The Tornier Aequalis Humeral Nail System is intended to provide temporary stabilization of various types of proximal and/or diaphyseal fractures of the humerus. Types of fractures include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures. Examples of specific indications according to AO classification include Type A-Fractures, dislocated, Type B Fractures, dislocated, Type C-Fractures, with intact humeral head, or Humeral Fractures according to Neer-Classification (2, 3 and 4 part fractures).

Device Description

The Tornier Aequalis Humeral Nail System includes intramedullary nails and screws. The Tornier Aequalis Humeral Nail is a straight, cannulated intramedullary nail with a tapered distal diameter. Nails are provided in right and left configurations with a 9mm diameter and 130mm length. The proximal end of the nail contains screw holes in four axes for proximal locking using 5mm cannulated or non-cannulated screws. The proximal end of the nail also contains a cannulated polyethylene insert with screw holes aligned with those of the nail. This insert is intended to help prevent the proximal screws from backing out. The distal end of the nail incorporates one screw hole for distal locking using 4.5mm screws. The nail and screws are manufactured from anodized Ti-6Al-4V alloy: The purpose of this 510(k) is to add 7mm or 8mm proximal diameter nails in lengths of 130mm, 210mm, 230mm, 250mm, and 270mm lengths to the predicate system.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tornier Aequalis Humeral Nail System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary is for a medical device (intramedullary nail), not a software or AI-based device. Therefore, the "acceptance criteria" and "reported device performance" are based on non-clinical engineering and material testing, not diagnostic performance metrics like sensitivity, specificity, or AUC.

Acceptance Criteria Category	Details/Metric	Reported Device Performance/Conclusion
Non-clinical Laboratory Assessment/Testing	Evaluated device performance per design requirements and risk analysis.	"All tests met the pre-established acceptance criteria."
Bending Calculation Comparisons	Comparison of bending properties.	Not explicitly detailed, but implied to have met criteria within "All tests met the pre-established acceptance criteria."
Torque Testing	Evaluation of torque resistance.	Not explicitly detailed, but implied to have met criteria within "All tests met the pre-established acceptance criteria."
Technological Characteristics Equivalence	Material, design, sizing, indications, sterilization, and failure strength compared to the predicate device (K082754).	"The technological characteristics... of the Tornier Aequalis Humeral Nail System are substantially equivalent to the predicate device."
Overall Equivalence to Predicate Device	Based on risk analysis and acceptable results from testing.	"Based on risk analysis and acceptable results from testing, the Tornier Aequalis Humeral Nail System was found to be substantially equivalent to the predicate device." (This is the overarching conclusion rather than a specific performance metric, but it indicates meeting regulatory acceptance.)

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable and not provided in the document. The studies conducted are non-clinical (engineering tests), not clinical studies involving patient data or test sets in the context of AI/software performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable and not provided. "Ground truth" in the context of this device would refer to material properties and mechanical integrity, which are established through standardized engineering tests, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are relevant for human interpretation or AI output, not for the direct measurement of mechanical properties in non-clinical tests.

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 information is not applicable. The device is an intramedullary nail, not an AI-based diagnostic or assistive software. Therefore, no MRMC study or AI assistance evaluation was performed.

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

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

7. The Type of Ground Truth Used

For this medical device, the "ground truth" used for evaluation would be:

Measured Material Properties: Standards for the Ti-6Al-4V alloy regarding its strength, biocompatibility, etc.
Mechanical Test Results: Direct measurements of bending strength, torque resistance, and other mechanical properties obtained through laboratory testing. These measurements are compared against pre-defined engineering specifications and performance of the predicate device.
Design Specifications: The documented design requirements and specifications for the nail's dimensions, features, and intended function.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The development and testing of this physical device do not involve "training sets" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

This information is not applicable and not provided. As explained above, there is no "training set" in the machine learning sense for this device. The development relies on engineering principles, materials science, and testing against established performance benchmarks for similar devices.

