· Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement

• All forms of osteoarthritis

· Patients with hips at risk of distocation

· Femoral neck fracture or proximal fracture to hip joint

The POLARSTEM Standard and Lateral Femoral Stem with Ti/HA is intended for single use only and is to be implanted without bone cement.

Device Description

The POLARSTEM Standard and Lateral Stems with Ti/HA are similar to the SL-PLUS Standard and Lateral Femoral Stems with TilHA cleared via K120211 and the Anthology Hip Stems cleared via K052792. The subject stems are made from forged titanium alloy Ti-6AI-4V with a double coating (triple layer): titanium plasma sprayed coating (two layers) with an additional thin layer of hydroxyapatite.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, specifically the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA, which are components of a total hip joint replacement system.

Based on the nature of this document, it describes a
medical device, not an AI/ML algorithm or a diagnostic tool.

Therefore, most of the requested information regarding acceptance criteria, study design, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details does not apply to this type of submission.

The document discusses mechanical testing to demonstrate the device's capability to withstand in vivo loading without failure, and it leverages equivalence to previously cleared predicate devices.

Here's the relevant information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a table format for mechanical performance or directly report numerical performance data for the POLARSTEM stems beyond general statements. Instead, it relies on demonstrating substantial equivalence to predicate devices through mechanical testing.

Acceptance Criterion (Inferred from documentation)	Reported Device Performance (Inferred from documentation)
Capable of withstanding expected in vivo loading without failure (Mechanical Strength and Durability)	"A review of the mechanical data indicates that the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are capable of withstanding expected in vivo loading without failure."
Equivalence in Design, Materials, and Indications for Use to Predicate Devices	"The overall design, materials, and indications for use for the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are substantially equivalent to the following commercially available predicate devices: SL-PLUS Standard and Lateral Femoral Stems with Ti/HA (K120211), ANTHOLOGY Hip Stems (K052792), CORAIL Hip Stems (K953111)."
Satisfy Specific Mechanical Tests (Referenced)	"The following mechanical tests were used as a basis for the determination of substantial equivalence: Stem Fatigue Testing, Neck Fatigue Testing." (Details of pass/fail criteria for these tests are not provided in this summary but would be in the full submission).
Surface Characterization (Physical, Chemical, Mechanical) for Ti/HA Coating	"All tests which are in relation to the surface characterization (physical, chemical or mechanical) are discussed in detail in the Ti/HA Coating Master File MAF -- 1762." (Implies meeting established standards or predicate characteristics).

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

This information is not applicable in the context of an AI/ML algorithm. For mechanical testing of medical devices, "sample size" refers to the number of physical devices tested. The document does not specify the exact number of stems subjected to fatigue testing, but standard practice involves testing multiple samples to statistical significance. The data provenance would be from laboratory mechanical testing, not human patient data in the typical sense of AI/ML.

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

This is not applicable. For this type of device, ground truth is established through engineering and material science principles, laboratory testing under controlled conditions, and compliance with recognized standards (e.g., ISO standards for orthopedic implants). There are no "experts" in the sense of clinical reviewers establishing ground truth for individual 'cases' in the way it would apply to an AI diagnostic.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication is a process typically used for human review of data, often in clinical trials or for establishing ground truth labels in AI. Mechanical tests have objective pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

This is not applicable. MRMC studies are used to evaluate the performance of diagnostic tools (often AI) with and without human assistance. This document describes a physical implantable device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable as it concerns a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is established through:

Mechanical Engineering Standards: Compliance with industry-recognized standards for orthopedic implants regarding fatigue, strength, and material properties.
Material Science Principles: Verification of the properties of the Ti-6Al-4V alloy and the Ti/HA coating.
Predicate Device Performance: The primary method for proving substantial equivalence involves demonstrating that the new device performs comparably to legally marketed predicate devices, which have a track record of safe and effective use.

8. The Sample Size for the Training Set:

This is not applicable. The device is not an AI/ML algorithm, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the same reason as point 8.

Summary

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We are smith&nephew

Nephew - POLARSTEM andard and Lateral Femoral Stems with Ti/HA

K130728 Paqe 1 of 2

Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices DivisionOCT 1 0 207135 Goodlett Farms ParkwayCordova, Tennessee 38016
Date of Summary:	October 7, 2013
Contact Person and Address:	Sameer Mansour, Regulatory Affairs SpecialistT (901) 399-5579F (901) 566-7569
Name of Device:	POLARSTEM Standard and Lateral Femoral Stemswith Ti/HA
Common Name:Device Classification Nameand Reference:	Total Hip Joint, Femoral Component, Cementless21 CFR 888.3353 - Hip joint metal/polymer/metal semi-
	constrained cemented or nonporous uncementedprosthesis
	21 CFR 888.3390 - Hip joint femoral (hemi-hip)metal/polymer cemented or uncemented prosthesis
	21 CFR 888.3360 - Hip joint femoral (hemi-hip)metallic cemented or uncemented prosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	LZO, KWY, LWJ, MEH

Device Description

Intended Use

The POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are intended for advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head; failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement; all forms osteoarthritis; patients with hips at risk of dislocation; femoral neck fracture or proximal fracture to hip joint.

The POLARSTEM Standard and Lateral Femoral Stem with Ti/HA is intended for single use only and is to be implanted without bone cement.

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Technological Characteristics

A review of the mechanical data indicates that the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are capable of withstanding expected in vivo loading without failure.

Substantial Equivalence Information

The overall design, materials, and indications for use for the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are substantially equivalent to the following commercially available predicate devices.

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew, Inc.	SL-PLUS Standard and LateralFemoral Stems with Ti/HA	K120211	07/19/2012
Smith & Nephew, Inc.	ANTHOLOGY Hip Stems	K052792	10/07/2005
Landos, Inc.	CORAIL Hip Stems	K953111	12/27/1996

The following mechanical tests were used as a basis for the determination of substantial equivalence:

Stem Fatigue Testing
· · Neck Fatigue Testing

All tests which are in relation to the surface characterization (physical, chemical or mechanical) are discussed in detail in the Ti/HA Coating Master File MAF -- 1762.

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the POLARSTEM Standard and Lateral Femoral Stems with Ti/HA. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the commercially available predicate devices listed in the table above.

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Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized symbol resembling an eagle or bird with three curved lines representing wings or feathers. The symbol is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gb09 Silver Spring, MD 20993-0002

October 10, 2013

Smith & Nephew, Incorporated Mr. Sameer Mansour Regulatory Affairs Specialist 7135 Goodlett Farms Parkwav Cordova. Tennessee 38016

Re: K130728

Trade/Device Name: POLARSTEM Standard & Lateral Femoral Stems with TilHA Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, KWY, LWJ. MEII Dated: September 12, 2013 Received: September 13, 2013

Dear Mr. Mansour:

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 enacunent 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH docs 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 - Mr. Sameer Mansour

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Erin I. Keith

for

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

Enclosure

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Premarket Notification Indications for Use Statement

K130728 510(k) Number (if known):

Device Name: POLARSTEM Standard & Lateral Femoral Stems with TilHA

Indications for Use:

The POLARSTEM Standard and Lateral Femoral Stems with Ti/HA are indicated for:

· Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.

· Fracture or avascular necrosis of the femoral head

· Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement

• All forms of osteoarthritis

· Patients with hips at risk of distocation

· Femoral neck fracture or proximal fracture to hip joint

The POLARSTEM Standard and Lateral Femoral Stem with Ti/HA is intended for single use only and is to be implanted without bone cement.

AND/OR

Prescription x Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth L. Frank -S

Division of Orthopedic Devices

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.