SHOULDER: Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs Biceps tenodesis

FOOT & ANKLE: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy

ELBOW, WRIST, & HAND: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair

KNEE: Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterioroblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Iliotiblal band tenodesis

Device Description

The CinchLock Flex Knotless Suture Anchor is a non-degradable PEEK suture anchor that is pre-assembled to a stainless steel inserter. Non-degradable Ultra High Molecular Weight Polyethylene (UHMWPE) suture is provided within the sterile package with the Knotless Suture Anchor and Inserter. The CinchLock Flex Knotless Suture Anchor with Inserter and Suture is provided as a sterile single use device.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "CinchLock Flex Knotless Suture Anchor." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the manner you've outlined for algorithms or diagnostic tools.

Therefore, much of the information you requested (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) is not applicable to this type of regulatory submission. This document describes the device, its intended use, and then asserts substantial equivalence based on non-clinical verification and validation testing.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific numerical acceptance criteria with corresponding performance data in the typical sense for algorithms. Instead, the performance is evaluated by "non-clinical verification and validation testing" demonstrating equivalence to the predicate device. The general acceptance criterion is that the subject device performs at least as well as or similarly to the predicate device for various mechanical properties and safety aspects.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Insertion Strength of the CinchLock Flex Knotless Suture Anchor is comparable to the predicate.	Verified to be substantially equivalent to the predicate.
Anchor Coupling Strength of the CinchLock Flex Knotless Suture Anchor is comparable to the predicate.	Verified to be substantially equivalent to the predicate.
Ultimate Tensile Strength of the CinchLock Flex Knotless Suture Anchor is comparable to the predicate.	Verified to be substantially equivalent to the predicate.
Anchor Cinch Force of the CinchLock Flex Knotless Suture Anchor is comparable to the predicate.	Verified to be substantially equivalent to the predicate.
Inserter Moment Testing results for the CinchLock Flex Knotless Suture Anchor are comparable to the predicate.	Verified to be substantially equivalent to the predicate.
Design Validation demonstrates the CinchLock Flex Knotless Suture Anchor meets design requirements and intended use.	Verified to be substantially equivalent to the predicate.
Packaging Validation ensures the integrity and sterility of the CinchLock Flex Knotless Suture Anchor.	Verified to be substantially equivalent to the predicate.
Sterilization Validation confirms the CinchLock Flex Knotless Suture Anchor is sterile.	Verified to be substantially equivalent to the predicate.
Shelf Life/Stability Validation ensures the device maintains its properties over its shelf life.	Verified to be substantially equivalent to the predicate.
Biological Safety Assessment confirms no new safety concerns for the CinchLock Flex Knotless Suture Anchor compared to the predicate material.	Verified to be substantially equivalent to the predicate; no changes to implantable material, other materials equivalent.

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

Sample Size: Not explicitly stated as "test set" in the context of an algorithm. The non-clinical verification and validation testing would have involved a sufficient number of device samples to ensure statistically sound results for mechanical and other tests. Specific numbers are not detailed in this summary document.
Data Provenance: The tests are described as "non-clinical verification and validation testing." This typically means laboratory bench testing, simulations, and material characterization performed by the manufacturer (Pivot Medical). It's not human clinical data or retrospective/prospective patient data.

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

Not Applicable. This is a mechanical device, not a diagnostic algorithm requiring expert interpretation to establish ground truth. The "ground truth" for the mechanical tests would be established by standardized testing methods and measurement instruments, comparing the results to established norms or the predicate device's performance.

4. Adjudication Method for the Test Set:

Not Applicable. No human adjudication of results is mentioned or relevant for these types of non-clinical mechanical tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study is specifically for evaluating the effectiveness of diagnostic or screening tools, particularly with human readers. This device is a surgical implant; an MRMC study is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be objective measurements obtained through calibrated equipment and standardized test protocols. The primary comparison point (the "truth" for demonstrating equivalence) is the performance of the legally marketed predicate device (CinchLock Knotless Suture Anchor, K131769).

8. The Sample Size for the Training Set:

Not Applicable. As a physical device, there isn't a "training set" in the computational or AI sense.

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

Not Applicable. See point 8.

