The AlphaVent PEEK Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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 and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary or adjunct fixation for ACL/PCL reconstruction or Repair.

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

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

Hip: Capsular Repair, Acetabular Labral Repair.

Device Description

The AlphaVent PEEK Suture Anchor (herein referred to as the proposed device(s)) are bone anchors with a screw-in design. Each anchor is vented and is provided pre-loaded with one or more working sutures with or without needles. The working sutures run through the cannulated anchor body and are attached to the distal end of the anchor by an integrated suture loop, referred to as a "soft eyelet." The anchor with working sutures is provided pre-assembled on an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The anchors are offered in a poly-ether-ether-keytone (PEEK) material with the integrated suture eyelet offered in non-absorbable USP braided ultra-high molecular weight polyethylene (UHMWPE) high strength suture. The devices are provided sterile and are packaged in sterile barrier systems (SBS) that include one anchor pre-loaded with suture on an inserter.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary regarding the AlphaVent PEEK Suture Anchor, focusing on "acceptance criteria" and the "study that proves the device meets the acceptance criteria."

Based on the provided document, the device described is a medical implant (suture anchor), not an AI/ML-driven diagnostic or assistive device. Therefore, many of the typical questions related to AI device evaluation (e.g., sample sizes for AI training/test sets, expert adjudication methods, MRMC studies, standalone AI performance, ground truth for AI) are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical benchtop testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for each test in a formal table, but rather describes the types of tests performed and the outcome in relation to the predicate.

Test Performed	Acceptance Criteria (Implied)	Reported Device Performance
Ultimate Tensile Strength (UTS) / Pull-out Strength	Comparable to or greater than the predicate device to ensure equivalent or superior mechanical fixation. (The standard approach for demonstrating substantial equivalence for mechanical properties.)	"The proposed devices demonstrated similar or increased pull-out strength to the predicate devices."
Insertion Testing	Successful and reliable insertion without device failure or significant issues, comparable to the predicate device.	Performed; specific quantitative results not detailed, but the overall conclusion is that "no new issues of safety and effectiveness were identified."
Biocompatibility	Conformance to ISO 10993-1 for patient contact nature and duration.	"Device conforms to ISO 10993-1 for patient contact nature and duration."
Sterilization	Achieves a Sterility Assurance Level (SAL) of 10^-6.	"SAL: 10^-6" (Ethylene Oxide sterilization method).
Bacterial Endotoxin	Meets specified endotoxin limits to ensure safety.	"results of testing met the acceptance criteria."
Shelf Life	Maintains performance characteristics for the stated shelf life.	"The shelf life of the device is 2 years."

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

Sample Size: The document does not specify the exact sample sizes (number of anchors) used for each non-clinical benchtop test (UTS, insertion testing, bacterial endotoxin, etc.). This information is typically detailed in the full test reports referenced in the 510(k) submission but not fully included in the summary.
Data Provenance: The data is generated from non-clinical benchtop testing conducted by the manufacturer, Stryker Endoscopy. It's not human patient data (retrospective or prospective) from a particular country.

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

This question is not applicable. The "ground truth" for non-clinical benchtop performance testing of a suture anchor is based on engineering specifications, standardized test methods (e.g., ASTM or ISO standards for material properties, pull-out strength), and comparison to a legally marketed predicate device. It does not involve human expert consensus in the way an AI diagnostic device would.

4. Adjudication Method for the Test Set

This question is not applicable. As this is non-clinical benchtop testing, there is no need for adjudication by multiple experts in the sense of reviewing clinical cases or interpreting images. The results are quantitative measurements against predefined engineering benchmarks or predicate performance.

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

No, this was not done. MRMC studies are typically conducted for diagnostic or AI-assisted devices where human readers interpret medical images or data. This submission is for a physical medical implant (suture anchor).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The AlphaVent PEEK Suture Anchor is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is based on:

Engineering specifications and measurements: Quantitative physical properties like ultimate tensile strength, insertion force, and sterilization efficacy.
Predicate device performance: The performance of the AlphaVent PEEK Suture Anchor is compared to a legally marketed predicate device (Arthrex SwiveLock Anchors, K191226) to demonstrate substantial equivalence, particularly regarding mechanical characteristics like pull-out strength.
Biocompatibility standards: Conformance to recognized international standards like ISO 10993-1.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI/ML system that requires training data.

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

This question is not applicable. There is no training set for a physical medical device.

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.

