The intended use of the Stryker Wedge Suture Anchor System is for securing soft tissue to bone in such procedures as rotator cuff tear repair, bankart lesion repair, and SLAP lesion repair in the shoulder, as well as achilles tendon repair in the foot/ankle, medial collateral ligament repair in the knee, scapholunate ligament reconstruction in the hand/wrist, and biceps tendon reattachment in the elbow. The Stryker Wedge Suture Anchor system is intended for the fixation of surgical suture material to the pelvis only for the purpose of bladder neck suspension female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency. The suture anchor engages in bone so as to provide a stable bony attachment site for the soft tissue. This device is intended to be used primarily in arthroscopic repairs, but is suitable in open procedure as well, and is intended for single-use only. This device is intended for use only for the fixation of non-absorbable synthetic sutures.

Device Description

Stryker Wedge Suture Anchors are titanium alloy implants used to anchor suture within bone sites for firmly securing soft tissue to bone. The Anchors are self-drilling, self-tapping, threaded devices. The Anchor is supplied with non-absorbable braided polyester suture assembled to a disposable inserter. The sutures are color-coded white and green for visual identification of the individual strands during use.

AI/ML Overview

The provided text describes the Stryker Wedge Suture Anchor System and its comparison to a predicate device, the Arthrex FASTak™ Suture Anchor, to demonstrate substantial equivalence for regulatory approval. The primary study presented focuses on pull-out strength in bone.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical format that must be met. Instead, it demonstrates substantial equivalence to a predicate device, Arthrex FASTak™ Suture Anchor, primarily by comparing pull-out strength in bone. The implication is that if the Stryker device performs similarly or better than the predicate, it meets the "acceptance criterion" of substantial equivalence.

Characteristic / Study Parameter	Acceptance Criteria (Implied by Predicate Performance)	Reported Stryker Wedge Suture Anchor Performance
Pull-out Strength (lbf):
2.4mm Anchor (Arthrex FASTak)	Diaphyseal: 38
	Metaphyseal: 43
	Cancellous: 43
1.9mm Anchor	Greater than or equal to Arthrex 2.4mm anchor	Diaphyseal: 43.5
		Metaphyseal: 51.8
		Cancellous: 40.7 (slightly lower than predicate's 43 for cancellous bone)*
2.7mm Anchor	Greater than or equal to Arthrex 2.4mm anchor	Diaphyseal: 53.9
		Metaphyseal: 47.6
		Cancellous: 49.9
3.4mm Anchor	Greater than or equal to Arthrex 2.4mm anchor	Diaphyseal: 73.7
		Metaphyseal: 72.9
		Cancellous: 74.7
4.5mm Anchor	Greater than or equal to Arthrex 2.4mm anchor	Diaphyseal: 73.6
		Metaphyseal: 72.8
		Cancellous: 75.4
4.9mm Anchor	Greater than or equal to Arthrex 2.4mm anchor	18 pcf foam: 47.6

Note: While 40.7 lbf in cancellous for the 1.9mm anchor is slightly below the predicate's 43 lbf, the device has various sizes, many of which significantly exceed the predicate's strength, supporting overall substantial equivalence. The document does not specify a minimum threshold for substantial equivalence, relying on comparative performance.

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

The document states "Study performed by Barber and Lorang, Plano Orthopedic & Sports Medicine J t Center". It also mentions "Testing performed using 18 pcf density foam block to simulate cancellous bone".

Sample Size for Test Set: Not explicitly stated. The table shows pull-out strength values, but does not specify how many individual tests were performed for each anchor size and bone type.
Data Provenance: The study was performed by "Barber and Lorang, Plano Orthopedic & Sports Medicine J t Center". The text doesn't explicitly state the country of origin, but "Plano" suggests the USA. The data is retrospective in the sense that it refers to previously conducted tests, including a published reference for the predicate device's data ("Barber, M.D., 'Suture Anchor Strength Revisited' Arthroscopy: The Journal of Arthroscopic and Related Surgery, February, 1996.").

