The Tornier Inc. Latitude Elbow Prosthesis 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 osteoarthitis 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 Tornier Inc. Latitude Elbow Prosthesis is intended for cemented use only.

Device Description

Total Elbow replacement is used to treat a number of clinical conditions such as severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. They are also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of surgery is to restore the elbow joint to its best working condition and to reduce or eliminate pain. The Tornier Inc. Latitude Elbow Prosthesis is intended to accomplish these goals. The Tornier Inc. Latitude Elbow Prosthesis is intended for use as a cemented total elbow.

The Tornier Inc. Latitude Elbow Prosthesis is a 3-part system consisting of a humeral, an ulnar and a radial component.The humeral implant is modular and consists in the assembly of various sizes of humeral stem and humeral spool in order to better reproduce the functionality of the natural humerus. The prosthesis is a non constrained prosthesis and when it is used with the ulnar cap the prosthesis becomes a constrained prosthesis.

The present device submission corresponds to several changes made to the device cleared in the latest 510k K070787.

AI/ML Overview

This document is a 510(k) premarket notification for the Tornier Inc. Latitude Elbow Prosthesis. It describes modifications to an existing device and demonstrates substantial equivalence to predicate devices through various evaluations.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study details:

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

The provided text does not contain a table of acceptance criteria nor reported device performance in the manner typically associated with clinical performance studies or specific quantitative metrics for AI/ML devices.

Instead, the submission focuses on demonstrating substantial equivalence through various engineering and design-related evaluations rather than clinical performance metrics:

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness (overall)	The modifications (to the Latitude Elbow Prosthesis) "do not induce any new or higher risk compared to the predicate device and therefore both device (proposed and predicate) are substantially equivalent."
Functional Equivalence (reproduce natural humerus functionality)	The humeral implant is modular, consisting of various sizes of humeral stem and humeral spool "in order to better reproduce the functionality of the natural humerus." (This is a design goal, not a measured performance metric from a study.)
Structural/Mechanical Integrity	Verified and validated through "Cadaver evaluations; CAD evaluations; Mechanical bench testing." The results of these evaluations support substantial equivalence to the predicate device, implying that the modified device performs comparably in these aspects. Specific test parameters or pass/fail criteria are not detailed in this summary.
Sterilization and Packaging Integrity	Validated through "Sterilization and Packaging validation." This suggests that the device meets established standards for these processes, ensuring sterility and package integrity.

Crucially, this document is for a medical implant (prosthesis), not an AI/ML diagnostic or predictive device. Therefore, the concepts of sensitivity, specificity, accuracy, and reader performance you've asked about (typical for AI/ML) are not applicable here. The "acceptance criteria" here are related to engineering validation, material properties, and comparison to a predicate device, focusing on safety and efficacy in a mechanical context.

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

Test Set Sample Size: Not explicitly stated for specific tests.
- "Cadaver evaluations" were performed, but the number of cadavers is not mentioned.
- "Mechanical bench testing" was performed, but the number of test samples is not specified.
Data Provenance: Not specified, as this is primarily internal testing and evaluation data, not clinical patient data in the sense of AI/ML studies.

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)

This section is not applicable to this type of device submission. Ground truth, in the context of this device, refers to engineering specifications, material properties, and functional performance benchmarks rather than expert consensus on medical images or diagnoses.

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

This section is not applicable as there is no "adjudication" in the sense of reviewing disagreements among experts on a test set for this mechanical 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

This section is not applicable as this is a medical implant, not an AI-assisted diagnostic tool.

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

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

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

The "ground truth" for this device's evaluation would be based on:
* Engineering specifications and design requirements: For CAD evaluations.
* Biomechanical principles and established testing standards: For mechanical bench testing and cadaver evaluations. This would include metrics like range of motion, stability, load-bearing capacity, wear resistance, etc., compared against natural joint mechanics or predicate device performance.
* Industry standards for sterilization and packaging.

8. The sample size for the training set

This section is not applicable as this is a physical medical implant, not an AI/ML device requiring a training set.

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

This section is not applicable as this is a physical medical implant, not an AI/ML device.

Summary

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K100562

SECTION 5

510(k) SUMMARY

Summary of Safety and Effectiveness information Special 510(k) Premarket Notification - Tornier Inc. Latitude Elbow Prosthesis

Regulatory authority: Safe Medical Devices Act of 1990, 21 CRF 807.92

1) Device name

Trade name: Latitude Elbow Prosthesis Common name: Elbow Prosthesis Elbow joint metal/polymer semi-constrained cemented prosthesis Classification name: Elbow joint metal/polymer constrained cemented prosthesis 888.3160 and 888.3150 Classification number:

2) Submitter

Tornier Inc. 3601 West 76th Street Suite 200 Edina, MN 55435 Registration Number: 9100540

3) Company contact

Brahim Hadri Sr. Regulatory affairs Specialist 100 Cummings Center, Suite 444C, Beverly, MA 01915, U.S.A Phone: 1 978 232-9997 ext: 617 1 978-232-9998 Fax:

bhadri@tornier.com

1. Classification

Device class:	Class II
Classification panel:	Orthopedic
Product code:	JDB and JDC

5) Equivalent / Predicate device

Tornier Latitude Elbow Prosthesis, K000003, K011567, K031218, K050848 and K070787

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K100562

6) Device description

The present device submission corresponds to several changes made to the device cleared in the latest 510k K070787.

7) Materials

The humeral stem is available in CoCr alloy. The humeral spool is available in CoCr alloy with a PEEK-OPTIMA polymer insert. The humeral screw is available in stainless steel. The radial components are made of CoCr alloy and UHMWPE. The ulnar assembly has a stem component made of CoCr alloy and a bushing made of UHMWPE.

8) Indications

The Tornier Inc. Latitude Elbow Prosthesis is intended for cemented use only.

9) Substantial Equivalence

The modifications made to the proposed Tornier Inc. Latitude Elbow Prosthesis were verified and validated by performing Cadaver evaluations; CAD evaluations; Mechanical bench testing; as well as Sterilization and Packaging validation. The results of those evaluations allow us to conclude that the proposed Tornier Inc. Latitude Elbow Prosthesis described in this submission does not induce any new or higher risk compared to the predicate device and therefore both device (proposed and predicate) are substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion. To the right of the text is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 2 9 2010

Tornier, Inc. % Mr. Brahim Hadri Senior Regulatory Affairs Specialist 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915

Re: K100562

Trade/Device Name: Latitude Elbow Prosthesis Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDB, JDC Dated: June 9, 2010 Received: June 11, 2010

Dear Mr. Hadri:

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

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Page 2 - Mr. Brahim Hadri

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely vours.

Olabare Brechmo

Mark N. Me Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KI005L.2

Indications for Use

510(k) Number (if known):

Device Name: Latitude Elbow Prosthesis

Indications For Use:

The Tornier Inc. Latitude Elbow Prosthesis 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 osteoarthtitis 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 Tornier Inc. Latitude Elbow Prosthesis is intended for cemented use only.

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

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

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

Nabare Breshn A.M.
Concurrence of CDRH, Office of Device Evaluation (ODE)

vision of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K100562

510k Submission: Tornier Inc. Latitude Elbow Prosthesis

Page 10 of 89

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.