The Parcus GFS Naked 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 are provided sterile.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study design that typically accompanies AI/CADe devices. This document describes a medical device, the Parcus GFS Naked, which is a physical implant (a smooth or threaded metallic bone fixation fastener). The information provided is a 510(k) premarket notification summary for this physical device, not an AI or software device.

Therefore, many of the requested categories (such as experts, adjudication methods, MRMC studies, standalone performance, ground truth for training data, etc.) are not applicable to this type of medical device submission.

However, based on the provided text, I can extract information related to the performance data and "acceptance criteria" through the lens of establishing substantial equivalence for a physical device.

Here's the information that can be extracted and how it relates (or doesn't) to your request:

Acceptance Criteria and Device Performance (Interpreted for a Physical Device)

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to Predicate Device: Performance characteristics (strength, elongation) of the Parcus GFS Naked devices must be comparable to the predicate devices (GFS II Standard, GFS II Large, and GFS Mini) to ensure similar safety and effectiveness for fixing ligaments and tendons.	Testing was conducted on worst-case configurations (implied across sizes to cover the range of the GFS Naked). Devices were evaluated for strength and elongation under cyclic loading and ultimate failure conditions. The results were compared with test data for the predicate device and demonstrated substantial equivalency.
Material Composition: Must be made from medical grade materials.	Devices are made from medical grade titanium.
Sterility: Must be provided in a sterile form.	Devices are provided sterile.
Biocompatibility: (Not explicitly stated as an acceptance criterion in this summary, but generally required for implants).	Implied by the use of medical-grade titanium and clearance through the 510(k) process for implants.

Study Details (Interpreted for a Physical Device)

1. Sample sized used for the test set and the data provenance:

Sample Size: Not explicitly stated as a number (e.g., "N=X devices"). The text states "Testing was conducted on the worst case configurations." This implies a selection of devices or conditions representing the most challenging scenarios for the device, but not a specific count of individual devices tested.
Data Provenance: Not applicable in the context of patient data for AI. This refers to in-vitro mechanical testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a mechanical performance study of a physical implant, not a diagnostic or AI device where expert consensus on "ground truth" (e.g., disease presence) would be established.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable. As above, this is a mechanical performance study.

4. 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:

Not Applicable. This is a physical implant validation, not an AI assistance device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a physical implant. The "standalone" performance here refers to the device's inherent mechanical properties without human intervention during use, which was tested.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Engineering Specifications and Predicate Device Data: The "ground truth" for this study is based on established engineering principles for mechanical strength and elongation, and critically, the previously established performance data of the legally marketed predicate devices. The goal was to show that the new device's performance aligns with these established benchmarks.

7. The sample size for the training set:

Not Applicable. This is a physical implant study, not an AI device with a "training set."

8. How the ground truth for the training set was established:

Not Applicable. As above, this is a physical implant.

In summary, the provided document is a 510(k) summary for a physical medical device. The "study" described is a mechanical performance testing regimen designed to demonstrate substantial equivalence to predicate devices based on properties like strength and elongation, not a clinical study involving patients or an evaluation of an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

November 20, 2015

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

Re: K152711

Trade/Device Name: Parcus GFS Naked Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class III Product Code: MBI Dated: October 21, 2015 Received: October 22, 2015

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

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):	K152711
Device Name:	Parcus GFS Naked

Indications for Use:

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

AND/OR Prescription Use __ X __

Over the Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(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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K152711 Page 1 of 1

510(k) Summ

Submitter:	Parcus Medical, LLC6423 Parkland DrSarasota, FL 34243
Company Contact:	Paul VagtsPhone: (941)755-7965Fax: (941)755-6543
Date Prepared:	September 17, 2015
Device Trade Name:	Parcus GFS Naked
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 GFS II Standard, GFS II Largeand GFS Mini, K133757, February 4, 2014.

Device Description:

Intended Use:

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

Substantial Equivalence Summary:

The GFS Naked are very similar to the predicate Parcus Medical GFS, GFS II and GFS Mini devices in that they are comprised of the same materials, are intended for the same indications and utilize similar designs. While the GFS Naked are offered in both smaller and larger sizes, testing has shown that this does not raise any concerns regarding the safety or efficacy of the device.

Summary Performance Data:

The GFS Naked were evaluated and testing was conducted on the worst case configurations. Devices were assembled with suture 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.