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

Device Description

The ALLthread PEEK Suture Anchors are soft tissue anchors with preloaded nonabsorbable polyethylene surgical sutures used to repair and reattach soft tissue to bone and are supplied in both double and triple loaded suture configurations. The ALLthread PEEK Suture Anchors are designed to reattach soft tissue to bone in procedures in the shoulder.

The purpose of this submission is: To submit a 510(k) for cumulative changes: Line extension including device configurations with 2 or 3 suture options, a white/black suture option, a white/green suture option and a tapered needle option. To update labeling in order to narrow the Indications for Use statements, describe the third suture options, and bring the Instructions for Use up to current practices; To ensure that the all of the instrumentation/accessories for use with this system are appropriately associated with a 510(k).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the ALLthread PEEK Suture Anchor. It primarily 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 one might expect for an AI/algorithm-based diagnostic device.

However, based on the information provided, I can extract details about the performance testing conducted and how it relates to demonstrating the device's safety and effectiveness.

Here's an attempt to structure the information according to your request, adapting it to the nature of the device and the provided document:

Device: ALLthread PEEK Suture Anchor

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Performance Metric	Reported Device Performance
Mechanical Strength	Suture Tensile Strength: Verification of the strength of the preloaded sutures.	"The test results indicate that the device modifications do not introduce any new risks to implant performance." (Implies the tensile strength is satisfactory and comparable to predicate, meeting safety and effectiveness requirements).
	Cyclic Loading: Verification of the cyclic performance of the threaded anchor implant.	"The test results indicate that the device and accessory modifications do not introduce any new risks to implant performance." (Implies satisfactory cyclic performance, meeting durability and safety requirements).
	Static Load (Pull-out Strength): Verification of the pull-out strength of the device.	"The test results indicate that the device and accessory modifications do not introduce any new risks to device performance." (Implies satisfactory pull-out strength, ensuring secure fixation).
	Insertion Torque: Verification of the measured insertion torque of the anchors and taps.	"The test results indicate that the device and accessory modifications do not introduce any new risks to device performance." (Implies controllable and safe insertion, minimizing surgical complications).
	Needle Attachment Strength: Verification of the minimum force required to detach the suture from the needle.	"The test results indicate that the device and accessory modifications do not introduce any new risks to device performance." (Implies secure needle attachment, preventing premature detachment during surgery).
Biocompatibility/Safety	Bacterial Endotoxins Test (BET) per ANSI/AAMI ST 72:2011: To demonstrate that the device meets pyrogenicity limits as part of cleaning validation. Acceptance Limit: ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter <161> Medical Devices.	"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." (Explicitly states the device meets the specified acceptance criterion for endotoxins, confirming a critical safety aspect related to sterility and patient infection risk).

2. Sample size used for the test set and the data provenance

Sample Size: Not explicitly stated for each test. The document mentions "test results indicate that the device modifications..." implying that the tests were conducted on a sample of the ALLthread PEEK Suture Anchors and their components.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). These are non-clinical tests performed in a laboratory setting, not on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to this type of device and study. The "ground truth" for the non-clinical tests (like tensile strength or cyclic loading) is based on engineering specifications, industry standards, and established physical properties, not expert consensus on medical images or patient outcomes. The tests verify adherence to pre-defined performance characteristics.

4. Adjudication method for the test set

This question is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple experts for interpreting medical data, which is not the nature of these mechanical and biological safety tests.

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 question is not applicable. This is a physical orthopedic implant (suture anchor), not an AI/algorithm-based diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

This question is not applicable. This is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used

The "ground truth" for these performance tests is defined engineering specifications, material properties, and regulatory standards (e.g., tensile strength limits, cyclic loading cycles, endotoxin limits). The tests demonstrate compliance with these objective, measurable standards.

8. The sample size for the training set

This question is not applicable. This is not an AI/machine learning device that requires a training set. The device design and materials are based on established engineering principles and prior predicate devices.

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

This question is not applicable as there is no training set for this device.

