(148 days)
The LeVeen SupersSlim Needle Electrode is intended to be used in conjunction with a radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
The description of the proposed modified LeVeen Needle Electrode is the same as the The description of the proposed inouthed Lovech Reetrode consists of a preshaped. multi-amed electrode array which is contained within a delivery cannula. The array is a revice is attached to a handle mechanism that deploys the array into targeted tissue. The device is attached to a generator so that RF energy passes from the array to a patient ground pad and heats the tissue surrounding the array.
Here's a breakdown of the acceptance criteria and study information for the LeVeen SuperSlim Needle Electrode, based on the provided text:
Important Note: The provided text is a 510(k) summary for a medical device modification. It details the safety and performance evaluation undertaken to demonstrate substantial equivalence to a predicate device. This is not a clinical study of the device's diagnostic performance or comparative effectiveness against human readers. Therefore, many of the requested fields, particularly those related to diagnostic accuracy, MRMC studies, or training sets, are not applicable in this context.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Material Performance | Required specifications for PEEK insulation in terms of design verification, electrical tests, and biocompatibility tests. | PEEK insulation met the required specifications for completed design verification, electrical tests, and biocompatibility tests. |
| Design Performance | Required specifications for the modified handle and cannula design in terms of design verification tests. | Modified handle and cannula re-design met the required specifications for completed design verification tests. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a "test set" in the context of clinical or diagnostic performance. The document describes "Bench Testing" which implies a set of manufactured units or components were tested, but the number of units is not specified.
- Data Provenance: The data is from "Bench Testing," meaning it was generated in a laboratory or manufacturing environment. There is no information about country of origin for this testing, nor is it retrospective or prospective in a clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not Applicable. This document describes engineering bench testing, not a study requiring expert clinical assessment for ground truth.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3. Bench testing typically relies on predefined engineering specifications and measurement protocols, not expert adjudication in the manner of medical image interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study was not performed. This premarket notification is for a modified electrosurgical needle electrode, not a diagnostic imaging device, and its purpose is to demonstrate substantial equivalence based on material and design changes.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
- Not Applicable. This device is a surgical instrument. "Standalone performance" in the context of an algorithm is not relevant here. The device's function is dependent on an accompanying RF generator and human operation. However, the bench testing described could be considered a "standalone" evaluation of the modified components' physical and electrical characteristics.
7. The Type of Ground Truth Used
- Engineering Specifications / Predicate Device Performance: The "ground truth" for this modification study was the established performance and safety specifications required for such devices, and the comparative performance against the legally marketed predicate device (K092009). The PEEK insulation, handle, and cannula had to meet the "required specifications" and demonstrate performance equivalent to the FEP insulation and original design.
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of machine learning or algorithms for this type of device and study.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
§ 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.