Search Results

The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and billiary tracts.

Device Description

The ELRA Electrode is a bipolar electrode. ELRA Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF generator (K163450). They are not intended to function with other RF generators.

The ELRA Electrode consists of an electrode tip, insulation part, handle. Patient contacting materials of ELRA Electrode are stainless steel 304, Teflon-ETFE, UV adhesive, Nylon, PEEK and polyether block amides.

The lengths of the flexible tube available for the ELRA Electrode length are 400 mm and 1,750 mm. The tip exposures available for the ELRA Electrode length are 11 mm, 18 mm, 22mm and 33 mm. The diameter available for the ELRA Electrode diameters is 7 French.

The model with longer length(1,750 mm) are used with endoscopes. This electrode is inserted into the body through the oral rout, and are used at the application site. The shorter length(400 mm) models are performed by percutaneous resection directly at the site of application. Both methods have to be used with fluoroscopy during the procedure.

AI/ML Overview

This document is a 510(k) summary for a medical device (ELRA Electrode) and focuses on expanding its shelf-life. As such, it does not contain information related to an AI/ML powered device, and therefore cannot provide data on acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth establishment, expert adjudication, or MRMC studies for AI/ML performance.

The content primarily addresses technical aspects of the ELRA Electrode and its equivalence to a predicate device, specifically for extending its shelf-life through performance testing.

Therefore, I cannot fulfill the request as the provided text does not contain the necessary information about an AI/ML powered device and its performance evaluation against acceptance criteria.

Ask a Question

Ask a specific question about this device

K Number

K181758

Device Name

ELRA Electrode

Manufacturer

STARmed Co., Ltd.

Date Cleared

2019-04-11

(283 days)

Product Code

KNS

Regulation Number

876.4300

Type

Traditional

Panel

Gastroenterology/Urology

Reference & Predicate Devices

K163450,K180165

Predicate For

K233113

Intended Use

The ELRA Electrode is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.

Device Description

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that the non-clinical tests all met the acceptance criteria specified in the standards, and similarly for the clinical trials. However, the specific quantitative acceptance criteria are not detailed in a table format within the provided text. Instead, it refers to compliance with established international and FDA-recognized consensus standards.

Here's an attempt to infer and structure the information:

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance
Non-Clinical Testing
Mechanical Failure	Minimized risks associated with mechanical failure (evaluated by drop and bending force tests)	Met acceptance criteria (implied by statement that tests "all met the acceptance criteria specified in the standards").
Temperature Sensing Function	Demonstrated function of temperature sensor	Met acceptance criteria (performance testing conducted to demonstrate this function).
Thermal Effects on Tissue	Equivalent ablation performance to predicate device (evaluated by ex vivo testing on width and depth of thermally damaged zones on liver, kidney, and muscle tissue according to FDA Guidance 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery').	Substantially equivalent ablation performance to predicate device, meeting acceptance criteria.
Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-2-2	Complies with stated standards.
Electromagnetic Compatibility	Compliance with IEC 60601-1-2	Complies with stated standard.
Biocompatibility	Compliance with ISO 10993 (Parts 1, 5, 10, 11)	Complies with stated standards.
Clinical Testing
Stenting Procedure Success	Successful stent placement	100% success rate in 30 patients.
Device-Related Adverse Events	No direct side effects associated with the device	No major complications identified. Three minor inflammatory reactions noted, but not directly associated with the device.
Safety and Effectiveness	Deemed "safe and effective"	Concluded as safe and effective.

2. Sample Size Used for the Test Set and Data Provenance

The document describes two clinical studies:

Prospective Clinical Trial:
- Sample Size: 30 patients
- Data Provenance: Not explicitly stated, but clinical trial implies prospective data collection. The manufacturer is based in the Republic of Korea, which might suggest the trial was conducted there, but this is not confirmed.
Retrospective Study:
- Sample Size: 10 patients
- Data Provenance: Retrospective study. The patients had malignant biliary hilar duct obstruction. Country of origin not specified, but again, likely related to the manufacturer's location.

For non-clinical tests (e.g., thermal effects): The sample size isn't specified in terms of "cases," but it mentions testing on "liver, kidney, and muscle tissue."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide information on the number of experts used to establish ground truth or their qualifications for either the clinical trials or the non-clinical tests.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in either the clinical or non-clinical studies. The clinical outcomes (stent success, complications) appear to be directly observed or reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted. This device is an electrosurgical electrode and does not involve AI for interpretation or assistance with human readers. The comparative effectiveness assessment was against a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical electrosurgical electrode, not an AI algorithm. Its performance is intrinsic to its design and how it affects tissue, not based on an algorithm's output. The performance studies detailed are for the device's physical and functional characteristics.

7. The Type of Ground Truth used

Clinical Trials: The ground truth appears to be based on direct clinical outcomes (successful stent placement, incidence of complications, absence of direct device-related side effects). This aligns with outcomes data.
Non-Clinical (Thermal Effects): The ground truth was based on objective measurements of "width and depth of thermally damaged zone" in tissue samples. This is a form of objective measurement/pathology-like assessment on ex vivo tissue samples.
Non-Clinical (Safety & Biocompatibility): Ground truth is established by adherence to and successful completion of tests outlined in international consensus standards (e.g., IEC 60601-1, ISO 10993 series).

8. The Sample Size for the Training Set

This information is not applicable as the ELRA Electrode is a hardware medical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Ask a Question

Ask a specific question about this device

Page 1 of 1