1. Elbow joint destruction which significantly compromises the activities of daily living
1. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
1. Rheumatoid arthritis or degenerative arthritis with incapacitating pain
1. Revision where other devices or treatments have failed.
1. Correction of severe functional deformity.
1. Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
1. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion

The unlinked, semi-constrained version is intended for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of dislocation or disengagement between ulnar and humeral components, when intraoperative manual testing is performed.

Device Description

TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations.

TEMA Elbow System consists of modular humeral and ulnar assemblies. The humeral assembly consists of a metallic humeral stem and a metallic humeral body component with pre-assembled polyethylene bushings. The ulnar assembly is composed of a metallic ulnar stem, a metallic ulnar body and a polyethylene ulnar liner. Screws are used to secure the taper couplings between the stems and bodies of the humeral and ulnar assemblies.

The constrained (linked) version of the elbow consists of the modular humeral assembly and the modular ulnar assembly with an axle component that is inserted across the joint to connect the humeral assembly to the ulnar assembly.

The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies.

All of the system components are available in different sizes.

The modularity of the polyethylene ulnar component also allows replacement of the ulnar bearing, if needed, without removal of the humeral and ulnar assemblies. The modularity also provides an additional advantage that if replacement of the humeral and/or ulnar body is needed (e.g. due to damage from a traumatic event or due to excessive wear of the bushing of the humeral body) and the stem components are well fixed. the stems do not need to be removed and only disconnection of the humeral and ulnar bodies from the stems is required for their revision.

AI/ML Overview

The provided text is a 510(k) Summary for the TEMA Elbow System. It describes the device, its indications for use, and compares it to predicate devices. However, this document does not contain information about the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.

The TEMA Elbow System is a mechanical prosthetic device, and the evaluation for its substantial equivalence relies on non-clinical mechanical testing and a comparison of its design and materials to existing predicate devices.

Therefore, I cannot provide the requested information for an AI/ML device, as the document pertains to a traditional medical implant.

Specifically, the document does NOT contain information on:

A table of acceptance criteria and reported device performance (for an AI/ML device).
Sample sizes for a test set or data provenance (relevant to AI/ML studies).
Number of experts or their qualifications for ground truth establishment (relevant to AI/ML studies).
Adjudication methods (relevant to AI/ML studies).
MRMC comparative effectiveness studies including effect sizes for human readers (relevant to AI/ML studies).
Standalone algorithm performance (relevant to AI/ML studies).
Type of ground truth used (relevant to AI/ML studies).
Sample size for the training set (relevant to AI/ML studies).
How ground truth for the training set was established (relevant to AI/ML studies).

The "Non-Clinical Testing" section mentions mechanical testing for the device's ability to perform in a substantially equivalent manner, but these are engineering tests for a physical implant, not a study of an AI/ML algorithm's diagnostic or prognostic performance. The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of TEMA Elbow System to the predicate devices."

Summary

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Image /page/0/Picture/0 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION".

February 16, 2019

Limacorporate S.p.A. % Stephen Peoples President Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814

Re: K181362

Trade/Device Name: TEMA Elbow System Regulation Number: 21 CFR 888.3150 Regulation Name: Elbow Joint Metal/Polymer Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDC, JDB Dated: January 28, 2019 Received: January 30, 2019

Dear Stephen Peoples:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vesa	Digitally signed by Vesa Vuniqi -S
Vuniqi -S	Date: 2019.02.16 20:05:07 -05'00'

For: 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

510(k) Number (if known)

K181362

Device Name

TEMA Elbow System

Indications for Use (Describe)

TEMA Elbow System is intended for use in cemented applications for patients suffering from disability due to:

1. Elbow joint destruction which significantly compromises the activities of daily living
1. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
1. Rheumatoid arthritis or degenerative arthritis with incapacitating pain
1. Revision where other devices or treatments have failed.
1. Correction of severe functional deformity.
1. Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
1. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

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510(k) Summary of Safety and Effectiveness

Date Prepared: May 15, 2018 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 SPeoplesVMD@gmail.com PEOPLE&ASSOCIATED CONSULTING, LLC 5010 LODGE POLE LANE FORT WAYNE INDIANA, 46814 USA Phone: 260-645-0327 FAX: +39 0432945512

Product	CommonName	ProductCode	Regulation and Classification Name
TEMAElbowSystem	Total ElbowProsthesis	JDC	21 CFR 888.3150 Elbow jointmetal/polymer constrained cementedprosthesis
		JDB	21 CFR 888.3160 Elbow jointmetal/polymer semi-constrained cementedprosthesis

Description:

TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations.

The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies.

All of the system components are available in different sizes.

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Indications for Use:

TEMA Elbow System is intended for use in cemented applications for patients suffering from disability due to:

Elbow joint destruction which significantly compromises the activities of daily living 1.
Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular 2. necrosis with hemophilia.
1. Rheumatoid arthritis or degenerative arthritis with incapacitating pain
Revision where other devices or treatments have failed. র্বা
റ് Correction of severe functional deformity.
Treatment of acute or chronic fractures with distal humerus epicondyle involvement. 6.
Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion 7.

The unlinked, semi-constrained version is for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of dislocation or disengagement between ulnar and humeral components when intraoperative manual testing is performed.

Predicate Devices:

The following predicate devices for Limacorporate TEMA Elbow System:

Conrad Morrey Total Elbow (Zimmer Inc., K001989 /K053189); ●
Latitude Elbow Prosthesis (Tornier Inc., K100562 /K171010); ●
. Solar Elbow Prosthesis (Howmedica Osteonics Corp aka Stryker Corporation, K980502);
Discovery Elbow (Biomet Inc., K013042 / K051975 / K090473); ●
Nexel Total Elbow (Zimmer Inc., K123862). ●

Reference Devices:

K100858 – SMR Shoulder System
K133349 - SMR TT Metal Back Glenoid

Technological Characteristics to the Predicate Device(s):

The TEMA Elbow System has the same intended use, similar design and materials to the predicate devices. All of the systems feature humeral and ulnar components with articulating bushings at the joint. The TEMA Elbow System consists of modular assemblies to allow the replacement of the ulnar bearing, if needed, without removal of the humeral and ulnar assemblies. The modularity also provides an additional advantage that if replacement of the humeral and/or ulnar body is needed (e.g. due to damage from a traumatic event or due to excessive wear of the bushing of the humeral body) and the stem components are well fixed, the stems do not need to be removed. Only the disconnection of the humeral and ulnar bodies from the stems is required for their revision.

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Non-Clinical Testing:

Mechanical testing demonstrated the device's ability to perform in a substantially equivalent manner to the predicate devices in terms of:

Range of motion;
Fatigue testing of humeral stem; ●
Fatigue testing of ulnar stem; ●
Stability, fatigue, and corrosion testing of modular connections; ●
Wear testing.

Clinical Testing:

Clinical testing was not necessary to demonstrate substantial equivalence of TEMA Elbow System to the predicate devices.

Conclusions

The intended use, design, and materials of TEMA Elbow System are substantially equivalent to the intended use, design and materials of the predicate devices. Design Control analyses and testing indicate that no new issues regarding safety and effectiveness are raised by the design, materials or intended use of the Lima Elbow System.

Regulation Number and Section

§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device 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,”
(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,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(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 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”