Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; .
Inflammatory degenerative joint disease such as rheumatoid arthritis; .
Treatment of acute fractures of the humeral head that cannot be treated with other fracture . fixation methods:
Revision of a failed primary implant; .
. Cuff tear arthropathy (CTA Heads only).

The SMR Metal Backed Glenoid/Liner construct when used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.

Device Description

The L1 6mm liners are a line extension of the existing SMR Glenoid liners that are used with the SMR Modular Glenoid and SMR TT Metal Back Glenoid. These components are used in anatomic total shoulder replacements as part of the SMR Anatomic Shoulder System. When used for SMR anatomic shoulder replacement, the SMR Modular Glenoid and SMR TT Metal Back Glenoid are intended to be used with bone cement.

The L1 6mm liners are manufactured from UHMWPE (ISO 5834-2 - ASTM F648) and are available in four sizes (Small-R, Small, Standard and Large).

A snap-fit mechanism is used to attach the liner to the glenoid metal back component. Four protrusions on the upper surface of the metal-back glenoid and the conformity between the spherical shaped upper surface of the metal-back and back-side surface of the liner help ensure stability of the coupling.

The articulating surface has a radius of curvature greater than the corresponding humeral head allowing translation in the superior/inferior and anterior/posterior directions. The liners are intended to articulate with all Limacorporate SMR standard and CTA humeral heads. There is no restriction in regard to the pairing of different sizes of humeral heads and glenoid components and each humeral head size can be combined with each glenoid size.

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a medical device called the "SMR Modular Glenoid." This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through an independent study. Therefore, robust clinical study details in the context of AI/ML performance metrics are not present here.

However, based on the non-clinical testing section, we can infer some information relevant to the device's performance and the "study" conducted.

Here's the breakdown based on the provided text, while acknowledging that it's not a study proving AI/ML performance:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance
Ability to withstand static shear forces for the L1 6mm liners.	The L1 6mm liners were tested in static shear and demonstrated the device's ability to fulfill the acceptance criteria imposed.
Ability to withstand dynamic mechanical forces for the L1 6mm liners.	The L1 6mm liners were tested in dynamic testing and demonstrated the device's ability to fulfill the acceptance criteria imposed.

Note: The specific numerical acceptance criteria (e.g., maximum shear force, number of cycles for dynamic testing) are not provided in this document.

2. Sample sized used for the test set and the data provenance:

Sample size: Not explicitly stated for either static shear or dynamic testing. Typically, mechanical testing involves a small number of samples (e.g., n=3 or n=5) per test condition.
Data provenance: The tests were conducted by Limacorporate S.p.A., the manufacturer, in Italy. These are non-clinical (laboratory/mechanical) tests.

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

This information is not applicable as this document describes mechanical testing of a physical implant device, not diagnostic performance of an AI/ML system. Ground truth in this context would refer to material properties and engineering specifications, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set:

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in interpreting diagnostic data, which is not relevant to mechanical device testing.

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:

This is not applicable. This document describes an orthopedic implant, not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or AI assistance was involved.

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

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

7. The type of ground truth used:

For mechanical testing, the "ground truth" is typically defined by:

Engineering specifications and design requirements.
Established material properties (e.g., ISO 5834-2 - ASTM F648 for UHMWPE).
Industry standards for mechanical strength and fatigue testing.
Performance of predicate devices under similar test conditions.

8. The sample size for the training set:

This is not applicable. As a physical device, there is no "training set" in the context of machine learning. The design and manufacturing process involves iterative development and testing, but not in the sense of an ML model training.

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

This is not applicable. As there is no training set in the AI/ML sense, there is no ground truth established for it. The design criteria for the device are based on biomechanical principles, clinical needs, and predicate device performance.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 28, 2015

Limacorporate S.P.A. Ms. Gabriele Calligaro Via Nazionale, 52 33038 - Villanova di San Daniele Udine, Italy

Re: K143256

Trade/Device Name: SMR Modular 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: April 30, 2015 Received: May 1, 2015

Dear Ms. Calligaro:

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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Gabriele Calligaro

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K143256

SMR Modular Glenoid Indications for Use

The SMR Modular Glenoid and liner is intended for use in total primary or revision shoulder joint replacement with the SMR Anatomic Shoulder System.

The SMR Anatomic Shoulder System is indicated for patients suffering from disability due to:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; .
Inflammatory degenerative joint disease such as rheumatoid arthritis; .
Treatment of acute fractures of the humeral head that cannot be treated with other fracture . fixation methods:
Revision of a failed primary implant; .
. Cuff tear arthropathy (CTA Heads only).

The SMR Metal Backed Glenoid/Liner construct when used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Special 510(k) - Device Modification: SMR Modular Glenoid November 03, 2014

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Date: April 30, 2015

Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy

U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant Phone: 260-645-0327 FAX: +39 0432945512

Product	CommonName	ProductCode	Regulation and Classification Name
SMR ModularGlenoid	ShoulderProsthesis	KWS, KWT	Shoulder joint metal/polymer semi-constrained cemented prosthesis per 21CFR 888.3660

Description:

The L1 6mm liners are manufactured from UHMWPE (ISO 5834-2 - ASTM F648) and are available in four sizes (Small-R, Small, Standard and Large).

Intended Use/Indications:

The SMR Modular Glenoid and liner is intended for use in total primary or revision shoulder joint replacement with the SMR Anatomic Shoulder System.

The SMR Anatomic Shoulder System is indicated for patients suffering from disability due to: Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

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Inflammatory degenerative joint disease such as rheumatoid arthritis; .
Treatment of acute fractures of the humeral head that cannot be treated with other fracture . fixation methods:
Revision of a failed primary implant; .
. Cuff tear arthropathy (CTA Heads only).

The SMR Metal Backed Glenoid/Liner construct when used as part of the SMR Anatomic Shoulder Replacement, is intended for use with bone cement and should be used without bone screws.

Predicate Devices:

SMR Metal Back Glenoid and liners (Limacorporate, K113254);
SMR TT Metal Back Glenoid and liners (Limacorporate, K133349); ●
Bio-modular Shoulder System (Biomet, K030710).

Comparable Features to Predicate Device(s):

The new sizes of the liners are identical in design, materials, function, and intended use to the liners cleared in K113254 and K133349. Liner thicknesses are comparable to those available for K030710.

Non-Clinical Testing:

The L1 6mm liners were tested in static shear and dynamic testing results demonstrated the device's ability to fulfill the acceptance criteria imposed.

Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the L1 6mm liners to the existing liners of the SMR Modular Glenoid.

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.”