The Stryker ProCinch Adjustable Loop Fixation Device is intended for the fixation of bone-to-bone or soft tissue-to-bone as fixation posts, a distribution bridge, or for distributing suture tension during Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.

Device Description

The Stryker ProCinch Adjustable Loop Device is a cortical suspensory fixation implant that consists of an adjustable nonabsorbable suture loop assembled to a titanium button. The device is offered in two configurations. Standard Tensioning and Reverse Tensioning.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Stryker ProCinch Adjustable Loop Device." The document focuses on establishing substantial equivalence to a predicate device through non-clinical bench testing. It does not contain information about acceptance criteria or a study proving device performance in the manner typically associated with clinical studies involving AI or imaging devices.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here's a breakdown of what can be extracted:

A table of acceptance criteria and the reported device performance

Acceptance Criteria Reported Device Performance
Not specified "Statistically equivalent or better than the predicate device" in Cyclic Extension and Ultimate Tensile Strength after cyclic loading.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the bench testing.
- Data Provenance: Not applicable as this was "Non-clinical bench testing."
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)
- Not applicable; "Clinical testing was not required." The ground truth was established through engineering tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable; "Clinical testing was not required."
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
- No. This is a physical orthopedic device, not an AI or imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable; this is a physical orthopedic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth: Engineering measurements (Cyclic Extension, Ultimate Tensile Strength) against a predicate device.
The sample size for the training set
- Not applicable; this is non-clinical bench testing, not an AI model requiring a training set.
How the ground truth for the training set was established
- Not applicable; this is non-clinical bench testing, not an AI model requiring a training set.

Acceptance Criteria	Reported Device Performance
Not specified	"Statistically equivalent or better than the predicate device" in Cyclic Extension and Ultimate Tensile Strength after cyclic loading.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2015

Stryker Endoscopy Ms. Kelly Kucharczyk Associate Manager, Regulatory Affairs 5900 Optical Court San Jose, California 95138

Re: K150416

Trade/Device Name: ProCinch Adjustable Loop Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY Dated: February 19, 2015 Received: February 20, 2015

Dear Ms. Kucharczyk:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kelly Kucharczyk

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K150416

The Stryker ProCinch Adjustable Loop Fixation Device is intended for the fixation of bone-tobone or soft tissue-to-bone as fixation posts, a distribution bridge, or for distributing suture tension during Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.

Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

I. SUBMITTER

Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138

Contact Person: Kelly Kucharczyk, RAC Associate Manager, Regulatory Affairs

Date Prepared: April 16, 2015

Phone: 810-813-4672 Fax: 303-993-6195

II. DEVICE

Name of Device: Stryker ProCinch Adjustable Loop Device (Models: Standard Tensioning, Reverse Tensioning)
Common Name: Pin, Fixation, Smooth
Classification Name: Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040
Regulatory Class: II
HTY Product Code:

III. PREDICATE DEVICE

Arthrex ACL TightRope, K112990

This predicate has not been reported by the manufacturer as being subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

Stryker Endoscopy is introducing the Stryker ProCinch Adjustable Loop device for use in orthopedic applications. The Stryker ProCinch Adjustable Loop Device is a cortical suspensory fixation implant that consists of an adjustable nonabsorbable suture loop assembled to a titanium button. The device is offered in two configurations. Standard Tensioning and Reverse Tensioning.

V. INDICATIONS FOR USE

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Stryker ProCinch Adjustable Loop Fixation Device is substantially equivalent to other commercially available cortical suspension fixation devices in regard to intended use, design, materials of construct, performance attributes, and operational principles. The Arthrex ACL TightRope Device has been identified as an appropriate predicate.

VII. PERFORMANCE DATA

Non-clinical bench testing was performed to verify the efficacy of the Stryker ProCinch Adjustable Loop Device as compared to the predicate. This testing included Cyclic Extension and Ultimate Tensile Strength after cyclic loading. The results of this testing verified that the subject device performs statistically equivalent or better than the predicate device. Clinical testing was not required to demonstrate substantial equivalence for this submission.

VIII. CONCLUSIONS

The information presented within this traditional premarket submission demonstrate that the Stryker ProCinch Adjustable Loop Device is substantially equivalent to the predicate device and should perform as designed within its intended use.

Regulation Number and Section

N/A