The Ovation Tribute and Ovation Narrow Hip Stems are intended for use in a total hip replacement surgery. Total hip arthroplasty is intended to provide increased patient mobility and to decrease pain by replacing the damaged hip joint in patients having sufficiently sound bone to support the implants.

Indications for Use:

Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic arthritis.
Previously failed hip surgery.
Proximal femoral neck fractures or dislocation.
Idiopathic avascular necrosis of femoral head.
Non-union of proximal femoral neck fractures.
Treatment of fractures that are unmanageable using other forms of therapy.
Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

Device Description

The Ovation Tribute and Ovation Narrow Hip Stems are one-piece, tapered prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stems are manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136. Proximally, the stems are coated with titanium plasma spray per ASTM F1580. The stems have a neck with a 12/14 trunnion taper for modular attachment to femoral heads. To accommodate varying patient anatomy, the stems are available in a variety of sizes: lengths (74-142mm), horizontal offsets (34-49mm), vertical offsets (29-36mm), resection angle of 130°, and neck angle of 132°.

AI/ML Overview

The provided document is a 510(k) summary for the Ovation Tribute and Ovation Narrow Hip Stems. It describes the device, its intended use, indications for use, and a comparison to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.

This document describes a hip stem prosthesis, which is a physical implant, not a software or AI/ML device. Therefore, the questions related to AI/ML device performance (like accuracy, sensitivity, specificity, ground truth, expert adjudication, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

The "study" mentioned in the document is non-clinical performance testing conducted on the physical hip stems, not a study of an AI/ML algorithm's effectiveness.

Here's a breakdown of the relevant information from the document, recognizing that it's for a physical device:

K133386 - Ovation Tribute Hip Stem; Ovation Narrow Hip Stem

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria (Implicit from standard)	Reported Device Performance (Summary from submission)
Mechanical Performance	ISO 7206-6:1992	Fatigue performance as per standard for hip joint prostheses	Testing conducted in accordance with standard
	ISO 7206-4:2010	Distal fatigue performance as per standard for hip joint prostheses	Testing conducted in accordance with standard
Range of Motion	ISO 21535:2007(E)	Range of motion as per standard for hip joint prostheses	Analysis performed per standard
Coating Properties	Not specified (implied by "mechanical properties and microstructure analysis")	Mechanical properties and microstructure suitable for titanium plasma spray coating (ASTM F1580)	Coating underwent testing for mechanical properties and microstructure analysis

Note: The document states that "Non-clinical performance testing has been conducted in accordance with ISO 7206-6:1992 and distal fatigue in accordance with ISO 7206-4:2010. Range of motion analysis was performed per ISO 21535:2007(E). The plasma spray coating underwent testing for mechanical properties and microstructure analysis." The specific numerical acceptance criteria and detailed performance results are not provided in this summary, but are implicitly met by "in accordance with" and "underwent testing for".

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

Not applicable. This submission is for a physical medical device (hip stem), not an AI/ML device that uses digital data for testing. The "test set" refers to physical samples of the hip stems subjected to mechanical testing. The sample size for these non-clinical mechanical tests is not specified in this summary.

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. Ground truth, in the context of AI/ML, refers to human-labeled data. For a physical device, testing against international standards does not involve expert adjudication of "ground truth" in the same way. The standards themselves define the criteria.

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

Not applicable. Adjudication methods are relevant for resolving discrepancies in human expert labeling for AI/ML ground truth. This is not pertinent to mechanical testing of a physical 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

Not applicable. MRMC studies are used to evaluate diagnostic imaging devices, often with AI assistance. This submission is for a hip stem implant.

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

Not applicable. This question pertains to AI/ML algorithm performance.

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

Not applicable. For this physical device, the "ground truth" for its performance is determined by established engineering principles and international standards (ISO standards for mechanical testing).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of a physical hip stem being submitted under 510(k). This term is exclusive to machine learning.

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

Not applicable. As there is no training set, this question is irrelevant.

