Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Revision where other devices or treatments have failed.
Correction of functional deformity.
Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Reverse Applications
The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is neeessary.

Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented application. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Device Description

The proposed device is an orthopaedic total joint intended to replace the damaged or diseased natural shoulder joint in shoulder arthroplasty to provide pain relief and restore function. It is modular in design, consisting of a baseplate held to the bone with bone screws and a modular liner. The device is designed to be implanted as the glenoid component of an anatomic total shoulder with the option to convert to a reverse shoulder configuration without removal of the metal components.

The current submission is to expand the product offering by the addition of a liner manufactured from Vivacit-E Vitamin E Highly Crosslinked Polyethylene (VEHXPE).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (shoulder prosthesis) and as such, it focuses on demonstrating substantial equivalence to a previously cleared device, rather than providing the kind of extensive performance study data that would be typical for a novel device or a clinical trial.

Therefore, the document does not contain the detailed information required to answer many of your specific questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information can be extracted:

No "Acceptance Criteria Table" or "Reported Device Performance": The 510(k) process for this type of device (a new material liner for an existing, cleared system) primarily relies on demonstrating that the new material (Vivacit-E Liner) performs equivalently to existing materials in relevant non-clinical tests (e.g., mechanical tests). Clinical studies with specific performance metrics and acceptance criteria are generally not required for substantial equivalence for this type of modification.
No "Study that proves the device meets the acceptance criteria" in the sense of a clinical trial: The "Summary of Performance Data" explicitly states "Clinical Tests: None provided." This means there was no multi-reader, multi-case study, no human-in-the-loop performance measurement, and no standalone algorithm performance assessment. This device is a passive implant, not an AI or diagnostic tool.

Based on the provided text, here's what can be answered or inferred:

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

Not Applicable in the traditional sense. This submission is for a material change (Vivacit-E Liner) to an existing device. The performance data listed are non-clinical tests designed to show that the new liner material performs equivalently to existing cleared materials/devices.
Types of Non-Clinical Tests Conducted:
- Dissociation Testing
- Shear Testing
- Insertion Testing
- Biocompatibility Assessment
- Packaging Assessment
"Acceptance Criteria" for these tests: While not explicitly stated with numerical values, the acceptance criterion for a 510(k) submission is that the performance of the new device (Vivacit-E Liner) is "as safe and effective as the legally marketed predicate devices" and that "any differences do not raise new questions of safety and effectiveness." This implies that the results of these non-clinical tests must fall within expected ranges or demonstrate equivalence to the predicate device for each test. Specific numerical thresholds or ranges are not provided in this summary.

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

Sample Size: Not specified for the non-clinical tests. For mechanical testing of medical devices, sample sizes are typically determined by engineering standards (e.g., ISO, ASTM) and statistical power requirements to demonstrate equivalence or meet specified performance criteria.
Data Provenance: Not specified, but given it's a submission by Biomet Manufacturing Corp. (a US company) to the FDA, the testing would typically be conducted according to internationally recognized standards in controlled laboratory environments. The data would be specific to components manufactured by the applicant. This is not patient data.

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

Not Applicable. This is not a study requiring expert readers or ground truth establishment in the clinical image interpretation sense. The "ground truth" for mechanical testing is the physical property being measured (e.g., force, displacement, material degradation) against defined engineering specifications.

4. Adjudication method for the test set

Not Applicable. No human adjudication is involved in the non-clinical mechanical testing of an implantable device like this.

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

No. The "Summary of Performance Data" explicitly states: "Clinical Tests: None provided." This device is a passive implant, not a diagnostic or AI-powered device that would involve human readers or image interpretation.

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

No. As above, this is a physical implant, not a software algorithm.

7. The type of ground truth used

For Non-Clinical Tests: The "ground truth" would be engineering specifications and material properties as defined by relevant standards (e.g., ISO, ASTM) and internal design requirements. For example, for "Shear Testing," the ground truth would be the measured shear strength compared to the designed minimum shear strength or the shear strength of the predicate device.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set" for the device itself.

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

Not Applicable. As there is no training set for the device, this question is irrelevant.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left, there 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.

Biomet Manufacturing Corp. Patricia Beres Regulatory Affairs Principal 56 East Bell Drive Warsaw, Indiana 46582

November 4, 2021

Re: K211729

Trade/Device Name: Comprehensive® Convertible Glenoid - Vivacit-E Liner Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWT, PAO, MBF Dated: October 5, 2021 Received: October 7, 2021

Dear Patricia Beres:

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 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

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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 (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-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and -CDRH Learn (https://www.fda.gov/training-and-continuing-education/odrh-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-devices/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 Jiping Chen, PhD Acting Division 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K211729

Device Name

Comprehensive® Convertible Glenoid - Vivacit-E Liner

Indications for Use (Describe)

Anatomic Applications

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Revision where other devices or treatments have failed.
1. Correction of functional deformity.
1. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.

Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Reverse Applications

The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is neeessary.

Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

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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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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Image /page/3/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a simple, sans-serif font. The text is in a dark gray color, providing a contrast against the white background.

510(k) Summary

Sponsor:	Biomet Manufacturing Corp.56 East Bell DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034
Contact Person:	Patricia Sandborn Berespatty.beres@zimmerbiomet.com(574) 267-6639
Date:	November 1, 2021
Subject Device:	Trade Name: Comprehensive® Convertible Glenoid –Vivacit-E LinerCommon Name: Shoulder prosthesisClassification Name:• PHX - Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR 888.3660)
	• KWS - Shoulder joint, metal/polymer, semi-constrained, cemented prosthesis (21 CFR888.3660)
	• KWT - Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR888.3650)
	• PAO - Shoulder joint metal/polymer semi-constrained cemented prosthesis (21 CFR888.3660)
	• MBF - Shoulder joint metal/polymer/metalnonconstrained or semi-constrained porous-coateduncemented prosthesis (21 CFR 888.3670)

Predicate Device(s):

Device	Manufacturer	510(k) Number
Primary Predicate
ComprehensiveConvertible Glenoid	Biomet Manufacturing Corp.	K130390

Reference Predicates for Testing
Bio-Modular ShoulderSystem	Biomet Manufacturing Corp.	K992119, K030710,K093803

Reference Predicates for Materials, Sterilization and Packaging

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Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a darker shade of gray.

Persona Revision KneeSystem	Zimmer Inc.	K191625
---------------------------------	-------------	---------

Device
Description:	The proposed device is an orthopaedic total joint intendedto replace the damaged or diseased natural shoulder jointin shoulder arthroplasty to provide pain relief and restorefunction. It is modular in design, consisting of a baseplateheld to the bone with bone screws and a modular liner.The device is designed to be implanted as the glenoidcomponent of an anatomic total shoulder with the optionto convert to a reverse shoulder configuration withoutremoval of the metal components.
	The current submission is to expand the product offeringby the addition of a liner manufactured from Vivacit-EVitamin E Highly Crosslinked Polyethylene (VEHXPE).
Indications for Use:	Anatomic Applications1. Non-inflammatory degenerative joint diseaseincluding osteoarthritis and avascular necrosis.2. Rheumatoid arthritis.3. Revision where other devices or treatments havefailed.4. Correction of functional deformity.5. Fractures of the proximal humerus, where othermethods of treatment are deemed inadequate.6. Difficult clinical management problems, includingcuff arthropathy, where other methods of treatmentmay not be suitable or may be inadequate.
	Reverse ApplicationsThe Comprehensive Reverse Shoulder is indicated for use inpatients whose shoulder joint has a grossly deficient rotatorcuff with severe arthropathy and/or previously failedshoulder joint replacement with a grossly deficient rotatorcuff. The patient must be anatomically and structurallysuited to receive the implants and a functional deltoidmuscle is necessary.
	Comprehensive Convertible Glenoid Baseplatecomponents are intended for cementless applications withthe addition of screw fixation.

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Image /page/5/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is also in blue, matching the color of the circle and the "Z" symbol.

Summary of Technological Characteristics:

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended Use: Identical to primary predicate ●
Indications for Use: Identical to primary predicate ●
Materials: Identical to reference predicate
Design Features: Identical to primary predicate with the exception of removal of cosmetic tabs
. Sterilization: The predicate Convertible Glenoid E1 Liners were Gamma sterilized whereas the subject Convertible Glenoid Vivacit-E Liners are EtO sterilized similar to the reference predicate device.

Summary of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Tests: ●

Dissociation Testing O
Shear Testing O
Insertion Testing O
Biocompatibility Assessment O
Packaging Assessment O

Clinical Tests: ●

0 None provided

Substantial Equivalence Conclusion

Based on the information contained within this submission, it is concluded that the Comprehensive Convertible Glenoid - Vivacit-E Liner is substantially equivalent to the identified predicate and reference devices. The subject device has similar technological characteristics to the previously cleared devices, and the performance data and analyses demonstrate that:

. anv differences do not raise new questions of safety and effectiveness; and
the proposed device is as safe and effective as the legally marketed predicate devices.

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.”