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 1 - Achilles tendon repairs - Midfoot and forefoot repairs - Hallux Valgus reconstruction; Elbow - Ulnar or radial collateral ligament reconstructions - Tennis elbow repair - Biceps tendon reattachment; Knee - Extra-capsular repairs: -Medial collateral ligament Lateral collateral ligament Posterior oblique ligament - Iliotibial band tenodesis - Patellar tendon repair - -VMO advancement - Joint capsule closure; Hand/Wrist - Collateral ligament repair (Gamekeeper's Thumb) - -Scapholunate ligament reconstruction - Tendon transfers in phalanx - Volar plate reconstruction

Device Description

The anchor is cylindrical in shape and is preassembled threaded with USP size 2-0 I he anchor is cynnurear in shape and if production Device holds the anchor and through 2 braided poryester suture. The mass of the sutures can then be used to secure the soft tissue to the bone.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device called the "Multitak Suture System." This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical studies to establish acceptance criteria and performance against those criteria.

Therefore, much of the requested information, specifically regarding detailed acceptance criteria, study methodologies (test set, ground truth, expert involvement, MRMC studies, standalone performance, training set details), and specific performance metrics in numerical terms, is not available in the provided text.

The document primarily focuses on:

Identifying the device and its intended use.
Listing predicate devices.
Stating that performance data was collected (pullout testing).
Concluding that the device is substantially equivalent to predicate devices based on this testing.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
*Not explicitly stated in numerical terms within the document.*	"The Multitak Suture System was compared in pullout testing to the predicate device... the Multitak Suture System demonstrated pullout strength equal to or better than the predicate device(s)."

2. Sample size used for the test set and the data provenance

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "pullout testing," which implies laboratory or bench testing rather than human clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not applicable, as this was likely bench testing, not an expert-driven ground truth assessment.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

Adjudication Method: Not applicable, as this was likely bench testing.

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

MRMC Study: No. This device is a surgical anchor, not an AI-assisted diagnostic tool, so an MRMC study is not relevant or described.

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

Standalone Performance: No, this device is a physical surgical implant, not an algorithm.

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

Type of Ground Truth: For the "pullout testing," the ground truth would inherently be against a quantitative measurement of the mechanical property (pullout strength) of the device itself and its predicate. It's not a clinical "ground truth" derived from patient outcomes or pathology.

8. The sample size for the training set

Sample Size: Not applicable. This device is a physical medical device, not an AI model, and therefore does not have a "training set."

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

Ground Truth Establishment: Not applicable, as there is no training set for this type of device.

Summary of the "Study" (Per the Document):

The document states that the Multitak Suture System underwent pullout testing. The "proof" that it meets acceptance criteria (which are implied to be "equal to or better than the predicate device's pullout strength") is the conclusion that the device "demonstrated pullout strength equal to or better than the predicate device(s)." This is a comparative biomechanical study, not a clinical trial with human subjects. The full details of this testing (e.g., specific test methods, number of samples, statistical analysis) are not provided in this summary.

Summary

{0}------------------------------------------------

I RESEARCH, INC

OCT - 9 1997

1303 evergreen avenue, effingham, illinois 62401 tel. (217) 342-3412 fax (217) 342-6416

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 .

August 8, 1997

Trade Name .

Multitak Suture System

Common Name .

Soft Tissue Anchor

Classification Name .

21 CFR 888.3040, Smooth or Threaded Metallic Bone Fixation Fastener

Predicate Devices .

Multitak SS Suture System, manufactured by Bonutti Research, K934183. .
Multitak SS Suture System, manufactured by Bonutti Research, K964532. ●
Statak Soft Tissue Attachment Device, manufactured by Zimmer, Inc., . Statur 84, cleared November 16, 1993 and K962397, cleared August 27, 1996.

{1}------------------------------------------------

BONUTTI RESEARCH, INC

1303 evergreen avenue, effingham, illinois 62401 tel. (217) 342-3412 fax (217) 342-5416

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 1
Achilles tendon repairs -
Midfoot and forefoot repairs -
Hallux Valgus reconstruction -

Elbow

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

Knee

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

Hand/Wrist

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

{2}------------------------------------------------

NUTTI RESEARCH, INC

1303 evergreen avenue, effingham, illinois 62401 tel. (217) 342-3412 fax (217) 342-6416

Performance Data

The Multitak Suture System was compared in pullout testing to the predicate I he Marinak Sutare System was vellipared sequal to or better than the predicate device(s).

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is composed of three thick, curved lines that form the body and wings, and the overall design is simple and clean.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 9 1997

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

Re: K973015 Multitak SS Suture System™ Trade Name: Requlatory Class: II Product Code: MBI Dated: August 8, 1997 Received: August 13, 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 against 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements 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 begin marketing your device as described in your 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 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 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.gov/cdrh/dsmamain.html".

Sincerely yours,

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 1 of 1

510(k) Number (if known): K973015

Device Name: MULTITAK SUTURE SySTEM

Indications For Use:

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 Patellar tendon repair Rotator cuff tear repairs VMO advancement 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

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)

Concurrence of CDRH, Office of Device Evaluation (ODE) t ﺔ، ﻓ Division of General Restorative Devices 73015 510(k) Number Prescription Use OR Over-The-Counter Use_ (Per 21 CFR 801.109)

(Optional Format 1-2-96)

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.