The Stryker Intraline Anchor is a soft tissue anchor which will be used for tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis. The anchor is intended for use in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift/Capsulolabral Reconstruction. Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis. Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction. Pelvis: Bladder Neck Suspension Procedures. The Stryker Soft Eyelet RC Anchor is intended for single-use only.

Device Description

Each configuration of the Stryker Intraline Anchor Family is a screw-in anchor that is pre-threaded with nonabsorbable USP braided ultra high molecular weight polyethylene (UHMWPE) suture (K033654, K040472 and K063778) and pre-assembled on a disposable inserter. The Stryker PEEK Intraline Anchor will be manufactured from PEEK-OPTIMA® (polyetheretherketone). The Stryker Titanium Intraline Anchor will be manufactured from titanium alloy Ti 6Al 4V EL1. The Stryker Intraline Anchor Family will be validated to a SAL of 10th using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7.

AI/ML Overview

The provided document is a 510(k) Summary for the Stryker Intraline Anchor, a medical device for tissue fixation to bone. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing a detailed study that proves the device meets specific performance acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and performance study specifics is not available in this document.

However, I can extract what is implied and stated regarding equivalence and the basis for approval.

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

1. A table of acceptance criteria and the reported device performance

Based on the document, direct quantitative acceptance criteria and reported device performance are not explicitly stated in a table format. The approval is based on "substantial equivalence" to a predicate device. The general acceptance criteria are implied to be that the device performs equivalently to the predicate and meets relevant safety and performance standards.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence in:	The device is considered substantially equivalent to the Arthrex 5.5mm PEEK Corkscrew FT (K061665) in:
- Performance	- Performance (Stryker PEEK & Titanium Intraline Anchor)
- Material composition	- Material composition (Stryker PEEK Intraline Anchor)
- Intended use	- Intended use (Stryker PEEK & Titanium Intraline Anchor)
- Safety	- Safety (Stryker PEEK & Titanium Intraline Anchor)
- Efficacy	- Efficacy (Stryker PEEK & Titanium Intraline Anchor)
Validation to a sterility assurance level (SAL) of $10^{-6}$ using ethylene oxide.	The Stryker Intraline Anchor Family will be validated to a SAL of $10^{-6}$ using ethylene oxide.
Ethylene oxide (EtO) residuals tested according to ISO 10993-7.	The EtO residuals will be tested according to ISO 10993-7.
Conformity to voluntary safety and performance standards (listed below).	Prior to market, devices will conform to: ISO 10993-1, Blue Book Memorandum G95-1, EN 550-1, EN 11607-1, EN 11607-2, EN 980, EN 1041, and EN ISO 14971.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided 510(k) summary. The document does not describe a specific clinical or performance test set with a sample size. The approval is based on equivalence to an already approved device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available. No specific "test set" and thus no experts for establishing ground truth are detailed in this regulatory summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available. No specific test set or adjudication method is described.

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

This is not applicable. The device is an orthopedic surgical anchor, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

This is not applicable. The device is a surgical implant, not an algorithm.

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

This information is not available. As no specific study with a "test set" and a defined ground truth is presented, this cannot be determined from the document. The "ground truth" for regulatory approval in this context is the safety and effectiveness of the predicate device to which the new device is compared.

8. The sample size for the training set

This information is not applicable. The device is a physical surgical implant, not a machine learning algorithm that requires a training set.

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

This information is not applicable. As above, this is not relevant for this type of device.

Summary

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K071157 page 1 of 2

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5900 Optical Ct San Jose, CA 95138 t: 408 754 2124 f: 408 754 2914 jeff.semone@stryker.com

Endoscopy

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

SEP 1 7 2007

Date: April 2, 2007

Contact Person:

K Jeffrey Semone Director, Regulatory Affairs 408-754-2124(phone) 408-754-2521 (fax) jeff.semone@stryker.com

Device Name:

Proprietary Names:	Stryker PEEK Intraline Anchor
	Stryker Titanium Intraline Anchor
Common and Usual Names:	Soft Eyelet Anchor
	PEEK Soft Eyelet Anchor
	Titanium Soft Eyelet Anchor
Classification Name:	Screw, Fastener, Fixation, Nonabsorbable, Bone, Soft Tissue
	(Class II, 21 CFR 888.3040, Product Code MBI, Orthopedics
	Review Panel)

Predicate Devices:

Arthrex 5.5mm PEEK Corkscrew FT: #K061665

Device Description and Intended Use:

The Stryker Intraline Anchors are soft tissue anchors which will be used for tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis. The anchors are intended for use in the following procedures:

This space is intentionally left blank

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Shoulder:

Rotator Cuff Repair
Bankart Repair
SLAP Lesion Repair
Biceps Tenodesis ■
י Acromio-Clavicular Separation Repair
Deltoid Repair
Capsular Shift/Capsulolabral Reconstruction.

