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eCareCoordinator and its accessories are indicated for use by patients and by care teams for collecting and reviewing patient data from patients who are capable and willing to engage in use of this software, to transmit medical and non-medical information through integrated technologies.

eCareCoordinator (eCC) is a software-only telemedicine system, designed to enable the support of patients in the home setting. eCC is intended to support the clinician with monitoring of remote patients. Clinicians use eCC to manage populations of ambulatory care patients, while keeping primary care physicians informed of patient status. eCC is a software-only device and does not contain any patient-contacting components.

The provided document, a 510(k) Pre-Market Notification for eCareCoordinator 1.5, does not contain a typical "acceptance criteria" table with reported device performance in a quantitative manner as one might expect for a diagnostic or interventional device. This is likely because the device is a software-only telemedicine system for data aggregation and communication facilitation, rather than a device with direct physiological measurement or diagnostic capabilities requiring numerical performance metrics (e.g., sensitivity, specificity).

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (eCareCoordinator 1.0) through a comparison of technological characteristics and verification/validation activities.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, a specific table of quantitative acceptance criteria and performance metrics for the eCareCoordinator 1.5 is not provided in the document. The "performance" is demonstrated through verification and validation efforts, ensuring the device meets its specifications and user needs. The comparison table (Table 5-1 on pages 5-6) lists features and provides a categorical comparison (e.g., "Same", "Enhanced user interfaces", "Added video communications"), but not numerical performance.

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

The document does not specify a "test set" in terms of patient data or clinical images for evaluating performance. The testing mentioned refers to:

• "Philips verification and validation processes"
• "detailed functional, system level and usability testing"

Given the nature of the device as a software-only telemedicine system for data aggregation and communication, a traditional test set with patient data provenance is not applicable in the way it would be for an AI diagnostic algorithm. The "test set" here would refer to the internal testing of the software's functionality and usability.

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

This information is not applicable and therefore not provided in the document. Since there's no clinical performance testing involving patient data for diagnostic or treatment decisions, there's no ground truth to be established by experts in the context of diagnostic accuracy. The device is described as an "informational tool only and is not to be used as a substitute for professional judgment of healthcare providers."

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document for the reasons stated above.

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

A MRMC comparative effectiveness study was not done. The document states:

• "Clinical Performance testing for Philips eCareCoordinator 1.5 was not performed, as there were no new clinical applications that had hazards or risk mitigations that required clinical performance testing to support equivalence."

Therefore, there is no effect size reported for human readers improving with or without AI assistance, as the device is not an AI diagnostic tool and no such study was conducted.

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

A standalone performance study of an "algorithm" in the typical sense (e.g., for diagnostic accuracy) was not done. The device is a "software-only telemedicine system" that facilitates data aggregation and communication for human care teams, not an autonomous algorithm making diagnostic or treatment decisions. The document explicitly states: "eCareCoordinator does not send any real time alarms and is not intended to provide automated treatment decisions. This software is an informational tool only..."

7. Type of Ground Truth Used

Not applicable/Not explicitly stated for clinical performance. The "ground truth" for this type of software would be its adherence to functional and user requirements during internal testing. For example, a ground truth for a communication feature would be "did the video call successfully connect and transmit audio/video as designed?" rather than "was the diagnosis correct?".

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The eCareCoordinator 1.5 is a traditional software system, not an AI/machine learning model that undergoes "training" on a dataset in the way a diagnostic algorithm would.

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

This information is not applicable as there is no training set mentioned for this traditional software.

Summary of Device Acceptance and Study:

The acceptance of eCareCoordinator 1.5 for 510(k) clearance is based on demonstrating substantial equivalence to its predicate device (eCareCoordinator 1.0). This was supported by:

• Non-clinical testing: This involved internal "Philips verification and validation processes," including Risk Analysis, Product Specifications, Design Reviews, Verification & Validations.
• Conclusion: "Test results demonstrated that eCareCoordinator 1.5 meets all specifications and user needs." This implies that the software functions as designed and fulfills its intended purpose as a telemedicine system for data aggregation and user communication.

The document emphasizes that the enhanced features (like two-way video communication and Bluetooth connectivity for measurements) do not change the intended use or introduce new questions of safety or effectiveness, thus obviating the need for clinical performance testing typically required for devices with direct clinical impact.

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