The Parcus GFS BTB is 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 and are intended on being used in conjunction with other Parcus Medical devices such as the GFS Ultimate, GFS Mini and GFS II. The GFS BTB is provided sterile.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria in the context of an AI/ML-based medical device.

The document is a 510(k) premarket notification for a medical device called "Parcus GFS BTB," which is a device for the fixation of ligaments and tendons. It discusses the device's substantial equivalence to predicate devices, its indications for use, and a summary of performance data related to its mechanical properties (strength and elongation under cycle loading and ultimate failure conditions).

Therefore, I cannot extract the requested information regarding AI/ML device performance, acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance.

Here's why the document doesn't contain the requested information:

Device Type: The "Parcus GFS BTB" is a mechanical implant (bone fixation fastener), not an AI/ML-based diagnostic or therapeutic device.
Performance Data: The performance data described relates to the physical and mechanical properties of the implant (strength, elongation, pyrogenicity), not to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with AI/ML models.
Regulatory Pathway: The 510(k) pathway for this device focuses on substantial equivalence to existing predicate devices, primarily through comparison of materials, design, indications for use, and mechanical performance. It does not involve the types of clinical studies, ground truth establishment, or human-in-the-loop assessments common in AI/ML device submissions.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA (U.S. Food & Drug Administration) logo.

February 7, 2019

Parcus Medical, LLC Paul Vagts Director of Regulatory Affairs 6423 Parkland Drive Sarasota, Florida 34243

Re: K183331

Trade/Device Name: Parcus GFS BTB Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 7, 2019 Received: January 8, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurence D. Coyne -S

For 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K183331

Device Name Parcus GFS BTB

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Surgical Innovation | Customer Driven

510(k) Summary

510(k):	K183331
510(k) Owner:	Parcus Medical, LLC6423 Parkland DrSarasota, FL 34243
Company Contact:	Paul VagtsPhone: (941)755-7965Fax: (941)755-6543
Date Prepared:	January 7, 2019
Device Trade Name:	GFS BTB
Common Name:	Ligament Retention Device
Device Class:	Class II
Classification Name:	Fastener, Fixation, Non-Degradable, Soft Tissue21 CFR 888.3040 - Product Code MBI
Predicate Device:	The predicate devices are the Parcus GFSUltimate, K162198, cleared November 18th, 2016,and the Parcus GFS II and GFS Mini, K133757,cleared February 4, 2014.

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 BTB is very similar to the predicate Parcus Medical GFS devices in that it is comprised of the same materials, intended for the same indications and utilizes similar designs. LAL testing was conducted on a representative device comprised of the same materials and general construction. The results of this testing met the

PARCUSMEDICAL.COM 6423 Parkland Drive, Sarasota, FL 34243

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Image /page/4/Picture/0 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 word. Below the word "PARCUS" is the phrase "MEDICAL, LLC." in a smaller, blue, sans-serif font.

Surgical Innovation | Customer Driven

acceptance criteria described in the FDA recognized standard and therefore it was concluded that the GFS BTB does not raise any additional concerns regarding pyrogenicity. While the GFS BTB is used in addition to other GFS devices and secures the graft to it, testing has shown that this does not raise any concerns regarding the safety or efficacy of the device.

Summary Performance Data:

The GFS BTB was evaluated and testing was conducted on the worst case configurations. Devices were assembled per the IFU 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.