The Parcus GFS II and GFS Mini are designed for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair. The devices are made from Ultra High Molecular Weight Polyethylene (UHMWPE) and titanium. The GFS II and GFS Mini are provided sterile.

AI/ML Overview

The provided text describes the Parcus GFS II and GFS Mini devices, which are suture retention devices intended for the fixation of ligaments and tendons. The information is from a 510(k) summary submitted to the FDA.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Strength	The device, when assembled with simulated grafts and subjected to cycle loading and ultimate failure conditions, must demonstrate sufficient strength and elongation properties to be substantially equivalent to the predicate device. This implies that the GFS II and GFS Mini should withstand similar forces and deformation as the predicate without premature failure, ensuring safe and effective ligament/tendon fixation.	"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." (This indicates that the GFS II and GFS Mini met the implicitly defined strength and elongation criteria by performing comparably to the predicate device under the specified test conditions.)
Elongation	The device, when assembled with simulated grafts and subjected to cycle loading and ultimate failure conditions, must demonstrate elongation characteristics comparable to the predicate device. This ensures the device maintains appropriate stability and does not stretch excessively during use, which could compromise fixation.	"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." (Similar to strength, the GFS II and GFS Mini were found to have comparable elongation to the predicate device, thus meeting the implicit criteria.)
Safety and Efficacy	The device must not raise any new concerns regarding safety or efficacy compared to the predicate device, even with new configurations. This is a general regulatory requirement for substantial equivalence.	"While the GFS II and GFS Mini are offered in more suture loop configurations than the predicate GFS device, testing has shown that this does not raise any concerns regarding the safety or efficacy of the device." (This explicitly states that despite design variations, no new safety or efficacy concerns were identified, supporting substantial equivalence.)
Biocompatibility	(Not explicitly stated as an acceptance criterion in the provided text, but implied as the device is made from UHMWPE and titanium, which are typically well-established biocompatible materials in medical devices.)	The devices are made from Ultra High Molecular Weight Polyethylene (UHMWPE) and titanium. (Suggests standard biocompatibility for these materials. No specific testing or results are mentioned, but use of these materials usually implies pre-established biocompatibility for such medical applications.)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document states that "testing was conducted on the worst case configurations." However, it does not specify the exact number of devices or "worst case configurations" tested.
Data Provenance: The document does not explicitly state the country of origin of the data. It is a 510(k) submission to the FDA in the USA, implying the testing was performed in a manner compliant with US regulatory standards, likely in the USA or by a recognized testing facility. The data is retrospective in the sense that the testing was performed before submission for regulatory clearance, but it is not clinical data. It is mechanical test data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the provided document. The study described is a mechanical performance study comparing the new devices to a predicate device based on engineering specifications and test data, not a clinical study involving human patients or expert interpretation of diagnostic outcomes. Therefore, there is no "ground truth" established by experts in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3. Mechanical testing does not involve adjudication by experts. The results are quantitative measurements against predefined engineering standards or comparative values.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or clinical decision support systems where multiple human readers interpret cases with and without AI assistance. The provided document describes a mechanical device and its performance testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical medical implant (a suture retention device), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by engineering test standards and comparative data from the predicate device. The performance of the GFS II and GFS Mini was measured against these mechanical properties, and the "truth" was whether its measured strength and elongation were sufficiently similar to the predicate to establish substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The document describes a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for PARCUS MEDICAL, LLC. The logo is in black and has a stylized font. The date "FEB - 4 2014" is to the right of the company name.

510(k) Summary

Submitter:	Parcus Medical, LLC6423 Parkland DrSarasota, FL 34243
Company Contact:	Paul VagtsPhone: (941)755-7965Fax: (941)755-6543
Date Prepared:	December 6, 2013
Device Trade Name:	GFS II StandardGFS II LargeGFS Mini
Common Name:	Suture 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 Graft Fixation System,K090923 June 30, 2009

Device Description:

Intended Use:

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

Substantial Equivalence Summary:

The GFS II and GFS Mini are very similar to the predicate Parcus Medical GFS device in that they are comprised of the same materials, are intended for the same indications and utilize similar designs. While the GFS II and GFS Mini are offered in more suture loop configurations than the predicate GFS device, testing has shown that this does not raise any concerns regarding the safety or efficacy of the device

Summary Performance Data:

The GFS II and GFS Mini were evaluated and testing was conducted on the worst case configurations. Devices were assembled with simulated grafts 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.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

Public Health Service

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

February 4, 2014

Parcus Medical, LLC Mr. Paul Vagts Regulatory Affairs / Quality Assurance Manager 6423 Parkland Drive Sarasota, Florida 34243

Re: K133757

Trade/Device Name: Parcus GFS II and GFS Mini Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: January 07, 2014 Received: January 08, 2014

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Paul Vagts

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Vincen Digevlin -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

K133757 510(k) Number (if known): Device Name: Parcus GFS II and GFS Mini

Indications for Use:

The Parcus GFS II and GFS Mini 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)

Casey L. Hanley, Ph.D.

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Division of Orthopedic Devices

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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.