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K Number
K192728
Device Name
Agnes
Manufacturer
Agnes Medical Co., Ltd
Date Cleared
2019-10-24

(27 days)

Product Code
GEI,KCW
Regulation Number
878.4400
Type
Special
Panel
SU
Reference & Predicate Devices
K171707,K102372,K160469
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Device Description

AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a footswitch, a hand-piece, FDA cleared Single use needle type RF electrodes (K171707) and FDA cleared Disposable neutral electrode pad (K102372).

AI/ML Overview

The provided text is a 510(k) summary for the AGNES RF electrosurgical device. It outlines changes made to an existing device (K160469) and asserts substantial equivalence to meet FDA requirements. However, this document does not contain the acceptance criteria or a study proving device performance against such criteria for a diagnostic or AI-driven device.

This 510(k) summary focuses on demonstrating that modifications made to an existing RF electrosurgical device (AGNES) do not negatively impact its safety and effectiveness compared to the predicate device. It primarily covers design changes, software changes, and performance testing related to international standards for electrosurgical equipment.

Therefore, I cannot provide the requested information from the given text as it is not present. The document focuses on regulatory compliance for modifications to an electrosurgical device, not on diagnostic performance or AI model validation studies.

Here's why the requested information cannot be extracted:

  • Acceptance Criteria & Reported Performance: There are no specific acceptance criteria for a diagnostic device or AI system in this document. The "performance" discussed relates to the electrosurgical unit's output power levels, operating time, and compliance with general safety standards for electrosurgical devices (e.g., IEC 60601-2-2).
  • Sample Size & Data Provenance (Test Set): No test set for an AI model or diagnostic performance is mentioned. The "tests" performed are for hardware changes and software validation of the electrosurgical unit.
  • Number of Experts & Qualifications (Ground Truth): Not applicable, as there's no diagnostic ground truth being established or evaluated.
  • Adjudication Method: Not applicable.
  • Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
  • Standalone Performance: The "standalone" performance mentioned refers to the electrosurgical unit functioning by itself, not an AI algorithm.
  • Type of Ground Truth: Not applicable; there is no diagnostic ground truth.
  • Sample Size (Training Set): Not applicable; no AI model training is mentioned.
  • Ground Truth for Training Set: Not applicable.

In summary, the provided FDA 510(k) notification is for a physical medical device (an electrosurgical unit) and its modifications, not for a diagnostic device or AI system that would have the types of performance studies and acceptance criteria you're asking about.

§ 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.