The GFS Ultimate devices are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from medical grade titanium and UHMWPE suture. The GFS Ultimate devices are provided sterile.

AI/ML Overview

The provided text is a 510(k) Substantial Equivalence Determination for the GFS Ultimate device. This type of document is for medical device regulation and focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It does not typically contain information about AI-based CADe/CADx systems or studies with acceptance criteria as commonly understood in that context.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details, as these are not present in the given document.

The document does include "Summary Performance Data" which states:

Summary Performance Data:

The GFS Ultimate were evaluated and testing was conducted on the worst case configurations.
Devices were assembled per the DFU and placed in a test fixture.
Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions.
Results were compared with test data for the predicate device and demonstrated substantial equivalency.

However, this summary does not provide specific acceptance criteria or quantitative performance metrics for the GFS Ultimate, nor does it detail the study design, sample sizes, or ground truth establishment that would be relevant for an AI-powered diagnostic/CADe device. Instead, it confirms that mechanical testing was performed and the results supported substantial equivalence to the predicate device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name in a circular arrangement around a symbol. The symbol features three stylized human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 18, 2016

Parcus Medical, LLC Mr. Paul Vagts RA/OA Manager 6423 Parkland Drive Sarasota, Florida 34243

Re: K162198

Trade/Device Name: GFS Ultimate Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: October 21, 2016 Received: October 24, 2016

Dear Mr. Vagts:

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 adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K162198 Device Name: GFS Ultimate

Indications for Use:

The GFS Ultimate are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D)

Over the Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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K162198 - Page 1 of 1

Image /page/3/Picture/1 description: The image shows the logo for PARCUS MEDICAL, LLC. The word "PARCUS" is in large, blue, sans-serif font, with a red square to the left of the "P". Below "PARCUS" is the phrase "MEDICAL, LLC.", also in blue, sans-serif font, but smaller than the word "PARCUS".

510(k) Summa

Submitter:	Parcus Medical, LLC6423 Parkland DrSarasota, FL 34243
Company Contact:	Paul VagtsPhone: (941)755-7965Fax: (941)755-6543
Date Prepared:	November 17th, 2016
Device Trade Name:	GFS Ultimate
Common Name:	Ligament Retention Device
Device Class:	Class II
Classification Name:	Fastener, Fixation, Non-Degradable, Soft Tissue 21 CFR888.3040 - Product Code MBI
Predicate Device:	The predicate devices are the Parcus GFS, K090923,cleared June 30, 2009

Device Description:

Intended Use:

The GFS Ultimate are indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.

Substantial Equivalence Summary:

The GFS Ultimate are very similar to the predicate Parcus Medical GFS devices in that they are comprised of the same materials, are manufactured in comparable fashion, are intended for the same indications and utilize similar designs. LAL testing was conducted on the GFS Ultimate and it was concluded that the GFS Ultimate does not raise any additional concerns regarding pyrogenicity. While the GFS Ultimate features an adjustable loop length, testing has shown that this does not raise any concerns regarding the safety or efficacy of the device.

Summary Performance Data:

The GFS Ultimate were evaluated and testing was conducted on the worst case configurations. Devices were assembled per the DFU and placed in a test fixture. Devices were evaluated for strength and elongation under cycle loading and ultimate failure conditions. Results were compared with test data for the predicate device and demonstrated substantial equivalency.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.