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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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