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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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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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For the ICG function (from K041294):

The BioZDx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include:

ECG
Cardiac Output
Thoracic Fluid Content
Left Vent. Ejection Time
End Diastolic Volume
Systemic Vascular Resistance
Left Cardiac Work
Pre-Ejection Period
Heart Rate
Acceleration Index
Index of Contractility
Mean Blood Pressure
Diastolic Blood Pressure
Systolic Time Ratio
End diastolic Index
Cardiac Index
Stroke Volume
Systolic Blood Pressure

For the optional 12-lead ECG function (from K031422):

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 rule-out causes for symptoms.

The new product is the combination of two individually 510(k) cleared devices onto a single device platform. Both predicate devices presently use the identical common platform (CPU, display, printer, operating system) in their separate forms. The submission covers the changes necessary to the two predicate devices to allow co-residency of the Philips ECG PIM and its application software and the CardioDynamics ICG PIM and its application software into a single device. The new product combines the ECG functionality of the existing Philips PageWriter Trim III Cardiograph and the ICG functionality of the existing BioZDx monitor and allows switching between ECG and ICG applications. The ECG PIM is identical to PageWriter Trim Product including Philips' original product labeling and manuals. The PageWriter Trim application was modified by Philips to add an "Exit to ICG" function button and a common HIPPA-compliant timeout screen and password compatible with the existing CardioDynamics ICG application. The CardioDynamics application was modified to have an "Exit to ECG" button, and a "home" screen which allows initial selection of one of the two applications.

This 510(k) submission describes the combination of two already cleared devices, not a new device with its own standalone performance characteristics in the traditional sense. The "acceptance criteria" and "device performance" here refer to the successful integration and continued functionality of the two predicate devices on a single platform.

Acceptance Criteria and Reported Device Performance

Study Details:

This submission describes a verification and validation study focused on the integration of existing, cleared technologies, rather than a clinical performance study of a novel diagnostic algorithm.

1. Sample size used for the test set and the data provenance: Not applicable in the context of typical clinical validation for a diagnostic device. The "test set" here refers to the validation activities performed on the software and system integration. These tests would involve specific use-case scenarios and configurations of the combined device. The data provenance is not explicitly detailed in terms of origin country of the data or retrospective/prospective as it's validation of system function, not a clinical data set. It states, "Modifications to the Page Writer Trim III application software were completed and tested by the Philips PageWriter Trim III design team in China." and "All testing (both at CardioDynamics and Philips) was performed with both PIMs attached." This indicates testing was likely performed internally by the manufacturers.

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 this context, would be the expected functional behavior of the software and hardware integration, as defined by engineering specifications and user requirements. This is established by the design teams and verified against those specifications, rather than by clinical experts establishing a medical "ground truth."

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Software and system integration testing typically relies on predefined test cases and expected outcomes. The success or failure of a test case is usually deterministic based on whether the system performs as specified.

4. 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. This is not an AI-based diagnostic device. It is a hardware and software integration of two existing medical devices.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No. This is a combined medical device with existing functionalities, not a new algorithm evaluated in standalone mode. The "standalone" performance here refers to the continued, independent functionality of the ECG and ICG components when integrated, which was tested.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for this type of submission is the engineering specifications and user requirements document (URS). The testing verified that the modified software met these predefined functional and performance requirements for integration and operation.

   • "These new functions are described in Section I-4 "DDR-071-10 BioZ Dx Combo Product CardioDynamics User Software Requirements Specification""
   • "The changes to the Philips PageWriter Trim III application are described in Section I-3, "CDIC BioZ Combo Product ECG Software Design Specification"."
   • "Test reports are included in Section J that verify the new functionality and demonstrate compatibility of the two applications and two PIM's co-residing on the platform."
   • "A verification report of this change is attached in Section J."
   • "All software changes to the new product from the predicate devices are verified and validated within the body of system and software testing."
   • "The validation reports from CardioDynamics and Philips are included in Section J."