Summary of the Study:

The document describes a series of non-clinical bench tests (mechanical and biocompatibility) performed on the ALLthread PEEK Suture Anchor. These tests were conducted to verify that specific design modifications (e.g., line extension, new suture options) and accessories do not introduce new risks and that the device maintains comparable performance to its predicate devices. The "study" here is a set of engineering and safety validation tests aimed at demonstrating "substantial equivalence" for regulatory clearance. The acceptance criteria are implicit in the statement that "test results indicate that the device modifications do not introduce any new risks to implant performance" and explicitly stated for the Bacterial Endotoxins Test. No clinical data or human studies were provided.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.

March 5, 2020

Biomet Inc. Haley Pioch Sr. Regulatory Affairs Specialist 56 East Bell Drive, PO Box 587 Warsaw, Indiana 46581

Re: K193402

Trade/Device Name: ALLthread PEEK Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: December 5, 2019 Received: December 6, 2019

Dear Ms. Pioch:

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 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

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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 mediation-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

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Indications for Use

510(k) Number (if known) K193402

Device Name ALLthread PEEK Suture Anchors

Indications for Use (Describe)

The ALLthread PEEK Suture Anchors 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.

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)

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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 PEEK 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:	Haley PiochSr. Regulatory Affairs SpecialistTelephone: (412-376-2510 extension 214)
Secondary Contact Person:	Jared CooperRegulatory Affairs ManagerTelephone: (574-372-1941)
Date:	December 05, 2019
Subject Device:	Trade Name: ALLthread PEEK Suture AnchorCommon Name: Suture Anchor
	Classification Name:
	MBI - Fastener, Fixation, Nondegradable, Soft Tissue, Smooth or Threaded Metallic Bone Fixation Fastener (21 CFR 888.3040)HWC- screw, fixation, bone (21 CFR 888.3040)

Predicate Device(s):

Primary Predicate3	510(k) Number
ALLthread PEEK Suture Anchor	K060693
ALLthread PEEK Suture Anchor	K080088

Purpose and Device Description:	The ALLthread PEEK Suture Anchors are soft tissueanchors with preloaded nonabsorbable polyethylene surgicalsutures used to repair and reattach soft tissue to bone and aresupplied in both double and triple loaded sutureconfigurations. The ALLthread PEEK Suture Anchors aredesigned to reattach soft tissue to bone in procedures in theshoulder.
	The purpose of this submission is:To submit a 510(k) for cumulative changes: Line extension including device configurations with 2 or 3 suture options, a white/black suture option, a white/green suture option and a tapered needle option. To update labeling in order to narrow the Indications for Use statements, describe the third suture options, and bring the Instructions for Use up to current practices; To ensure that the all of the instrumentation/accessories for use with this system are appropriately associated with a 510(k).
Intended Use andIndications for Use:	The ALLthread PEEK Suture Anchor devices are intended for soft tissue fixation.The ALLthread PEEK Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder.Specific indications for the shoulder include: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Summary of TechnologicalCharacteristics:	The rationale for substantial equivalence is based on consideration of the following characteristics:The rationale for substantial equivalence is based on consideration of the following characteristics: Intended Use: Identical 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:Suture tensile strength testing of the ALLthread PEEK Suture Anchor device was performed to verify the strength of the sutures. The test results indicate that the device modifications do not introduce any new risks to implant performance. Cyclic loading testing of the ALLthread PEEK Suture Anchors was performed to verify cyclic performance of the threaded anchor implant. The test results indicate that the device and accessory modifications do not introduce any new risks to implant performance.

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Static load testing of the ALLthread PEEK Suture ● Anchors was performed to verify the pull out strength of the device. The test results indicate that the device and accessory modifications do not introduce any new risks to device performance.
Insertion torque testing of the ALLthread PEEK . Suture Anchors and taps was performed to verify the measured insertion torque or the anchors and taps. The test results indicate that the device and accessory modifications do not introduce any new risks to device performance.
. Needle attachment strength testing of the ALLthread PEEK Suture Anchor devices was performed to verify the minimum force required to detach the suture from needle. The test results indicate that the device and accessory 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.

Clinical Tests:

. None provided
The subject ALLthread PEEK Suture Anchor has the same intended use and similar indications for use as the predicate devices. The subject device has 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 subject device is 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.