Rotator Cuff Quickanchor Plus (with ORTHOCORD) is a preloaded metallic disposable suture anchor/ inserter assembly designed to allow soft tissue repair to bone. The metal anchor is an identical anchor as that of the Rotator Cuff Quickanchor Plus in design, configuration and dimensions. The anchor system may be sold with Ethibond Suture dimensions. (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

AI/ML Overview

The provided text is a 510(k) summary for the "Rotator Cuff Quickanchor Plus" device. It describes a suture anchor system used for rotator cuff repair. However, it does not include a study that proves the device meets specific acceptance criteria in the way described in your request (i.e., with reported device performance alongside acceptance criteria, detailed sample sizes, expert involvement, etc.).

Instead, the document states:

"The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria."

This indicates that some bench testing was done against "predetermined acceptance criteria" for suture compatibility and deployment, and that the ORTHOCORD suture conformed to a USP monograph. However, the document does not provide the specific acceptance criteria themselves, nor does it detail the results of this bench testing beyond a general statement of conformance.

Therefore, I cannot fulfill your request to create a table of acceptance criteria and reported device performance, or provide details about sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance, as this information is not present in the provided text.

The document primarily focuses on establishing substantial equivalence to a predicate device (Rotator Cuff Quickanchor Plus, K992611) manufactured by the same company, based on design, configuration, and intended use, rather than presenting a performance study with detailed acceptance criteria and results.

Summary

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K052630 p/2

OCT 1 7 2005

510(k) SUMMARY

Rotator Cuff Quickanchor Plus

Submitter's Name andAddress:	DePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062
Contact Person	Denise LucianoSenior Regulatory Affairs SpecialistDePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062Telephone:781-251-2794Facsimile:781-278-9578e-mail:dluciano@depuy.jnj.com
Name of Medical Device	Classification Name:Screw, Fixation, Bone Staple
	Common Usual Name:Smooth or threaded metallic bone fixationfastener
	Proprietary Name:Rotator Cuff Quickanchor Plus
Substantial Equivalence	Rotator Cuff Quickanchor Plus (with ORTHOCORD) is substantiallyequivalent to:Rotator Cuff Quickanchor Plus, K992611, manufactured by DePuyMitek.
Device Classification	Bone anchors/screws are classified by the FDA as Class II MedicalDevices under the generic category of Smooth or threaded metallicbone fixation fasteners.
	Rotator Cuff Quickanchor Plus carry FDA product code HWC, and isclassified as a fixation fastener under 21 CFR 888.3040.
Device Description	Rotator Cuff Quickanchor Plus (with ORTHOCORD) is a preloadedmetallic disposable suture anchor/ inserter assembly designed to allowsoft tissue repair to bone. The metal anchor is an identical anchor asthat of the Rotator Cuff Quickanchor Plus in design, configuration and
510(k) Premarket Notification: SpecialRotator Cuff Quickanchor Plus	Confidential

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5263

The anchor system may be sold with Ethibond Suture dimensions. (NDA 17-804 and 17-809), Panacryl Suture (K964345), or Orthocord Suture (K040004 and K043298).

Indications for Use

The Mitek Rotator Cuff QuickAnchor" Plus is indicated for Rotator cuff repair.

Safety and Performance

The determination of substantial equivalence for this device was based on a detailed device description, and conformance to consensus and voluntary standards. Bench testing was performed demonstrating that the ORTHOCORD suture conformed to the USP monograph for absorbable sutures, and the suture compatibility and deployment met predetermined acceptance criteria.

Based on the indications for use, technological characteristics, and comparison to predicate devices, the Rotator Cuff Quickanchor Plus has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

510(k) Premarket Notification: Special
Rotator Cuff Quickanchor Plus

Confidential

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing movement or connection.

OCT 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Denise Luciano Senior Regulatory Affairs Specialist DePuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K052630

Trade/Device Name: Rotator Cuff Quickanchor Plus Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: September 23, 2005 Received: September 26, 2005

Dear Ms. Luciano:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave roviewed your 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 for assumer to May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner to rial to 1125 2011 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 r ou mays arouse provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your de rice to such additional controls. Existing major regulations affecting your device can may or subject to data are are a 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or A rate 80 7) its extens (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.

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Page 2-Denise Luciano

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to ough maning of substantial equivalence of your device to a legally prematics notification: "The a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice 101 your as (240) 276-0120. Also, please note the regulation entitled, Comacs the Office of Compullier and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, international and Octess http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

SaMark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤ ≤

Device Names: Rotator Cuff Quickanchor Plus

Indications for Use:

The Mitek Rotator Cuff QuickAnchor® Plus is indicated for Rotator cuff repair.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number_________________________________________________________________________________________________________________________________________________________________

510(k) Premarket Notification: Special Rotator Cuff Quickanchor Plus

Confidential

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.