(17 days)
The Medline Cautery Tip Cleaner is a disposable, single use sterile product. It is intended to be used as an electrosurgical accessory. The Cautery Tip Cleaner provides a method of removing eschar build-up from the tip of electrosurgical instruments during the course of a surgical procedure.
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The provided text is a 510(k) clearance letter from the FDA for the "Medline Cautery Tip Cleaner." This document primarily deals with the regulatory clearance of a medical device based on its substantial equivalence to a predicate device.
Critically, this document does NOT contain information about acceptance criteria, device performance, or any studies proving the device meets acceptance criteria as typically found in clinical trials or performance evaluations for AI/software devices.
The Medline Cautery Tip Cleaner is a physical accessory (a disposable, single-use sterile product) intended to remove eschar build-up from electrosurgical instruments. The approval is based on its similarity to existing cleared devices, not on a new study demonstrating its efficacy against specific performance metrics for an AI/software product.
Therefore, I cannot provide the requested information for the following reasons:
- No Acceptance Criteria or Reported Device Performance: This document does not list any specific, quantifiable acceptance criteria or reported device performance metrics in the way a study for an AI algorithm would (e.g., sensitivity, specificity, AUC). The "performance" for this type of device is inherent in its physical function to clean a cautery tip.
- No Study Described: There is no mention of a study (clinical, laboratory, or otherwise) that involved a "test set," "training set," "experts," "ground truth," or "MRMC comparative effectiveness studies." The FDA clearance for this device is based on "substantial equivalence" to a predicate device, meaning it's similar enough in intended use, technology, and safety/effectiveness principles that it doesn't raise new questions of safety or effectiveness. This typically involves bench testing for basic safety and functionality (like material compatibility or sterility), not comparative performance studies against strict statistical metrics.
- No AI/Software Component: The Medline Cautery Tip Cleaner is a physical device, not an AI or software-driven device. Thus, concepts like "algorithm performance," "human readers improve with AI," or "standalone algorithm performance" are not applicable.
In summary, the provided document does not contain the type of information requested about acceptance criteria and a study demonstrating performance for an AI/software device. The document is strictly an FDA 510(k) clearance letter for a physical medical accessory.
§ 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.