The Lattude EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The Latitude EVIM Total Elbow Arthroplasty system is intended for cemented use only.

Device Description

The Latitude EV™ Total Elbow Arthroplasty system is a 2- or 3-part total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The Latitude EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the elbow. The prosthesis is a semi-constrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.

The Latitude EV™ humeral and ulnar stems are available in multiple sizes for primary and revision surgery and include a plasma spray coating. The optional radial implant is uncoated and is available in several sizes corresponding to the humeral and ulnar construct size selected.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Latitude EV™ Total Elbow Arthroplasty device:

Based on the provided 510(k) summary, this device is a medical implant, not an AI/software device, which explains why many of the requested AI-specific points (like MRMC studies, standalone performance, training data, etc.) are not applicable.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Metric	Acceptance Criteria	Reported Device Performance
Humeral and Ulnar Stem Fatigue	Not explicitly stated in terms of specific pass/fail values, but implied to meet "substantial equivalence" to predicate device.	Testing performed to demonstrate substantial equivalence to the predicate device. (Specific numerical results or direct comparison values not provided in this summary).
Ulnar Cap Modular Connection Static Disassociation	Not explicitly stated in terms of specific pass/fail values, but implied to meet "substantial equivalence" to predicate device.	Testing performed to demonstrate substantial equivalence to the predicate device. (Specific numerical results or direct comparison values not provided in this summary).
Endotoxin Content	<20 EU/device	<20 EU/device
Indications for Use (Clinical Efficacy)	Relief of severe pain or significant disability, correction of deformities, revision procedures, treatment of unmanageable fractures.	Claimed to achieve these indications based on substantial equivalence to predicate devices, without new clinical studies.
Cemented Use	Device intended for cemented use only.	Device is intended for cemented use only as confirmed by design.
Design and Functionality	The device should not affect safety or effectiveness or raise new issues of safety or effectiveness compared to the predicate.	Design differences (making the radial implant optional and allowing a 2-part system) were demonstrated to not affect safety or effectiveness or raise new issues.

Study Details

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

Sample Size: Not specified for the bench tests. For mechanical testing, this typically refers to the number of components or assemblies tested.
Data Provenance: The studies were non-clinical performance bench testing. Thus, there is no patient data provenance (country of origin, retrospective/prospective) as it involves laboratory testing of physical devices.

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. This is a physical device (Class II medical implant), and the studies described are non-clinical mechanical bench tests and an endotoxin test. There is no "ground truth" in the clinical sense established by human experts for these types of tests. Compliance is typically assessed against engineering standards and specifications by engineers and quality control personnel.

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

Not Applicable. As mentioned above, this is non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnosis where there can be inter-reader variability.

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. An MRMC comparative effectiveness study was not done. This device is a physical total elbow arthroplasty, not an AI algorithm or a diagnostic tool that assists human readers.

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

No. This is a physical medical device. The concept of "standalone performance" applies to AI algorithms operating independently, which is not relevant here.

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

Not Applicable in the clinical sense. The "ground truth" for the non-clinical tests would be the established engineering specifications, material standards, and performance characteristics for mechanical strength, durability (fatigue), and biocompatibility (endotoxin levels). For the "substantial equivalence" claim, the predicate device's established performance serves as a comparative benchmark.

8. The sample size for the training set:

Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

Not Applicable. As there is no training set, there is no ground truth established for it.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with a triple-line element above them, resembling a stylized caduceus without the snake.

Public Health Service

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

August 31, 2017

Tornier Inc. Renee Stoffel Sr. Regulatory Affairs Specialist 10801 Nesbitt Ave South Bloomington, Minnesota 55437

Re: K171010

Trade/Device Name: Latitude EVTM Total Elbow Arthroplasty Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDB, JDC Dated: August 2, 2017 Received: August 3, 2017

Dear Renee Stoffel:

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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 (DICE) 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. 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 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 (DICE) 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,

Katherine D. Kavlock -S

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) K171010

Device Name Latitude EVTM Total Elbow Arthroplasty

Indications for Use (Describe)

The Latitude EVIM Total Elbow Arthroplasty system is intended for cemented use only.

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)

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510(k) Summary

Date Prepared: April 3, 2017

I. Administrative Information

Name:	Tornier, Inc.
Address:	10801 Nesbitt Avenue SouthBloomington, MN 55437United States of America
Contact Person:	Renee StoffelSr. Regulatory Affairs Specialist
Phone:	952-683-7471
Fax:	952-426-7601

II. Device Information

Name of Device:	Latitude EV TM Total Elbow Arthroplasty
Common Name:	Elbow Prosthesis
Classification Name:	21 CFR 888.3160, elbow joint metal/polymer semi-constrained cementedprosthesis.21 CFR 888.3150, elbow joint metal/polymer constrained cementedprosthesis.
Regulatory Class:	Class II
Product Code:	JDBJDC

III. Predicate Device Information

Latitude™ Elbow Prosthesis, K100562 Primary Predicate: Additional Predicate: Coonrad/Morrey Total Elbow, K053189

IV. Device Description

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V. Indications for Use

The Latitude EVTM Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The Latitude EVIM Total Elbow Arthroplasty system is intended for cemented use only.

VI. Comparison of Technological Characteristics with the Predicate Devices

The Latitude EVTM Total Elbow Arthroplasty system has the same intended use as the predicate devices. The humeral, ulnar, and optional radial implants are identical to those currently marketed in the Latitude EVTM Total Elbow Arthroplasty system (cleared as the Latitude™ Elbow Prosthesis, K100562). The purpose of this submission is to allow implantation of the Latitude EV prosthesis as a 2-part system consisting only of the humeral and ulnar implants. The radial implant will become optional. The two-part configuration is similar in function and design to the Coonrad/Morrey Total Elbow, K053189. The design differences have been demonstrated to not affect safety or effectiveness or raise new issues of safety or effectiveness.

VII. Performance Data

Non-clinical performance bench testing (mechanical testing) was performed to demonstrate substantial equivalence to the predicate device.

. Humeral and Ulnar Stem Fatigue Testing
Ulnar Cap Modular Connection Static Disassociation Testing
Endotoxin (<20 EU/device)

VIII. Clinical Study

Clinical studies were not required to demonstrate substantial equivalence between the subject device and the predicate device.

IX. Conclusions

The Latitude EVTM system described in this section has the same intended use and the same fundamental scientific technology as the predicate devices. The testing presented for the technological differences between the subject and predicate devices demonstrate that the Latitude EV™ Total Elbow Arthroplasty system is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow 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 consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.