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

The concept of "ground truth" established by experts, as typically seen in diagnostic AI studies, does not directly apply here. The "ground truth" for this device's performance is the mechanical pull-out strength, which is an objective measurement obtained through physical testing, not expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. This is a physical mechanical test, not reliant on human interpretation or adjudication.

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

Not applicable. This is a medical device (suture anchor), not an AI-powered diagnostic or interpretive tool. There are no "human readers" or "AI assistance" involved in its direct function.

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

Not applicable. This is a physical medical device.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is objective physical measurement of pull-out strength in bone (or simulated bone). This is a direct measure of the device's mechanical performance.

8. The Sample Size for the Training Set

Not applicable. This document describes a physical medical device, not a machine learning algorithm. Therefore, there is no "training set."

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

Not applicable. As there's no training set for an algorithm, there's no ground truth established for it.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Stryker Endoscopy. The word "stryker" is written in a bold, sans-serif font, with the "s" and "t" connected. A registered trademark symbol is located to the right of the word "stryker". Below "stryker" is the word "ENDOSCOPY" in a smaller, sans-serif font.

2590 Walsh Avenue Santa Clara, CA 95054 Phone: (408) 567-9100 x2228 Fax: (408) 567-2507

Todd Miller

October 8, 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

Device Name:

Classification Name:	Smooth or Threaded Metallic Bone Fixation Fasteners:CFR 888.3040, Class II
Device Product Code:	Panel Code 87, Orthopedic Devices, MBI
Common and Usual Name:	Fastener, Fixation, Non-degradable, Soft Tissue(87MBI)
Proprietary Name:	Stryker Wedge Suture Anchor System
Regulatory Classification:	Class II

Safety and Effectiveness Summary:

This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.

The Stryker Wedge Suture Anchor System is intended for use in securing soft tissue to bone in such procedures as rotator cuff tear repair, bankart lesion repair, and SLAP lesion repair in the shoulder, as well as achilles tendon repair in the foot/ankle, medial collateral ligament repair in the knee, scapholunate ligament reconstruction in the hand/wrist, and biceps tendon reattachment in the elbow. The Stryker Wedge Suture Anchor system is intended for the fixation of surgical suture material to the pelvis only for the purpose of bladder neck suspension female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency. The Stryker Wedge Suture Anchor System is equivalent in intended use, safety and effectiveness to other fixation devices in commercial distribution. The Stryker Wedge Suture Anchor System will be provided sterile for single-use applications (ASTM 4169). This device will be sterilized by Gamma irradiation and validated (AAMI ST32) to a sterility assurance level (SAL) of 10-6. The material of construction and its overall design are equivalent to currently marketed products. The device materials are biocompatible per ASTM F136 and ISO-10993.

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The anchor system does not raise any new safety and efficacy concerns when compared to other devices currently on the market. Therefore, the Stryker Wedge Suture Anchor System is substantially equivalent to other suture anchor devices.

The Stryker Wedge Suture Anchor System is substantially equivalent to the Arthrex FASTak™ Suture Anchor, marketed under 510(k) K960516, in the following fields:

� Intended use
Material .

Geometry ◆
. Thread design
. Head design
Eyelet design �
. Operational principles
Indications & Contraindications ●

See Table 1 and Table 2 for comparison of anchor systems.

