Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis

Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair

Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon reattachment

Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure

Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in phalanx; Volar plate reconstruction

Hip: Acetabular labral repair

Device Description

The Q-Fix Suture Anchor System (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures.

The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.

The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.

The Q-Fix Suture Anchor System consists of the bone anchor and associated instruments for implanting the bone anchor.

AI/ML Overview

Here's an analysis of the provided text regarding the ArthroCare Q-Fix Suture Anchor System, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

The document does not explicitly state quantitative-only acceptance criteria in a dedicated table format. Instead, it describes acceptance based on the device performing as intended and its mechanical properties being "substantially equivalent" to a predicate device. The "Comparison of Technological Characteristics" table serves as a form of acceptance criteria by showing that the proposed device is largely identical or very similar to the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (based on Predicate Device K122336)	Reported Device Performance (Proposed Device ArthroCare Q-Fix)
Intended Use	Fixation of soft tissue to bone	Same
Delivery Method	Arthroscopic and Limited Access	Same
How Supplied	Packaged in pouch, Sterile (EtO), Single Use	Packaged in thermoform tray with Tyvek® lid, Sterile (EtO), Single Use (minor packaging difference)
Suture Material	No. 2 UHMWPE Suture	Same
Anchor Material	Braided Polyester	Same
Inserter Handle Materials	Medical Grade Plastics and Surgical Grade Stainless Steels	Same
Method of Anchor Insertion	Inserted into a predrilled hole	Same
Bone Locking Mechanism	Expandable Compression Fit	Same
Suture Locking Mechanism	Manually tied suture knot	Same
# of Suture Legs	Two (1.8mm) & Four (2.8mm)	Same
Sizes Offered	1.8mm & 2.8mm	Same
Deployed Length	15mm for 1.8mm anchor, 20mm for 2.8mm anchor	Same
Bone Hole Size	2.1mm (0.083") for 1.8mm anchor, 3.1mm (0.121") for 2.8mm anchor	2.2mm (0.085") for 1.8mm anchor, 3.1mm (0.123") for 2.8mm anchor (minor dimensional difference)
Accessory Instruments	Drill, Drill Guide, Obturator	Same (with additional listed instruments: Bone Punch, Knot Pusher, FirstPass* Suture Punch)
Overall Performance	Adherence to "design, performance, and safety specifications" and "substantially equivalent" to predicate based on FDA Guidance Document, Testing Bone Anchors, April 1996.	"meets its design, performance, and safety specifications" and "mechanical properties are substantially equivalent to the predicate devices."

Study Information

Sample Size used for the test set and data provenance:
- The document states: "Bench testing was performed on both the proposed and predicate devices in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996."
- It mentions "insertion of the anchors into a simulated human bone substrate followed by both static and cyclic fatigue testing."
- Sample Size: The exact sample size (number of anchors tested) for the bench testing is not specified in the provided text.
- Data Provenance: The data is from in vitro bench testing using a "simulated human bone substrate." There is no mention of country of origin as it's not human data. The study is inherently prospective in its design as laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- There is no mention of human experts being used to establish ground truth for this mechanical/bench test. The "ground truth" here is objective mechanical performance measured against predefined standards or comparison to a predicate device.
Adjudication method for the test set:
- No adjudication method (like 2+1, 3+1, none) is applicable or mentioned, as this involves mechanical testing, not expert review of subjective 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:
- No, an MRMC comparative effectiveness study was not done. This device is a mechanical medical implant (suture anchor), not an AI diagnostic or assistance system. Therefore, the concept of "human readers improve with AI" is not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm-only performance study was not done. As mentioned, this is a mechanical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" used for this submission is based on objective mechanical test results (static and cyclic fatigue testing) against established FDA guidance for bone anchors, and direct comparison of technological characteristics to a legally marketed predicate device to establish substantial equivalence.
The sample size for the training set:
- This is not an AI/machine learning device, so there is no training set in the traditional sense.
How the ground truth for the training set was established:
- Not applicable as there is no training set.

Summary

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510(k) Summary

ArthroCare® Corporation Q-Fix™ Suture Anchor System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

Submitter Name:	ArthroCare Corporation
Address	7000 West William Cannon DriveAustin, TX 78735
Contact Person:	Laura KasperowiczSr. Manager, Regulatory AffairsPhone: 949-585-2406Fax: 949-585-2401
Date Prepared:	August 9, 2013

Date Prepared:

Device Name

Proprietary Name:	Q-Fix™ Suture Anchor System
Common Name:	Bone Anchor
Classification Name:	Smooth or threaded metallic bone fixation fastener
Device Class:	Class II
Product Code:	MBI
CFR Section:	21 CFR 888.3040

Predicate Device

Eleven Blade Q-FixTM Suture Anchor: K122336 (cleared January 9, 2013)

Description

The Q-Fix Suture Anchor System (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures.

