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STAR Apollo™ Mapping System assists users in the interpretation and manual annotation of 3D anatomical and electrical maps of human atria using data from multipolar, intracardiac, atrial, electrograms during atrial fibrillation. The clinical significance of utilizing the STAR Apollo Mapping System, to help identify areas with intracardiac atrial electrograms, of atrial arrhythmias, such as atrial fibrillation, has not been established by clinical investigations.

The STAR Apollo Mapping System (v1.8) is a software driven system designed to assist operators in identifying Early Sites of Activation (ESA) and Repetitive Patterns of Activation (RPA) in patients undergoing a cardiac mapping procedure for Atrial Fibrillation (AF). The software is designed for use with FDA cleared electroanatomic mapping systems specifically:

• CARTO™ 3 EP Navigation System (V8.1) (K252302) (Biosense Webster) and
  • OPTRELL™ Mapping Catheter with TRUEref™ Technology (K230253) (Biosense Webster)

for exporting geometry data, electrograms and electrode locations over ethernet connection during the electrophysiology procedure with CARTO 3 API (K231207) to provide input data for the STAR Apollo Mapping System.

• Ensite Precision Model EE 3000 Cardiac Mapping System (V2.6) (K201148) and
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
• EnSite X EP System (V 1.1.1, V 2.0, V 3.0) (K213364) (K221213) (K231415) (Abbott Medical) and
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
• Ensite X EP System (V 3.1) (K242016) (Abbott Medical) and either:
  • Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ (K172393) (Abbott Medical) or
  • Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ (K242016) (Abbott Medical)

for exporting geometry data, electrograms and electrode locations via a portable external storage device or over ethernet data connection (Ensite X EP System (V 3.0, V 3.1) with LiveSync module) (K231415) (K242016) during the electrophysiology procedure to provide input data for the STAR Apollo Mapping System.

The principle of STAR Apollo Mapping System analysis is to use data on multiple individual wavefront trajectories to identify Repetitive Patterns of Activation (RPA) or regions of the atrium that represent Early Sites of Activation (ESA) which most often precede activation of neighboring areas, with the aim of helping clinicians to identify regions of the atria that may be the origins for AF activation. The system consists of proprietary STAR Apollo Mapping System software and a hardware component. STAR Apollo Mapping System software consists of 3 main components: Electroanatomic data import, the STAR Apollo Mapping System engine (C++ code) and Graphics User Interface (GUI). The STAR Apollo Mapping System is designed to run on a laptop computer running Windows 11 Operating System. STAR Apollo Mapping System software is pre-installed onto the laptop.

The STAR Apollo Mapping System uses export data from the compatible Mapping System that has been collected with the compatible Mapping Catheter during the electrophysiology procedure. The Mapping Catheter is used to collect anatomy and electrogram data in the atria. Recordings are made for at least 30 seconds with the Mapping Catheter in a stable position and in contact with the atrial wall. These ≥30 second acquisitions are made in multiple, non-overlapping locations, to generate recordings over the entire atrial chamber. The data is exported via an external portable storage device or by streaming via an ethernet data cable connected to the data ethernet port of the EnSite X or CARTO 3 workstation. It is transferred to the laptop computer running the STAR Apollo Mapping System. The export data accepted from the Mapping Systems consists of electrograms, electrode coordinates, ECG recordings and the geometry model. The data is imported utilizing the portable external data storage device or via ethernet into the STAR Apollo Mapping System and then processed by the STAR Apollo Engine to generate a STAR Apollo Map visualized by the GUI. The STAR Apollo Map will highlight sites deemed to be Early Sites of Activation (ESA), as a red sphere at the endocardial locations corresponding to the recording electrode position. These sites are areas where the myocardium has initiated activation earlier than its neighboring sites on multiple occasions and therefore may be a potential site of AF initiation or maintenance. The more repetitive these sites are, the larger the red sphere appears on the STAR Apollo Map. The system will rank the ESA according to their repetition frequency and cycle length and identify the most relevant 3 sites. The system is designed to show the physician Repetitive Patterns of Activation (RPA). These are shown as colored arrows, which start from the leading electrode position, following the summarized activation sequence. The more repetitive or consistent that activation pattern is, the wider the white arrow. Based on this information the physicians may then use this as an additional guide for further mapping of the AF, using FDA cleared mapping system catheters.

The STAR Apollo Mapping System operates outside the sterile field and is only connected to the EnSite Precision, EnSite X EP or CARTO 3 workstation and not to the amplifier, patient, or any other devices used in the procedure. No data is transferred from the STAR Apollo Mapping System back to the EnSite Precision, EnSite X EP mapping system, or CARTO 3 i.e., data transfer is only in one direction. No modifications to the EnSite Precision, EnSite X EP mapping systems or CARTO 3 are made to accommodate the STAR Apollo Mapping System. The STAR Apollo Maps may be used to give physicians additional information about the AF activations. The physician may use them as an additional aid to identify areas within the atria that may warrant further and close examination using the mapping system, and the compatible Mapping Catheter. The STAR Apollo System is never directly connected to a patient, nor does it deliver therapy. It is used as a software tool that provides supplementary information to the physician in an electrophysiology procedure.

