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The M1765A ECG Manager is a computer software program which allows viewing, manual editing, printing and archiving of digitized electrocardiograph records from Hewlett-Packard Company electrocardiograph machines.

The M1765A ECG Manager is a data management system which allows users to receive, store, view, manually edit, copy, print, and delete 12 lead ECG information which originated on HP PageWriter cardiographs. The M1765A ECG Manager employs the Microsoft Windows 95 or NT operating system, and Microsoft's Access relational database. Ease of use is assured by use of timetested, industry standard graphical user interfaces. The system consists of a software application which is installed by the user on a user-provided IBMcompatible personal computer running the Microsoft Windows 95 or NT operating system. The product is designed to be installed and operated by users with minimal computer skills. Voluminous, context-sensitive online HELP facilities are provided as part of the product. There are no diagnostic algorithms built into M1765A ECG Manager applications. All clinical rules and decision logic is embedded in the software of the electrocardiographs.

This 510(k) summary (K974746) for the M1765A ECG Manager describes a data management system for ECG information. It explicitly states that the device does not perform any computerized interpretation of the ECG waveform and There are no diagnostic algorithms built into M1765A ECG Manager applications. Given this, the concept of "acceptance criteria" for diagnostic performance, as well as a "study that proves the device meets the acceptance criteria" in terms of clinical accuracy, sensitivity, or specificity, is not applicable in the traditional sense for AI/ML devices.

Instead, the "acceptance criteria" for this device would relate to its functionality as a data management system (e.g., ability to receive, store, view, edit, copy, print, delete ECG data, and ease of use, stability, and absence of critical software bugs). The "study" proving it meets these criteria would be software validation testing.

Here's an attempt to answer using the provided information, noting the significant limitations due to the nature of this device as a non-diagnostic software:

Description of Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria

The M1765A ECG Manager is a software application designed for the management of digitized electrocardiograph records. It explicitly states that it does not perform any computerized interpretation of the ECG waveform and There are no diagnostic algorithms built into M1765A ECG Manager applications. Therefore, the acceptance criteria and study described here are for the device's functional performance as a data management system, not for diagnostic accuracy or clinical effectiveness in interpreting ECGs.

The "acceptance criteria" implicitly revolve around the system's ability to reliably perform its stated functions: receiving, storing, viewing, manually editing, copying, printing, and deleting 12-lead ECG information. The "study" demonstrating this involves non-clinical software validation testing.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device, explicit quantitative "acceptance criteria" and "reported device performance" in terms of clinical metrics (like sensitivity, specificity) are not provided in the document. Instead, the criteria are functional, and the performance is reported as successful validation.

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

Not applicable in the context of clinical data for diagnostic performance. The testing was non-clinical software validation. The document does not specify a "test set" sample size in terms of clinical ECG cases, nor does it refer to data provenance (country of origin, retrospective/prospective). The "data" being tested would be the functionality of the software itself rather than its performance on a specific dataset of ECGs.

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

Not applicable. As this device does not perform diagnostic functions, there is no "ground truth" related to ECG interpretation that needs to be established by experts. Ground truth in this context would be whether the software performs its stated data management functions correctly, which is verified through software testing procedures, not expert adjudication of clinical cases.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical "test set" requiring adjudication for diagnostic accuracy.

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

No, an MRMC comparative effectiveness study was not done. The device does not involve AI for interpretation or diagnosis, and therefore, does not aim to improve human reader performance in interpreting ECGs.

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

Yes, in a sense, the primary "performance" assessed was the standalone functionality of the software as a data management system. The "algorithm" here refers to the software's functional logic for managing data, not a diagnostic algorithm. The document states: "Non-clinical tests were conducted to demonstrate that the ECG Manager software meets all product requirements." This indicates a standalone assessment of the software's capabilities.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the non-clinical tests would be the predefined functional and non-functional software requirements and specifications. The software is tested against these specifications to ensure it performs as intended (e.g., an ECG stored is retrievable, an ECG printed matches the displayed version, etc.). There is no medical "ground truth" (e.g., pathology, outcomes data, or expert consensus on disease presence) required.

8. The Sample Size for the Training Set

Not applicable. The M1765A ECG Manager does not employ AI/ML algorithms that require training data. It is a traditional software application performing data management functions.

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

Not applicable, as there is no training set for this device.

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