7. The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.

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

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The BioZDx Hemodynamic Monitor is intended to monitor and display a patient's hemodynamic parameters. These parameters include: ECG, Cardiac Output, Thoracic Fluid Content, Left Vent. Ejection Time, End Diastolic Volume, Systemic Vascular Resistance, PressureLeft Cardiac Work, Diastolic Blood Pressure, Pre-Ejection Period, Heart Rate, Acceleration Index, Index of Contractility, Mean Blood Pressure, Systolic Time Ratio, End diastolic Index, Cardiac Index, Stroke Volume, Systolic Blood Pressure.

The BioZDx Hemodynamic Monitor is a portable device for use in the hospital, outpatient and clinical settings. It noninvasively measures a patient's hemodynamic parameters using Impedance Cardiography (ICG) by attaching 8 electrodes to the patient, injecting a minimal current, and reading the returning voltage waveform. It utilizes proprietary DSP electronic circuitry and software incorporating formulas and algorithms to calculate various hemodynamic parameters based on patient inputs (gender, body frame size, height, weight, age, blood pressure) and measured ICG signals. The device includes a built-in printer for reports and an improved patient cable.

This 510(k) submission (K041294) describes the BioZDx Hemodynamic Monitor, which is stated to be substantially equivalent to its predicate devices, the BioZ.pc System (K001081) and the BioZ.com System (K974725). The submission primarily focuses on the device's design, operational principles, software characteristics, and the similarities to the predicate devices, rather than presenting a standalone study with defined acceptance criteria and performance metrics for a novel medical device. The device is largely a repackaging and porting of existing functionality to a new platform.

Therefore, for the BioZDx Hemodynamic Monitor, a direct "acceptance criteria" table with specific quantitative performance metrics and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical or performance study demonstrating a new level of accuracy or effectiveness are not provided or required in this 510(k) submission.

Instead, the submission relies on demonstrating substantial equivalence to already cleared predicate devices. The "acceptance criteria" are implicitly met by showing that the new device performs equivalently to the predicate devices for its intended use, with any changes verified and validated.

Here's an analysis based on the provided document, addressing your points where possible, and noting where information is not present due to the nature of a substantial equivalence submission for a re-packaged device:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit acceptance criteria with specific quantitative performance metrics for the BioZDx Hemodynamic Monitor are not presented in this 510(k) summary. The submission focuses on hardware, software, and functional equivalency to the predicate devices. The "performance" is implicitly considered equivalent to the predicate devices.

The justification for substantial equivalence is primarily presented in "Table 1 Device Equivalency" which compares attributes of the new device to the predicates. This table highlights design and functional aspects rather than quantitative performance.

The document states, "There were no unexpected test results due to these changes and the validation of these changes is included in Section J." This implies that the validation confirmed the device continued to perform as expected, consistent with the predicate devices, despite the modifications.

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

This information is not provided in the summary. The submission primarily discusses design controls, verification, and validation processes, but does not detail a specific test set (e.g., patient data) for evaluating the device's hemodynamic measurement accuracy. As it's a re-packaging, the core algorithms and signal processing are stated to be "nearly identical" or improved versions of the predicate. The validation would likely involve engineering tests and comparison to the predicate's known performance, rather than a new clinical study.

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

This information is not provided as there is no mention of a clinical test set that required ground truth establishment by experts. The focus is on the device's engineering and software changes and their verification.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a clinical test set or expert adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typical for medical imaging AI systems to evaluate human reader performance with and without AI assistance. The BioZDx is a hemodynamic monitoring device, and this type of study is not applicable to its function.

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

The device is a standalone hemodynamic monitor. Its performance would inherently be "algorithm only" in terms of its ability to measure and calculate hemodynamic parameters. However, the document does not present separate standalone performance metrics (e.g., accuracy, precision) against a defined ground truth for the algorithms themselves. Instead, it states that "the validation of these changes is included in Section J" for the enhanced fiducial point detection techniques and the statistical based modulation factor for dZ/dTmax. This implies internal testing was done to ensure algorithm performance was maintained or improved, but specific results are not detailed in this summary.

7. The Type of Ground Truth Used

The type of ground truth is not explicitly stated for any performance evaluation. Given the context of a 510(k) for a re-packaged device, it is highly likely that the "ground truth" for validation of algorithmic changes would involve known physiological signals generated by test equipment or validated against established measurement standards rather than pathology or outcomes data. For example, a patient simulator (which the BioZDx now has built-in, where predicates used an external one) would be used to simulate expected hemodynamic signals, and the device's measurements would be compared against the known simulator outputs.

