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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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