TABLE 1 Comparison of Stryker Wedge Suture Anchor System to Arthrex FASTak Suture Anchor

COMPANY	Stryker	Arthrex
TRADE NAME	Stryker Wedge Suture AnchorSystem	Arthrex FASTak™ SutureAnchor
INTENDED USE	Soft tissue fixation to bone	Soft tissue fixation to bone
MATERIAL	Titanium(Ti 6Al 4V)	Titanium(Ti 6Al 4V)
DESIGN:
1. Body geometry	Wedge shaped or tapered	Cylindrical then tapered
2. Thread design	Spiral	Spiral
3. Driving headdesign	Standard hexagonal	Standard hexagonal
4. Suture eyeletdesign	Large, round, smooth	Large, round, smooth
5. Diameters (mm)	1.92.73.44.54.9	2.4
6. Lengths (mm)	811141613.6	11.7
OPERATIONALPRINCIPLES	Provide stable fixation of softtissue to bone; simple anchorinsertion technique	Provide stable fixation of softtissue to bone; simple anchorinsertion technique
INDICATIONS &CONTRAINDICATIONS	See Users Insert (Tab B)	same
STERILIZATION	Gamma Radiation	EtO, Gamma Radiation

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Company/Device	Size (mm)	Insertion	Failure Strength (lbf)
Stryker WedgeSuture Anchor	1.9	Screw in	Diaphyseal: 43.5 *Metaphyseal: 51.8Cancellous: 40.7
Stryker WedgeSuture Anchor	2.7	Screw in	Diaphyseal: 53.9 *Metaphyseal: 47.6Cancellous: 49.9
Stryker WedgeSuture Anchor	3.4	Screw in	Diaphyseal: 73.7 *Metaphyseal: 72.9Cancellous: 74.7
Stryker WedgeSuture Anchor	4.5	Screw in	Diaphyseal: 73.6 *Metaphyseal: 72.8Cancellous: 75.4
Stryker WedgeSuture Anchor	4.9	Screw in	18 pcf foam: 47.6**
Arthrex FASTakK960516	2.4	Screw in	Diaphyseal: 38 ***Metaphyseal: 43Cancellous: 43

TABLE 2 Comparison of Anchor Pull-out Strength in Bone

Study performed by Barber and Lorang, Plano Orthopedic & Sports Medicine J t Center

Testing performed using 18 pcf density foam block to simulate cancellous bone **

*** Barber, M.D., "Suture Anchor Strength Revisited" Arthroscopy: The Journal of Arthroscopic and Related Surgery,
February, 1996.

Todd Miller Design Engineer

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, and is often used as a symbol of medicine. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the caduceus symbol.

DEC 1 8 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Todd Miller Design Engineer Stryker Endoscopy 2590 Walsh Avenue 95054 Santa Clara, California

Re: K983557 Styker Wedge Suture Anchor System Requlatory Class: II Product Codes: MBI and GAT Dated: October 8, 1998 Received: October 13, 1998

Dear Mr. Miller:

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. ದ 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 requlation 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 - Mr. Todd Miller

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberious in four alone of your device to a legally marketed predicate device results in a classification for your markets predicate and the 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 che promocron and (301) 594-4639. Also, please note the Orice Of Compiland. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be rhroimation 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

510(k) Number (if known): _ 9 8 3 5 5 7

Device Name: Stryker Wedge Suture Anchor System

Indications For Use:

The intended use of the Stryker Wedge Suture Anchor System is for securing soft tissue to bone in such procedures as rotator cuff tear repair, bankart lesion repair, and SLAP lesion repair in the shoulder, as well as achilles tendon repair in the foot/ankle, medial collateral ligament repair in the knee, scapholunate ligament reconstruction in the hand/wrist, and biceps tendon reattachment in the elbow. The Stryker Wedge Suture Anchor system is intended for the fixation of surgical suture material to the pelvis only for the purpose of bladder neck suspension female urinary incontinence due to urethral hyper mobility or intrinsic sphincter deficiency. The suture anchor engages in bone so as to provide a stable bony attachment site for the soft tissue. This device is intended to be used primarily in arthroscopic repairs, but is suitable in open procedure as well, and is intended for single-use only. This device is infended for use only for the fixation of non-absorbable synthetic sutures.

(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 Devices
510(k) Number. K983557

Prescription Use_	X
(Per 21 CFR 801.109)

Over-The-Counter Use

Regulation Number and Section

N/A