8. The Sample Size for the Training Set

This information is not provided. The device uses "proprietary DSP electronic circuitry and software incorporating formulas and algorithms," including "enhanced fiducial point detection techniques" and "a statistical based modulation factor for dZ/dTmax." While these might imply some form of algorithm development, the document does not refer to a "training set" in the context of contemporary machine learning. The algorithms are likely based on established impedance cardiography principles and refined through engineering.

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

This information is not provided, as there is no mention of a training set or its ground truth.

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The BioZtect Sensor and BioZtect Cable are used with the GE Medical Systems Solar ICG (Impedance Cardiography) Module (K010164) and are intended to monitor and display a patient's hemodynamic parameters. The following are parameters that are available, to be used as needed by the ICG Module:

Acceleration Index, Cardiac Output, Cardiac Index, ECG, End Diastolic Volume, End Diastolic Index, Heart Rate, Index of Contractility, Indexed Systemic Vascular Diastone Indon, Indexed Left Cardiac Work, Left Cardiac Work, Left Ventricular Ejection Time, Pre-Ejection Period, Stroke Volume, Stroke Index, Systolic Time Ratio, Systemic Vascular Resistance, Thoracic Fluid Content, Respiration Rate, Velocity Index

The ICG Module with accessories BioZtect Sensor and BioZtect Cable are substantially equivalent to the predicate BioZ.com System in terms of design, intended use and principle of operation, having minimally modified these accessories. Both systems are for use in the hospital, outpatient and clinical settings. The intended use is to noninvasively measure a patient's hemodynamic parameters using Impedance Cardiography (ICG). Monitoring is accomplished by attaching 8 electrodes to the patient (two on each side of the neck and thorax), injecting a minimal current through the upper electrodes, and reading the returning voltage waveform from the inner electrodes.

The ICG Module utilizes CardioDynamics' proprietary DSP electronic circuitry and software, incorporating formulas and algorithms to calculate the various hemodynamic parameters. The user inputs patient parameters into the ICG Module, including patient gender, body frame size, height, weight, age and blood pressure. The module then utilizes these parameters and measures the ICG signals to determine the hemodynamic properties of that particular patient.

Both the predicate BioZ.com System and the ICG Module with accessories BioZtect Sensor and BioZtect Cable utilize a computer-based system. Each system contains the following:

1. BioZ or ICG Module

a) CardioDynamics' proprietary DSP hardware and Patient Interface Circuitry

b) CardioDynamics proprietary DSP firmware and user software

2. BioZtect Sensors

3. BioZtect Patient Cable

This 510(k) submission (K011797) is for modifications to accessories (BioZtect Sensor and BioZtect Cable) used with the GE Medical Systems Solar ICG Module, and it asserts substantial equivalence to a predicate device. As such, it does not include a study demonstrating the device meets acceptance criteria in the way a de novo or PMA submission might.

Instead, the submission focuses on demonstrating that the modified accessories do not introduce new questions of safety or effectiveness compared to the existing predicate device. The core of the argument for substantial equivalence is that the changes are minimal and do not alter the fundamental design, intended use, or principle of operation.

Therefore, the requested information elements related to specific performance metrics and studies (acceptance criteria, sample size, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.

The document primarily states:

• Substantial Equivalence: The modified BioZtect Sensor and BioZtect Cable are substantially equivalent to the predicate CardioDynamics BioZtect Sensor and BioZtect Cable within the BioZ.com System (predicate K001100).
• Reason for Submission (for predicate accessories):
  • Sensor: Modifications to electrode shape, material, gel, thickness, and snap size.
  • Cable: Modifications to leadwire connector size, change style of module connector, addition of series inductors for each conductor, and addition of identification integrated circuit.
• Intended Use: Noninvasively measure a patient's hemodynamic parameters using Impedance Cardiography (ICG).
• Principle of Operation: Attaching 8 electrodes, injecting minimal current through upper electrodes, and reading returning voltage waveform from inner electrodes. The ICG Module uses DSP electronic circuitry and software to calculate hemodynamic parameters based on patient inputs and ICG signals.

