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The ICON® is intended for noninvasive continuous monitoring of hemodynamic parameters for adult, pediatric, and neonatal patients in hospitals, hospital-type facilities, mobile, and home environments under the care of a physician, nurse or medical technician.

The ICON® is a noninvasive cardiac output monitor, also known as a hemodynamic monitor. By application of an array of adhesive ECG type surface electrode to the body, the ICON® measures thoracic electrical bioimpedance (TEB) and in particular the changes of bioimpedance related to the cardiac cycle. The ICON® determines hemodynamic parameters related to blood flow, contractility and fluid status.

The provided text is a 510(k) Summary for the DSYPKA MEDICAL 510(k) K082242 submission, introducing the CARDIOTRONIC® ICON® (also known as OSYPKA MEDICAL® ICON®) hemodynamic monitor. This document explicitly states that the submission is based on demonstrating substantial equivalence to a predicate device, the AESCULON® Type (Version) C2 (K081035).

Here's an analysis of the acceptance criteria and supporting study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance" in the traditional sense of a clinical trial where specific numerical thresholds are met by the new device. Instead, the entire submission hinges on demonstrating substantial equivalence to a predicate device.

The "acceptance criteria" here are implicitly that the ICON® device performs "as well as" the predicate device, the AESCULON®. The "reported device performance" is a qualitative assessment of equivalence rather than quantitative measurements against predefined targets.

Implicit Acceptance Criteria and Performance (based on Substantial Equivalence):

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

• Sample Size for Test Set: Not applicable/Not reported. The document explicitly states: "Clinical testing not part of this submission." The demonstration of substantial equivalence was based on non-clinical performance data and a comparison to the predicate device.
• Data Provenance: The document explicitly states: "Demonstration of substantial equivalence between the ICON® (new device) and the AESCULON® (predicate device) was based on an assessment of non-clinical performance data." No specific country of origin for this non-clinical data is provided, nor is it specified if it's retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts and Qualifications: Not applicable/Not reported. Since clinical testing was not part of the submission and the approach was substantial equivalence based on non-clinical data, there would be no "ground truth" established by experts in the context of clinical performance evaluation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not reported. As no clinical "test set" was used for performance evaluation (only non-clinical data for substantial equivalence), no adjudication method is relevant or 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

• MRMC Study: No. This device is a hemodynamic monitor, not an AI-assisted diagnostic imaging tool with human readers. The concept of an MRMC study and "human readers" is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance Study: The document focuses on demonstrating that the device itself (the ICON® monitor) is substantially equivalent to the predicate device (AESCULON®). It's a medical device, not an AI algorithm in the typical sense that would have "human-in-the-loop performance" as a separate consideration. The comparison is between two complete physical devices. While the device contains algorithms for hemodynamic parameter calculation, a separate "standalone algorithm only" performance study, distinct from the device's overall performance, is not mentioned or implied.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Type of Ground Truth: Not applicable/Not reported for a clinical test set. Given that clinical testing was "not part of this submission," there was no clinical ground truth established for the new device's performance against actual patient conditions. The ground truth, in the context of this 510(k), is implicitly the established safety and effectiveness of the predicate device (AESCULON®), against which the new device (ICON®) is being compared for substantial equivalence using non-clinical data.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/Not reported. This document does not describe the development or training of a new algorithm where a "training set" would be used in the AI sense. It compares a new medical device to a legally marketed predicate device.

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

• Ground Truth for Training Set: Not applicable/Not reported. As there's no mention of a "training set" for an AI algorithm, this information is not relevant to the provided text.

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