Foot and Ankle:

Lateral Stabilization
. Medial Stabilization
Achilles Tendon Repair
Hallux Valgus Reconstruction
Midfoot Reconstruction
Metatarsal Ligament Repair.

Knee:

Anterior Cruciate Ligament Repair
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
. Patellar Tendon Repair
Posterior Oblique Ligament Repair
Illiotibial Band Tenodesis

Hand and Wrist:

Scapholunate Ligament Reconstruction
Ulnar Collateral Ligament Reconstruction .
Radial Collateral Ligament Reconstruction

Elbow

Biceps Tendon Reattachment
Ulnar or Radial Collateral Ligament Reconstruction

Pelvis:

Bladder Neck Suspension Procedures
Each configuration of the Stryker Intraline Anchor Family is a screw-in anchor that is pre-threaded with nonabsorbable USP braided ultra high molecular weight polyethylene (UHMWPE) suture (K033654, K040472 and K063778) and pre-assembled on a disposable inserter. The Stryker PEEK Intraline Anchor will be manufactured from PEEK-OPTIMA® (polyetheretherketone). The Stryker Titanium Intraline Anchor will be manufactured from titanium alloy Ti 6Al 4V EL1 The Stryker Intraline Anchor Family will be validated to a SAL of 10th using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7.

Prior to introducing the Stryker Intraline Anchor Family to market, the devices will conform to the following voluntary safety and performance standards: ISO 10993-1, Blue Book Memorandum G95-1, EN 550-1, EN 11607-1, EN 11607-2, EN 980, EN 1041, and EN ISO 14971.

The Stryker PEEK and Intraline Anchor is considered substantially equivalent in performance, material composition, intended use, safety, and efficacy to the Arthrex PEEK Corkscrew FT.

The Stryker Titanium Intraline Anchor is considered substantially equivalent in performance, intended use, safety, and efficacy to the Arthrex PEEK Corkscrew FT.

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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 stylized caduceus symbol, which is a staff with two snakes entwined around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Endoscopy c/o Mr. K. Jeffrey Semone Director, Regulatory Affairs 5900 Optical Court San Jose, CA 95138

SEP 17 2007

Re: K071157

Trade/Device Name: Stryker PEEK and Titanium Intraline Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, JDR, MBI Dated: August 20, 2007 Received: August 22, 2007

Dear Mr. Semone:

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 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 - Mr. K. Jeffrey Semone

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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buchr

Mark N. Melkerson 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

Device Name: Stryker Intraline Anchor

510(k) Number if known: K071157

Hand and Wrist:

Elbow

Pelvis:

Scapholunate Ligament Reconstruction

Bladder Neck Suspension Procedures.

Biceps Tendon Reattachment

Ulnar Collateral Ligament Reconstruction Radial Collateral Ligament Reconstruction

Ulnar or Radial Collateral Ligament Reconstruction

Shoulder:

Rotator Cuff Repair
Bankari Repair
SLAP Lesion Repair
Biceps Tenodesis
Acromio-Clavicular Separation Repair
Deltoid Repair
Capsular Shift/Capsulolabral Reconstruction.

Foot and Ankle:

Lateral Stabilization
Medial Stabilization
Achilles Tendon Repair
Hallux Valgus Reconstruction
Midfoot Reconstruction
Metatarsal Ligament Repair.

Knee:

Anterior Cruciate Ligament Repair
Medial Collateral Ligament Repair
Lateral Collateral Ligament Repair
Patellar Tendon Repair
Posterior Oblique Ligament Repair
Illiotibial Band Tenodesis

The Stryker Soft Eyelet RC Anchor is intended for single-use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter AND/OR (21 CFR 801 Subpart C)

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Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Houban Buchnd

Division of General. Restorative. and Neurological Devices

510(k) Number K071157

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.