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The OptiMap System is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.

The OptiMap™ System is intended to be used during electrophysiology procedures on patients for whom an electrophysiology procedure has been prescribed and only by qualified medical professionals who are trained in electrophysiology.

The OptiMap™ System is an electrophysiology mapping system for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an Amplifier, Cart, Monitor, and Workstation that contains proprietary mapping software. Signals from a 64-electrode mapping basket catheter are transmitted to the Workstation by the Amplifier, processed by the mapping software, and the results are displayed on the Monitor.

The OptiMap System utilizes proprietary algorithms to process intra-cardiac electrogram (EGM) signals from a 64-electrode unipolar mapping basket catheter. The software transforms the time domain waveform information from the electrodes into space domain information which calculates the Electrographic Flow™ (EGF™) vectors for Atrial Fibrillation. The system also has algorithms that display action potential wavefront propagation or Activation Cycle Path (ACP). The ACP maps are a reconstruction of the activation wavefront propagation and may be used to visualize organized atrial arrhythmias.

The software output includes static and dynamic EGF maps that graphically depict the temporal activity and location of sources of EGF with respect to the catheter electrodes. The software displays active sources of flow and passive flow phenomena, detects spatial and temporal stability of sources of flow and detects the prevalence of sources of flow. In addition, the software output includes ACP maps displaying isochrones and a wavefront animation for each cycle.

The provided text is a 510(k) Clearance Letter and a 510(k) Summary for the OptiMap™ System. While it details the device, its intended use, and substantial equivalence to a predicate, it does not contain the specific performance study results, acceptance criteria, or details regarding the methodologies of testing (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies).

The relevant section, "VII. Summary of Non-Clinical Performance Testing," states:

"Software verification and validation testing was completed on the subject device demonstrating that the OptiMap System with Version 1.3 Software (including ACP functionality) successfully performed at the unit, integration and system levels. All open issues from the verification and validation activities have been resolved or documented as unresolved anomalies. The OptiMap System met the acceptance criteria listed in the test protocols, performs as designed, and is suitable for its intended use."

This statement confirms that testing was performed and acceptance criteria were met, but it does not provide the specific criteria or the quantitative results of these tests. Therefore, I cannot populate the requested tables and information based solely on the provided text.

To answer your request, the necessary information (specific performance metrics, acceptance thresholds, sample sizes, ground truth details, etc.) would typically be found in the actual validation study report, which is not part of this 510(k) clearance letter or summary.

If such a document were available, the information would likely be organized as follows:

Acceptance Criteria and Device Performance Study

Since the provided text does not contain the specific performance study details, the following tables and sections are illustrative, showing what information would be required to fulfill the request. This information was not found in the provided 510(k) document.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size: (Not provided in the document. Would typically specify number of patient cases, EGM recordings, or arrhythmias analyzed.)
• Data Provenance: (Not provided in the document. Would specify country of origin, if retrospective or prospective data collection, and if multi-center.)

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: (Not provided in the document. Would specify the count of experts.)
• Qualifications of Experts: (Not provided in the document. Would specify their medical specialization, board certifications, and years of experience, e.g., "3 Board-Certified Electrophysiologists, each with >10 years of experience in cardiac arrhythmia diagnosis and treatment.")

4. Adjudication Method for the Test Set

• Adjudication Method: (Not provided in the document. Common methods include:
  • 2+1: Two experts review independently, and a third adjudicates disagreements.
  • 3+1: Three experts review independently, and a fourth adjudicates if necessary, or majority agreement is used.
  • Consensus: All experts discuss and reach a consensus.
  • None: A single expert's reading is considered ground truth, or adjudicated by a pre-defined process.)

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

• MRMC Study Conducted?: (Not provided in the document. Typically stated if human-in-the-loop performance with and without AI assistance was evaluated.)
• Effect Size (if applicable): (Not provided in the document. Would quantify the improvement in human reader performance, e.g., "Radiologists' diagnostic accuracy improved by X% (from Y% to Z%) when using OptiMap™ System assistance compared to without assistance.")

6. Standalone (Algorithm Only) Performance Study

• Standalone Performance Study Conducted?: Yes, the summary for "Software verification and validation" implies that the system's performance was evaluated independently, as it describes the system successfully performing at unit, integration, and system levels. However, the specific metrics and results are not detailed.

7. Type of Ground Truth Used

• Type of Ground Truth: (Not provided in the document. For cardiac arrhythmia diagnosis, this could be:
  • Expert Consensus: Agreement among multiple expert electrophysiologists based on clinical data.
  • Electrogram Analysis: Detailed analysis of raw EGM signals by experts, potentially correlated with clinical outcomes.
  • Clinical Outcomes Data: Correlation with patient outcomes (e.g., successful ablation, recurrence of arrhythmia).
  • Pathology/Histology: Less common for electrophysiology mapping, but relevant for some cardiac conditions.)

8. Sample Size for the Training Set

• Training Set Sample Size: (Not provided in the document. This is distinct from the test set and crucial for machine learning model development.)

9. How Ground Truth for the Training Set Was Established

• Training Set Ground Truth Establishment: (Not provided in the document. Similar methods to the test set ground truth would apply, but often with a larger scale and potentially more automated or semi-automated labeling steps initially, followed by expert review.)

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