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The Rhythmia Mapping System and accessories are indicated for catheter based atrial and ventricular mapping. The mapping system allows real-time visualization of intra-cardiac catheters as well as display of cardiac maps in a number of different formats. The acquired patient signals, including body surface ECG and intra-cardiac electrograms, may also be recorded and displayed on the system's display screen.

The Rhythmia Mapping System and accessories are designed for electroanatomical mapping and is able to simultaneously acquire data from multiple electrodes. The Rhythmia Mapping System tracks catheters inside the heart in order to visualize their location and construct geometric shells. The Rhythmia Mapping System is also capable of using intra-cardiac location and electrical information to display electroanatomical maps - electrical activity information on the constructed geometry. Such electrical information can be visualized in 3D in color. The Rhythmia Mapping System can display various types of electroanatomical maps including geometrical shell only, activation maps, voltage maps and fractionation maps.

{
  "acceptance_criteria_and_performance_table": {
    "title": "Device Performance",
    "headers": [
      "Test/Study Type",
      "Acceptance Criteria (Implicit)",
      "Reported Device Performance"
    ],
    "rows": [
      [
        "In vitro testing (Software V&V, Hardware V&V)",
        "Meets requirements in applicable standards and specifications; substantially equivalent to predicate device",
        "Test results demonstrate that the Rhythmia Mapping System meets the requirements in the applicable standards and specifications, and is substantially equivalent to the legally marketed predicate device."
      ],
      [
        "In vivo testing (GLP animal study)",
        "Ability to record/display intracardiac electrograms, share signals, route stimulator signals, create geometrical shells, create activation maps, create voltage maps, accurately track Rhythmia Mapping Catheter, accurately track third-party catheters; no safety issues.",
        "The Rhythmia Mapping System worked as intended and there were no safety issues identified."
      ],
      [
        "Clinical experience (Outside US)",
        "System performs as intended; no adverse events related to the Rhythmia Mapping System",
        "There were no adverse events related to the Rhythmia Mapping System, and the System performed as intended."
      ]
    ]
  },
  "sample_size_test_set_and_data_provenance": {
    "in_vivo_animal_study": "The in vivo study was performed in a GLP animal study using a swine model. The exact number of animals is not specified in this document.",
    "clinical_experience_study": "33 subjects were included in the studies. The study was performed outside the US, suggesting international data provenance. The study description implies it was prospective for the purpose of validating the device's performance in a clinical setting."
  },
  "number_of_experts_ground_truth_test_set": "Not specified. The document does not mention the use of experts to establish ground truth for the test sets. The 'ground truth' for the animal and clinical studies would instead be determined by the observed system performance and absence of adverse events.",
  "qualifications_of_experts": "Not applicable as the number of experts is not specified.",
  "adjudication_method": "Not applicable. The document does not describe any expert adjudication process for ground truth establishment.",
  "multireader_multicase_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The studies described focus on the device's standalone performance and safety rather than comparing human reader performance with and without AI assistance.",
  "standalone_performance_study": "Yes, standalone performance was demonstrated through the 'In vitro testing' and 'In vivo testing' sections. The 'In vitro testing' evaluated the system's compliance with standards and specifications, and the 'In vivo testing' in a swine model assessed its ability to perform its core functions (recording, displaying, mapping, tracking) as intended, without direct human-in-the-loop performance measurement. The clinical experience section also confirms the system performed as intended in humans.",
  "type_of_ground_truth_used": {
    "in_vitro_testing": "Compliance with applicable standards and specifications.",
    "in_vivo_animal_study": "Observed system functionality (e.g., ability to record/display electrograms, create maps, track catheters) and absence of safety issues.",
    "clinical_experience_study": "Observed system functionality ('performed as intended') and absence of adverse events."
  },
  "sample_size_training_set": "The document does not detail a separate training set or its sample size. The studies described are for validation and clinical experience, not for training a machine learning model, as this device (Rhythmia Mapping System) is described as an 'electroanatomical mapping' system, not an AI/ML-driven diagnostic algorithm in the context of this summary.",
  "how_ground_truth_training_set_established": "Not applicable. A separate training set and its ground truth establishment are not discussed for this device."
}

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