Search Results

INFINITY MegaCare is a software application for viewing, manual editing, printing, and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, Ambulance ECG devices, Holter ECG devices and the Infinity Monitoring System.

INFINITY MegaCare is intended to provide analysis of Rest ECG's and to provide preliminary data for editing and confirmation by a physician. INFINITY MegaCare can provide a serial comparison of Rest ECG data to facilitate the review of current and previous Rest ECG's.

INFINITY MegaCare is designed for network compatibility to facilitate retrieval of data and to interface with other hospital information systems though HL7 protocols.

INFINITY MegaCare is a computer software program that allows viewing, manual editing, printing and archiving of digitized electrocardiograph records from Rest ECG devices, Exercise ECG devices, ambulance ECG devices, Holter ECG devices and the INFINITY Monitoring System.

INFINITY MegaCare uses the Microsoft Windows 2000 server operating system, Microsoft IIS Web server, and Microsoft SOL Server 2000 relational database. The system consists of a software application, which is installed on a user provided IBM compatible server running the Microsoft Windows 2000 Server operation system. MegaCare utilizes the ECG analysis algorithm developed under the direction of Dr. Peter MacFarlane at the University of Glasgow and used for the INFINITY MVWS Rest ECG (K980625) and Burdick's Eclipse 4 Electrocardiograph (K946281).

Here's an analysis of the provided text, focusing on acceptance criteria, study details, and ground truth establishment:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific acceptance criteria in a quantitative or pass/fail manner. It claims "substantially equivalent" for both non-clinical and clinical performance.

However, the "Device Description" and "Intended Use" sections imply general performance expectations related to analysis of Rest ECGs, serial comparison, viewing, editing, printing, and archiving. The text also mentions that the device "utilizes the ECG analysis algorithm developed under the direction of Dr. Peter MacFarlane at the University of Glasgow and used for the INFINITY MVWS Rest ECG (K980625) and Burdick's Eclipse 4 Electrocardiograph (K946281)." This suggests that the performance of those predicate devices effectively sets the "acceptance criteria" for the analysis algorithm within INFINITY MegaCare.

Given this, the table would primarily reflect the reliance on the predicate device's performance rather than independently stated criteria for INFINITY MegaCare's analysis algorithm.

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

The provided text does not explicitly state a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to predicate devices for which the ECG analysis algorithm was already validated.

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

The document does not provide this information. It mentions that the ECG analysis algorithm was "developed under the direction of Dr. Peter MacFarlane at the University of Glasgow," implying expert involvement in the algorithm's initial development and validation for the predicate devices. However, it does not specify how ground truth was established for the INFINITY MegaCare's own assessment.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method.

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

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the device's standalone performance and its equivalence to predicate devices, not on human readers' improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study of the algorithm was implicitly done for the predicate devices, and that performance is leveraged for INFINITY MegaCare. The filing states: "MegaCare utilizes the ECG analysis algorithm developed under the direction of Dr. Peter MacFarlane at the University of Glasgow and used for the INFINITY MVWS Rest ECG (K980625) and Burdick's Eclipse 4 Electrocardiograph (K946281)." This indicates that the core analytical capabilities of INFINITY MegaCare are based on an already validated standalone algorithm. The submission itself then claims "Assessment of non-clinical performance data for equivalence: Substantially equivalent (Section S)" and "Assessment of clinical performance data for equivalence: Substantially equivalent (Section T)," further implying that the standalone performance of the algorithm (inherited from the predicate) was deemed sufficient.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the algorithm's original validation or for INFINITY MegaCare's assessment. Given it's an ECG analysis algorithm intended "to provide preliminary data for editing and confirmation by a physician," it is highly probable that the ground truth for an ECG analysis algorithm would involve a consensus of expert cardiologists or electrophysiologists, meticulously reviewing and annotating ECG waveforms and clinical outcomes.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set of the ECG analysis algorithm. This information would typically be tied to the initial development and validation of the algorithm by Dr. MacFarlane.

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

The document does not detail how the ground truth for the training set was established. As inferred in point 7, it's highly likely that it involved expert review and consensus of ECGs, possibly correlated with patient outcomes, for the development of Dr. MacFarlane's algorithm.

Ask a specific question about this device