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 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 is a 510(k) summary for the ArthroCare Corporation Spartan™ PEEK Suture Implant System, outlining its substantial equivalence to a predicate device. It does not describe a study involving AI, human readers, or a test set with ground truth established by experts.

Therefore, many of the requested categories related to acceptance criteria, AI performance, expert adjudication, and ground truth establishment cannot be extracted from this document as they are not present.

However, I can provide the available information regarding the device's performance based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Bench Performance Test)	Reported Device Performance
Ultimate strength testing	Testing completed to demonstrate substantial equivalence to predicate device.
Cyclic loading tests	Testing completed to demonstrate substantial equivalence to predicate device.

Note: The document states "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." It does not provide specific numerical acceptance thresholds or detailed numerical results for the ultimate strength or cyclic loading tests beyond confirming they were performed and supported substantial equivalence.

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. The study described is a bench performance test for a medical device (suture implant), not a study involving a test set of data with human subjects or images.

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 was a physical bench performance test, not a study requiring expert-established ground truth for a test set.

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

Not applicable. This was a physical bench performance test.

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 document does not mention any MRMC study or AI assistance.

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

No. This document does not mention any algorithm or AI performance.

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

The "ground truth" equivalent for this device's performance evaluation was its mechanical behavior (ultimate strength and cyclic loading) in a simulated human bone substrate, compared against the predicate device. This is based on physical testing standards and comparisons.

8. The sample size for the training set

Not applicable. This was a physical bench performance test, not a machine learning study.

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

Not applicable. This was a physical bench performance test, not a machine learning study.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria was a series of bench performance tests. These tests involved:

Insertion of anchors in a simulated human bone substrate.
Ultimate strength testing.
Cyclic loading tests.

The purpose of these tests was to demonstrate the substantial equivalence of the ArthroCare Spartan PEEK Suture Implant to its predicate device (Arthrocare 5.5mm Spartan PEEK Suture Implant System, K102262) in accordance with the "FDA Guidance Document Testing for Bone Anchors." The summary concludes that "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."

The document does not provide specific methodologies, number of samples tested, or detailed quantitative results for these bench tests, but states they were completed and supported the substantial equivalence claim.

Summary

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K 110164 (1/2)

510(k) Summary

FEB - 7 2011

ArthroCare Corporation Spartan™ PEEK Suture Implant System

General Information
Submitter Name/Address:	ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA 94085-2936
Establishment Registration Number:	2951580
Contact Person:	Valerie Defiesta-Ng Director, Regulatory Affairs
Date Prepared:	January 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 Fixation Fastener (21 CFR 888.3040)
Device Classification:	Class II, 21 CFR 888.3040 Product Code MBI
Predicate DeviceArthrocare 5.5mm Spartan PEEK Suture Implant 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 devices, 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

ArthroCare Corporation % Ms. Valerie Defiesta-Ng Director, Regulatory Affairs 680 Vaqueros Avenue Sunnyvale, California 94085-3523

FEB - 7 201

Re: K110164

Trade/Device Name: ArthroCare® Spartan™ PEEK Suture Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: January 18, 2011 Received: January 19, 2011

Dear Mr. Defiesta-Ng:

11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 -

: 上一篇:

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

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Page 2 - Ms. Valerie Defiesta-Ng

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 Patt 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html far the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 3 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/ReportalProblem/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.

https://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely vours.

Aty vs. Rh
for

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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Indications for Use

X 110164 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 X (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)

M. Mulkerson

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K110164

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.