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For the ICG function:

The BioZ Rx 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/Index of Contractility (VI, IC) Thoracic Fluid Content (TFC)

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) Systemic Stroke Resistance Index (SSRI/SSVRI) Base Impedance (TFI or Za) Electrocardiogram (ECG)

For the optional 12-lead ECG function:

Where the clinician decides to evaluate the electrocardiogram of adult and pediatric patients as part of decisions regarding possible diagnosis, potential treatment, effectiveness of treatment or to ruleout causes for symptoms.

This submission for the BioZ Rx covers a PC platform/printer/cart change and user software modifications compared to the predicate BioZ Dx System (K070156 and K051228), which is a noninvasive impedance cardiography (ICG) device that provides hemodynamic parameters based on the measurement of thoracic electrical bioimpedance. The BioZ Rx 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 Rx 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 using previously cleared Welch/Allyn software and USB patient interface accessories (K052158 and K962854).

All ICG signal processing and parameter measurements and calculations are identical to predicate device. Those tasks are performed within the ICG Patient Interface Module (PIM) which is essentially unchanged from the predicate device.

The provided 510(k) summary for the BioZ Rx Hemodynamic Monitor with Optional 12-lead ECG does not contain the typical information required to describe acceptance criteria and a study proving those criteria are met, especially in the context of diagnostic accuracy for new algorithms or AI.

This submission focuses heavily on demonstrating substantial equivalence to predicate devices through technical modifications and compliance with electrical safety and electromagnetic compatibility standards, rather than proving performance against specific acceptance criteria for diagnostic accuracy.

Here's an attempt to extract what little information is available and highlight what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

"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."

"The results of all testing demonstrate that the BioZ Rx Hemodynamic Monitor with Optional 12-Lead ECG does not raise any new significant issues of safety, effectiveness or performance of the device when compare to the existing predicate devices." |
| Electrical Safety & EMC Compliance: Device complies with relevant recognized consensus standards (EN60601-1, EN60601-1-1, EN60601-1-25). | "Both the predicate device and the ECG device and software of the BioZ Rx are tested and certified to comply with the relevant recognized consensus standards, including EN60601-1, EN60601-1-1, and EN60601-1-25."
"The new user interface platform, including the cart, printer, ICG and ECG interface modules and all cables have been tested by NEMKO and TUV for electrical safety, electromagnetic emissions, and electromagnetic immunity to the appropriate International consensus standards." |
| Software/System Verification & Validation: Functionality and performance comparable to predicate. | "Unit and system level software and firmware verifications"
"System level validations"
"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." |

Key takeaway: The acceptance criteria here largely revolve around equivalence to a predicate device and compliance with technical standards for device hardware and modifications. There are no performance metrics related to diagnostic accuracy (e.g., sensitivity, specificity, AUC) for the hemodynamic parameters or ECG interpretation that would be typical for a device with a novel algorithm or AI component.

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

• Test Set Sample Size: Not applicable/not stated in the document for performance related to diagnostic accuracy. The document mentions testing for electrical safety, EMC, and system/software verification and validation, but these typically involve engineering tests rather than patient studies with sample sizes.
• Data Provenance: Not applicable/not stated. The focus is on the modified components (PC platform, printer, software, ECG PIM supplier change) and their adherence to safety/performance standards, rather than clinical data demonstrating diagnostic performance on a particular dataset.

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

• Not applicable/not stated. Ground truth establishment for diagnostic performance is not described as part of this submission. The "ground truth" for the tests performed appears to be the predicate device's performance characteristics and recognized consensus standards.

4. Adjudication Method for the Test Set

• Not applicable/not stated. Adjudication methods are relevant for clinical accuracy studies, which are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described. This study is primarily focused on demonstrating substantial equivalence of a modified device (hardware/software platform changes) to an already cleared predicate, rather than evaluating a new diagnostic algorithm's impact on human readers.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done.

• Not applicable/not stated. The ICG signal processing and parameter calculations are stated to be "identical to predicate device." The ECG function uses previously cleared software. Therefore, there's no mention of a new standalone algorithm whose performance needed to be validated in this submission outside the context of its integration and equivalence.

7. The Type of Ground Truth Used

• The implicit "ground truth" for this submission are:
  • The performance and safety characteristics of the predicate BioZ Dx device.
  • Recognized consensus standards for electrical safety (EN60601-1, EN60601-1-1, EN60601-1-25) and electromagnetic compatibility.
  • Internal design controls and quality assurance measures (risk analysis, design requirements, verification/validation).

8. The Sample Size for the Training Set

• Not applicable/not stated. This submission describes modifications to an existing device and its certification, not the development or training of a new algorithm (AI or otherwise) that would require a training set.

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

• Not applicable/not stated, as no training set for a new algorithm is mentioned.

Summary of this Document's Approach:

This 510(k) submission for the BioZ Rx device is a "changes to a cleared device" type of submission. The manufacturer is demonstrating that updates to the computer platform, user interface software, and a change in the ECG patient interface module supplier do not change the fundamental performance or safety of the device's core ICG functionality (which remains identical to its predicate) and that the new components (like the Welch/Allyn ECG) are themselves certified and compatible.

Therefore, the "acceptance criteria" discussed are primarily about maintaining equivalence to a predicate device and complying with general device safety and performance standards for the modified components, rather than establishing de novo diagnostic performance for a new AI or algorithm.

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