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The Medtronic Ablation Frontiers Achieve Mapping Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The Achieve Catheter is designed to obtain electrograms in the atrial regions of the heart.

The Achieve™ diagnostic mapping catheter is an intra-cardiac electrophysiology recording catheter and can be used for cardiac stimulation during electrophysiology studies. The distal mapping section of the Achieve catheter is a circular loop with eight evenly spaced electrodes to map electrical conduction within the atrium. The Achieve catheter should only be used with the corresponding electrical cable for Achieve. The Achieve catheter is available with two distal loop diameter sizes described in the following table:

The sterile, single use only Electrical Cable (Model 990066) provides the conduction elements from the proximal end of the Achieve Catheter handle to standard shielded ECG pins that connect into standard electrophysiology recording and pacing equipment.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Medtronic Achieve™ Mapping Catheter:

Summary of Acceptance Criteria and Device Performance:

The document describes the Medtronic Achieve™ Mapping Catheter, a Class II device intended for electrophysiological mapping of cardiac structures. It achieves substantial equivalence to predicate devices (ProMap™ and Lasso™) through a series of performance, sterilization, and biocompatibility tests.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not explicitly state the sample size used for each individual test. It broadly mentions "in vitro bench testing and in vivo testing have been performed on the device materials and finished devices."
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a medical device seeking substantial equivalence, it's highly likely that the in vivo testing would be prospective, and the in vitro bench testing would be conducted in a controlled laboratory environment (likely in the US or a country with comparable regulatory standards).

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

• This information is not provided in the document. The studies listed are primarily engineering and biological performance tests, not clinical studies involving expert interpretation of results to establish a "ground truth" for diagnostic accuracy in a human population.

4. Adjudication Method for the Test Set

• This information is not applicable/provided in the context of the described performance and biocompatibility testing. Adjudication methods are typically relevant for clinical studies where multiple experts interpret data (e.g., medical images, patient outcomes) and their interpretations need to be reconciled.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The document describes bench and in vivo performance tests and biocompatibility tests to demonstrate substantial equivalence to predicate devices, not a study comparing human reader performance with or without AI assistance.

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

• This question is not applicable. The device is a physical catheter, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept for this product.

7. The Type of Ground Truth Used

• For the performance testing, the "ground truth" would be established by engineering specifications, validated test methods (e.g., ISO standards), and pre-defined acceptance criteria for physical and electrical properties (e.g., acceptable range for torque, tensile strength, electrical resistance, stiffness, etc.).
• For the biocompatibility testing, the "ground truth" is established by adherence to recognized ISO standards (e.g., ISO 10993 series) and the absence of adverse biological reactions (e.g., no cytotoxicity, no sensitization, no systemic toxicity).
• For electrical safety testing, the "ground truth" is adherence to ISO and BS EN standards for medical electrical equipment.

Essentially, the ground truth is based on objective, measurable physical, electrical, and biological parameters as defined by international standards and engineering best practices.

8. The Sample Size for the Training Set

• This question is not applicable/provided. The device is a physical catheter, not a machine learning model, so there is no concept of a "training set" in the context of AI development.

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

• This question is not applicable. As there is no AI training set, there is no ground truth establishment for it.

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