(218 days)
Soft tissue cutting & coagulation
Intraepithelial neoplasia
Condylomata acuminata
Misc. Iesions; polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon, etc.
The Gynex Electrodes are made of thin 0.18mm hard tungsten wire with a high melting temperature and excellent conductiveness of electric current. The electrodes are available in three different styles intended for use in two different types of electrosurgical procedure. The three styles are curved wire loop electrodes, square wire loop electrodes and ball-type electrodes. The two intended uses are excisional procedures (wire loop) and fulguration or coagulation procedures (ball electrode).
All electrode styles consist of an insulated conductive metallic shaft of varing length terminating in a bare metalic "ball" a "square wire loop" or a "curved wire loop". The wire loop electrodes vary in both width and depth of the loop. Electrode shaft diameter is constant at 2,5mm.
The provided document is a 510(k) premarket notification for Gynex Electrodes, a gynecologic electrocautery device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as typically found for novel AI/ML devices.
Therefore, the information required to answer your specific questions about acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, and standalone performance for an AI/ML device is not present in this document.
However, I can extract information related to the comparison with the predicate device, which serves as the basis for demonstrating equivalence in a 510(k) submission.
Here's a breakdown of the available information in the context of your questions, explaining why certain sections are not applicable:
1. A table of acceptance criteria and the reported device performance
-
Not Applicable in this context. For a 510(k) submission of a traditional medical device like electrocautery electrodes, "acceptance criteria" and "reported device performance" are typically demonstrated through comparison to a legally marketed predicate device rather than through a novel performance study with specific metrics like sensitivity, specificity, etc., as would be expected for an AI/ML device. The "acceptance criteria" here is substantial equivalence to the predicate.
The comparison table provided in the document (Section 11) is the closest equivalent, demonstrating how the Gynex Electrodes are substantially equivalent to the predicate device (Cooper Surgical Single-Use Wire Electrodes) across various features.
Feature Gynex Disposable Electrodes Predicate Device (Cooper Surgical Single-Use Wire Electrodes) Substantially Equivalent (SE)? Intended Use Soft tissue cutting & coagulation, Intraepithelial neoplasia, Condylomata acuminata, Misc. lesions (polyps, molluscum contagiosum, nevi, seborrheic keratosis, achricordon) Same YES Design Tugnsten wire, Curved loop, Square loop, Brass ball electrode Tugnsten wire, Curved loop, Square loop, Brass ball electrode YES Sterile Yes Yes YES Sizes Various curved, square, and ball electrodes (listed) Various curved, square, and ball electrodes (listed), plus additional sizes YES Material Tungsten wire, Stainless steel, Brass, Teflon Tungsten wire, Stainless steel, Brass, Teflon YES Origin Europe Europe YES Manufacturer Gynex Corporation Cooper Surgical YES Product Code HGI HGI YES K - Number Pending K952483 YES
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This document describes a medical device (electrodes) that falls under a 510(k) submission. It does not involve a diagnostic AI/ML algorithm that would typically require test sets or data provenance in the way your question implies. The "study" is primarily a physical and functional comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable. As above, there is no "test set" and thus no need for experts to establish ground truth as would be relevant for an AI/ML diagnostic algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring expert adjudication is involved.
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 is not an AI/ML device, so no MRMC study or assessment of human reader improvement with AI assistance would be performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. The "ground truth" equivalent in a 510(k) for a device like this is the established performance and safety profile of the legally marketed predicate device. The comparison demonstrates that the new device shares fundamental scientific technology, design, materials, and intended use with this predicate, implying equivalent safety and effectiveness.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
In summary: The provided document is a regulatory submission (510(k)) for a conventional medical device (electrocautery electrodes). The criteria you've asked about are specifically designed for evaluating Artificial Intelligence/Machine Learning (AI/ML) medical devices, which operate under different regulatory and evidentiary standards than the device described in this 1999 filing. This document demonstrates substantial equivalence to a predicate device based on design, materials, intended use, and performance characteristics, rather than through a clinical performance study with AI-specific metrics.
§ 884.4120 Gynecologic electrocautery and accessories.
(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).