Search Results

Ask a specific question about this device

Ask a specific question about this device

The Geiger Disposable Electrosurgical Electrode is intended to be utilized for basic non-sterile electrosurgical procedures. Examples of non-sterile procedures include the removal of moles, warts and skin tags. The electrodes are a standard 3/32" in diameter and will fit the majority of electrosurgical generators and handpieces in the marketplace.

Utilized for basic electrosurgical procedures, such as, cutting, blended cutting, coagulation, fulguration, or desiccation.

The Geiger Disposable Electrosurgical Electrode is a non-sterile, disposable, electrosurgical electrode, designed to be used to deliver electrosurgical current generated by an electrosurgical generator.

The provided text describes a 510(k) premarket notification for the "Geiger Disposable Electrosurgical Electrode." This submission aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a dedicated study. As such, the document does not contain the detailed information typically found in a study designed to establish device performance metrics and acceptance criteria.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission.

However, I can extract the relevant information from the document regarding the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific acceptance criteria and reported device performance values in the way a clinical or technical performance study would. Instead, the "acceptance criteria" for a 510(k) submission is met by demonstrating substantial equivalence to a predicate device.

The reported "performance" in this context is the assertion that the device is substantially equivalent to the predicate.

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

• Sample Size for Test Set: Not applicable. This submission relies on demonstrating similarity to a predicate device, not on testing a sample set against specific performance metrics.
• Data Provenance: Not applicable. No new performance data from a test set is provided. The submission references engineering specifications and material information (chemical makeup of stainless steel and polystyrene insulation), but these are not "test set" data in the context of a performance study.

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

• Not applicable. No "ground truth" for a test set was established as part of this 510(k) submission.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication was performed.

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 device is an electrosurgical electrode and does not involve AI or human "readers" in the context of medical imaging or diagnosis.

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

• Not applicable. This device is a physical electrosurgical electrode, not an algorithm.

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

• Not applicable. The submission focuses on substantial equivalence to an existing legally marketed predicate device (E & M Engineering Blade Electrode, K945531). The "ground truth" in this context is the regulatory acceptance and established safety/effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable. As this is not an AI/algorithm-driven device, there is no "training set."

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

• Not applicable. There is no training set for this device.

Ask a specific question about this device

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.

Ask a specific question about this device

The Blue Value Line of Electrosurgical Electrodes is a line of non-sterile, reusable electrosurgical electrodes designed to be used in conjunction with an electrosurgical generator and handpiece where cutting, blended cutting, coagulation, desiccation, or fulguration procedures are to be performed.

Utilized for basic electrosurgical procedures such as cutting, Utilized for basic electrosurgicul problement of desiccation.
blended cutting, coagulation, fulguration, or desiccation.

The Blue Value Line of Electrosurgical Electrodes is a line of non-sterile, reusable electrosurgical electrodes designed to be used in conjunction with an electrosurgical generator and handpiece where cutting, blended cutting, coagulation, desiccation, or fulguration procedures are to be performed.

The provided document is a 510(k) summary for the "Blue Value Line of Electrosurgical Electrodes." This type of document is for medical device clearance, not for AI/ML-based medical devices, so many of the requested details about acceptance criteria, study design, and ground truth for AI models are not applicable.

However, I can extract the information that is present concerning the device's performance justification.

Acceptance Criteria and Device Performance:

Study Details (as relevant to a traditional medical device 510(k)):

• Sample size used for the test set and the data provenance: Not applicable. This is a traditional device clearance based on substantial equivalence and compliance with a standard, not a data-driven AI/ML study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device is its physical performance characteristics and adherence to a recognized standard.
• Adjudication method for the test set: Not applicable.
• 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/ML device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For compliance with the ANSI/AAMI standard, the "ground truth" would be the results of objective engineering and performance tests as defined by the standard. For substantial equivalence, the "ground truth" is the established performance and safety of the predicate devices.
• The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
• How the ground truth for the training set was established: Not applicable.

Summary of the Device's Claimed Performance Basis:

The "Blue Value Line of Electrosurgical Electrodes" meets its acceptance criteria by demonstrating conformance to a specific industry standard (ANSI/AAMI HF-18-1993, Sec. 5.2.5.4) and by proving substantial equivalence to several previously cleared predicate electrosurgical electrodes. The supporting "study" is the testing performed to demonstrate compliance with this standard and the comparison of the device's characteristics to those of the predicate devices. This is a standard approach for 510(k) clearance of non-AI medical devices.

Ask a specific question about this device