The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.

The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.

The Q-Fix Suture Anchor System consists of the bone anchor and associated instruments for implanting the bone anchor. In accordance with the ArthroCare Product Development Process, testing

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was performed to demonstrate the proposed device is substantially equivalent to the predicate device. Mechanical testing was performed in accordance with the requirements of the FDA Guidance Document, Testing Bone Anchor Devices, April 1996.

Intended Use/Indications For Use

The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:

Shoulder:	Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsularshift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; bicepstenodesis
Foot & Ankle:	Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Halluxvalgus reconstruction; Metatarsal ligament/tendon repair or reconstruction;Achilles tendon repair
Elbow:	Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair;biceps tendon reattachment
Knee:	Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament(LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellartendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure
Hand & Wrist:	Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfersin phalanx; Volar plate reconstruction
Hip:	Acetabular labral repair

Non-Clinical Data

Bench testing was performed on both the proposed and predicate devices in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996. This in vitro testing involved insertion of the anchors into a simulated human bone substrate followed by both static and cyclic fatigue testing.

The test results demonstrate that the Q-Fix meets its design, performance, and safety specifications. Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate devices when used in accordance with labeling.

Clinical Data

No clinical or animal data are included in this submission.

Summary

All testing demonstrates that the Q-Fix performs as intended and has acceptable mechanical properties when used in accordance with its labeling.

As the intended use, operating principle, materials and technological characteristics are comparable to the predicate device, the Q-Fix Suture Anchor System is substantially equivalent. The minor differences between the Q-Fix and predicate device do not raise any new questions of safety or effectiveness.

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Comparison of Technological Characteristics
Characteristics	Predicate DeviceEleven Blade Q-Fix(K122336)	Proposed DeviceArthroCare Q-Fix
Intended Use	Fixation of soft tissue to bone	Same
Delivery Method	Arthroscopic and Limited Access	Same
How Supplied	Packaged in pouch, Sterile (EtO), SingleUse	Packaged in thermoform tray with Tyveklid, Sterile (EtO), Single Use
Suture Material	No. 2 UHMWPE Suture	Same
Anchor Material	Braided Polyester	Same
Inserter Handle Materials	Medical Grade Plastics andSurgical Grade Stainless Steels	Same
Method of Anchor Insertion	Inserted into a predrilled hole	Same
Bone Locking Mechanism	Expandable Compression Fit	Same
Suture Locking Mechanism	Manually tied suture knot	Same
# of Suture Legs	Two (1.8mm) & Four (2.8mm)	Same
Sizes Offered	1.8mm & 2.8mm	Same
Deployed Length	15mm for 1.8mm anchor20mm for 2.8mm anchor	Same
Bone hole size	2.1mm (0.083") for 1.8mm anchor3.1mm (0.121") for 2.8mm anchor	2.2mm (0.085") for 1.8mm anchor3.1mm (0.123") for 2.8mm anchor
Accessory Instruments	Drill, Drill Guide, Obturator,	SameBone Punch, Knot Pusher,FirstPass* Suture Punch

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or other bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

September 19, 2013

ArthroCare Corporation Mr. Mitchell Dhority Vice President, Regulatory Affairs 7000 West William Cannon Drive Austin, Texas 78735

Re: K132513

Trade/Device Name: Q-Fix™ 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 Dated: August 22, 2013 Received: August 23, 2013

Dear Mr. Dhority:

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. Mitchell Dhority

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" (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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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

510(k) Number (if known): K132513

Device Name: Q-Fix™ Suture Anchor System

Indications for Use:

The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:

Shoulder:	Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsularshift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; bicepstenodesis
Foot & Ankle:	Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Halluxvalgus reconstruction; Metatarsal ligament/tendon repair or reconstruction;Achilles tendon repair
Elbow:	Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair;biceps tendon reattachment
Knee:	Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament(LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellartendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure
Hand & Wrist:	Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfersin phalanx; Volar plate reconstruction
Hip:	Acetabular labral 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.
Division of Orthopedic Devices

Page 1 of __ 1__

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.