(44 days)
The American Biosurgical Inc. Bipolar Cables are intended to transfer electrical current from a electrosurgical generator to a coagulating instrument.
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This document is a 510(k) clearance letter for an electrosurgical bipolar cable. It primarily focuses on regulatory approval based on substantial equivalence to a predicate device and adherence to manufacturing standards. It does not contain information about the acceptance criteria or a study proving the device meets those criteria, as typically found for complex AI/ML-enabled devices or those requiring clinical performance studies to demonstrate safety and effectiveness.
Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states "The American Biosurgical Inc. bipolar cables were designed and are manufactured in compliance with ANSI/AAMI Standards" and mentions "Testing Procedures Include: 100% Visual Inspection, Electrical Continuity Testing, Cable Insulation, Leakage, and Strain Relief Testing." However, it does not specify quantitative acceptance criteria (e.g., specific resistance values, insulation breakdown voltage thresholds) or report specific performance values from these tests. These would typically be detailed in a separate test report or device specification.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document refers to "Testing Procedures have been established in the standard operating procedures of the American Biosurgical, Inc. GMP Manual to ensure all products are manufactured to the ANSI/AAMI Standards." This implies manufacturing quality control rather than a specific clinical or performance test set as would be relevant for AI devices. There is no mention of sample sizes or data provenance.
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)
- Not applicable. This device is a cable, not a diagnostic or therapeutic device requiring expert interpretation for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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
- Not applicable. This is not an AI-enabled device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI-enabled device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device would be its adherence to established engineering and safety standards after manufacturing, verified through physical and electrical testing, not clinical outcomes or expert interpretation.
8. The sample size for the training set
- Not applicable. This is not a machine learning device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.