Summary

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K133386

ﻧﺰ

Section 5 510(k) Summary

MAR 1 1 2014

NAME OF SPONSOR:	Ortho Development Corporation12187 South Business Park DriveDraper, Utah 84020
510(k) CONTACT:	Mike EnsignDirector of Regulatory Affairs and Quality AssuranceTelephone: (801) 553-9991Facsimile: (801) 553-9993Email: mensign@odev.com
DATE PREPARED:	October 28, 2013
PROPRIETARY NAME:	Ovation Tribute Hip StemOvation Narrow Hip Stem
COMMON NAME:	Hip Stem Prosthesis
CLASSIFICATION:	Class II device21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis
DEVICE PRODUCT CODE:	LPH
PREDICATE DEVICES:	Ovation® Hip Stem, Ortho Development (K062775)Ovation 10/12 Hip Stem, Ortho Development (K131022)Taperloc® Complete Microplasty System, Biomet (K110400)Smith & Nephew SMF Hip Stem, Smith & Nephew (K103256)

5.1. Device Description

The Ovation Tribute and Ovation Narrow Hip Stems are one-piece, tapered prostheses, designed for single, uncemented use. Device fixation is achieved via press-fit in the medullary canal, which maximizes contact between the stem and bone. The stems are manufactured from titanium alloy Tì-6Al-4V ELI per ASTM F136. Proximally, the stems are coated with titanium plasma spray per ASTM F1580. The stems have a neck with a 12/14 trunnion taper for modular attachment to femoral heads. To accommodate varying patient anatomy, the stems are available in a variety of sizes: lengths (74-142mm), horizontal offsets (34-49mm), vertical offsets (29-36mm), resection angle of 130°, and neck angle of 132°.

Section 5, 510(k) Summary

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5.2. Intended Use

5.3. Indications for Use

Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis and/or post traumatic 1. arthritis.
1. Previously failed hip surgery.
1. Proximal femoral neck fractures or dislocation.
1. Idiopathic avascular necrosis of femoral head.
1. Non-union of proximal femoral neck fractures.
1. Treatment of fractures that are unmanageable using other forms of therapy.
Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities 7. where sufficient bone stock exists to properly seat the prosthesis.

Summary of Technological Characteristics 5.4.

The Ovation Tribute and Ovation Narrow Hip Stems represent an update to the existing predicate device Ovation® Hip Stem (K062775). The Ovation Tribute and Ovation Narrow Hip Stems combine the design features of the Ovation® Hip Stem (K062775) with a narrowed distal body to accommodate varying patient anatomy. Additionally, the Ovation Tribute stem features a reduced overall length in order to provide a microplasty option. The Ovation Tribute and Ovation Narrow Hip Stems have the same technological characteristics as the predicate devices. These include:

. Intended use (as described above)
. Basic design
. Material
. Sizes

Therefore, the fundamental scientific technology of Ovation Tribute and Ovation Narrow Hip Stems is the same as previously cleared devices.

5.5. Basis of Substantial Equivalence

The Ovation Tribute and Ovation Narrow Hip Stems are substantially equivalent to the previously cleared predicate devices based on similarities in intended use, overall design, materials, manufacturing methods, packaging, mechanical performance, and sterilization.

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Non-Clinical Test Summary 5.6.

Non-clinical performance testing has been conducted in accordance with ISO 7206-6:1992 and distal fatigue in accordance with ISO 7206-4:2010. Range of motion analysis was performed per ISO 21535:2007(E). The plasma spray coating underwent testing for mechanical properties and microstructure analysis.

5.7. Clinical Test Summary

No clinical studies were performed.

5.8. Conclusions

Based on the similarities to the predicate devices, and a review of the testing, the devices are substantially equivalent to femoral stem components that were cleared under K062775, K131022, K110400, and K103256.

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Public Health Service

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

March 11, 2014

Ortho Development Corporation Mr. Mike Ensign Director of Quality Assurance/Regulatory Affairs 12187 South Business Park Drive Draper, Utah 84020

Re: K133386

Trade/Device Name: Ovation Tribute Hip Stem; Ovation Narrow Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH Dated: January 28, 2014 Received: January 29, 2014

Dear Mr. Ensign:

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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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,

Lori A. Wigqins

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K133386

Device Name

Ovation Tribute Hip Stem; Ovation Narrow Hip Stem

Indications for Use (Describe)

Notably impaired hip joint due to ostcoarthritis, theumatoid arthrilis and/or post traumatic arthritis.
Previously failed hip surgery.
Proximal femoral neck fractures or dislocation.
Idiopathic avascular necrosis of femoral head.
Non-union of proximal femoral neck fractures.
Treatment of fractures that are unnanageable using other forms of therapy.
Benign or malignant bone tumors, congenital denormalities where sufficient bone stock exists to properly seat the prosthesis.

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

[x] Prescription Use (Parl 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE BORNEY CONTRACT PORTEDA USE ONLY CORPOR FOR FOR THE CONTRACT CONTRACT CONTRACTOR CONTRACTOR C

Concurrence of Center for Devices and Radlological Health (CDRH) (Signalure)

Elizabeth₪‎ ‎gank -S

Division of Orthopedic Devices

FORM FDA 3881 (9/13)

PSC Tok Schip Sortives (30) } 41 624)

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.