1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
1. Difficult clinical management problems, where other methods of treatment may not be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

The Alliance Monoblock glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

Device Description

The Alliance Glenoid system is a series of glenoid components which includes previously cleared (K191814) monoblock glenoids with 2 or 3 pegs and modular glenoids with 3 or 4 pegs. In addition to the predicate neutral (flat) modular 4-pegged design, an augmented configuration for correction of glenoid bone defects is being added to the product line. All glenoid types are available in various sizes. The posts of the modular glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium® substrate with Porous Plasma Spray (PPS) coating.

The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.

AI/ML Overview

The provided FDA 510(k) document for the Alliance Augmented Glenoid focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that a device meets specific acceptance criteria for performance in an AI/software context.

The document discusses a medical device (an augmented glenoid component for shoulder replacement), not an AI/software device. Therefore, the questions related to AI/software performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, and standalone performance are not applicable to this document.

The "Summary of Performance Data" explicitly states "Non-Clinical Tests: o Glenoid Loosening (Rocking Horse) (ASTM F2028)" and "Clinical Tests: o None provided." This indicates that the performance evaluation was based on mechanical testing, a common approach for physical medical implants, not a clinical study involving human patients or an evaluation of an AI algorithm's diagnostic capabilities.

Here's a breakdown of the relevant information provided in the document based on your request, along with explanations of why certain points are not applicable:

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

The document doesn't define specific "acceptance criteria" in terms of numerical performance thresholds for diagnostic accuracy, sensitivity, or specificity, as would be expected for an AI/software device. Instead, it relies on demonstrating that the Alliance Augmented Glenoid is substantially equivalent to a legally marketed predicate device (Alliance Glenoid K191814) through design similarities and non-clinical mechanical testing.

The primary performance data reported is for Glenoid Loosening (Rocking Horse) (ASTM F2028). The document implies that the results of this test demonstrated comparable performance to the predicate device, thereby supporting the claim of substantial equivalence. However, the specific metrics or acceptance values from this test are not explicitly detailed in the provided text.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Glenoid Loosening (Rocking Horse)	Comparable to predicate device (Alliance Glenoid K191814)	"information provided herein demonstrates that: any differences do not raise new questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate device"
(ASTM F2028) mechanical testing results	No new questions of safety or effectiveness compared to predicate.	Implied to meet or exceed predicate performance. Details not provided.

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 is a physical medical device (implant), not an AI/software device evaluated on patient data. The "test set" would refer to the physical components subjected to mechanical testing. The document does not specify the number of physical samples tested under ASTM F2028.

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, in the context of diagnostic performance, is not relevant here as this is a physical implant. The evaluation is based on engineering and materials science principles, typically involving qualified engineers and technicians performing the ASTM F2028 mechanical test.

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

Not Applicable. Adjudication methods are used to establish ground truth in diagnostic studies, which is not relevant for this physical device.

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. MRMC studies are for evaluating diagnostic performance (often with AI assistance), which is not the subject of this 510(k). The document explicitly states "Clinical Tests: o None provided."

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

Not Applicable. This is not an algorithm or AI device.

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

Not Applicable. Ground truth in the diagnostic sense is not relevant here. The "ground truth" for the device's mechanical integrity would be derived from the objective results of the ASTM F2028 mechanical stress test.

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. As there is no training set.

Summary

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February 24, 2020

Image /page/0/Picture/1 description: The image shows 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 consists of 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.

Zimmer Inc. Patricia Beres Regulatory Affairs Principal P.O. Box 708 WARSAW, IN 46581-0708

Re: K193180

Trade/Device Name: Alliance Augmented Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT Dated: January 23, 2020 Received: January 24, 2020

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 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 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.

Michael C. Owens Acting 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) K193180

Device Name Alliance Augmented Glenoid

Indications for Use (Describe)

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
1. Difficult clinical management problems, where other methods of treatment may not be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

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 ALLIANCE AUGMENTED GLENOID 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 August 12, 2005.

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708Establishment Registration Number: 1822565
Contact Person:	Patricia Sandborn BeresRegulatory Affairs PrincipalTelephone: (574-267-6639 extension 1278)Email: patty.beres@zimmerbiomet.com
Date:	November 15, 2019
Subject Device:	Trade Name: Alliance Augmented GlenoidCommon Name: Anatomic Glenoid Prosthesis
	Classification Name:• KWS - Prosthesis Shoulder, Semi-ConstrainedMetal/Polymer Cemented (21 CFR 888.3660)• KWT - Prosthesis, Shoulder, Non-ConstrainedMetal/Polymer (21 CFR 888.3650)

Predicate Device(s):

Predicates	Device	Manufacturer	510(k)Number
Primary Predicate	Alliance Glenoid	Zimmer, Inc.	K191814
Reference Predicate	Aequalis Perform+	Tornier	K150583

Purpose and Device Description:

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glenoids are made of either a Tivanium® substrate with Trabecular Metal (TM) sleeve or the Tivanium® substrate with Porous Plasma Spray (PPS) coating.

The Alliance Glenoids are intended to be used with existing humeral stem and head components to complete a total shoulder replacement construct.

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis. 2.
1. Correction of functional deformity.
1. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
1. Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate.

Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.

The Alliance Monoblock Glenoid components are indicated for cemented application only. The Alliance Modular Glenoid components are intended to be implanted with bone cement. The TM and porous posts may be inserted without bone cement.

Summary of Technological Characteristics:

The following items are identical between the proposed and predicate devices:

. Indications for use
Articulating Geometry
Sizing (Size 2-5) ●
. Modular Post attachment
Polyethylene peripheral peg design and splay
Material (UHMWPE and Ti-6Al-4V) ●
Sterilization method (gamma radiation, SAL 10-6) ●
Instrument Materials

This submission proposed the following design change:

Addition of a 12.5-degree augment wedge to the ● under surface of the component.
Addition of associated implant specific instruments ●

Intended Use and Indications for Use:

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Updated packaging/sterilization references ●

Summary of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Tests: ●
- o Glenoid Loosening (Rocking Horse) (ASTM F2028)
Clinical Tests: ● O None provided

Substantial Equivalence Conclusion

The proposed Alliance Augmented Glenoid has the same intended use and indications for use as the predicate device. The proposed device has similar technological characteristics to the predicate, and the information provided herein demonstrates that:

any differences do not raise new questions of safety and . effectiveness; and
. the proposed device is at least as safe and effective as the legally 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.”