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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.

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The disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.

The disposable cautery tip cleaner is a 50mm by 50mm small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel', with a polyurethane foam pad and polyurethane adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.

The document discusses the Key Surgical® Cautery Tip Cleaner and its substantial equivalence to a predicate device. It addresses performance data primarily for sterility, functional aspects, and packaging, rather than diagnostic accuracy or AI assistance.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for each test or the data provenance (country of origin, retrospective/prospective). The tests listed are for device manufacturing and packaging quality, not for clinical performance on patients directly.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests performed are engineering and manufacturing quality control tests (e.g., sterility, adhesive function, packaging integrity), not clinical studies requiring expert interpretation of results to establish ground truth for a diagnostic or AI-assisted device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically relevant for clinical studies where multiple experts evaluate cases and discrepancies need to be resolved. This document describes tests for product quality where results are determined by standardized methods.

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. The device is a "Cautery Tip Cleaner," a physical accessory for surgical tools, not a diagnostic imaging device or an AI-assisted tool requiring human interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

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

Not applicable. This device is not an algorithm or software; it is a physical medical accessory.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests described are the established specifications and methods outlined in recognized standards (e.g., ISO 11137-2, ISO 11607, ASTM F series). For example:

• Sterility: Ground truth is defined by the SAL 10-6 specification, confirmed using ISO 11137-2 methods.
• Functional (adhesive removal): Ground truth is the observable characteristic of being "easily removed," likely assessed against internal engineering standards.
• Packaging: Ground truth is the successful adherence to specific physical properties and integrity tests as defined by the cited ISO and ASTM standards.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

9. How the ground truth for the training set was established

Not applicable. Since there is no training set, there is no ground truth to establish for it.

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The disposable Cautery Tip Cleaner is a single use sterile product. Its intended use is as an electrosurgical accessory to clean uncoated cautery blades that are part of an electrosurgical pencil. The cautery blade is "scratched" on the cautery tip cleaner to remove eschar build-up during surgical procedures to allow the cautery blade to function effectively throughout the procedure. The product is usually placed somewhere on the sterile field, typically on the mayo stand. This product does not come in contact with the patient.

The disposable Cautery Tip Cleaner is a small 2" x 2" square polyurethane foam pad which features a textile abrasive layer with an adhesive backing. A radiopaque strip within the adhesive makes the device x-ray detectable. The adhesive backing allows for universal placement as well as allowing the device to remain in place while the tip of the electrosurgical cauterization device is "scratched" on the abrasive surface to remove eschar buildup.

The provided text is a 510(k) summary for a Cautery Tip Cleaner and does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document focuses on the device description, intended use, technological characteristics comparison to a predicate device, and the FDA's determination of substantial equivalence.

Therefore, I cannot provide the requested information from the given text.

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The disposable Cautery Tip Cleaner is a 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 electro surgical instruments during the course of a surgical procedure.

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This is a premarket notification for an Electro-Cautery Tip Cleaner, a device designed to remove eschar build-up from electrosurgical instruments. The FDA has determined it is substantially equivalent to legally marketed predicate devices. Unfortunately, the provided document does not contain any information regarding specific acceptance criteria, performance data, or a study report for this device.

Therefore, I cannot provide the detailed information requested regarding the acceptance criteria and the study proving the device meets them. The document focuses on the regulatory approval process and not on the performance testing of the device itself.

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