The ALLthread™ Titanium Suture Anchor devices are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

Device Description

The ALLthread Titanium Suture Anchor is a non-resorbable suture anchor used to provide soft tissue fixation to bone during healing.

AI/ML Overview

This document is a 510(k) premarket notification for the ALLthread™ Titanium Suture Anchor, a medical device for soft tissue reattachment, and not a study describing the acceptance criteria and performance of an AI product. Therefore, I cannot extract the requested information. The document focuses on establishing substantial equivalence to predicate devices based on non-clinical testing of mechanical properties and sterility.

Here's why the requested information cannot be found:

No AI component: The device described is a physical medical implant (suture anchor), not an AI-powered diagnostic or assistive tool.
Non-clinical testing: The "Summary of Performance Data" details non-clinical tests (cyclic loading, static loading, insertion torque, failure torque, needle attachment strength, suture tensile strength, bacterial endotoxins). These tests assess the physical properties and safety of the anchor itself, not the performance of an algorithm.
No "acceptance criteria" in the AI sense: The document's closest equivalent to "acceptance criteria" are the performance levels achieved in the non-clinical tests, indicating the device performs "within the intended use" and does "not raise any new risks to device performance." These are not acceptance criteria for an AI model's accuracy, sensitivity, specificity, etc.
No ground truth, training data, or expert adjudication: Since there's no AI algorithm, there's no concept of ground truth, training set, test set, expert readers, or adjudication methods as they relate to AI performance evaluation.
No MRMC study: A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is specific to evaluating AI's impact on human performance, which is not applicable here.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 16, 2020

Biomet Inc. Jared Cooper Regulatory Affairs Manager 56 East Bell Drive, PO Box 587 Warsaw, Indiana 46581

Re: K192942

Trade/Device Name: ALthread™ Titanium 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: October 17, 2019 Received: October 18, 2019

Dear Jared Cooper:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laura C. Rose, Ph.D. Acting Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known)

K192942

Device Name ALLthread™ Titanium Suture Anchor

Indications for Use (Describe)

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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."

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

510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the ALLthread Titanium Suture Anchor 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on September 13, 2019.

Sponsor:	Biomet Inc.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Primary Contact Person:	Saveetha RaghupathiRegulatory Affairs SpecialistTelephone: (877.652.0830 ext. 236)
Secondary Contact Person:	Jared CooperRegulatory Affairs ManagerTelephone: (574-372-1941)
Date:	December 18, 2019
Subject Device:	Trade Name: ALLthread™ Titanium Suture AnchorCommon Name: Soft Tissue Fixation DeviceClassification Name:
	MBI - Fastener, Fixation, Nondegradable, Soft Tissue (21CFR 888.3040)

Predicate Device(s):

Primary Predicates	510(k) Number
Ti - Screw Anchor SP	K042460
ALLthread Titanium Anchor	K080088

Purpose and DeviceDescription:	The purpose of this submission is:
	To submit a 510(k) for cumulative changes: Line extension including device configurationswith 2 or 3 suture options, a white/black suturecolor option, and modified needle attachmentoptions. Change in manufacturing site location andsterilization site location.
	To update labeling in order to narrow the Indications forUse statements and bring the Instructions for Use up tocurrent practices.
	The ALLthread Titanium Suture Anchor is a non-resorbablesuture anchor used to provide soft tissue fixation to boneduring healing.
Intended Use andIndications for Use:	The ALLthread Titanium Suture Anchor is intended for usein soft tissue fixation.The ALLthread™ Titanium Suture Anchor devices areindicated for use in soft tissue reattachment procedures inthe shoulder. Specific indications for the shoulder include:Bankart repair, SLAP lesion repair, acromio-clavicularseparation, rotator cuff repair, capsule repair orcapsulolabral reconstruction, biceps tenodesis, deltoidrepair.
Summary of TechnologicalCharacteristics:	The rationale for substantial equivalence is based onconsideration of the following characteristics:Intended Use: Similar to predicate Indications for Use: Similar to predicate Materials: Similar to predicate Design Features: Similar to predicate Sterilization: Similar to predicate
Summary of Performance Data:(Nonclinical and/or Clinical)	Non-Clinical Tests:Cyclic loading testing of the ALLthread TitaniumSuture Anchor device was performed to verify cyclicperformance of the threaded anchor implant. The testresults indicate that the device and the modificationsdo not introduce any new risks to deviceperformance. Static loading testing of the ALLthread TitaniumSuture Anchor device was performed to verify thepull out strength of the device. The test resultsindicate that the device and the modifications do not

{4}------------------------------------------------

introduce any new risks to device performance. . Insertion torque testing of the ALLthread Titanium Suture Anchor device was performed to verify the insertion torque of the device. The test results indicate that the device and the modifications do not introduce any new risks to device performance.
Failure torque testing of the ALLthread Titanium ●

{5}------------------------------------------------

Suture Anchor device was performed to verify the failure torque of the device. The test results indicate that the device and the modifications do not introduce any new risks to device performance.

Needle attachment strength testing of the ALLthread Titanium Suture Anchor device was performed to verify the minimum force required to detach the suture from the needle. The test results indicate that the device and the modifications do not introduce any new risks to device performance.
Suture tensile strength testing of the ALLthread ● Titanium Suture Anchor device was performed to verify the strength of the sutures. The test results indicate that the device and the modifications do not introduce any new risks to device performance.
Bacterial Endotoxins Test (BET) per ANSI/AAMI ST 72:2011 as a part of cleaning validation was performed, demonstrating that the device meets the limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter <161> Medical Devices -Bacterial Endotoxin and Pyrogen Tests.

The testing indicates that the device performs within the intended use and did not raise any new safety and efficacy issues.

Clinical Tests:

None provided .
The proposed ALLthread Titanium Suture Anchor has similar intended use and indications for use as the predicate devices. The proposed devices have similar technological characteristics to the predicates, and the information provided herein demonstrates that:
any differences do not raise new questions of safety ● and effectiveness; and
the proposed devices are at least as safe and effective as the legally marketed predicate devices.

Substantial Equivalence Conclusion:

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.