The Mitek Electrosurgical System is intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

Device Description

The Mitek Electrosurgical System is comprised of four components: the electrosurgical generator, a footswitch, a handpiece with a cable to connect to the generator and five types of electrode tip configurations are used in the arthroscopic procedure.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Resection, ablation, and excision of soft tissue	Preclinical and cadaveric evaluations showed the device functions as intended.
Hemostasis of blood vessels	Preclinical and cadaveric evaluations showed the device functions as intended.
Use in arthroscopic surgery of knee, shoulder, ankle, elbow, and wrist	Preclinical and cadaveric evaluations confirmed suitability for these applications.
Substantial equivalence to predicate device	Concluded to be substantially equivalent based on preclinical and cadaveric testing.

Sample size used for the test set and the data provenance:
The document refers to "preclinical and cadaveric evaluations." It does not specify a numerical sample size for either the test set (if cadaveric falls under this) or the preclinical tests.
The data provenance is from "preclinical and laboratory cadaveric evaluations." No specific country of origin is mentioned, and the nature of these evaluations implies they are prospective tests performed for the purpose of this submission. They are not explicitly stated as retrospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document does not provide information about the number or qualifications of experts used to establish ground truth for the test set.
Adjudication method for the test set:
The document does not describe any specific adjudication method for the test set.
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 MRMC comparative effectiveness study was done. This device is an electrosurgical system, not an AI or imaging diagnostic tool that would typically involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This question is not applicable. The device is an electrosurgical system, not an algorithm, and is inherently used with a human in the loop (the surgeon).
The type of ground truth used:
The ground truth for the performance evaluations (resection, ablation, hemostasis) was established through direct observation and assessment of the device's functional capabilities during "preclinical and laboratory cadaveric evaluations." The predicate device (ArthroCare Arthroscopic Electrosurgical System) was used for comparison, suggesting its performance served as a de facto benchmark for acceptable "ground truth" performance.
The sample size for the training set:
The document does not explicitly mention a "training set" in the context of machine learning. The "preclinical and laboratory cadaveric evaluations" served as the primary performance data, which could be considered the "test set" in a broader sense.
How the ground truth for the training set was established:
Given that this is not an AI/ML device, there isn't a "training set" in the typical sense for which ground truth would be established through expert annotation. The "ground truth" for the device's functional performance was simply whether it achieved its intended effects (resection, ablation, hemostasis) as observed during the preclinical and cadaveric evaluations, often in comparison to the predicate device.

Summary

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SECTION 7

SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) Summary of Safety and Effectiveness Information supporting claims of substantial equivalence as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule " ... 510(k) Summaries and 510(k) Statements ... " (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

NEW DEVICE NAME: Mitek Electrosurgical System for Arthroscopic Use

PREDICATE DEVICE NAME: ArthroCare Arthroscopic Electrosurgical System

510(K) SUMMARY

Device Description

Intended Use

Continued on next page

Mitek Electrosurgical System for Arthroscopic Use Mitek Products

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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued

Indications Statement

Technological Characteristics

Performance Data

Conclusions

Contact

The Mitek Electrosurgical System is intended for soft tissue resection, ablation, and excision and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The new device is technologically the same as the predicate device. Both devices use high frequency electrosurgical current to achieve the intended clinical purpose. A single pair of electrode is used in the new device, while the predicate device uses multiple electrodes. This difference does not raise any new question of safety and effectiveness.

Preclinical and laboratory cadaveric evaluations were conducted to show that the device functions as intended. In preclinical and cadaveric evaluations, the ArthroCare Arthroscopic Electrosurgical System was used for comparison. Clinical data was deemed unnecessary to support the Premarket Notification. Sufficient data has been obtained from preclinical and cadaveric testing to assess safety and effectiveness characteristics of the device when compared to the predicate device.

Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act.

Mr. Edward F. Kent Vice President. Regulatory Affairs Mitek Surgical Products, Inc. 60 Glacier Drive Westwood, MA 02090

Date

September 19, 1996

Mitek Electrosurgical System for Arthroscopic Use Mitek Products

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.