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The EnSite X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated.

The EnSite X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological procedures.

The EnSite™ X EP System is a catheter navigation and mapping system. A catheter navigation and mapping system is capable of displaying the 3-dimensional (3-D) position of conventional and Sensor Enabled™ (SE) electrophysiology catheters, as well as displaying cardiac electrical activity as waveform traces and as three-dimensional (3D) isopotential and isochronal maps of the cardiac chamber.

The contoured surfaces of the 3D maps are based on the anatomy of the patient's own cardiac chamber. The system creates a model by collecting and labeling the anatomic locations within the chamber. A surface is created by moving a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected at and between all electrodes on the catheter. A surface is wrapped around the outermost points.

The provided FDA 510(k) clearance letter for the EnSite™ X EP System (K251234) details the device's regulatory pathway and general testing conducted. However, it does not contain the specific information required to populate a table of acceptance criteria and reported device performance. It focuses on the regulatory aspects, substantial equivalence to a predicate device, and the general types of testing performed (e.g., software verification, amplifier design verification, system design validation) to demonstrate that the device meets user requirements and its intended use.

The document states: "Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., a numerical threshold for accuracy or precision) and the reported device performance values against those criteria are not presented in this public clearance letter.

Similarly, the letter does not provide details regarding:

• Sample sizes used for test sets (beyond stating "design verification" and "system design validation" were performed).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts, their qualifications, or adjudication methods for establishing ground truth for any test set.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human readers.
• Whether standalone (algorithm-only) performance was assessed.
• The type of ground truth used (expert consensus, pathology, outcomes data).
• The sample size for the training set.
• How ground truth for the training set was established.

This type of detailed performance data is typically found within the confidential 510(k) submission itself, not routinely published in the public clearance letter.

Therefore,Based on the provided FDA 510(k) clearance letter for the EnSite™ X EP System, the following information can be extracted regarding the device's acceptance criteria and the study that proves it meets those criteria:

Key Takeaway: The provided FDA 510(k) clearance letter asserts that acceptance criteria were met through various design verification and validation activities, demonstrating substantial equivalence to a predicate device. However, it does not disclose the specific numerical acceptance criteria or the quantitative results of the device's performance against those criteria. The details below are based on what is stated or can be inferred from the document.

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided document, specific numerical acceptance criteria and reported device performance data are not explicitly stated or detailed. The document generally states:

"Design verification activities were performed and met their respective acceptance criteria to ensure that the devices in scope of this submission are substantially equivalent to the predicate device."

And

"System Design Validation to confirm the system could meet user requirements and its intended use after modifications"

Without specific numerical cut-offs or performance metrics (e.g., accuracy, precision, error rates), a table cannot be populated as requested. The clearance indicates that internal testing demonstrated the device met pre-defined acceptance criteria, but those criteria and the actual performance results are not publicly available in this document.

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

• Sample Size Used for Test Set: Not specified in the provided document. The document mentions "Design verification activities" and "System Design Validation" but does not give the number of cases, patients, or data points used for these tests.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified in the provided document.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • (It's common for electrophysiology systems that ground truth would be established by electrophysiologists, but this document does not confirm that.)

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. (e.g., 2+1, 3+1, none)

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No indication that an MRMC comparative effectiveness study was performed or required for this 510(k) clearance. The focus of this submission is on substantial equivalence to a predicate device, which often relies on non-clinical testing for software updates or minor changes, rather than clinical efficacy studies comparing human readers with and without AI assistance.
• Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: Not applicable/Not provided, as an MRMC study is not mentioned.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Performance: The document describes "Software Verification at unit, software and system level" and "Amplifier Design Verification," which are types of standalone-like algorithmic or component-level testing. However, the exact metrics and results for pure "algorithm-only" performance (e.g., for automated mapping or analysis features if present) are not detailed. The system is described as a "diagnostic tool" that "provides information" and "displays catheter location," implying human interaction is integral.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not explicitly stated. Given the nature of an EP system, ground truth would likely involve a combination of:
  • Validated phantom models: For physical accuracy of catheter tracking and mapping.
  • Clinical expert consensus: For validating the interpretation of electrical activity and the accuracy of generated 3D maps or anatomical models.
  • Reference measurements: From other validated systems or direct measurements during testing.
  • The document implies ground truth was used for "Design verification" and "System Design Validation," which "confirm the system could meet user requirements."

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable/Not specified. This 510(k) is for a software update (v5.0) to an existing system (EnSite™ X EP System, predicate K242016). The document describes changes related to compatibility with new catheters and ultrasound systems, rather than the development of entirely new AI/ML algorithms requiring a "training set" in the conventional sense of deep learning. While software is involved, the primary testing discussed is verification and validation, not model training.

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

• Ground Truth for Training Set Establishment: Not applicable/Not specified, as the document does not indicate the use of a "training set" in the context of machine learning model development. The 'ground truth' concept would apply more to the test and validation steps, as discussed in point 7.

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