Summary based on the document:

The document describes the CinchLock Flex Knotless Suture Anchor as a line extension to an existing device. The study to prove the device meets acceptance criteria primarily involved non-clinical verification and validation testing. The core of this study was to demonstrate substantial equivalence to a previously cleared predicate device (CinchLock Knotless Suture Anchor, K131769). The modifications were to the inserter, handle, and anchor coupling, with no changes to the implantable material.

The testing covered aspects like:

Insertion Strength
Anchor Coupling Strength
Ultimate Tensile Strength
Anchor Cinch Force
Inserter Moment Testing
Design Validation
Packaging Validation
Sterilization Validation
Shelf Life/Stability Validation
Biological Safety Assessment

The results of this testing verified that the subject device is substantially equivalent to the predicate, and raises no new questions of safety or effectiveness. Clinical testing was explicitly stated as "not required to demonstrate substantial equivalence for this submission."

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.

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

July 23, 2015

Pivot Medical Ms. Kelly Kucharczyk Regulatory Affairs Associate Manager 247 Humboldt Court Sunnyvale, California 94089

Re: K151314

Trade/Device Name: CinchLock Flex Knotless Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: May 14, 2015 Received: May 18, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K151314

Device Name

CinchLock Flex Knotless Suture Anchor

Indications for Use (Describe) HIP: Hip capsule repair, Acetabular labrum reattachment

FOOT & ANKLE: Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/ reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy

ELBOW, WRIST, & HAND: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions. Lateral epicondylitis repair

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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l. SUBMITTER

Pivot Medical 247 Humboldt Ct Sunnyvale, CA 94049

Contact Person:	Kelly Kucharczyk, RACAssociate Manager, Regulatory Affairs
Phone:	810-813-4672
Fax:	303-993-6195

Date Prepared: June 25, 2015

II. DEVICE

Name of Device:	CinchLock Flex Knotless Suture Anchor
Common Name:	Fastener, Fixation, Nondegradable, Soft Tissue
Classification Name:	Smooth or threaded metallic bone fixation fastener (21CFR 888.3040)
Regulatory Class:	II
Product Code:	MBI

PREDICATE DEVICE lll.

CinchLock Knotless Suture Anchor, K131769 This predicate has not been subject to any recalls since it was introduced to market

No reference devices were used in this submission.

DEVICE DESCRIPTION IV.

Pivot Medical is introducing the CinchLock Flex Knotless Suture Anchor as a line extension to the existing CinchLock Knotless Suture Anchor. The CinchLock Flex Knotless Suture Anchor is a non-degradable PEEK suture anchor that is pre-assembled to a stainless steel inserter. Non-degradable Ultra High Molecular Weight Polyethylene (UHMWPE) suture is provided within the sterile package with the Knotless Suture Anchor and Inserter. The CinchLock Flex Knotless Suture Anchor with Inserter and Suture is provided as a sterile single use device.

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V. INDICATIONS FOR USE

HIP: Hip capsule repair, Acetabular labrum reattachment

ELBOW, WRIST, & HAND: Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The intent of this premarket notification is to provide the CinchLock Anchor on a flexible delivery system, designated the CinchLock Flex Knotless Suture Anchor. In order to achieve this, modifications have been made to the inserter, handle, and anchor coupling as compared to the predicate device. There have been no changes to material of the implantable portion of the device, and all other materials have been established to be equivalent to the predicate with respect to performance and biological safety. These modifications have been assessed via risk analysis and verification and/or validation activities and determined to not raise any new questions of safety or effectiveness of the subject device. Given this, the CinchLock Flex Knotless Suture Anchor is substantially equivalent to the predicate CinchLock Knotless Suture Anchor in regard to intended use, technological characteristics, performance attributes, and operational principles.

VII. PERFORMANCE DATA

Non-clinical verification and validation testing has been performed to verify the efficacy of the CinchLock Flex Knotless Suture Anchor as compared to the predicate. This included Insertion Strength, Anchor Coupling Strength, Ultimate Tensile Strength, Anchor Cinch Force, Inserter Moment Testing, Design Validation, Packaging Validation, Sterilization Validation, Shelf Life/Stability Validation, and Biological Safety Assessment. The results of this testing verified that the subject device is substantially equivalent to the predicate, and raises no new questions of safety or effectiveness. Clinical testing was not required to demonstrate substantial equivalence for this submission.

CONCLUSIONS VIII.

The information presented within this special 510(k) premarket notification demonstrates that the CinchLock Flex Knotless Suture Anchor is substantially equivalent to the identified predicate device.

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.