VAPOR-TECH SLED ELECTRODE

• K Number: K970717
• Device Name: VAPOR-TECH SLED ELECTRODE
• Manufacturer: NORTHGATE TECHNOLOGIES, INC.
• Date Cleared: 1997-05-08 ( 70 days)
• Product Code: FAS
• Regulation Number: 876.4300
• Type: Traditional
• Panel: GU
• Reference & Predicate Devices: N/A

Intended Use

Northgate Technologies Inc. Resectoscope Sled™ Electrodes are intended to be used for resection/coagulation of urinary tract soft tissue.

Device Description

Northgate's Resectoscope Sled™ Electrode is designed to be used with most major brands of Resectoscopes. The electrodes are used for resection/ coagulation of urinary tract soft tissue.

AI/ML Overview

This document is a SUMMARY OF SAFETY AND EFFECTIVENESS for a medical device cleared in 1997. It describes the device, its materials, intended use, and claims substantial equivalence to other marketed devices.

This type of document (a 510(k) summary from 1997) does not typically contain the detailed acceptance criteria and study information requested in your prompt. 510(k) clearances, especially from this era, primarily focus on device description, materials, intended use, and demonstrating substantial equivalence to a predicate device based on those factors. They rarely involve extensive clinical performance studies with detailed acceptance criteria, sample sizes, ground truth establishment, or multi-reader studies as would be expected for AI/ML-based devices or devices requiring detailed performance metrics.

Therefore, I cannot provide the requested information from the provided text. The document states:

• Common/Usual Name: Resectoscope Sled™ Electrode
• Proprietary Name: Vapor-Tech Sled™ Electrosurgical Electrode
• Classification: CLASS II
• Intended Use: Used for resection/coagulation of urinary tract soft tissue.
• Substantial Equivalence: Claimed based on design, materials, and intended use to existing devices from Circon/ACMI and Greenwald Surgical Company, Inc.

The document does not include any of the following, which are necessary to answer your specific questions:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This document is a regulatory submission for a physical medical device, not an AI/ML diagnostic tool, which is where those types of performance metrics and study designs would be highly relevant.

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).