The Augmented VaultLock Glenoid is indicated in replacement(s) when conditions include severe pain or significant disability resulting from degenerative, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or, other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.

The glenoid components are designed fixation in the joint and must only be used with appropriate bone cement.

Device Description

The Augmented VaultLock Glenoid is made of the same materials as the predicate (UHMWPE). The Augmented VaultLock Glenoid is designed with a half-wedge augment. The proposed device has an identical spherical articulating surface as that of the previously cleared glenoids and is available in 4 nominal sizes. The proposed device is a line extension to the Arthrex VaultLock Glenoid cleared under K161108.

AI/ML Overview

This document is a 510(k) premarket notification for the "Augmented VaultLock Glenoid" by Arthrex Inc. It is a medical device, specifically a shoulder prosthesis. The document mainly focuses on proving the substantial equivalence of the new device to existing predicate devices, rather than establishing acceptance criteria and proving performance through a standalone clinical study with specific metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, and details on training sets for an AI device, are not applicable to this type of submission. This is a submission for a physical medical implant, not an AI or algorithmic diagnostic device.

The "Performance Data" section in the document refers to mechanical testing and biocompatibility testing, which are standard for physical implants, not clinical performance metrics in the way typically discussed for diagnostic algorithms.

Here's an attempt to fill in the table and address the questions based only on the provided text, recognizing that many fields will be "Not Applicable" for this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (if stated)	Reported Device Performance
Mechanical Testing	Meets standards requirements (per ASTM F2028)	Demonstrated that the proposed device meets standards requirements (Rocking horse testing)
Biocompatibility	Meets pyrogen limit specifications (per ANSI/AAMI ST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14)	Bacterial Endotoxin test conducted and meets specifications
MRI Safety	N/A (implied to be safe in MR environment)	MRI testing conducted in accordance with FDA guidance and ASTM F2182
Substantial Equivalence	Demonstrates equivalence to predicate device in terms of design features and intended use, with minor differences not raising safety/effectiveness questions.	Conclusion states: "The mechanical testing data demonstrates that the proposed device performance is equivalent to the predicate device for the desired indications. Any differences between the proposed device and the predicate device are considered minor and do not raise questions regarding safety or effectiveness."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission describes mechanical and biocompatibility testing for a physical implant, not a clinical test set for an algorithmic device to establish diagnostic performance. The "tests" mentioned are physical and laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth establishment by experts is relevant for diagnostic algorithms or subjective clinical assessments. This submission focuses on engineering performance (mechanical strength, material safety).

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

Not applicable. Adjudication methods are typically used for reconciling expert opinions in diagnostic studies. This is not a diagnostic study.

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 evaluating the impact of AI on human reader performance in diagnostic tasks. This device is a physical shoulder implant.

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

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

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

The "ground truth" for this device's performance is based on engineering standards (e.g., ASTM F2028 for mechanical testing) and international standards for biocompatibility (e.g., ANSI/AAMI ST72). Compliance with these established industry standards serves as the benchmark for safety and performance in this context.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/algorithmic device for this physical implant.

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

Not applicable. There is no "training set" for this physical implant.

Summary

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Arthrex Inc. Ivette Galmez Official Correspondent, Regulatory Affairs 1370 Creekside Boulevard Naples. Florida 34108-1945

Re: K210050

Trade/Device Name: Augmented VaultLock Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS Dated: May 21, 2021 Received: May 25, 2021

Dear Ivette Galmez:

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

June 7, 2021

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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,

Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty 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)

K210050

Device Name

Augmented VaultLock Glenoid

Indications for Use (Describe)

The glenoid components are designed fixation in the joint and must only be used with appropriate bone cement.

Type of Use ( Select one or both, as applicable )
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Date Prepared	December 24, 2020
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	Ivette GalmezRegulatory Affairs1-239-643-5553, ext. 71263Ivette.galmez@arthrex.com
Name of Device	Augmented VaultLock Glenoid
Common Name	Shoulder Prosthesis
Product Code	KWS
Classification Name	21 CFR 888.3660: Prosthesis, Shoulder, semi-constrained metal/polymer, cemented
Regulatory Class	II
Predicate Device	K161108: Arthrex VaultLock Glenoid
Reference Device	K191960: Arthrex Univers Revers Modular Glenoid SystemK071032: Arthrex Univers II Shoulder Prosthesis
Purpose of Submission	This Traditional 510(k) premarket notification is submitted to obtain clearance forthe Augmented VaultLock Glenoid for use with the existing Univers II ShoulderProsthesis system (K071032).
Device Description	The Augmented VaultLock Glenoid is made of the same materials as the predicate(UHMWPE). The Augmented VaultLock Glenoid is designed with a half-wedgeaugment. The proposed device has an identical spherical articulating surface as thatof the previously cleared glenoids and is available in 4 nominal sizes. The proposeddevice is a line extension to the Arthrex VaultLock Glenoid cleared under K161108.
Indications for Use	The Augmented VaultLock Glenoid is indicated in replacement(s) when conditionsinclude severe pain or significant disability resulting from degenerative, rheumatoid,traumatic disease, or injury of the glenohumeral joint; non-union humeral headfractures of long duration; irreducible 2- and 4- part proximal humeral fractures;avascular necrosis of the humeral head; or, other difficult clinical managementproblems where arthrodesis or resectional arthroplasty is not acceptable.The glenoid components are designed for cemented fixation in the joint and mustonly be used with appropriate bone cement.
Performance Data	Mechanical testing (i.e. Rocking horse testing per ASTM F2028) was performed todemonstrate that the proposed device meets the standards requirements.Bacterial Endotoxin test was conducted in accordance with ANSI/AAMIST72:2011/(R)2016, USP <161>, USP <85>, EP 2.6.14 to demonstrate that theproposed device meets pyrogen limit specifications.MRI testing was conducted in accordance with FDA guidance Testing and LabelingMedical Devices for Safety in the Magnetic Resonance (MR) Environment and ASTMF2182.
Conclusion	The Augmented VaultLock Glenoid is substantially equivalent to the predicate devicein which the basic design features and intended use are the same. The mechanicaltesting data demonstrates that the proposed device performance is equivalent to thepredicate device for the desired indications. Any differences between the proposeddevice and the predicate device are considered minor and do not raise questionsregarding safety or effectiveness.Based on the indications for use, technological characteristics, and the summary ofdata submitted, Arthrex Inc. has determined that the proposed device is substantiallyequivalent to the currently marketed predicate device.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”