The Parcus AcTiFlip is used for fixation of bone or soft tissue to bone, and is intended as fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair in the knee, shoulder, and elbow and may include the following indications; anterior cruciate ligament, posterior cruciate ligament, pectoralis repair (minor/major), biceps tendon repair and reattachment (distal/proximal), acromioclavicular repair, and ulnar collateral ligament reconstruction.

The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.

Device Description

The Parcus AcTiFlip and GFS Ultimate Hip 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 and are provided sterile.

AI/ML Overview

This FDA 510(k) summary provides limited information regarding the acceptance criteria and study data for the Parcus Medical AcTiFlip and GFS Ultimate Hip devices.

Here's an analysis based on the provided text, highlighting where information is available and where it's missing for your specific requests:

Summary of Acceptance Criteria and Device Performance (Limited Information):

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Mechanical Strength	- Meet or exceed predicate device performance for strength	- "Results were compared with test data for the predicate device and demonstrated substantial equivalency." (Specifically for strength under cycle loading and ultimate failure conditions)
Elongation	- Meet or exceed predicate device performance for elongation	- "Results were compared with test data for the predicate device and demonstrated substantial equivalency." (Specifically for elongation under cycle loading and ultimate failure conditions)
Pyrogenicity / Endotoxin	- Meet endotoxin limit specifications	- "It was concluded that both the Parcus AcTiFlip and the GFS Ultimate Hip devices meet endotoxin limit specifications and do not raise any additional concerns regarding pyrogenicity."

Detailed Responses to Specific Questions:

A table of acceptance criteria and the reported device performance:
- See the table above. The document primarily states that the devices demonstrate "substantial equivalency" to predicate devices for mechanical properties (strength and elongation) and meet endotoxin specifications. Specific numerical acceptance criteria for strength and elongation are not
  provided in this summary, nor are the precise numerical results of the testing.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document states that "testing was conducted on the worst case configurations," but does not specify the sample size (N) for these tests.
- Data Provenance: Not specified. The document does not mention the country of origin of the data or whether the study was retrospective or prospective. It describes laboratory testing, not clinical studies.
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 is not applicable as the summary describes mechanical and biocompatibility laboratory testing of a medical device (fixation fasteners), not a diagnostic or AI-driven device requiring expert-established ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for mechanical and biocompatibility testing. Adjudication methods are typically used in clinical studies or studies involving human assessment of data.
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 is not applicable. The device (fixation fasteners) is not an AI/diagnostic device that would involve human readers or AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. The device is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical tests, the "ground truth" (or more accurately, the reference standard for comparison) was the performance of the predicate device. The testing aimed to show that the new device's performance was "substantially equivalent" to this established predicate.
- For pyrogenicity, the "ground truth" was established based on endotoxin limit specifications, which are regulatory standards.
The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI/machine learning device. The testing described is for physical properties and biocompatibility.
How the ground truth for the training set was established:
- This is not applicable for the reasons stated above.

In summary, the provided FDA 510(k) letter and summary focus on demonstrating substantial equivalence of a physical medical device (bone/soft tissue fixation fasteners) to already cleared predicate devices through mechanical testing and biocompatibility assessments. It does not involve AI, diagnostic algorithms, or human interpretation studies.

Summary

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January 16, 2020

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

Re: K192750

Trade/Device Name: AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: October 18, 2019 Received: October 21, 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/cdrh/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, 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

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laura C. Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

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

510(k) Number (if known)

K192750

Device Name

AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip

Indications for Use (Describe)

The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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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 and white curved line 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

	510(k) Summary
510(k) Owner & Submitter:	Parcus Medical, LLC
	6423 Parkland Dr
	Sarasota, FL 34243
Company Contact:	Paul Vagts
	Phone: (941)755-7965
	Fax: (941)755-6543
Date Prepared:	January 15, 2020
Device Trade Name:	AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip w/ WHIP,GFS Ultimate Hip
Common Name:	Fastener, Fixation, Non-Degradable, Soft Tissue
Device Class:	Class II
Classification Name:	21 CFR 888.3040 - Product Code MBI

Predicate Device:

Parcus GFS II and GFS Mini, K133757, cleared 2/4/14; GFS Naked, K152711, cleared 12/10/15, Parcus GFS Ultimate, K162198, cleared 11/18/16; and Arthrex K190288, cleared 9/13/19.

Device Description:

Intended Use:

The Parcus GFS Ultimate Hip is used for fixation of soft tissue to bone in the hip and is indicated for ligamentum teres reconstruction.

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Surgical Innovation | Customer Drive

Substantial Equivalence Summary:

The Parcus AcTiFlip Naked, AcTiFlip Cinch and AcTiFlip w/ WHIP devices are very similar to the predicate devices in that they are comprised of the same materials, intended for the same indications and utilize similar designs. The titanium button used by the AcTiFlip devices is very similar in design to that of the GFS Naked devices. The suture portion of the AcTiFlip Cinch builds upon the technology utilized by the GFS Ultimate. The suture used by the AcTiFlip w/ WHIP is manufactured by the same supplier as all other suture components and functions in a comparable manner.

The Parcus GFS Ultimate Hip device is very similar to the predicate Parcus Medical GFS Ultimate in that they are comprised of the same materials, intended for the same indications and utilize similar designs. The only difference is the use of an inserter for placement of the titanium button in the hip.

All AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip w/ WHIP and GFS Ultimate Hip are very similar to the Arthrex predicate in that they are all capable of achieving fixation using either extramedular or intramedular fixation.

LAL testing was conducted on a representative device comprised of the same materials manufactured in a comparable fashion and it was concluded that both the Parcus AcTiFlip and the GFS Ultimate Hip devices meet endotoxin limit specifications and do not raise any additional concerns regarding pyrogenicity.

Summary Performance Data:

The Parcus AcTiFlip and GFS Ultimate Hip devices were evaluated and testing was conducted on the worst case configurations. Devices were assembled to test blocks 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.