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The OLSEN Medical Electrosurgical Monopolar and Bipolar Forceps are intended to be used as active electrosurgical devices where monopolar or bipolar electrosurgical cutting and coagulation is desired during surgery and are intended to grasp, manipulate cut or coagulate selected soft tissue.

OLSEN Medical® Electrosurgical Monopolar and Bipolar Forceps have been designed as active electrosurgical instruments to grasp, manipulate, cut or coagulate selected soft tissue. These stainless steel forceps are connected through a suitable active electrosurgical cable (bipolar or monopolar) to the specified output terminal of an electrosurgical generator. The bipolar forceps are intended for use with a maximum voltage of 500 volts while the monopolar forceps have a maximum voltage of 2000 volts. The forceps are offered either as single (disposable) or multiple-use (reuseable).

This document is a 510(k) Premarket Notification for Olsen Medical Bipolar and Monopolar Forceps. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study to prove acceptance criteria for a novel artificial intelligence or software-as-a-medical-device (SaMD) product.

Therefore, many of the requested categories for AI/SaMD performance studies (like sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this 510(k) submission.

However, I can extract the relevant information regarding acceptance criteria and the type of studies performed to show device safety and equivalence.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. This document describes a 510(k) submission for conventional medical devices (bipolar and monopolar forceps), not an AI/SaMD. The "testing" refers to compliance with established international and national standards for medical device safety and performance (e.g., electrical safety, sterilization, biocompatibility), rather than a clinical study with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. See point 2. Ground truth in the context of AI/SaMD studies involves expert interpretations of data. For these forceps, "ground truth" is adherence to engineering and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This type of study is specifically for evaluating AI/SaMD performance in a clinical setting involving human readers/interpreters. It's not relevant for assessing electrosurgical forceps.

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

• No. This is not software or an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for these devices is adherence to established engineering, electrical, biological, and sterilization standards for electrosurgical equipment (e.g., IEC 60601-2-2, ISO 10993, ANSI/AAMI HF18, ANSI/AAMI/ISO 11137-2). The ultimate validation is "substantial equivalence" to legally marketed predicate devices, meaning they function and are as safe and effective as existing, cleared devices.

8. The sample size for the training set

• Not applicable. No AI model is being trained.

9. How the ground truth for the training set was established

• Not applicable. No AI model is being trained.

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