August 4, 2021

Stryker Endoscopy Christie Samsa Principal Regulatory Affairs Specialist 5900 Optical Ct. San Jose, California 95138

Re: K211502

Trade/Device Name: Alpha Vent 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 Dated: May 13, 2021 Received: May 14, 2021

Dear Christie Samsa:

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

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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 (OS) 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,

for

Laura C. Rose, 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

Enclosure

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Indications for Use

510(k) Number (if known) K211502

Device Name AlphaVent PEEK Suture Anchors

Indications for Use (Describe)

The AlphaVent PEEK Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Siceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.

Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair and Bunionectomy.

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

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

Hip: Capsular Repair, Acetabular Labral 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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Image /page/3/Picture/0 description: The image shows the Stryker logo in black, with the text "K211502" above it. The logo is a stylized version of the company name, with bold, sans-serif letters. The text "K211502" is in a smaller font size and is centered above the logo. The logo and text are set against a white background.

510(k) Summary

Submitter:

Applicant	Stryker Endoscopy5900 Optical CourtSan Jose, CA 95138
Contact Person	Christie SamsaPrincipal Regulatory Affairs SpecialistPhone: (978) 500-1303Facsimile: (408) 754-2598Email: christie.samsa@stryker.com
Date Prepared	May 13, 2021

Subject Device:

Name of Device	AlphaVent PEEK Suture Anchor
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 Device:

Name of Device	Arthrex Swivelock Anchors, K191226
----------------	------------------------------------

Note: The predicate device has not been subject to a design-related recall.

Device Description:

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Indications for Use:

The AlphaVent PEEK Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip 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 and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

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

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

Hip: Capsular Repair, Acetabular Labral Repair.

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	Subject Device(This Submission)	Predicate Device(K191226)
Feature	AlphaVent PEEK Suture Anchor	Arthrex SwiveLockSuture Anchor
Intended Use	Fixation of soft tissue to bone	Same as subject device
Indications forUse	The AlphaVent PEEK Suture Anchors are intendedfor fixation of suture (soft tissue) to bone in theshoulder, foot/ankle, knee, hand/wrist, elbow, andhip 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 and Ankle: Lateral Stabilization, MedialStabilization, Achilles Tendon Repair, HalluxValgus Reconstruction, Midfoot Reconstruction,Metatarsal Ligament Repair/Tendon Repair andBunionectomy.Knee: Anterior Cruciate Ligament Repair, MedialCollateral Ligament Repair, Lateral CollateralLigament Repair, Patellar Tendon Repair, PosteriorOblique Ligament Repair, Illiotibial Band Tenodesisand Quadriceps Tendon Repair. Secondary oradjunct fixation for ACL/PCL reconstruction orRepair.Hand/Wrist: Scapholunate Ligament Reconstruction,Ulnar or Radial Collateral Ligament Reconstruction.Elbow: Biceps Tendon Reattachment, Tennis ElbowRepair, Ulnar or Radial Collateral LigamentReconstruction, Lateral Epicondylitis Repair.Hip: Capsular Repair, Acetabular Labral Repair.	Same as subject device
OperationalPrinciple	Fixation of suture to bone achieved by interferencefit with screw-in anchor, suture fixated by eyelet	Fixation of suture to boneachieved by interferencefit with sutures and screw-in anchor
Key Patient-ContactingMaterials	Material: Poly-ether-ether ketone (PEEK),UHMWPE	Same as subject device
Anchor SystemDesign	Screw in anchor with eyeletInserterSutures for fixation	Similar to subject device
Eyelet Design	Integrated Closed eyelet	Separate Closed eyelet
Feature	Subject Device(This Submission)	Predicate Device(K191226)
	AlphaVent PEEK Suture Anchor	Arthrex SwiveLockSuture Anchor
AnchorDiameter	4.75mm5.5mm6.5mm	3.5mm - 9mm
SterilizationMethod, SAL	Ethylene Oxide (EO),SAL: 10-6	Similar to subject device
Packaging	Double Barrier Blister or PouchSingle Use Only	Similar to subject device
Biocompatibility	Device conforms to ISO 10993-1 for patient contactnature and duration	Similar to subject device

Comparison of Technological Characteristics with the Predicate Device:

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Performance Testing:

Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Stryker AlphaVent PEEK Suture Anchor, including ultimate tensile strength (UTS) and insertion testing. The proposed devices demonstrated similar or increased pull-out strength to the predicate devices, and no new issues of safety and effectiveness were identified. The shelf life of the device is 2 years. Additionally, bacterial endotoxin testing was performed and results of testing met the acceptance criteria.

Conclusions:

The AlphaVent PEEK Suture Anchor is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no new issues of safety and/or effectiveness introduced by the AlphaVent PEEK Suture Anchor when used as instructed.

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.