The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.
Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsulo-labral reconstruction, biceps tenodesis, deltoid repair.
Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.
Foot: Hallux valgus reconstruction.
Wrist: Scapholunate ligament.
Hand: Ulnar or lateral collateral ligament reconstruction.
Elbow: Tennis elbow repair, biceps tendon reattachment.
Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions.

Device Description

The GII QuickAnchor Plus is intended as an upgrade of the current GII Anchor. While retaining the current GII Anchor design, the new system includes enhanced ergonomics, and improved visualization. The product will be offered with both Ethibond and Panacryl suture. The ergonomics are improved by allowing a single-handed operation. In addition, the visualization of the anchor is improved by increasing the length of the inserter shafts. The GII Anchor is a metallic (6A1-4V ELI Titanium base and NiTi Titanium Alloy arcs) and is used to assist in the reattachment of soft tissue to bone. The anchor is identical to the currently marketed Mitek GII Anchor (K915889).

AI/ML Overview

The provided text is a 510(k) summary for the GII QuickAnchor Plus device, which is a bone fixation staple. The primary purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove it meets specific performance criteria through a detailed clinical study with acceptance criteria.

Based on the provided text, there is no detailed information regarding acceptance criteria or specific studies proving the device meets them in the format requested. The submission focuses on demonstrating substantial equivalence to a predicate device (Mitek GII Anchor, K915889).

Here's an analysis of why the requested information isn't available in this document:

Type of Device: The GII QuickAnchor Plus is a bone fixation staple. For this type of device, substantial equivalence often relies on material equivalence, design similarity, and biomechanical testing (demonstrating equivalent strength, pull-out force, etc.), rather than complex clinical studies with human participants and AI assistance.
510(k) Process: A 510(k) notification is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). It generally doesn't require new clinical data unless the technological characteristics differ significantly and raise new questions of safety or effectiveness.
Content of the Document: The document explicitly states: "Based on the type of changes being made and the fact that the GII QuickAnchor Plus represents the same fundamental scientific technology as the existing GII Anchor; Mitek believes the GII QuickAnchor Plus is substantially equivalent to Mitek's existing GII Anchor (K915889)." It also mentions "Biocompatibility studies have demonstrated the GII QuickAnchor Plus Safety to be non-toxic, non-irritating, and non-cytotoxic." This paragraph serves as the equivalent of "proving acceptance criteria" for this type of submission.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided document.

However, I can extract the following relevant information:

Device Type: Staple, Fixation, Bone (21 CFR 888.3030)
Predicate Device: Mitek GII Anchor (K915889)
Basis for Equivalence: Same fundamental scientific technology, design updates for ergonomics and visualization, identical metallic anchor components.
Safety Testing Mentioned: Biocompatibility studies demonstrated the GII QuickAnchor Plus to be non-toxic, non-irritating, and non-cytotoxic.

Regarding the specific questions, here's what can be inferred or stated as not applicable/provided:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantitative performance metrics for a study. The primary "acceptance criterion" for a 510(k) is substantial equivalence to the predicate device in terms of safety and effectiveness.
- Reported Device Performance: The document highlights improvements in ergonomics (single-handed operation) and visualization (increased inserter shaft length) over the predicate, but these are design features, not performance metrics like accuracy, sensitivity, or specificity. Biocompatibility is mentioned as demonstrating non-toxicity, non-irritation, and non-cytotoxicity.
Sample size used for the test set and the data provenance: Not applicable. This document does not describe a test set or clinical study of that nature.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth establishment described for diagnostic performance.
Adjudication method for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used: Not applicable in the context of diagnostic device ground truth. For the biocompatibility studies, the "ground truth" would be the biological response (e.g., cell viability, irritation levels) measured against established safety thresholds.
The sample size for the training set: Not applicable. This is not an AI algorithm.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a medical device (bone fixation staple). It aims to demonstrate substantial equivalence to a predicate device, focusing on material, design, and basic safety (biocompatibility), rather than presenting a performance study with acceptance criteria often associated with diagnostic or AI-powered devices.

Summary

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Image /page/0/Picture/2 description: The image shows a sequence of alphanumeric characters, specifically 'K041115'. The characters are written in a bold, sans-serif font, and they appear to be handwritten. The numbers are clearly distinguishable, and the overall impression is that of a label or identifier.

