Ankle: Mid-foot reconstruction
Foot: Hallux valgus reconstruction
Hand: Ulnar or lateral collateral ligament reconstruction
Wrist: Scapholunate ligament reconstruction

Device Description

The MINILOK QuickAnchor Plus is preloaded disposable Device Description anchor/inserter assembly designed to facilitate the delivery and installation of the MINILOK QuickAnchor Plus into bone.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to complete the requested analysis. The document is a 510(k) summary for a medical device (MINILOK QuickAnchor Plus bone anchor) and focuses on describing the device, its intended use, and its substantial equivalence to predicate devices for regulatory approval.

Here's why I cannot fulfill your request based on the provided text:

No Acceptance Criteria or Device Performance Table: The document does not specify any quantitative acceptance criteria or report specific performance metrics from a study that would demonstrate the device meets those criteria. The only safety information provided is a general statement about "Biocompatibility studies have demonstrated the MINILOK QuickAnchor Plus to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic." This is a qualitative statement, not a performance metric with acceptance criteria.
No Description of a Study for Performance Evaluation: The text does not describe any specific study (clinical trial, bench test with performance endpoints, etc.) that was conducted to prove the device meets performance criteria. The mention of "biocompatibility studies" is the only hint of testing, but no details are given about their methodology, sample size, or results in relation to performance criteria.
Missing Information for AI/Algorithm-Specific Questions:
- The device described (bone anchor) is a physical medical device, not an AI or algorithm-driven product. Therefore, questions related to AI performance, sample sizes for test/training sets, ground truth establishment for algorithms, expert adjudication, MRMC studies, or standalone algorithm performance are not applicable and cannot be answered from this document.

In summary, the provided document is a regulatory submission for a physical medical device, not a performance study report for an AI/algorithmic medical device. Therefore, it lacks all the specific information you've requested regarding acceptance criteria, study details, and AI-related metrics.

Summary

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K030995 pge 1/2

JUN 2 6 2003

SECTION 2 -- 510(k) SUMMARY

MINILOK QuickAnchor Plus

Submitter's Name andAddress:	Mitek Worldwidea division of ETHICON Inc.a Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062
Contact Person	Ruth C. ForstadtSenior Regulatory Affairs AssociateMitek Worldwidea division of ETHICON Inc.a Johnson & Johnson Company249 Vanderbilt AvenueNorwood, MA 02062Telephone: 781-251-3188Facsimile: 781-278-9578e-mail: rcforstad@ethus.jnj.com
Name of Medical Device	Classification Name: Fastener, Fixation, Biodegradable, SoftTissueCommon/Usual Name: Bone AnchorProprietary Name: MINILOK QuickAnchor Plus
Substantial Equivalence	MINILOK QuickAnchor Plus is substantially equivalent to:Mini QuickAnchor Plus (K930892, K992487 and K992623) andMicroFix QuickAnchor Plus (K0224115) manufactured by MitekWorldwide, a division of Ethicon, Inc., a Johnson & JohnsonCompany, 249 Vanderbilt Avenue, Norwood, MA 02062. In addition,the MINILOK QuickAnchor Plus is substantially equivalent to theabsorbable Mini Bio-Anchor, K022234, manufactured by Arthrex,Inc., in Naples, Florida.
Device Classification	Bone anchors/screws are classified by FDA as a Class II MedicalDevices under the generic category of Single/Multiple ComponentMetallic Bone Fixation Appliances, Orthopedic Devices Panel(reference 21 CFR §888.3030). Product code MAI.

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The MINILOK QuickAnchor Plus is preloaded disposable Device Description anchor/inserter assembly designed to facilitate the delivery and installation of the MINILOK QuickAnchor Plus into bone. Indications for Use The MINILOK QuickAnchor Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below: Ankle: Mid-foot reconstruction Foot: Hallux valgus reconstruction Hand: Ulnar or lateral collateral ligament reconstruction Wrist: Scapholunate ligament reconstruction Safety Biocompatibility studies have demonstrated the MINILOK QuickAnchor Plus to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Public Health Service

JUN 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Ruth C. Forstadt Senior Regulatory Affairs Associate Mitek Worldwide 249 Vanderbilt Ave. Norwood, MA 02062

Re: K030995

Trade/Device Name: MINILOK Anchor Plus Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: March 28, 2003 Received: March 31, 2003

Dear Ms. Forstadt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Ruth C. Forstadt

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

R. Mark McMullen

Celia M. Witten, Ph.D., M.D. 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): K610995

Device Name: MINILOK QuickAnchor Plus

Indications for Use:

MINILOK QuickAnchor Plus is intended for fixation of soft tissue to bone, using suture, for the indications listed below:

Ankle: Mid-foot reconstruction Foot: Hallux Valgus reconstruction Hand: Ulnar or lateral collateral ligament reconstruction Wrist: Scapholunate ligament reconstruction

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
or
Over-the-Counter Use No

/ Mark M
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K030995

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.