In summary, there is no detailed performance study presented in this 510(k) summary that would provide the quantitative information requested. The acceptance is based on the argument that the modifications are minor and the device's performance is assumed to be equivalent to the predicate device whose performance would have been established previously.

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The BioZ.com Hemodynamic Monitor is intended to monitor a patient's hemodynamic parameters. These parameters include: ECG, Heart Rate, Pre-ejection Period, Left Ventricular Ejection Time, Systolic Time Ratio, Stroke Volume, Cardiac Output, Cardiac Index, Systemic Vascular Resistance, End Diastolic Volume, End Diastolic Index, Index of Contractility, Acceleration Index, Left Cardiac Work, Thoracic Fluid Content, Respiration Rate.

The BioZ.com System is a self-contained computer-based product utilizing the same CardioDynamics proprietary DSP circuitry and software as its predicate device. It consists of an Instrument (containing DSP and Patient Interface Circuitry, Intel 80X86 Processor Board, DSP firmware and user software, power supply, built-in flat-panel screen, keyboard/keypad, power cord), Patient Cable, and Electrodes/Transducers. It is portable and can operate from AC power or an internal rechargeable battery. It uses thoracic electrical bioimpedance (TEB) by attaching 8 electrodes to the patient and injecting a minimal current to measure hemodynamic parameters.

Here's an analysis of the provided text regarding the acceptance criteria and study for the BioZ.com System:

1. Table of Acceptance Criteria and Reported Device Performance

The submission acts as a 510(k) summary, aiming to demonstrate substantial equivalence to a predicate device rather than setting new, explicit performance-based acceptance criteria in the traditional sense for a novel device. The "acceptance criteria" here are implied by the claim of functional equivalence to the predicate.

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

• Sample Size: "a number of patients" (specific number not provided).
• Data Provenance: "Digitized waveforms from a number of patients with various clinical conditions." This suggests retrospective data, likely from existing patient recordings that were processed by both devices. The country of origin is not specified.

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

• This information is not provided in the document. The study description focuses on comparing the output of the two devices against each other, rather than against a separate "ground truth" established by experts.

4. Adjudication Method for the Test Set

• None specified. The study describes a direct comparison between the two devices' outputs rather than an adjudication process involving human review against a benchmark.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

• No, an MRMC study was not done. The study was a "device-to-device" comparison using digitized waveforms, not an assessment of human readers' performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, in effect. The study described is a standalone performance assessment comparing the BioZ.com's output to the BioZ Portable's output when processing the same "digitized waveforms." There is no mention of human intervention or interpretation influencing the output being compared.

7. Type of Ground Truth Used

• The "ground truth" in this context is the output of the predicate device (CardioDynamics BioZ Portable System). The study's purpose was to demonstrate that the BioZ.com System is "substantially equivalent" to this established predicate.
  • It is not expert consensus, pathology, or outcomes data external to the device capabilities themselves.

8. Sample Size for the Training Set

• Not applicable / Not provided. This device is a medical monitoring system that calculates hemodynamic parameters using bioimpedance, not a machine learning or AI device that typically involves a distinct "training set." The algorithms and software are described as essentially the same as the predicate, derived from "CardioDynamics proprietary DSP circuitry and software."

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

• Not applicable / Not provided. As noted above, there is no mention of a training set for machine learning. The "ground truth" (or established performance) for the underlying algorithms would have been developed during the initial creation and validation of CardioDynamics' proprietary DSP circuitry and software for the predicate device, but that information is not detailed here.

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The BioZ System was designed to monitor a patients hemodynamic parameters. These include ECG, HR, PEP, LVET, STR, SV, SI, CO, CI, SVR. SVRI, EDV, EDI, IC, ACI, LCW and TFC.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called the "BioZ System." It indicates that the device has been found substantially equivalent to predicate devices, allowing it to be marketed.

The document lists:

• The device name (BioZ System, Models BZ-100, 101, 102, and BioZ Portable Model BZ-125).
• Its regulatory class (Class II).
• Its product code (74 DSB).
• Indications for Use (monitoring hemodynamic parameters such as ECG, HR, PEP, LVET, etc.).
• A list of abbreviations for the hemodynamic parameters.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training data information).

Therefore, I cannot fulfill your request based on the provided text.

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