULON® Version C1.1), which itself would have undergone its own studies to establish its ground truth against recognized physiological measurements or clinical outcomes. The equivalence is established by comparing design, intended use, and principal of operation, as well as the underlying mathematical models and derived parameters.

8. Sample Size for the Training Set:

• Sample Size: Not applicable.

The document does not describe the use of machine learning or AI that would require a distinct "training set" in the conventional sense. The device appears to be based on established biophysical principles and algorithms rather than trained models from a large dataset.

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

• Ground Truth Establishment: Not applicable.

As there is no mention of a dedicated training set, the question of how its ground truth was established is not relevant to this submission. The core "truth" being referred to is the established performance and safety profile of the predicate device, against which the new device is compared for equivalence.

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