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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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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 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 works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance. Base Impedance also known as Zo, decreases when fluid increases and increases when fluid decreases. The ZOE Fluid Status Monitor is designed for use with disposable, self-adhesive silver / silver chloride electrodes that are readily 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 document is a 510(k) premarket notification for the ZOE Fluid Status Monitor (Model ZOE 2b-5k). It addresses the safety and effectiveness of the device by establishing its substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance:

The document does not detail specific quantitative acceptance criteria or a dedicated study showing the device meets such criteria in terms of accuracy, sensitivity, or specificity for diagnosing fluid status. Instead, the primary "acceptance criterion" for this 510(k) submission is substantial equivalence to a previously cleared predicate device.

The reported "device performance" is based on the claim of functional equivalence and identical indications for use as the predicate device.

Study Details:

The document describes a 510(k) premarket notification process, not a clinical study in the traditional sense that generates new performance data to prove efficacy. The "study" here is the comparative analysis against the predicate device to demonstrate substantial equivalence.

1. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical test set with human subjects for performance evaluation. The "test set" for this 510(k) is the comparison of device characteristics (design, materials, operating principles, indications for use, safety standards) to the predicate device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in a clinical sense (e.g., diagnosis of a condition) is not established in this document. The "ground truth" for the substantial equivalence claim is the pre-existing FDA clearance of the predicate device (K112830).

3. Adjudication method for the test set: Not applicable. There was no clinical test set requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. An MRMC study was not described or performed for this 510(k) submission. The document focuses on device characteristics and regulatory compliance, not on human reader performance with or without AI assistance.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The ZOE Fluid Status Monitor is a hardware device (impedance plethysmograph) that measures electrical impedance. It does not appear to involve an AI algorithm that would have standalone performance in the way a diagnostic imaging algorithm might. Its "performance" revolves around accurate impedance measurement, which is addressed by electrical safety and EMC testing, not standalone algorithmic evaluations.

6. The type of ground truth used: For the purposes of this 510(k) submission, the "ground truth" is the established safety and effectiveness of the predicate device (ZOE Fluid Status Monitor K112830), as previously cleared by the FDA. The current device is deemed "substantially equivalent" based on direct comparison of its attributes to those of the predicate. Compliance with electrical safety and EMC standards (UL 2601-1 / CSA C22.2 No. 60601, EN 60601-1, EN 60601-1-2) serves as "ground truth" for those specific engineering performance aspects.

7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.

8. How the ground truth for the training set was established: Not applicable, as there is no training set mentioned for this device.

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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 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 works by applying a low amplitude high frequency electrical current to the body and measuring the electrical impedance. Base Impedance also known as Zo, decreases when fluid increases and increases when fluid decreases.

The ZOE Fluid Status Monitor is designed for use with disposable, self-adhesive silver chloride electrodes that are readly available / commercially approved within the United States for other approved cardiovascular monitoring systems.

The provided document does not contain information about specific acceptance criteria, a study proving device performance against such criteria, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document is a 510(k) Premarket Notification summary for the ZOE Fluid Status Monitor. It asserts substantial equivalence to a previously cleared device (K042113), stating that the hardware is identical and the indications for use are the same. This type of submission typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies with defined acceptance criteria and performance metrics against a de novo ground truth.

Here's what can be extracted from the document regarding a "study":

Study Information Pertaining to K112830 (ZOE Fluid Status Monitor):

1. A table of acceptance criteria and the reported device performance:

   • N/A. The document does not specify performance acceptance criteria or report specific device performance metrics from a new study. Instead, it relies on substantial equivalence to the predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • N/A. No new clinical data (test set) is mentioned or presented for K112830. The submission is based on the device being identical to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • N/A. No new clinical data or ground truth establishment process is described for K112830.

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

   • N/A. Not applicable as no new test set is 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:

   • N/A. This device is an impedance plethysmograph, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was conducted or is relevant.

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

   • N/A. While the device works independently to measure impedance, the filing does not discuss performance of a standalone algorithm in the context of a new study. Its performance is considered equivalent to the predicate device.

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

   • N/A. No new ground truth is established or discussed for K112830 as its substantial equivalence is based on being identical to a previously cleared device.

8. The sample size for the training set:

   • N/A. There is no mention of a training set as this is not an AI/machine learning device undergoing a new performance study.

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

   • N/A. Not applicable.

Summary from the Document:

The basis for clearance of ZOE Fluid Status Monitor (K112830) is substantial equivalence to a predicate device (ZOE Fluid Status Monitor K042113). The document explicitly states:

• "The hardware utilized in the ZOE Fluid Status Monitor is identical to the hardware utilized in the currently marketed approved device the ZOE Fluid Status Monitor K042113 (September 14, 2004)."
• "The ZOE Fluid Status Monitor has the identical indications for use as the predicate devices the ZOE Fluid Status Monitor K042113 (September 14, 2004)"
• "The ZOE Fluid Status Monitor has the same method of operation and is functionally equivalent to the predicate device."
• "There is no performance standards published for Product Code DSB Impedance Plethysmograph (870.2770)"

Therefore, the "study that proves the device meets the acceptance criteria" is implicitly the prior regulatory clearance of the predicate device (K042113), which established its safety and effectiveness. This new submission asserts that because the device is identical in hardware, function, and intended use, it inherently meets the same safety and effectiveness profile as the predicate without requiring new performance data. The quality and safety testing mentioned (ISO13485 certification, UL 2601-1, CSA C22.2 No. 60601, EN 60601-1 2003, EN 60601-1-2) are primarily related to manufacturing quality systems and electrical safety/EMC standards, not clinical performance studies with specific patient cohorts or ground truths.

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