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 the 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 stock exists to properly seat the prosthesis.

Device Description

Alpine® Cemented Hip System is comprised of a single piece, conical tapered, collared, femoral hip stem and centralizer designed for single, cemented use. Alpine® Cemented Hip Stem is manufactured from cobalt-chrome alloy (per ASTM F799-11) and Alpine® Centralizer is manufactured from poly(methyl methacrylate), PMMA. See MAF-300, PolyOne Corporation. Device fixation is achieved by cement mantle in the medullary canal.

Alpine® Cemented Hip Stem has a neck with a 12/14 trunnion for modular attachment to femoral heads and is offered in a variety of sizes to accommodate various patient anatomies. Sizes include the following ranges: lengths (114-132mm), horizontal offsets (35-48mm), and vertical offsets (26-30mm), with a resection angle of 40° and a neck angle of 130°.

Alpine® Centralizer is offered in sizes 8mm to 18mm in diameter to accommodate various combinations of stem/centralizer diameters depending on surgeon preference.

AI/ML Overview

This document does not describe an AI/ML powered medical device. It details the Alpine® Cemented Hip System, a medical device for hip replacement surgery. Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes, ground truth establishment, and MRMC studies is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and similarities in intended use, design, materials, manufacturing, packaging, and sterilization.

Here's an analysis of the provided information, noting what's present and what's explicitly absent (due to the nature of the device):

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

Acceptance Criteria (Non-Clinical Standards)	Reported Device Performance
Proximal fatigue (ISO 7206-6:2013(E))	Testing conducted. (Specific results not detailed in this summary, but implied to meet standards given "substantial equivalence" conclusion.)
Distal fatigue (ISO 7206-4:2010(E))	Testing conducted. (Specific results not detailed in this summary.)
Range of motion analysis (ISO 21535:2007(E))	Analysis performed. (Specific results not detailed in this summary.)

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

Not applicable. This document pertains to a physical medical device (hip implant) and its mechanical performance testing, not an AI/ML algorithm requiring a test set of data. The "test set" refers to mechanical samples of the device undergoing fatigue and range of motion tests.
The provenance of data for a mechanical test typically refers to the lab where the testing was performed. This information is not explicitly provided beyond stating the ISO standards.

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 information is for AI/ML performance evaluation. The "ground truth" for a mechanical device is its physical behavior under stress, measured objectively by engineering tests, not by expert consensus on data.

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

Not applicable. This is for AI/ML evaluation. Mechanical performance tests are objective measurements, not subject to adjudication.

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. The document explicitly states: "No clinical studies were performed." MRMC studies are used for evaluating diagnostic or interpretive AI/ML systems.

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

Not applicable. This is not an algorithm.

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

For the non-clinical tests, the "ground truth" would be the objective measurements of force, cycles, and displacement as defined and specified by the referenced ISO standards (e.g., whether the device fractured or deformed beyond acceptable limits under specified loads). This is determined by the testing methodology itself, not expert consensus on data.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm. There is no "training set."

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

Not applicable. There is no "training set" or ground truth for an AI/ML model for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three faces in profile, stacked on top of each other. The faces are black and are oriented to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the image.

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

February 18, 2016

Ortho Development Corporation Drew Weaver Director of Quality Assurance and Regulatory Affairs 12187 South Business Park Drive Draper, Utah 84020

Re: K153216

Trade/Device Name: Alpine® Cemented Hip System Regulation Number: 21 CFR 888.3350 Regulation Name: Hip joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: JDI, KWL, KWY, LPH, LZO, MBL Dated: November 3, 2015 Received: November 5, 2015

Dear Drew Weaver:

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 Parts 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 Industry and Consumer Education 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" (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 Industry and Consumer Education 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 N. Melkerson -S

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

See PRA Statement below.

Pg.1/1

510(k) Number (if known)

Device Name

Alpine® Cemented Hip System

Indications for Use (Describe)

This device is intended for use in total and hemi hip arthroplasty. The device is intended for single, cemented use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
1. Previously failed hip surgery.
1. Proximal femoral neck fractures or dislocation.
1. Idiopathic avascular necrosis of the 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 where stock exists to properly seat the prosthesis.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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12187 So. Business Park Drive Draper, Utah 84020 801-553-9991/fax 553-9993

orthodevelopment.com

Image /page/3/Picture/2 description: The image is a logo for "Ortho Development". The logo features a stylized purple circle with three curved lines emanating from it, followed by the word "ORTHO" in purple, block letters. Below "ORTHO" is the word "DEVELOPMENT" in a smaller, gray font with a trademark symbol.

Section 5 510(k) Summary

Name of Sponsor:	Ortho Development Corporation12187 South Business Park DriveDraper, Utah 84020
510(k) Contact:	Drew WeaverDirector of Quality Assurance and Regulatory AffairsTelephone: (801) 553-9991Facsimile: (801) 553-9993Email: DWeaver@orthodevelopment.com
Date Prepared:	February 17, 2016
Trade Name:	Alpine® Cemented Hip System
Common Name:	Total and Hemi Hip Replacement Prosthesis
Device ProductCode/Classification:	JDI- 21 CFR 888.3350, Hip joint metal/polymer semi-constrained cementedprosthesis
Subsequent DeviceProductCodes/Classifications:	KWL- 21 CFR 888.3360, Hip joint femoral (hemi-hip) metallic cemented oruncemented prosthesis
	KWY- 21 CFR 888.3390, Hip joint femoral (hemi-hip) metal/polymer cementedor uncemented prosthesis
	LPH- 21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis
	LZO- 21 CFR 888.3353, Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis
	MBL- 21 CFR 888.3358, Hip joint metal/polymer/metal semi-constrainedporous-coated uncemented prosthesis
Device Class:	Class II
Predicate Devices:	Encompass™ Cemented Hip System, K050637, Ortho Development CorporationSynergy Cemented Hip Stems, K990369, Smith & Nephew

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Device Description

Alpine® Centralizer is offered in sizes 8mm to 18mm in diameter to accommodate various combinations of stem/centralizer diameters depending on surgeon preference.

Intended Use

Alpine® Cemented Hip System is intended for use in total and hemi hip replacement surgery.

Indications for Use

This device is intended for use in total and hemi hip arthroplasty. The device is intended for single, cemented use only in cases of:

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

Summary of Technological Characteristics

Alpine® Cemented Hip System has the same technological characteristics as the predicate devices. Subject device stem is single piece, conical tapered, and collared. The proximal body has a recess in the anterior and posterior walls to aid in proximal cement fixation. The distal body has flattened geometries in the anterior and posterior walls to aid in distal cement fixation. The highly polished neck has an oval cross section for increased range of motion.

Subject device centralizer uses a tapered pin for fixation with the stem. It has 3 fins that aid in centering the stem within the medullary canal.

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Basis of Substantial Equivalence

Alpine® Cemented Hip System is substantially equivalent to previously cleared predicate devices based on similarities in intended use, overall design, materials, manufacturing methods, packaging, mechanical performance, and sterilization.

Non-Clinical Test Summary

Non-clinical performance testing has been conducted in proximal fatigue in accordance with ISO 7206-6:2013(E) and distal fatigue in accordance with ISO 7206-4:2010(E). Range of motion analysis was performed per ISO 21535:2007(E).

Clinical Test Summary

No clinical studies were performed.

Conclusions

Based on the similarities to the predicate devices, and a review of testing, Alpine® Cemented Hip System is substantially equivalent to predicate devices cleared in K050637 and K990369.

Regulation Number and Section

N/A