(30 days)
The Nikomed USA electrosurgical grounding pad (sold under various commercial names through repackagers and resellers) is indicated for use with electrosurgical generators for cutting and coagulation.
The Nikopad Electrosurgical Grounding Pad is a flexible, conductive adhesive electrosurgical grounding pad with integrated 3 meter transparent cable and standard US 2-female connector. The conductive area is 143 sq cm and the adhesive area is 242 sq cm. Units are packaged individually and typically sold 25 pieces to a box.
This document describes a 510(k) submission for the Nikomed Electrosurgical Grounding Pad. However, the provided text does not contain detailed acceptance criteria or a study design with specific performance metrics (like sensitivity, specificity, AUC, etc.) that are typically associated with AI/ML device evaluations.
The submission is for a medical device that appears to be a passive electrosurgical grounding pad, not an AI/ML-driven diagnostic or therapeutic device. The "SUMMARY of TESTING" section only mentions biocompatibility testing.
Therefore, many of the requested items (e.g., acceptance criteria for diagnostic performance, sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted from this particular document.
Here's an attempt to answer the questions based on the provided text, highlighting where information is missing or not applicable:
Description of Acceptance Criteria and Study for Nikomed Electrosurgical Grounding Pad
This 510(k) submission is for a traditional medical device (an electrosurgical grounding pad), not an AI/ML diagnostic or therapeutic device. Consequently, the "acceptance criteria" and "study" described herein are primarily focused on safety, fundamental device function, and substantial equivalence to a predicate device, rather than performance metrics typically associated with AI/ML.
1. A table of acceptance criteria and the reported device performance
Given the nature of the device (an electrosurgical grounding pad), the "acceptance criteria" appear to be related to safety and material compatibility rather than diagnostic performance.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Biocompatibility (e.g., irritation, sensitization, cytotoxicity based on ISO 10993-1 for acute |
§ 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.