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The ESA620 Electrical Safety Analyzer is an electronic signal source and measurement device for verifying the electrical safety of medical devices. The ESA620 also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications.

The ESA620 provides following function categories:

• ECG Functions .
• ECG-Performance Testing ●

Fluke Biomedical's ESA620 Electrical Safety Analyzer (hereafter referred to as the ESA620) provides a basis for verifying the electrical safety of medical devices. The Product also provides ECG simulation and performance waveforms to verify patient monitors are performing within their operating specifications.

The ESA620 consists of the following components:

1. Printed Circuit Board Assemblies using surface mount components and firmware loaded in embedded processors.
2. Plastic injection molded case parts.
3. Liquid Crystal Display for user interface.
4. Power cord for powering the unit at 120V and 60Hz.

This document describes the regulatory submission for the Fluke Biomedical ESA620 Electrical Safety Analyzer. It focuses on demonstrating substantial equivalence to a predicate device (MPS450), rather than proving that a device meets and acceptance criteria via a study. As such, many of the requested details about a study to prove acceptance criteria are not present in the provided text.

Here is an analysis based on the provided document:

Study Type and Purpose:
The document describes non-clinical testing performed to verify and validate the ESA620. The primary purpose of this testing was to demonstrate substantial equivalence to the predicate device (MPS450), not to meet predefined acceptance criteria in a robust clinical or standalone AI study.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in the traditional sense of a performance study with specific target metrics for accuracy, sensitivity, specificity, etc. Instead, it compares the technological characteristics and intended use of the ESA620 against its predicate device, the MPS450, to establish substantial equivalence.

The "differences" column in the provided table implicitly represents areas where the ESA620's performance or features might be considered against the predicate. However, these are presented as factual differences rather than "acceptance criteria" where a specific pass/fail threshold is defined for each.

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

• Sample Size: The document states "Laboratory studies have been conducted with a representative patient monitor to verify and validate the ESA620 will perform within its' published specifications -Document: NPI-05012012-00002". This indicates a very limited "sample size" of only one representative patient monitor for the non-clinical tests. This is typical for a device meant for testing other equipment, where the focus is on the device's output accuracy and stability, rather than diverse patient data.
• Data Provenance: The studies were conducted in a laboratory setting ("Non-Clinical Test Data"). The country of origin for the data is not specified, but given the submitter (Fluke Biomedical) is US-based and the submission is to the FDA, it is highly likely to be U.S.-based. The data is prospective in the sense that it was generated specifically for this submission to validate the new device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• This information is not provided in the document. For a technical device like an electrical safety analyzer, "ground truth" would typically refer to the accuracy of its measurements and simulations compared to established standards and calibrated reference equipment, rather than expert human interpretation. The "validation" likely refers to engineering design verification and validation by qualified engineers rather than clinical experts.

4. Adjudication Method for the Test Set:

• This information is not applicable/not provided as the validation described is non-clinical performance testing of measurement parameters against specifications, not an assessment requiring multiple human readers and adjudication.

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

• No, an MRMC study was not done. This type of study is specifically designed for assessing the impact of AI assistance on human reader performance, typically in diagnostic imaging. The ESA620 is a test and measurement device, not a diagnostic tool requiring human interpretation.

6. Standalone (Algorithm Only) Performance Study:

• The document implies a standalone performance assessment of the device, but not in the context of an "algorithm" as would be found in AI/ML devices. The "Non-Clinical Test Data" section states "The ESA620 software has been successfully validated to confirm the performance of the device." This confirms that the device's technical performance (measurements, simulations) was evaluated independently against its specifications.

7. Type of Ground Truth Used:

• The "ground truth" for this device would be established engineering specifications, calibrated reference standards, and potentially a "golden standard" or master device that has been proven accurate. The statement "to verify and validate the ESA620 will perform within its' published specifications" indicates that the ground truth was the published specifications themselves, which are derived from metrology standards.

8. Sample Size for the Training Set:

• This information is not applicable/not provided. The ESA620 is a hardware device with embedded firmware; it is not an AI/ML device that requires a "training set" in the context of machine learning. The validation described is traditional software and hardware verification.

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

• This information is not applicable. As it's not an AI/ML device, there's no "training set" or corresponding ground truth establishment process in that sense. The "ground truth" for the device's function (e.g., whether it accurately outputs a 1mV ECG signal) would be based on fundamental electrical engineering principles, national/international standards (e.g., IEC 60601 for medical electrical equipment safety), and calibration to a higher-level physical standard.

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