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K Number
K123310
Device Name
FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)
Manufacturer
UTAH MEDICAL PRODUCTS, INC.
Date Cleared
2013-01-23

(90 days)

Product Code
GEI,HGI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K951032,K941251
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The FINESSE+ and FINESSE II+ are intended to deliver high frequency electrical current for surgical procedures that can be performed with monopolar cutting and/or coagulation of tissue. One intended use of the FINESSE+ and FINESSE II+ systems is Loop Excision of the Transformation Zone (LETZ®).

Device Description

The Finesse 3rd Generation combines a high-quality, class I type BF electrosurgical generator and a smoke evacuation system into a single compact unit. This integrated system is designed to perform low-power excision and coagulation procedures of short duration. The Finesse 3rd Generation is comprised of two models: FINESSE+ and FINESSE II+. The FINESSE II+ is identical to the FINESSE+, but does not have as many user adjustable features.

AI/ML Overview

The provided text is a 510(k) summary for the Utah Medical Products, Inc. Finesse 3rd Generation electrosurgical and suction unit. This document focuses on demonstrating substantial equivalence to predicate devices and compliance with relevant safety standards.

Therefore, the supplied text does not contain information typically found in a clinical study report for AI/ML-enabled devices. Specifically, it does not include details on:

  • Acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
  • A test set sample size, provenance, or how ground truth was established for AI/ML performance evaluation.
  • The number or qualifications of experts used for ground truth.
  • Adjudication methods.
  • Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
  • Standalone algorithm-only performance.
  • Training set sample size or ground truth establishment for a training set.

The performance data mentioned in the document states:

"Laboratory testing was conducted to certify the Finesse 3rd Generation's compliance with the requirements of ANSI / AAMI ES 60601-1:2005, AAMI / ANSI / IEC 60601-1-2:2007, and ANSI / AAMI / IEC 60601-2-2:2009. The operating principle of the Finesse 3rd Generation is identical to the predicate device."

This indicates that the acceptance criteria and study proving device performance are based on compliance with electrical safety and electromagnetic compatibility standards for electrosurgical devices, rather than performance metrics for an AI/ML algorithm.

Given the information provided, it is not possible to fill out the requested table or answer the specific questions about AI/ML device performance or clinical study details. The device described is an electrosurgical unit, not an AI/ML-enabled medical device requiring a study of AI performance.

§ 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.