The Gyrus ACMI General Surgery Workstation is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery.
The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.

Device Description

The currently marketed Gyrus ACMI General Surgery Workstation is a bipolar RF generator that accepts a variety of disposable hand pieces that utilize a PlasmaKinetic (PK) or PlasmaCision (PC) waveform. The generator face includes two sockets that allow a range of hand pieces to be utilized in a dry field environment, although only one socket may be active at any given time.
The Gyrus ACMI General Surgery Workstation General Purpose Electrosurgical Generator employs a system of automatic instrument detection, through a resistor located in the hand piece connector plug. This ensures that only the allowable range of waveform output and power level can only be applied to the instrument irrespective of the output socket. Accessories presently provided with the Gyrus ACMI General Surgery Workstation include a power cable and a foot switch. It should be noted that this footswitch is also used with the Gyrus ACMI SuperPulse generator (cleared under K031085).
This Special 510(k) proposes the addition of a new optional accessory, the Dual Footswitch Connector Cable. The Dual Footswitch Connector Cable allows for easier use of the Gyrus ACMI General Surgery Workstation when multiple surgeons are present. This is achieved by allowing the connection and use of two footswitches on the same generator. The indications for use, principles of operation, energy waveform outputs, and accessories of the Gyrus ACMI General Surgery Workstation with the Dual Footswitch Connector Cable accessory remain the same as the currently marketed Gyrus ACMI General Surgery Workstation.

AI/ML Overview

The provided text is a 510(k) summary for the Gyrus ACMI General Surgery Workstation. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device. However, it does not contain information about:

Specific acceptance criteria in a quantitative or qualitative table format.
A study designed to "prove" the device meets acceptance criteria, beyond the claim of substantial equivalence.
Sample sizes for test sets or training sets.
Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or types of ground truth.

The document primarily focuses on regulatory approval based on equivalence, not on a detailed performance study with specific metrics. Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred and explicitly stated:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device (Gyrus General Purpose Electrosurgical System K050550)	The proposed modifications (addition of Dual Footswitch Connector Cable) are deemed to not "significantly affect the safety or efficacy of the devices" and are "substantially equivalent" to the predicate.
Intended Use: Ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery.	The indications for use, principles of operation, energy waveform outputs, and accessories of the Gyrus ACMI General Surgery Workstation with the Dual Footswitch Connector Cable accessory remain the same as the currently marketed Gyrus ACMI General Surgery Workstation. (Implicitly met as functionality and intended use are unchanged).
Safety and Efficacy	The modifications are presented as not substantially changing safety or efficacy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission is a Special 510(k) for an accessory, focusing on substantial equivalence rather than a new clinical study.

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)
This information is not provided in the document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.

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
This information is not provided in the document. This device is an electrosurgical workstation, not an AI or imaging device, so an MRMC study would not be relevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. This is not an algorithm-only device. The submission is for a physical medical device and an accessory.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This information is not provided in the document. Given this is a 510(k) for an electrosurgical device accessory, the "truth" is typically established through engineering bench testing and comparison to the predicate device's established performance, rather than clinical ground truth as might be seen for diagnostic devices.

8. The sample size for the training set
This information is not provided in the document.

9. How the ground truth for the training set was established
This information is not provided in the document.

Summary

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Gyrus ACMI General Surgery Workstation ? Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772

Special 510(k) Notification 510(k) Summary of Safety and Effectiveness July 2, 2008

JUL 3 1 2008

510(k) Summary of Safety and Effectiveness Gyrus ACMI, Inc. Gyrus ACMI Y-Connector

K 081954

General Information

Manufacturer:

જ

Gyrus Medical Ltd. Fortran Road, St. Mellons Cardiff, United Kingdom

Establishment Registration Number:

Submitter:

Establishment Registration Number:

Contact Person:

Date Prepared:

Trade Name:

Device Description

Classification Name:

9617070

Gyrus ACMI, Inc. 136 Turnpike Rd. Southborough, MA 01772-2104

3003790304

Terrence E. Sullivan Vice President, Regulatory Affairs

July 2, 2008

Electrosurgical Cutting & Coagulation Device and Accessories (21 CFR 878.4400), Class II General & Plastic Surgery Panel

Gyrus ACMI General Surgery (G400) Workstation

Electrosurgical Generator and Accessories

Predicate Device

Generic/Common Name:

Gyrus General Purpose Electrosurgical System

K050550

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Special 510(k) Notification 510(k) Summary of afety and Effectiveness Inly 2, 2008

K081954

Intended Uses

Page 2 of (2)

The Gyrus ACMI General Surgery Workstation is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in surgery.

These devices are marketed as reusable devices; methods for cleaning, disinfecting and sterilization are included in latter sections of this submission under Section 12.0, "Cleaning".

Product Description

The Gyrus ACMI General Surgery Workstation General Purpose Electrosurgical Generator employs a system of automatic instrument detection, through a resistor located in the hand piece connector plug. This ensures that only the allowable range of waveform output and power level can only be applied to the instrument irrespective of the output socket. Accessories presently provided with the Gyrus ACMI General Surgery Workstation include a power cable and a foot switch. It should be noted that this footswitch is also used with the Gyrus ACMI SuperPulse generator (cleared under K031085).

This Special 510(k) proposes the addition of a new optional accessory, the Dual Footswitch Connector Cable. The Dual Footswitch Connector Cable allows for easier use of the Gyrus ACMI General Surgery Workstation when multiple surgeons are present. This is achieved by allowing the connection and use of two footswitches on the same generator. The indications for use, principles of operation, energy waveform outputs, and accessories of the Gyrus ACMI General Surgery Workstation with the Dual Footswitch Connector Cable accessory remain the same as the currently marketed Gyrus ACMI General Surgery Workstation.

Summary of Safety and Effectiveness

The proposed modifications for the Gyrus ACMI General Surgery Workstation, as described in this submission, are substantially equivalent to the predicate device. The proposed addition of the Dual Footswitch Connector Cable as an accessory is not a substantial change or modification, and do not significantly affect the safety or efficacy of the devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Gyrus ACMI, Inc. % Mr. Terrence E. Sullivan VP, Regulatory Affairs 136 Turnpike Road Southborough, Massachusetts, 01772

JUL 3 1 2008

Re: K081954

Trade/Device Name: Gyrus ACMI General Surgery (G400) Workstation Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: July 02, 2008 Received: July 09, 2008

Dear Mr. Sullivan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Terrence E. Sullivan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilitics under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M Wilkinson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Device Name: Gyrus ACMI General Surgery (G400) Workstation

510(k) Number:

Intended use:

The generator is indicated for ablation, resection and coagulation of soft tissue and hemostasis of blood vessels in surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: X

OR Over-the-Counter Use:

(Per 21 CFR 801.109)

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K081957

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.