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The IntellaMap Orion™ High Resolution Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The IntellaMap Orion™ High Resolution Mapping Catheter is intended for multiple electrode electrophysiology mapping of the heart and is intended for recording of electrograms and stimulation of cardiac tissue. The IntellaMap Orion™ High Resolution Mapping Catheter is a 8.5 French (2.8mm), 115 cm, bidirectional, 64 electrode, non-linear (basket shaped) diagnostic catheter. The catheter consists of a polymer handle, a polymer shaft and a platinum/iridium and polymer distal mapping section mounted with iridium electrodes ('electrode array'). The catheter contains a flushing port capable of providing continuous flushing into the electrode array. The catheter is supplied with an 8.5 French insertion sleeve for insertion through the hemostasis valve of an introducer sheath. The catheter is provided sterile and is for single use only. The IntellaMap Orion™ High Resolution Mapping Catheter simultaneously acquires 64 electrograms from the electrodes on its splines. The catheter is designed to enter the vasculature with a low profile (8.5F) through a percutaneous approach. The catheter can be maneuvered with the aid of a handle that controls bidirectional steering and array deployment.

The provided document is a 510(k) summary for the IntellaMap Orion High Resolution Mapping Catheter. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing of a handle design modification. This type of regulatory submission does not typically include the detailed clinical study information requested in your prompt (e.g., acceptance criteria for diagnostic performance, human reader studies, ground truth establishment, sample sizes for training/test sets for AI devices).

This device is an "Electrode Recording Catheter," which is a medical instrument used for electrophysiological mapping of cardiac structures. It captures electrograms and can stimulate cardiac tissue. It is not an AI-powered diagnostic device in the sense of analyzing images or data to provide a diagnosis or improve human reader performance. Therefore, many of your requested points relate to AI/diagnostic device performance studies, which are not applicable to the information presented in this 510(k) summary.

However, I can extract the relevant information regarding the non-clinical performance described in the document.

Here's the information that can be extracted relevant to the performance criteria and study from the provided document:

1. A table of acceptance criteria and the reported device performance

Note: The document states "The verification testing confirmed that the new handle design met the product performance requirements of the predicate device." It does not specify the numerical or qualitative requirements themselves, only that they were met.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "bench top testing," which implies laboratory-based tests rather than data from human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable/provided. The testing described is benchtop testing for a handle modification, not a diagnostic or AI performance study requiring expert ground truth establishment in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are typically for clinical studies involving interpretation, not for benchtop engineering verification.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This is not an AI-assisted diagnostic device, and no MRMC study is mentioned. The device is a physical catheter for electrophysiological mapping.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable. This is not an algorithm-only device. It's a medical instrument used by clinicians.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

This information is not provided. For benchtop testing of a handle, ground truth would relate to engineering specifications and measurements, which are not detailed here.

8. The sample size for the training set

This information is not applicable/provided. "Training set" refers to data used for machine learning or AI model development, which is not relevant to this device's description.

9. How the ground truth for the training set was established

This information is not applicable/provided. As above, "ground truth for training set" is for AI models, not a physical medical device like this catheter.

Summary of what is clear from the document:

• Device Type: IntellaMap Orion High Resolution Mapping Catheter (a physical medical instrument).
• Purpose: Electrophysiological mapping (recording or stimulating) of cardiac structures.
• Regulatory Submission Reason: Modification to the handle design of an already cleared device.
• Performance Study Type: Non-clinical benchtop testing.
• Key Finding: The new handle design met the product performance requirements of the predicate device.
• Conclusion: The modified device is considered substantially equivalent to its predicate.

The document does not describe the specific performance metrics or acceptance criteria for the electrophysiological mapping overall, nor does it delve into the clinical accuracy of the mapping capability, as the focus of this particular 510(k) was on a modification to a previously cleared device's handle.

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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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The Rhythmia Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.

The Rhythmia Mapping Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart. The Rhythmia Catheter is an 8.5 French (2.8mm), 115 cm, bidirectional, 64 electrode, non-linear (basket shaped) diagnostic catheter consists of a polymer handle, a polymer shaft and a platinum/iridium and polymer distal mapping section mounted with iridium electrodes ('electrode array'). The catheter contains a flushing port capable of providing continuous flushing into the electrode array. The catheter is supplied with an 8.5 French insertion sleeve for insertion through the hemostasis valve of an introducer sheath. The catheter is provided sterile and is for single use only.

The Rhythmia Catheter simultaneously acquires 64 electrograms from the electrodes on its splines. The catheter is designed to enter the vasculature with a low profile (8.5F) through a percutaneous approach. The catheter can be maneuvered with the aid of a handle that controls bidirectional steering and array deployment. The catheter can be connected to commercially available EP diagnostic systems such as recording systems or 3D mapping systems.

The provided text describes a 510(k) summary for the Rhythmia Mapping Catheter, focusing on its substantial equivalence to a predicate device. It details a variety of bench and animal tests, and mentions a clinical evaluation, but it does not include acceptance criteria for those tests, nor does it present device performance against such criteria in a tabular format.

Therefore, I cannot populate the table or provide specific details for points 1-9 as requested, because the information is not present in the provided document.

The document discusses the following types of testing:

• Bench Tests (In vitro testing): Performed to assure reliable design and performance in accordance with ISO 10555-1:2004. These included Physical Dimensions, Essential Catheter Features, Array Stiffness, Handle Control Forces, Compatibility with Sheaths, Array Shape Reproducibility, Radiopacity, Flushing Flow Rate, Labeling Content, Surface Inspection, Leak and Fluid Ingress Resistance, Corrosion Resistance, Joint Strengths, Catheter Tip Flexibility, Catheter Torsion Resistance, Catheter Kink Resistance, Simulated Use Bench Test, Particulate Evaluation, Spling and Strength, Array Shape Resilience, Pigtail Performance, Labeling Durability, Handle Marking Content and Durability, Connector Mate Life, Connector Latch Holding Force, Catheter Electrical Performance, Catheter Memory Function, Compatibility with Third-Party Recording Systems, Catheter Defibrillation Survival, and Electrical Cross-Talk. The text states "The test results demonstrate that the Rhythmia Mapping Catheter meets the requirements in the applicable standards and specifications," but does not explicitly list those requirements or the specific performance results.
• In vivo testing (GLP animal study): Designed to determine the catheter's ability to safely access, maneuver, stimulate, and record electrical signals in the cardiac chambers as intended. It states "The GLP study met the predefined endpoints in terms of safety and performance," but does not detail these endpoints or the results.
• Clinical experience (outside the US): Involved 29 subjects across 3 sites. It states "There were no adverse events related to the Rhythmia Mapping Catheter, and the catheter performed as intended," but does not provide quantitative performance metrics or specific acceptance criteria for "performed as intended."

Without explicit acceptance criteria and corresponding performance data, detailed responses to your specific questions are not possible based solely on the provided text.

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