In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;
In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;
In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon. lateral lateral stabilization tendons/ligaments, stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments, Tendon Transfers, tendon reattachments, and ligament reconstructions of the midfoot, forefoot, and hindfoot procedures associated with flatfoot reconstruction, hindfoot deformity, midfoot reconstruction, lateral/medial ankle reconstruction or instability, Hallux Valgus or Varus, and MTP instability including:
- o Achilles reattachment/reconstruction
- o Flexor Digitorum Longus Transfer
- Flexor Hallucis Longus Transfer o
- Extensor Hallucis Longus Transfer O
- Brostrom Procedures 0
- Peroneal Tendon Relocation 0
- Capsule Repair o
- Deltoid reconstruction / reattachment o
- Plantar Plate Repair o
- Spring Ligament Repair o

Device Description

The G-FORCE® Gen 2 Ti Suture Anchor is a sterile, single-use, hand-held device intended to aid in the attachment of soft tissue to bone. The G-FORCE® Gen 2 Ti Suture Anchor comes preloaded with non-absorbable polyethylene sutures, needles and titanium alloy anchors. The anchors are available in a variety of sizes with correspondingly sized sutures.

AI/ML Overview

The provided document, a 510(k) summary for the G-FORCE® Gen 2 Ti Suture Anchor System, describes the device's indications for use and performance data. However, it is a premarket notification for a medical device that demonstrates substantial equivalence to a predicate device, rather than a study proving a device meets specific acceptance criteria in the context of an AI/ML algorithm.

Therefore, the requested information regarding acceptance criteria and a study proving device performance as typically understood for AI/ML devices is not explicitly available in this document. The document focuses on demonstrating substantial equivalence through bench testing and comparison to a predicate device.

Here's an analysis based on the provided text, highlighting what is and isn't available for the requested categories:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit)	Reported Device Performance
Pullout strength equal to or superior to predicate device	"Bench testing was used to demonstrate that the pullout strength characteristics of the G-FORCE® Gen 2 Ti Suture Anchor System are substantially equivalent to the predicate." (The specific numerical values or comparison data for pullout strength are not provided in this summary but would have been part of the full 510(k) submission.)
Safety and Effectiveness	"The safety and effectiveness of the G-FORCE® Gen 2 Ti Suture Anchor System is adequately supported by the pullout testing performed, substantial equivalence information, literature review, and comparison of design characteristics provided within this premarket notification."
No new types of questions regarding safety or efficacy	"The design characteristics of the subject device do not raise any new types of questions in terms of either safety or efficacy."
Performance equal or superior to predicate device	"Based on the evidence submitted in this 510(k), the subject device can be expected to perform in a manner equal or superior to the predicate device and is substantially equivalent."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable: This document describes bench testing for a physical medical device (suture anchor system), not a test set for an AI/ML algorithm. The "test set" in this context would refer to the samples used in the bench testing, which is not detailed in this summary.

3. 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)

Not Applicable: This document describes bench testing for a physical medical device (suture anchor system), not a test set for an AI/ML algorithm that requires expert ground truth.

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

Not Applicable: This document describes bench testing for a physical medical device, not a test set for an AI/ML algorithm.

5. 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 document is for a physical medical device, not an AI/ML system that would involve human readers or an MRMC study.

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

Not Applicable: This document is for a physical medical device, not an AI/ML algorithm.

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

Not Applicable / Implied by Bench Testing: For a physical device like a suture anchor, the "ground truth" for performance is typically established through standardized physical tests (e.g., measuring pullout strength according to an established protocol) rather than expert consensus on medical images or pathology. The performance metrics themselves (e.g., maximum load, displacement) are the "ground truth" derived from the physical testing.

8. The sample size for the training set

Not Applicable: This document describes bench testing for a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not Applicable: This document describes bench testing for a physical medical device, not an AI/ML algorithm that requires a training set.

Summary of the Study per the Document:

The study conducted to support the G-FORCE® Gen 2 Ti Suture Anchor System's safety and effectiveness was bench testing. This testing aimed to demonstrate that the device's pullout strength characteristics are substantially equivalent to a predicate device (G-FORCE® Ti Suture Anchor System, K100579). The document states that the safety and effectiveness are "adequately supported by the pullout testing performed, substantial equivalence information, literature review, and comparison of design characteristics." The specific details of the bench testing (e.g., exact number of samples tested, methodology) are not provided in this summary but were part of the full 510(k) submission.

Summary

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JUL 30 2014

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the G-FORCE® Gen 2 Ti Suture Anchor System.

