The Multitak Suture System is intended for soft tissue to bone suture fixation for the following indications: Knee Shoulder Extra-capsular repairs: Bankart lesion repairs Medial collateral ligament S.L.A.P. lesion repairs Lateral collateral ligament Acromio-clavicular repairs Posterior oblique ligament Capsular shift/capsulolabral reconstruction Iliotibial band tenodesis Deltoid repair Rotator cuff tear repairs Biceps tenodesis Foot and Ankle Medial/lateral repairs, reconstructions Achilles tendon repairs (Gamekeeper's Thumb) Midfoot and forefoot repairs Hallux valgus reconstruction Elbow Ulnar or radial collateral ligament reconstructions Tennis elbow repair Biceps tendon reattachment Patellar tendon repair VMO advancement Joint capsule closure Hand/Wrist Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction

Device Description

The anchor is tubular in shape and is preassembled threaded with USP size 2-0 through 2 braided polyester suture. An Introduction Device holds the anchor and delivers it into the bone through a predrilled hole. The sutures can then be used to secure the soft tissue to the bone.

AI/ML Overview

The provided text describes the "Multitak Suture System" and its intended use, but it does not contain acceptance criteria or a detailed study that proves the device meets specific performance criteria. The "Performance Data" section is very brief and general.

Here's an analysis of the information that is available, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not Explicitly Stated: The document does not define specific quantitative acceptance criteria (e.g., minimum pullout strength in Newtons, insertion force limits).	"found to demonstrate pullout strengths superior to those of a suture only reattachment technique."
Not Explicitly Stated: The document does not define specific quantitative acceptance criteria for insertion and locking.	"Insertion testing was performed to verify insertion and locking at all indicated sites."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The study appears to be a laboratory-based biomechanical test.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" here relates to biomechanical performance (pullout strength, insertion), not expert interpretation of medical images or clinical outcomes. The study was a laboratory-based mechanical test.

4. Adjudication Method for the Test Set

Not applicable. This was a laboratory mechanical test, not a study requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a MRMC comparative effectiveness study was not done. The study described is a laboratory-based mechanical test comparing the device to a "suture only reattachment technique."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device (suture anchor), not an algorithm or AI system.

7. The Type of Ground Truth Used

Biomechanical Measurements: The ground truth was established through direct physical measurements of pullout strength and verification of insertion and locking mechanisms in a laboratory setting. This is a form of engineered or physical ground truth, not pathology, expert consensus, or outcomes data.

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of What's Missing and Why:

The provided document is a 510(k) summary for a medical device (a suture anchor system). These summaries typically focus on demonstrating substantial equivalence to predicate devices, rather than providing the detailed technical and statistical results of comprehensive clinical or AI performance studies.

Specifically, for the "Performance Data" section:

It states that the device was "compared in pullout testing to the predicate device" and "found to demonstrate pullout strengths superior to those of a suture only reattachment technique." However, it does not provide:
- Specific quantitative pullout strength values for the device or the comparator.
- Statistical significance testing details (e.g., p-values, confidence intervals).
- The type of material used for testing (e.g., cadaver bone, synthetic bone).
- The number of samples tested (sample size).
It states "Insertion testing was performed to verify insertion and locking at all indicated sites." Again, no specific data, methodology, or acceptance criteria are given.

Therefore, while the document confirms performance testing was done, it lacks the detailed information required to fully answer many of your questions, particularly regarding specific numerical acceptance criteria, sample sizes, and detailed performance metrics.

Summary

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K97 11414 JUN 25 1997

Summary of Safety and Effectiveness Multitak Suture System™

Submitted by

Bonutti Research, Inc. 1303 Evergreen Ave. Effingham, IL 62401

Prepared by

Lynnette Whitaker Director Regulatory Affairs/Quality Assurance

Date
June 24, 1997

Trade Name .

Multitak Suture System

Common Name .

Soft Tissue Anchor

Classification Name t

21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener

Predicate Devices

Multitak SS Suture System, manufactured by Bonutti Research, K934183. .
GII Anchor System, manufactured by Mitek Surgical Products, Inc., . K953877.
Mini QuickAnchor, manufactured by Mitek Surgical Products, Inc., . K930892 and K904436.
Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., . K926384, cleared November 16, 1993 and K962397, cleared August 27, 1996.

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Device Description

Intended Use

The devices are intended for soft tissue to bone suture fixation for the following indications:

Shoulder

Bankart lesion repairs .
S.L.A.P. lesion repairs .
Acromio-clavicular Repairs .
-Capsular Shift/Capsulolabral Reconstruction
Deltoid Repair .
Rotator cuff tear repairs -
-Biceps tenodesis

Foot and Ankle

Medial/lateral repairs, reconstructions
Achilles tendon repairs ・
Midfoot and forefoot repairs ﻪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
ﮯ Hallux Valgus reconstruction

Elbow

•

Ulnar or radial collateral ligament reconstructions -
-Tennis elbow repair
ー Biceps tendon reattachment

Knee

Extra-capsular repairs:
- Medial collateral-ligament--------------------------------------
- Lateral collateral ligament
- Posterior oblique ligament
Iliotibial band tenodesis *
-Patellar tendon repair ... ...................................................................................................................................................
VMO advancement -
ﻪ Joint capsule closure

Hand/Wrist

. Collateral ligament repair (Gamekeeper's Thumb)
2
Scapholunate ligament reconstruction
Tendon transfers in phalanx
Volar plate reconstruction

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Performance Data

The Multitak Suture System was compared in pullout testing to the predicate device and found to demonstrate pullout strengths superior to those of a suture only reattachment technique. Insertion testing was performed to verify insertion and locking at all indicated sites.

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Image /page/3/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 its wings spread, surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement. The eagle is a prominent symbol, representing the department's role in protecting and promoting the health and well-being of the nation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lynnette Whitaker, RAC Director, Regulatory Affairs/Quality Assurance Bonutti Research, Inc. 1303 Evergreen Avenue Effingham, Illinois 62401

JIN 2 5 1397

K971144 Re : Multitak SS Suture System® Regulatory Class: II Product Codes: MBI and HWC Dated: March 27, 1997 Received: March 28, 1997

Dear Ms. Whitaker:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Lynnette Whitaker, RAC

This letter will allow you to beqin marketinq your device as described in your 510(k) premarket notification. The FDA findinq 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html".

Sincerely yours,

Marie Schroeder, MS, PT

for

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices

Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known):_

Device Name: MULTITAK SUTURE SysTEM

Indications For Use:

Rotator cuff tear repairs Biceps tenodesis

Foot and Ankle Medial/lateral repairs, reconstructions Achilles tendon repairs (Gamekeeper's Thumb) Midfoot and forefoot repairs Hallux valgus reconstruction

Elbow Ulnar or radial collateral ligament reconstructions Tennis elbow repair Biceps tendon reattachment

Patellar tendon repair VMO advancement Joint capsule closure

Hand/Wrist

Collateral ligament repair Scapholunate ligament reconstruction Tendon transfers in phalanx Volar plate reconstruction

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

oncurrence of CDRH, Office of Device Evaluation (ODE)

Marie H. Schroeder, MS PT fa rmu.

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971144

Prescription Use
(Per 21 CFR 801.109)

ರಿಗ

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

N/A