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RescueNet ePCR is intended for the collection, storage and printing of patient data that is entered by a user (caregiver), or captured from specified medical devices, and integrated into a patient care report (patient electronic medical record). RescueNet ePCR is intended for use by qualified medical personnel providing direct patient care in the pre-hospital environment to document the care provided. RescueNet ePCR is indicated for use by health care providers whenever there is a need for generation of a patient record.

The proposed RescueNet ePCR is a software-only product. RescueNet ePCR is a medical data collection system used to collect, store and print patient data that is entered by a user (caregiver), or captured from specified medical devices, and is integrated into a patient care report (patient electronic medical record). RescueNet ePCR is non-alarming software that runs on a variety of commercial off-the-shelf hardware.

Here's an analysis of the provided text regarding the acceptance criteria and study for the RescueNet ePCR device:

Based on the provided FDA 510(k) summary for RescueNet ePCR (K103473), the information regarding acceptance criteria and a detailed study proving performance is very limited. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical performance study with specific acceptance criteria.

However, I can extract the relevant (and often limited) information and structure it according to your requested format.

Acceptance Criteria and Device Performance Study for RescueNet ePCR (K103473)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document states "Extensive performance testing," but does not provide details on the number of cases, data points, or scenarios used in the testing.
• Data Provenance: Not specified. It's highly likely that this involved internal testing and validation by ZOLL Medical Corporation, but the country of origin of any test data or whether it was retrospective or prospective is not mentioned. Given the nature of a software-only device for data management, the "data" would likely refer to simulated scenarios, test cases, and possibly real-world data processed through the software.

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

• Not specified. The document does not describe the establishment of a "ground truth" in the traditional sense of a clinical diagnostic study. The testing likely focused on functional verification and validation (e.g., data input accuracy, report generation accuracy, integration with other devices), rather than diagnostic accuracy against a clinical gold standard.

4. Adjudication Method for the Test Set

• Not specified. This information is not relevant or not provided for the type of performance testing described in the summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study was not conducted or mentioned. The device is a data collection and management software, not a diagnostic imaging or interpretive device that would typically involve human readers evaluating cases.

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

• Yes, effectively. The device itself is a "software-only product." The performance testing described focuses on the software's ability to collect, store, and print data, and integrate with other medical devices. The evaluation is implicitly standalone in that it assesses the software's functionality and accuracy in its designed tasks. However, its intended use always involves a "user (caregiver)" for data entry and interaction.

7. The type of ground truth used

• Not explicitly defined as "ground truth" in the diagnostic sense. For functional validation of a data management system, the "ground truth" would likely be:
  • Defined specifications and requirements: The software must correctly perform actions as per its design.
  • Source data accuracy: Data received from medical devices or entered by users must be stored and presented accurately.
  • Output accuracy: Printed reports must accurately reflect the stored data.
  • Predicate device's known performance: The primary comparison is to a legally marketed predicate device, implying its performance serves as a de facto "ground truth" for what is acceptable.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This device is a data collection and management system, not a machine learning or AI algorithm that typically has a "training set." Its development would involve traditional software engineering and testing methodologies.

9. How the ground truth for the training set was established

• Not applicable. As there is no "training set" for this type of software, no ground truth was established for it.

Summary of the Study:

The document describes a performance testing study conducted by ZOLL Medical Corporation to demonstrate that RescueNet ePCR's "features and functions are substantially equivalent to the corresponding features and functions of the indicated commercially distributed predicate device (Philips Medical Systems IntelliVue Clinical Information Portfolio K100272)."

The study primarily focused on functional equivalence, safety, and effectiveness through internal performance testing. It aimed to prove that the proposed device performs the same intended uses and does not raise new questions of safety or effectiveness compared to the predicate. The details of this "extensive performance testing" such as specific methodologies, sample sizes (e.g., number of test cases, simulated data inputs), or detailed quantitative results are not provided in this 510(k) summary. The conclusion is a qualitative assertion that the testing demonstrates substantial equivalence.

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