Summary

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510(k) Summary

510(K) Owner's Name:	Tornier Inc.
Address:	10801 Nesbitt Avenue SouthBloomington, Minnesota 55437
Phone and Fax Numbers:	Phone: 952.426.7600Fax: 952.426.7601
Name of Contact Person:	Janell A. Colley
Date Prepared:	December 5, 2013	DEC 05 2013
Trade or Proprietary Name:	Tornier Aequalis Humeral Nail System
Common or Usual Name:	Intramedullary Fixation Rod
Classification Name:	Product Code: HSB21 CFR 888.3020
Legally Marketed Device toWhich Your Firm IsClaiming Equivalence:	Tornier Aequalis Humeral Nail System, K082754
Description of The Device:	The Tornier Aequalis Humeral Nail System includes intramedullary nailsand screws. The Tornier Aequalis Humeral Nail is a straight, cannulatedintramedullary nail with a tapered distal diameter. Nails are provided inright and left configurations with a 9mm diameter and 130mm length. Theproximal end of the nail contains screw holes in four axes for proximallocking using 5mm cannulated or non-cannulated screws. The proximalend of the nail also contains a cannulated polyethylene insert with screwholes aligned with those of the nail. This insert is intended to help preventthe proximal screws from backing out. The distal end of the nailincorporates one screw hole for distal locking using 4.5mm screws. Thenail and screws are manufactured from anodized Ti-6Al-4V alloy:The purpose of this 510(k) is to add 7mm or 8mm proximal diameter nailsin lengths of 130mm, 210mm, 230mm, 250mm, and 270mm lengths to thepredicate system.
Intended Use of the Device:	The Tornier Aequalis Humeral Nail System is intended to providetemporary stabilization of various types of proximal and/or diaphysealfractures of the humerus. Types of fractures include, but are not limited to,non-unions, malunions, malalignments, pathological fractures, andimpending pathological fractures. Examples of specific indicationsaccording to AO classification include Type A-Fractures, dislocated, TypeB Fractures, dislocated; Type C-Fractures, with intact humeral head, orHumeral Fractures according to Neer-Classification (2, 3 and 4 partfractures).
TechnologicalCharacteristics ComparedTo Predicate Device:	The technological characteristics (material, design, sizing, indications,sterilization, and failure strength) of the Tornier Aequalis Humeral NailSystem are substantially equivalent to the predicate device.
Summary of theNonclinical TestsSubmitted:	Non-clinical laboratory assessment/testing was performed to evaluate thedevice performance per design requirements and risk analysis, includingbending calculation comparisons and torque testing. All tests met the pre-established acceptance criteria.
Conclusions Drawn Fromthe Nonclinical and ClinicalTests:	Based on risk analysis and acceptable results from testing, the TornierAequalis Humeral Nail System was found to be substantially equivalent tothe predicate device.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white and appears to be a scanned image.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

December 5, 2013

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

Tornier, Incorporated Ms. Janell A. Colley Regulatory Affairs Manager 10801 Nesbitt Avenue South Bloomington, Minnesota 55437

Re: K133376

Trade/Device Name: Tornier Aequalis Humeral Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: November 6, 2013 Received: November 7, 2013

Dear Ms. Colley:

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. Janell A. Colley

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark Nighterson -S

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

Enclosure

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Statement of Indications for Use

510(k) Number: K133376

Device Name: Tornier Aequalis Humeral Nail System

Indications for Use

Prescription Use X

Over-The-Counter Use

DEC 0 5 2013

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/3/Picture/11 description: The image shows a logo with the text "Casey L. Hanley, Ph.D." at the top and "Division of Orthopedic Devices" at the bottom. A horizontal line separates the two lines of text. The logo appears to be a seal or emblem, possibly associated with a medical or research institution.

Fax: (952) 426-7601 Phone: (952) 426-7600 Bloomington, MN 55437 10801 Nesbitt Avenue South

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.