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The ZOE Fluid Status Monitor is intended for patients: With fluid management problems, Taking diuretic medication, Living with Heart Failure, Living with End-stage Renal Disease, Recovering from Coronary Artery Disease related event, Suffering from Recurrent Dehydration. This device is intended for use under the direction of a physician, for the non-invasive monitoring and management of patients with fluid management problems in a variety of medically accepted clinical applications.

The ZOE Fluid Status Monitor Model ZOE3 is a non-invasive, battery powered impedance monitor designed as an 'early warning' monitor for determining changes in the fluid status of patients with fluid management problems. The ZOE Fluid Status Monitor Model ZOE3 works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance also known as Zo, decreases when fluid increases and increases when fluid decreases. The ZOE Fluid Status Monitor Model ZOE3 is designed for use with disposable, self-adhesive silver i silver chloride electrodes that are readliy available from Noninvasive Medical Technologies, Inc. NMT approved electrodes must be used with the ZOE Fluid Status Monitor. Zo readings obtained from unapproved electrodes may not be accurate!

This 510(k) premarket notification for the ZOE Fluid Status Monitor Model ZOE3 does not contain the detailed performance study information requested.

The document states: "The ZOE Fluid Status Monitor Model ZOE3 has the same method of operation and is functionally equivalent to the predicate devices K112830 (November 13, 2012) & K131509 (June 28, 2013). The ZOE Fluid Status Monitor has the identical indications for use as the ZOE Fluid Status Monitor K112830 (November 13, 2012) & K131509 (June 28, 2013)." and "The ZOE3 Fluid Status Monitor does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate devices ZOE Fluid Status Monitor K112830 (November 13, 2012) & K131509 (June 28, 2013)."

This indicates that the device's acceptance is based on its substantial equivalence to previously cleared predicate devices, rather than new performance studies detailed in this specific submission. The submission focuses on general quality and safety testing relevant to device manufacturing and electrical standards, not clinical performance metrics.

Therefore, many of the requested details about a specific performance study are not available in this document.

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

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for this specific submission, beyond meeting the general safety and functional equivalence of the predicate devices.
• Reported Device Performance: No specific performance metrics (e.g., accuracy, sensitivity, specificity) for fluid status monitoring are reported in this document for the ZOE3. The document only confirms functional equivalence to predicate devices.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified, as no new clinical performance study is detailed here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of Experts: Not applicable, as no new clinical performance study is detailed here.
• Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable, as no new clinical performance study is detailed here.

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. This device is an impedance monitor for fluid status, not an AI-assisted diagnostic imaging device with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• A standalone performance in the context of clinical metrics is not detailed. The device itself is "standalone" in its measurement, but the document does not present a standalone clinical performance study to establish new efficacy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable, as no new clinical performance study is detailed here.

8. The sample size for the training set:

• Not applicable, as the document doesn't describe an AI/ML algorithm or a training set for clinical performance.

9. How the ground truth for the training set was established:

• Not applicable.

Summary of available information:

This 510(k) submission for the ZOE Fluid Status Monitor Model ZOE3 relies on substantial equivalence to predicate devices (K112830 and K131509) for its acceptance. It emphasizes that the new model has the "same method of operation" and is "functionally equivalent" with "identical indications for use." The only specific "testing" mentioned relates to quality assurance measures (Risk Analysis, Requirements Review, Design reviews, Code Inspections, Verification and Validation, H/W and S/W Implementation Verification Testing) and electrical safety and EMI safety standards (CAN/CSA C22.2 No. 60601-1:08, IEC 60601-1, IEC 60601-1-2). No new clinical performance studies are presented in this document.

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