(189 days)
The AchieveTM ST mapping catheter is indicated for multiple electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The AchieveTM ST mapping catheter is designed to obtain electrograms in the atrial regions of the heart.
The Achieve ST Mapping diagnostic 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 ST Mapping Catheter is a circular loop with evenly spaced electrodes to map electrical conduction within the atrium. The Achieve ST Mapping Catheter is available in a 25mm pre-shaped distal loop diameter.
This document does not contain the information required to populate all sections of the requested table. The provided text is an FDA 510(k) summary for the Medtronic Achieve™ ST Mapping Catheter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a diagnostic algorithm would.
Specifically, the document does not contain information about:
- Specific acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy targets).
- Any in-vivo or clinical study conducted to assess the performance of the device against such criteria. The "in vivo testing" mentioned is general and not detailed with performance metrics.
- Sample sizes for test or training sets related to a performance study.
- Data provenance, expert involvement, adjudication methods, or MRMC studies.
- Standalone algorithm performance or human-in-the-loop performance.
- How ground truth was established for any performance evaluation.
The "Performance Data" section lists various bench and biocompatibility tests, but these are related to safety and fundamental functionality (e.g., radial loop compliance, electrical continuity, corrosion resistance), not diagnostic accuracy or effectiveness in terms of a clinical outcome that would require the type of acceptance criteria and study details you're requesting.
Therefore, I cannot construct the table as requested using the provided text.
However, I can extract information about the types of performance tests conducted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Performance Metric | Reported Device Performance / Outcome |
|---|---|---|
| Mechanical/Physical | Radial Loop Compliance | Performs as designed |
| Distal Stiffness | Performs as designed | |
| Axial Load | Performs as designed | |
| Torque Response | Performs as designed | |
| Turns to Failure | Performs as designed | |
| Kink Resistance | Performs as designed | |
| Joint Strength | Performs as designed | |
| Contrast Media Flow Rate | Performs as designed | |
| Stiffness | Performs as designed | |
| Electrical | Electrical Continuity | Performs as designed |
| Electrical Testing | Performs as designed | |
| Electrical Safety Testing | Safe and effective per ISO 60601-1:2006 | |
| Material/Biocompatibility | Cytotoxicity (ISO 10993-5) | Biocompatible |
| Kligman Sensitization (ISO 10993-10) | Biocompatible | |
| Intracutaneous Injection (ISO 10993-10) | Biocompatible | |
| Systemic Injection, Acute (ISO 10993-11) | Biocompatible | |
| Rabbit Pyrogen, Material Mediated (ISO 10993-11) | Biocompatible | |
| Hemolysis (ASTM F756) | Biocompatible | |
| Prothombin Time Assay (ISO 10993-4) | Biocompatible | |
| Unactivated Partial Thromboplastin Time Assay (ISO 10993-4) | Biocompatible | |
| Complement Activation Assay (ISO 10993-4) | Biocompatible | |
| Thrombogenicity (ISO 10993-4) | Biocompatible | |
| Corrosion Resistance (ISO 10555-1:2009) | Performs as designed | |
| Sterilization | Sterilization | Verified |
Regarding the other information requested, based only on the provided text:
- Sample size used for the test set and the data provenance: Not provided. The document mentions "in vitro bench testing and in vivo testing" but does not detail sample sizes, study design, or data provenance for these tests in a way that aligns with evaluating diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This type of expert assessment for ground truth is typically for diagnostic/AI performance studies, which are not detailed here. The "Performance Data" section describes engineering and biocompatibility tests.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the provided information.
- 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: Not applicable. This device is a physical catheter, not an AI diagnostic algorithm.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the engineering and biocompatibility tests, the "ground truth" would be the established scientific and engineering principles, standards (e.g., ISO, ASTM), and specifications against which the device was tested.
- The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/algorithm-based device.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a physical medical device (catheter) focused on demonstrating manufacturing, material, and electrical safety and basic functionality in comparison to a predicate device, rather than a performance study of a diagnostic or AI-enabled system.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).