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The Geiger Electrosurgical Handpiece Sheath is intended to be placed over an electrosurgical handpiece and act as a non-sterile barrier.

The Geiger Electrosurgical Handpiece Sheath is a non-sterile, clear plastic, disposable, electrosurgical handpiece cover, designed to be used over an electrosurgical handpiece to limit contamination.

The provided text is a 510(k) summary for the Geiger Electrosurgical Handpiece Sheath. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.

Therefore, most of the requested information regarding acceptance criteria and performance study details cannot be extracted from the provided text.

Here's what can be stated based on the given information:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the provided text. The submission is a 510(k) for substantial equivalence, which primarily relies on comparing the new device to existing legally marketed predicate devices, not on a new performance study with explicit acceptance criteria.

2. Sample size used for the test set and the data provenance:

This information is not present in the provided text. No specific test set or data provenance for performance evaluation is mentioned.

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

This information is not present in the provided text. No ground truth establishment for a test set is discussed.

4. Adjudication method for the test set:

This information is not present in the provided text. No adjudication method for a test set is discussed.

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:

This information is not present in the provided text. The device is an electrosurgical handpiece sheath, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable.

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

This information is not present in the provided text. The device is a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.

7. The type of ground truth used:

This information is not present in the provided text. The submission relies on substantial equivalence to predicate devices, not on establishing ground truth for a new performance claim.

8. The sample size for the training set:

This information is not present in the provided text. There is no mention of a training set as this is not an AI/ML device.

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

This information is not present in the provided text. There is no mention of a training set or ground truth establishment for such.

In summary: The provided document is a 510(k) submission for a non-sterile, clear plastic, disposable electrosurgical handpiece cover. It establishes substantial equivalence to predicate devices (ConMed Non-Sterile Handpiece Sheath, ConMed Sterile Handpiece Sheath K963088, and Banta Healthcare Products Sanitherm Oral Thermometer Sheaths K983406) based on design, operation, intended use, materials, method of preparation, and performance claims, rather than presenting performance data from a specific study against predefined acceptance criteria.

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