Search Results

The Astronomer Plus™ System is a computerized system to assist in the diagnosis of complex cardiac arrhythmias. The Astronomer Plus™ System can be used to:

• Display the relative location of catheters during cardiac mapping procedures (used exclusively with the Constellation® Catheter);
• Route externally generated pacing stimuli and transmit cardiac electrogram (EGM) signals to electrophysiology recorders; and
• Document electrophysiological procedures which make use of the Constellation® Catheter.

This device is a data management system intended for use within a cardiac electrophysiology lab for the creation, maintenance, and review of patient files generated during a typical electrophysiology study to assist in the diagnosis of complex cardiac arrhythmias. The device consists of a workstation running proprietary software, and catheter interface.

The Astronomer Plus™ system is comprised of a catheter input box (the Switching & Locating Device) and a Computer, running a proprietary GUI (Astronomer Plus™). The system provides data to the physician obtained from the Constellation Catheter and a Roving (or auxiliary) Catheter (typically a quad catheter). The System has two window displays that simultaneously show: Constellation catheter orientation, roving catheter proximity indication, and user-defined markers. Additionally, the SLD routes signals received from the Constellation and Roving Catheters 1-to-1 to stand-alone EP recorders for acquisition, storage, and display purposes.

Here's an analysis of the provided 510(k) summary regarding the Astronomer Plus™ with SLD device, focusing on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed reported device performance metrics. It broadly mentions that "Tests were performed both in vitro and in vivo to confirm further, conformance to several recognized standards is safety and effectiveness."

Without specific numerical targets for performance (e.g., accuracy, precision, sensitivity, specificity for a particular function), a table of acceptance criteria and reported performance cannot be generated from the given text. The submission focuses on substantial equivalence based on intended use and technological characteristics rather than providing a detailed performance study with quantifiable outcomes against pre-defined criteria.

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

The summary does not specify the sample size used for the test set in either in vitro or in vivo testing. It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the data).

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

The summary does not mention the use of experts to establish a "ground truth" for a test set, nor does it specify the number or qualifications of any experts involved. The testing appears to be focused on confirming safety and effectiveness primarily through engineering verification and validation against functional requirements of the device itself and its interaction with the Constellation® Catheter, rather than against a clinical ground truth established by expert review.

4. Adjudication Method for the Test Set

Since the summary does not detail the process of establishing ground truth with experts, an adjudication method is not discussed or implied.

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

The summary does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The device is described as assisting in diagnosis and displaying information, but there's no mention of a study evaluating human reader improvement with or without AI assistance.

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

The device is explicitly described as a "computerized system to assist in the diagnosis" and "provides data to the physician." This indicates a human-in-the-loop system. Therefore, a standalone (algorithm only) performance study would not be applicable or described for this type of device. Its function is inherently assistive to a human operator.

7. Type of Ground Truth Used

The summary does not explicitly define a "ground truth" in the clinical sense (e.g., pathology, outcomes data). The testing performed seems to be geared towards functional verification and validation of the device's ability to display catheter locations, route signals, and document procedures as intended. The "ground truth" in this context would likely be the accurate functioning of the system itself and its sensors, rather than a clinical diagnostic outcome.

8. Sample Size for the Training Set

The summary does not mention a training set or its sample size. Given the device's apparent function of displaying and routing data rather than performing complex AI-driven diagnostic interpretations requiring extensive training data, the concept of a "training set" in the context of machine learning might not be applicable here.

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

As no training set is mentioned, the method for establishing its ground truth is also not discussed.

Ask a specific question about this device