510(k) Summary – GII QuickAnchor Plus

Submitter's Name andAddress:	DePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062
Contact Person	Allyson BarfordRegulatory Affairs AssociateDePuy Miteka Johnson & Johnson company249 Vanderbilt AvenueNorwood, MA 02062Telephone: 781-251-2794Facsimile: 781-278-9578e-mail: abarford@dpyus.jnj.com
Name of Medical Device	Device Regulation:Staple, Fixation, Bone(21 CFR 888.3030)Product code: MBICommon/Usual Name:Staple, Fixation, BoneProprietary Name:GII Quick Anchor Plus
Device Classification	Staple, Fixation, Bone devices have been classified as Class II, MBIaccording to 21 CFR 888.3030. No performance standards have beenestablished under Section 514 of the Food, Drug and Cosmetic Act forStaple, Fixation, Bone devices.
Indications for Use	The Mitek GII Anchor (QUICKANCHOR) is intended for fixation ofUSP size #2 suture to bone for the indications listed below.Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicularseparation, rotator cuff repair, capsule shift/capsulo-labralreconstruction, biceps tenodesis, deltoid repair.Ankle: Lateral instability, medial instability, achilles tendonrepair/reconstruction, midfoot reconstruction.Foot: Hallux valgus reconstruction.
Special 510(k) Premarket Notification: GII QuickAnchor PlusDePuy Mitek	CONFIDENTIAL

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Wrist: Scapholunate ligament. Hand: Ulnar or lateral collateral ligament reconstruction. Filbow: Tennis elbow repair, biceps tendon reattachment. Knee: Extra capsular repairs; Reattachment of: medial collateral ligament, lateral collateral ligament, posterior oblique ligament or joint capsule to tibia and joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions. The GII QuickAnchor Plus is intended as an upgrade of the current GII Device Description Anchor. While retaining the current GII Anchor design, the new system includes enhanced ergonomics, and improved visualization. The product will be offered with both Ethibond and Panacryl suture. The ergonomics are improved by allowing a single-handed operation. In addition, the visualization of the anchor is improved by increasing the length of the inserter shafts. The GII Anchor is a metallic (6A1-4V ELI Titanium base and NiTi Titanium Alloy arcs) and is used to assist in the reattachment of soft tissue to bone. The anchor is identical to the currently marketed Mitek GII Anchor (K915889). Based on the type of changes being made and the fact that the GII Substantial Equivalence QuickAnchor Plus represents the same fundamental scientific technology as the existing GII Anchor; Mitek believes the GII QuickAnchor Plus is substantially equivalent to Mitek's existing GII Anchor (K915889). Biocompatibility studies have demonstrated the GII QuickAnchor Plus Safety to be non-toxic, non-irritating, and non-cytotoxic.

CONFIDENTIAL

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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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 8 2004

Allyson Barford Regulatory Affairs Associate Depuy Mitek a Johnson & Johnson Company 249 Vanderbilt Avenue Norwood, Massachusetts 02062

Re: K041115 Trade/Device Name: GII QuickAnchor Plus Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JDR Dated: April 6, 2004 Received: April 29, 2004

Dear Ms Barford:

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 10 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, I'DA 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 rcquirements 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.

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Page 2 - Allyson Barford

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter 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 in you attire Office of Compliance at (301) 594-4659. 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 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,

Mark N. Mallekerson

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

041115 510(k) Number (if known):

Device Names

GII QuickAnchor Plus

Indications for Use:

The Mitek GII Anchor (QUICKANCHOR) is intended for fixation of USP size #2 suture to bone for the indications listed below.

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

Ankle: Lateral instability, medial instability, achilles tendon repair/reconstruction, midfoot reconstruction.

Foot: Hallux valgus reconstruction.

Wrist: Scapholunate ligament.

Hand: Ulnar or lateral collateral ligament reconstruction.

Elbow: Tennis elbow repair, biceps tendon reattachment.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use

(Division Sign-Off)

Special 510(k) Premarket Notification: GII Quick DePuy Mitck

510(k) Number K041115

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.