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For the ICG function: The BioZ Dx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: Heart Rate (HR) Systolic Blood Pressure (SBP) Diastolic Blood Pressure (DBP) Mean Arterial Blood Pressure (MAP) Stroke Index (SI) Stroke Volume (SV) Cardiac Index (CI) Cardiac Output (CO) Systemic Vascular Resistance (SVR) Systemic Vascular Resistance Index (SVRI) Left Cardiac Work (LCW) Acceleration Index (ACI) Velocity Index or Index of Contractility (VI, IC) Thoracic Fluid Content (TFC) Base Impedance (TFI or Zo) Thoracic Fluid Content Index (TFCI) Systolic Time Ratio (STR) Systolic Time Ratio Index (STRI) Pre-Ejection Period (PEP) Left Ventricular Ejection Time (LVET) Total Arterial Compliance (TAC) Total Arterial Compliance Index (TACI) Left Stroke Work Index (LSWI) Heather Index (HI) Q-C Interval (QC) Left Cardiac Work Index (LCWI) Electrocardiograph (ECG) Systemic Stroke Resistance Index (SSRI or SSVRI) End Diastolic Volume (EDV) End Diastolic Index (EDI) For the optional 12-lead ECG function: Where the clinician decides to evaluate the electrocardiogram of adult and pediatric as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to ruleout causes for symptoms.

This submission covers Version 4.0b5 of the BioZ Dx System Software for the BioZ Dx (K051228), which is a noninvasive impedance cardiography (ICG) device that provides hemodynamic parameters based on the measurement of thoracic electrical bioimpedance. The BioZ Dx measures this change in impedance by injecting a high frequency, low amplitude alternating electrical current through the thorax between a pair of sensors placed on the neck and another pair placed on the mid-axillary line at the xiphoid process level. By detecting and measuring the change in thoracic impedance as a function of time, the BioZ Dx is able to calculate stroke volume, cardiac output and many other hemodynamic parameters. The device additionally includes the capability of performing a standard 12-Lead ECG test. The modified BioZ Dx software and firmware applies the same functions and scientific concepts as the predicate devices. Additional parameters have been added in this release that exists in the predicate devices, and a small number of routine software bugs were corrected with this release.

The provided text does not contain acceptance criteria or a study proving the device meets them in the way typically expected for a medical device regulatory submission.

Instead, this document is a Premarket Notification 510(k) Summary for a modified medical device. Its primary purpose is to demonstrate substantial equivalence to existing, legally marketed predicate devices, not to establish new performance criteria or conduct a de novo performance study against defined acceptance criteria.

Here's why and what information is present:

• Substantial Equivalence: The core argument for this 510(k) is that the "modified BioZ Dx software and firmware applies the same functions and scientific concepts as the predicate devices." This means they are not introducing a fundamentally new technology requiring entirely new performance benchmarks.
• Performance Testing: The "Performance Testing" section states: "The results of verification and validation tests concluded that the functionality and performance characteristics of the modified BioZ Dx are comparable to the currently marketed predicate devices." This implies testing was done to ensure the modifications didn't degrade performance compared to the predicate, but it doesn't specify what those performance characteristics are or what the acceptance criteria were.

To directly answer your request based on the provided text:

Acceptance Criteria and Study for BioZ Dx Hemodynamic Monitor with 12-Lead ECG (Modified Software/Firmware)

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list specific acceptance criteria in measurable terms (e.g., accuracy percentages, precision ranges) for the hemodynamic parameters or ECG function. The "performance" reported is a determination of comparability to predicate devices.

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

The document does not specify a patient sample size used for performance testing (verification and validation). It refers to "system level validations" and "unit and system level software and firmware verifications" but doesn't provide details on patient data, if any was used, or its origin.

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

The document does not mention the use of experts to establish ground truth for a test set. The evaluation focuses on comparing the device to predicate devices and previous versions of the BioZ Dx for functional equivalency, rather than against an independently established clinical ground truth.

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

No adjudication method is mentioned, as the nature of the "performance testing" described is not a clinical study requiring such a process.

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:

No MRMC study was done, nor is AI assistance mentioned. This device (from 2007) is an Impedance Cardiograph and 12-Lead ECG monitor, not an AI-assisted diagnostic tool.

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

The document describes software and firmware verification and validation, which would constitute standalone testing of the algorithm/device's functionality. The primary conclusion is that its functionality and performance characteristics are "comparable" to predicate devices. However, no specific metrics from this "standalone" performance are provided beyond the statement of comparability.

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

The "ground truth" for this submission is implicitly the performance and accepted functionality of the predicate devices. The modified device's performance was compared to these established devices. It does not refer to external clinical ground truth like pathology or outcomes data.

8. The sample size for the training set:

No information is provided about a training set. This device is hardware with embedded software for calculations and displaying parameters; it is not a machine learning or AI algorithm that typically requires a distinct "training set."

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

As no training set is mentioned or applicable in the AI/ML sense, this question is not addressed by the document.

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