(99 days)
The Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by remote means located at the proximal end of the catheter.
The provided document is a 510(k) premarket notification letter for a reprocessed medical device, specifically a "Reprocessed Livewire Steerable Diagnostic EP Catheter." This type of document is focused on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a standalone study report for a novel AI/software device.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in the provided text. The document describes bench and laboratory testing for a reprocessed physical catheter, not an AI or software algorithm.
Here's a breakdown of why each point cannot be answered from the provided text:
- A table of acceptance criteria and the reported device performance: This document lists "Functional and Safety Testing" categories (Biocompatibility, Cleaning Validation, Sterilization Validation, Functional Testing, Electrical Safety Testing, Packaging Validation), but it does not provide specific acceptance criteria values or detailed performance results for these tests. It broadly states that testing "was conducted to demonstrate performance (safety and effectiveness)."
- Sample size used for the test set and the data provenance: Not applicable or provided. The testing relates to physical properties and reprocessing of the catheter, not a dataset for an AI model.
- 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): Not applicable or provided. Ground truth for AI models involves expert labeling of data, which is not relevant to testing a reprocessed physical catheter.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or provided.
- 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 is for AI-assisted diagnostic tools, not a reprocessed physical catheter.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be established engineering standards and performance specifications for physical and material properties, which are not detailed here.
- The sample size for the training set: Not applicable. There is no training set for a reprocessed physical catheter.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a regulatory submission for a reprocessed physical medical device and does not contain the information requested for evaluating an AI or software-based device.
§ 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).