BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224

• K Number: K982748
• Device Name: BI-POLAR CORD SET 1.88 TR, BI-POLAR CORD SET 1.83 TR, MODEL #'S SB223, SB 224
• Manufacturer: NEW DEANTRONICS TAIWAN, LTD.
• Date Cleared: 1998-11-03 ( 89 days)
• Product Code: GEI
• Regulation Number: 878.4400
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

Electrosurgical accessory. BiPolar Cord Set for use with foot switching electrosurgical accessories to conduct high-frequency electrical current intended to remove tissue and control bleeding.

Device Description

New Deantronics, Inc. Model SB 223 and SB 224 BiPolar Cord Sets.

AI/ML Overview

I am sorry, but based on the provided document, I cannot answer your request. The document is a 510(k) clearance letter from the FDA for a BiPolar Cord Set. It confirms that the device is substantially equivalent to a predicate device and can be marketed.

However, the document does not contain any information regarding:

• Acceptance criteria or reported device performance metrics.
• Details of any specific studies (e.g., sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information about multi-reader multi-case studies or standalone algorithm performance.
• Details about training sets for any AI/ML models.

The document is purely an administrative clearance and does not delve into the technical study details you are asking for.

Regulation Number and Section

§ 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.