(49 days)
The LeVeen™ Needle Electrode Family (which includes the LeVeen™ Standard Needle Electrode System and the LeVeen™ CoAccess™ Need Electrode System') is intended to be used in coniunction with the RF3000 Generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
LeVeen Standard Needle Electrode System:
The description of the proposed LeVeen Standard Needle Electrode System is the same as the predicate LeVeen Standard Needle Electrode System. The LeVeen Standard Needle Electrode System consists of a pre-shaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into targeted tissue. The device is connected to a generator so that RF.energy passes from the array to a patient ground pad and heats the tissue surrounding the array.
LeVeen CoAccess Needle Electrode System:
The description of the proposed LeVcen CoAccess Needle Electrode System is the same as the predicate LeVeen CoAccess Needle Electrode System. The LeVeen CoAccess Needle Flectrode System is a disposable, monopolar electrosurgical device used for the coagulation necrosis of soft tissue, including partial or complete ablation of nonresectable liver lesions.
The LeVeen CoAccess Needle Electrode System consists of the CoAccess' Introducer (an insulated cannula with a locking stylet) and the LeVeen CoAccess Electrode (array with integrated deployment handle) capable of fixed coaxial placement within the insulated cannula. The LeVeen CoAccess Electrode also has an array of wires that is deployed into the targeted soft tissue.
The provided text describes a 510(k) summary for the Boston Scientific LeVeen Standard Needle Electrode System and LeVeen CoAccess Needle Electrode System. This document outlines the device description, intended use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, it does not describe acceptance criteria for a study involving AI, clinical performance metrics like sensitivity/specificity, or details commonly found in studies evaluating software devices.
The document focuses on demonstrating that modifications to existing devices (change in insulation material and hub material) do not alter their safety and effectiveness. The "acceptance criteria" discussed are related to engineering specifications and biocompatibility, not diagnostic performance of an AI application.
Therefore, many of your requested fields cannot be filled from the provided text.
Here's an attempt to answer based on the available information, noting where information is not present or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Type | Acceptance Criteria Description | Reported Device Performance |
|---|---|---|
| Mechanical/Physical | Required specifications for various physical properties (OD, adhesion, tensile, compression, luminal access, connection strength, protrusion) | Met the required specifications for completed design verification. |
| Biocompatibility | Required specifications for biological safety (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Latex) | Met the required specifications for biocompatibility tests. |
| Electrical Safety | Compliance with IEC 60601-1:2005 and IEC 60601-2-2:2009 | Compliance demonstrated per the requirements of these electrical standards. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The performance data section lists the types of bench tests performed on the devices themselves, not a test set of data for an AI algorithm.
- Data Provenance: Not applicable, as this refers to physical device testing rather than clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information is relevant for studies validating AI models against expert interpretations of medical images or data. The provided document describes physical device testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This is for establishing ground truth in clinical/imaging studies.
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:
- No. This is not an AI device, and no MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of AI. For the device performance, the "ground truth" was defined by engineering specifications, biocompatibility standards, and electrical safety standards.
8. The sample size for the training set:
- Not applicable. This is not an AI device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI device.
Summary of the Study:
The study described in the 510(k) summary is not an AI performance study. Instead, it is a set of engineering bench tests, biocompatibility tests, and electrical safety tests conducted to demonstrate that two modified medical devices (LeVeen Standard Needle Electrode System and LeVeen CoAccess Needle Electrode System), with changes in their insulation and hub materials, are substantially equivalent to their previously cleared predicate devices. The "acceptance criteria" were the pre-defined specifications and regulatory standards for these physical, biological, and electrical characteristics. The goal was to prove the safety and effectiveness of the updated materials and designs, not to evaluate a diagnostic algorithm.
§ 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.