Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon reattachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

Device Description

The ArthroCare Spartan PEEK (polyether-etherketone) Suture Implant is a fullythreaded, corkscrew shape anchor available in 5.5mm diameter size. The suture anchor comes preconfigured with MagnumWire® sutures for traditional knot tying and is mounted on a disposable delivery driver. The device is supplied sterile and is available with our without needles. Associated instruments (Punch Tap and Extraction Tool) for implantation and removal of the implant are available separately and altogether are referred to as the ArthroCare Spartan PEEK Suture Implant System.

AI/ML Overview

The provided text describes a 510(k) submission for the ArthroCare Spartan PEEK Suture Implant System, which is a medical device for fixing soft tissue to bone. However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of typical AI/ML device evaluations.

The "study" mentioned in the document is a "bench performance testing" to demonstrate substantial equivalence to predicate devices, and it involves "ultimate strength and cyclic loading tests" in a simulated human bone substrate. This is a biomechanical engineering test, not a clinical study or an AI/ML performance evaluation.

Therefore, for aspects related to AI/ML device performance (like specific metrics, test sets, expert adjudication, MRMC studies, and training data information), the provided document does not contain the requested details.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

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

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Substantial equivalence to predicate devices for intended use, device design, technology, and components.	Demonstrated through bench performance testing.
Performance testing in accordance with FDA Guidance Document Testing for Bone Anchors.	Performed "ultimate strength and cyclic loading tests."
Safe and effective for its intended use.	Performance testing and device comparison demonstrate substantial equivalence, and thus, implicitly, safe and effective for intended use.

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

Sample Size for Test Set: Not specified. The study involved "insertion of the anchors in a simulated human bone substrate," implying a number of implanted anchors and test cycles, but a specific count is not given.
Data Provenance: Not applicable in the human data sense. The tests were performed in a "simulated human bone substrate," which suggests a lab-based, synthetic or cadaveric bone analog environment, not human patient data. This is a form of prospective bench testing.

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. Ground truth for a biomechanical bench test is typically established by the results of the physical tests (e.g., force at failure, cycles to failure) as measured by calibrated equipment, not by human experts.

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

Not applicable. This concept is relevant for clinical studies or image interpretation, not for biomechanical bench testing.

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

No. This is not an AI/ML device, and no MRMC study was performed.

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

Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the physical device's mechanical properties.

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

The ground truth for this type of device (bone anchor) would be directly measured mechanical properties:
- Ultimate Strength: The maximum force the anchor can withstand before failure or pullout.
- Cyclic Loading Performance: The number of cycles the anchor can endure under specified loads without significant displacement or failure, simulating repetitive physiological stresses.
- These are directly measured physical parameters, not derived from expert opinion or clinical outcomes in the traditional sense.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the AI/ML sense. "Training" for such a device would involve its design, manufacturing processes, and materials science.

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

Not applicable for AI/ML training data. For the device itself, "ground truth" (i.e., meeting design specifications and material properties) would be established through material testing, engineering calculations, and quality control during manufacturing.

Summary

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K110781 (112)

MAY 2 7 2011

510(k) Summary

ArthroCare Corporation Spartan™ PEEK Suture Implant System

General Information

Submitter Name/Address:	ArthroCare Corporation680 Vaqueros AvenueSunnyvale, CA 94085-2936
Establishment Registration Number:	2951580
Contact Person:	Valerie Defiesta-NgDirector, Regulatory Affairs
Date Prepared:	March 18, 2011

Device Description

Trade Name:	ArthroCare Spartan PEEK Suture Implant System
Generic/Common Name:	Screw, Fixation, Bone
Classification Name:	Smooth or Threaded Metallic Bone FixationFastener (21 CFR 888.3040)
Device Classification:	Class II, 21 CFR 888.3040Product Code MBI

Predicate Device

ArthroCare 5.5mm Spartan PEEK SutureImplant System	K110164 (February 7, 2011)
ArthroCare 5.5mm Spartan PEEK SutureImplant System	K102262 (October 21, 2010)

Product Description

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Intended Uses/Indications for Use

The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon reattachment

Substantial Equivalence

In establishing substantial equivalence to the predicate. ArthroCare compared the intended use, device design, technology, and device components of the subject device with the predicate device. Bench performance testing has been completed to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture Implant in accordance with FDA Guidance Document Testing for Bone Anchors. The in vitro testing performed involved insertion of the anchors in a simulated human bone substrate followed by both ultimate strength and cyclic loading tests. The performance testing and device comparison demonstrate that the subject device is substantially equivalent to the predicate device, and is safe and effective for its intended use.

Summary of Safety and Effectiveness

The proposed modifications to the Spartan PEEK Suture Implant System are not substantial changes, and do not significantly affect the safety or efficacy of the proposed device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure with three curved lines representing wings or snakes.

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

ArthoCare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-2936

MAY 2 7 2011

Re: K110781

Trade/Device Name: ArthoCare® Spartan™ PEEK Suture Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 13, 2011 Received: May 16, 2011

Dear Ms. Ng:

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 mav 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

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Page 2 - Ms. Valerie Defiesta-Ng

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

E.Id Keith

for Mark
Director

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

Enclosure

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110781 (111)

Indications for Use

510(k) Number (if known):

Device Name:

ArthroCare® Spartan™ PEEK Suture Implant System

Indications For Use:

The ArthroCare Spartan PEEK Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis, and deltoid repair

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction, and midfoot reconstruction

Foot: Hallux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon reattachment

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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)

Eiel Keitt

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, Division of Son of Societive Devices

K110781
510(k) Number

Page 1 of

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.