Submitted By:	Wright Medical Technology, Inc.
Date:	April 17, 2010
Contact Person:	Dmitri Falkner
	Regulatory Affairs Specialist I
Proprietary Name:	G-FORCE® Gen 2 Ti Suture Anchor System
Common Name:	Soft Tissue Anchor
Classification Name and Reference:	21 CFR 888.3040 - Smooth or threaded metallic bone fixation fastener - Class II
Device Product Code and Panel Code:	Orthopedics/87/MBI/HWC
Predicate Device:	G-FORCE® Ti Suture Anchor System (K100579)

DEVICE INFORMATION

A. DEVICE DESCRIPTION

B. INDICATIONS FOR USE

The G-FORCE® Gen 2 Suture Anchor System is indicated for use:

In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a ● slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;
In the repair of elbow instability secondary to biceps tendon detachment, tennis . elbow, or ulnar or radial collateral ligament tear/separation;
. In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;

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. In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;
In the repair of foot/ankle instability secondary to tear or separation of the Achilles . tendon. lateral lateral stabilization tendons/ligaments, stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments, Tendon Transfers, tendon reattachments, and ligament reconstructions of the midfoot, forefoot, and hindfoot procedures associated with flatfoot reconstruction, hindfoot deformity, midfoot reconstruction, lateral/medial ankle reconstruction or instability, Hallux Valgus or Varus, and MTP instability including:
- o Achilles reattachment/reconstruction
- o Flexor Digitorum Longus Transfer
- Flexor Hallucis Longus Transfer o
- Extensor Hallucis Longus Transfer O
- Brostrom Procedures 0
- Peroneal Tendon Relocation 0
- Capsule Repair o
- Deltoid reconstruction / reattachment o
- Plantar Plate Repair o
- Spring Ligament Repair o

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use of the G-FORCE® Gen 2 Ti Suture Anchor System have a larger scope when compared to that of the predicate. As the technological characteristics by which the intended use is achieved is the same for both the subject and predicate systems. As such, the inclusion of additional indications does not constitute a deviation from substantial equivalence.

The design characteristics of the subject device do not raise any new types of questions in terms of either safety or efficacy. Based on the evidence submitted in this 510(k), the subject device can be expected to perform in a manner equal or superior to the predicate device and is substantially equivalent.

D. PERFORMANCE DATA

Bench testing was used to demonstrate that the pullout strength characteristics of the G-FORCE® Gen 2 Ti Suture Anchor System are substantially equivalent to the predicate. The safety and effectiveness of the G-FORCE® Gen 2 Ti Suture Anchor System is adequately supported by the pullout testing performed, substantial equivalence information, literature review, and comparison of design characteristics provided within this premarket notification.

{2}------------------------------------------------

Public Health Service

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

July 30, 2014

Wright Medical Technology, Incorporated Mr. Dmitri Falkner Regulatory Affairs Specialist 1023 Cherry Road Memphis, Tennessee 38117

Re: K141011

Trade/Device Name: G-FORCE® Gen 2 Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: July 2, 2014 Received: July 3, 2014

Dear Mr. Faikner:

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

{3}------------------------------------------------

Page 2 - Mr. Dmitri Falkner

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/ResourcesforYou/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,

Lori A. Wiggins

for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141011

Device Name

G-FORCE® Gen 2 Suture Anchor System

Indications for Use (Describe)

The G-FORCE® Gen 2 Suture Anchor System is indicated for use:

· In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromicelavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;

· In the repair of elbow instability secondary to bicens tennis elbow, or ulnar or radial collateral ligament tearl separation;

• In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, or radial collateral ligament;

· In the repair of knee instability secondary to tear or separation of the medial collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;

· In the repair of foot/ankle instability secondary of the Achiles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendon Transfers, tendon reattachments, and ligament reconstructions of the midfoot procedures associated with flaffoot reconstruction, hindfoot deformity, midfoot reconstruction, lateral/medial ankle reconstruction or instability, Hallux Valgus or Varus, and MTP instability including:

o Achilles reattachment/reconstruction

o Flexor Digitorum Longus Transfer
o Flexor Hallucis Longus Transfer
o Extensor Hallucis Longus Transfer
o Brostrom Procedures
o Peroneal Tendon Relocation
o Capsule Repair
o Deltoid reconstruction / reattachment
o Plantar Plate Repair
o Spring Ligament 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY . . : ﻟﻠﻤﻮﺿﻮﻉ ﺍﻟﻤﻮﺿﻮﻋﺎﺕ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤ 12.000

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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.