(25 days)
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.
| Acceptance Criteria (Implied for 510(k) Equivalence) | Reported Device Performance (Assertion from Submission) |
|---|---|
| Substantial equivalence to predicate device in: | The Geiger Disposable Electrosurgical Electrode is substantially equivalent to the E & M Engineering Blade Electrode (K945531) in design, operation, intended use, materials, method of preparation, and performance claims. |
| - Design | Equivalent |
| - Operation | Equivalent |
| - Intended Use | Equivalent |
| - Materials | Equivalent (Stainless steel electrode, Polystyrene insulation) |
| - Method of Preparation | Equivalent (Manufactured by Modern Medical Equipment Mfg., Ltd. in Hong Kong to Geiger's specifications) |
| - Performance Claims | Equivalent (Utilizes radio frequency current for cutting and coagulation of tissue) |
| - Safety and Effectiveness | Considered a safe and effective product based on provided information and equivalence to 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.
§ 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.