The AlphaVent Knotless SP PEEK Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated 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 or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or Adjunct Fixation for ACL/PCL Reconstruction or Repair, Meniscal Root Repair, MPFL Repair/Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair, Proximal Hamstring Repair

Device Description

The AlphaVent Knotless SP PEEK Anchors (herein referred to as the subject device(s)) are bone anchors with a screw-in mechanism. The subject device system is comprised of a poly-ether-etherketone (PEEK) eyelet and anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone via self-punching or after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS). The AlphaVent Knotless SP PEEK Anchors are sterilized via Ethylene Oxide to a Sterility Assurance Level of 106. The devices are intended to be used in a professional healthcare facility.

AI/ML Overview

This document is a 510(k) summary for the AlphaVent Knotless SP PEEK Anchor, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the way typically seen for a diagnostic or AI-driven device.

Therefore, many of the requested categories for describing acceptance criteria and a study proving device performance are not applicable or cannot be extracted from this type of regulatory submission. This document highlights benchtop testing for product safety and equivalence, not clinical performance against ground truth.

Here's an attempt to answer the questions based only on the provided text, indicating when information is not present:

Acceptance Criteria and Device Performance Study (Based on 510(k) Summary)

This 510(k) summary focuses on demonstrating substantial equivalence of the AlphaVent Knotless SP PEEK Anchor to a legally marketed predicate device (Arthrex SwiveLock Anchor, K203495) and a reference device (Stryker AlphaVent PEEK Suture Anchor, K231093). The "study" described is a series of non-clinical benchtop tests, a biological risk assessment, and bacterial endotoxin testing, designed to show the new device performs at least as safely and effectively as the predicate.

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

Test	Acceptance Criteria	Reported Device Performance	Comments
Ultimate Tensile Strength (UTS)	Equivalent or higher UTS as compared to predicate devices	Demonstrated equivalent or higher UTS as compared to the predicate devices	Non-clinical benchtop testing. No specific numerical values provided for criteria or performance; reported comparatively.
Insertion Testing	Successful insertion	Successful insertion	Non-clinical benchtop testing. No specific metrics provided.
Biological Risk Assessment	Met requirements of ISO10993-1	Met requirements of ISO10993-1
Bacterial Endotoxin Testing (LAL test)	< 20 EU/device	Met the limit acceptance criterion of < 20 EU/device	Based on FDA guidance "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile''.

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

Sample size for test set: Not specified in the provided text for any of the benchtop tests.
Data provenance: The tests are non-clinical benchtop tests, implying laboratory-controlled conditions. There is no mention of country of origin of data or whether it's retrospective or prospective, as these terms typically apply to patient-level clinical data.

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

Not applicable. For this device (a mechanical anchor used for soft-tissue to bone fixation), "ground truth" is established through engineering and biological performance standards, not through expert human interpretation of data/images. The tests evaluate physical properties and biocompatibility.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data (e.g., image interpretation). This submission details benchtop engineering and biological tests, not clinical performance requiring human expert adjudication.

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

Not applicable. An MRMC study is relevant for diagnostic devices, especially those incorporating AI. This document concerns a physical surgical anchor. There is no AI component mentioned.

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

Not applicable. This device is a component of a surgical procedure, not a standalone algorithm.

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

For the non-clinical tests, the "ground truth" is defined by established engineering standards, material specifications, and biological safety guidelines (e.g., ISO10993-1, USP <85>). The performance is measured against these objective criteria rather than subjective human interpretation or clinical outcomes data presented in this document.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable. (See point 8).

Summary

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January 25, 2024

Stryker Endoscopy Madison Mutchler Senior Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138

Re: K233893

Trade/Device Name: AlphaVent Knotless SP PEEK Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: December 8, 2023 Received: December 8, 2023

Dear Madison Mutchler:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Sara S. Thompson -S

For

Jesse Muir, Ph.D. 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

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Enclosure

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Indications for Use

Submission Number (if known)

K233893

Device Name

AlphaVent Knotless SP PEEK Anchor

Indications for Use (Describe)

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization. Medial Stabilization. Achilles Tendon Repair, Hallux Valqus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair, Proximal Hamstring Repair

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Submitter:

Applicant	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person	Madison MutchlerSenior Regulatory Affairs SpecialistPhone: (408) 754-2000Email: madison.mutchler@stryker.com
Date Prepared	December 8, 2023

Subject Device:

Name of Device	AlphaVent Knotless SP PEEK Anchor
Device Size	4.75mm, 5.5mm, 6.5mm
Common or Usual Name	Suture, Fastener, Fixation, Nondegradable, Soft Tissue
Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue, 21 CFR 888.3040
Regulatory Class	Class II
Product Code	MBI

Predicate and Reference Devices:

Name of Device	Predicate – Arthrex SwiveLock Anchor (K203495)
	Reference – Stryker AlphaVent PEEK Suture Anchor (K231093)

Device Description:

Intended Use:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair

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Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair, Proximal Hamstring Repair

Comparison of Technological Characteristics with the Predicate Device:

The AlphaVent Knotless SP PEEK Anchor is identical to the predicate devices in terms of intended use, indications for use, raw material intended for implantation, general anchor system design features. It is equivalent in terms of other technological characteristics and performance attributes. Any minor differences between the proposed and predicate device do not raise new questions of safety and effectiveness, and these devices are substantially equivalent based on the criteria described in 21 CFR §807.100.

Performance Testing:

Non-clinical benchtop testing was performed to evaluate the performance characteristics of the AlphaVent Knotless SP PEEK Anchors, including ultimate tensile strength (UTS) and insertion testing. The proposed devices demonstrated equivalent or higher UTS as compared to the predicate devices as well as successful insertion, and no new issues of safety and effectiveness were identified.

A biological risk assessment was completed, and the devices met the requirements of ISO10993-1.

Bacterial endotoxin testing has been performed to ensure the device meets pyrogen limit specifications. The limulus amebocyte lysate (LAL) test, kinetic chromogenic method, was performed according to USP <85> Bacterial Endotoxins Test. The LAL testing met the limit acceptance criterion of < 20 EU/device, based upon the recommendations for implanted devices in the FDA guidance document "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile'', issued January 21, 2016.

Conclusions:

The information presented within this Traditional 510(k) demonstrates that the AlphaVent Knotless SP PEEK Anchors are substantially equivalent to the predicate devices, and will perform as safely and effectively within the intended use.

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.