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

Device Description

The POLARSTEM Collared (Standard and Lateral) and Valgus femoral stems designed for noncemented use are made of a titanium alloy (Ti-6Al-4V) with a fully porous titanium plasma/hydroxyapatite coating (Ti/HA). The design incorporates a highly polished neck area, distal grooves to increase rotational stability, and a 12/14 taper. The collared and valgus femoral stems are substantially equivalent to the POLARSTEM standard and lateral femoral stem with Ti/HA cleared via K130728.

AI/ML Overview

The provided document pertains to a 510(k) premarket notification for a hip joint femoral stem (POLARSTEM Collared and Valgus Femoral Stem with Ti/HA). This type of submission is a regulatory pathway for medical devices that are "substantially equivalent" to a legally marketed predicate device.

Unlike studies for AI/software as a medical device (SaMD) or diagnostic devices, a 510(k) for a physical implantable device like a hip stem does not typically involve the acceptance criteria, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance metrics that are common for AI/SaMD studies. Instead, the "acceptance criteria" here refers to demonstrating substantial equivalence to a predicate device through engineering and mechanical testing.

Here's an attempt to answer your questions based on the provided document, interpreting "acceptance criteria" and "study" within the context of a 510(k) for an orthopedic implant:

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

For a 510(k) of an orthopedic implant, acceptance criteria are generally met by demonstrating that the new device performs similarly or better than a predicate device in specific mechanical and material tests, ensuring it is safe and effective for its intended use. The document confirms that the device meets these criteria by being "substantially equivalent" to its predicate.

Acceptance Criterion (Implicit)	Reported Device Performance (Achieved)
Withstand expected in vivo loading without failure.	Capable of withstanding expected in vivo loading without failure (based on mechanical data and testing).
Comparable mechanical characteristics to predicate device.	Mechanical data indicates substantial equivalence to the predicate (K130728).
Comparable material composition and properties to predicate.	The Ti/HA coating is identical in composition, properties, and manufacturing location to the predicate. Device is made of titanium alloy (Ti-6Al-4V).
Comparable indications for use to predicate.	Indications for use are substantially equivalent to the predicate, with minor clarifications.
Biocompatibility and material safety (implied by Ti/HA coating).	Surface characterization (physical, chemical, mechanical) discussed in Ti/HA Coating Master File MAF - 1762 Amendment 1 and 2 (not included in 510(k) summary but part of overall safety).

2. Sample sizes used for the test set and the data provenance

The document does not specify exact sample sizes for each mechanical test (e.g., number of stems tested for fatigue). It refers to "mechanical data" and "tests," implying standard engineering test methods using a sufficient number of samples according to relevant ASTM or ISO standards for orthopedic implants.

Sample Size for Test Set: Not explicitly stated for each test, but implied to be sufficient for engineering characterization according.
Data Provenance: The tests are performed by the manufacturer, Smith & Nephew, Inc., and the Ti/HA coating manufacturing is at Smith & Nephew AG. This is prospective testing performed for regulatory submission. Data origin is within a controlled manufacturing/testing environment, likely in the US or Europe given the company's global presence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable in the context of a 510(k) for a physical implant. "Ground truth" for mechanical properties is established through standardized engineering tests, not expert consensus on interpretations of medical data. The "experts" involve engineers and material scientists who design and test the device against established performance benchmarks and regulatory standards.

4. Adjudication method for the test set

Not applicable. Adjudication is relevant for subjective assessments (e.g., medical image interpretation). Mechanical testing results are objective measurements (e.g., breaking strength, fatigue cycles) that are compared against predefined limits or predicate device performance.

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 for diagnostic devices involving human interpretation of medical data, particularly in the context of AI/SaMD. This document is for a physical orthopedic implant.

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

Not applicable. This device is a physical implant, not an algorithm or software.

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

For this type of device, the "ground truth" for proving safety and effectiveness (i.e., substantial equivalence) is based on:

Engineering and Mechanical Test Standards: Adherence to recognized standards (e.g., ASTM, ISO) for implant materials and performance (e.g., fatigue strength, range of motion, material properties).
Predicate Device Performance: Direct comparison of the new device's performance against that of the legally marketed predicate device.
Material Characterization: Ensuring the materials meet established specifications for biocompatibility and mechanical properties, often referenced via master files (like the Ti/HA Coating Master File MAF - 1762 mentioned).

8. The sample size for the training set

Not applicable. There is no "training set" in the machine learning sense for this device.

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

Not applicable. There is no "training set" for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized image of a human face in profile, with three overlapping profiles suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

April 20, 2015

Smith & Nephew, Incorporated Mr. Jeff Sprague Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016

Re: K143739

Trade/Device Name: POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA 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, MEH Dated: March 10, 2015 Received: March 11, 2015

Dear Mr. Sprague:

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

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Page 2 - Mr. Jeff Sprague

(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 forth in the quality systems (OS) 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,

Lori A. Wiggins -S

for 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

Smith & Nephew POLARSTEM Collared and Valgus Femoral Stem with Ti/HA

510(k) Number (if known): K143739

Device Name: POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA

Indications for Use:

The POLARSTEM Collared and Valgus Stem with Ti/HA (INTEGRATION-PLUSY) is 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

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

X Prescription 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)

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510(k) Summary Smith & Nephew POLARSTEM Collared and Valgus Femoral Stem with Ti/HA

Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
Date of Summary:	April 1, 2015
Contact Person	Jeff Sprague, Regulatory AffairsT (901) 399-5215 F (901) 721-2736
Name of Device:	POLARSTEM Collared (Standard and Lateral)and Valgus Femoral Stem with Ti/HA
Common Name:	Total Hip Joint, Femoral Component,Cementless
Device Classification Name and Reference:	21 CFR 888.3353 – Hip jointmetal/polymer/metal semi-constrainedcemented or nonporous uncementedprosthesis21 CFR 888.3390 – Hip joint femoral (hemi-hipmetal/polymer cemented or uncementedprosthesis21 CFR 888.3360 – Hip joint femoral (hemi-hipmetallic cemented or uncemented prosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	LZO, KWY, LWJ, MEH

Device Description

Intended Use

The POLARSTEM Collared (Standard and Lateral) and Valgus Stem with Ti/HA (INTEGRATION-PLUS®) is indicated for:

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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

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

The above indications are substantially equivalent to the indications cleared for the POLARSTEM standard and lateral femoral stem with Ti/HA (K130728). The only difference is the removal of the following bullet points as they are considered subsets of the more general indications seen above. Removal of the following points does not change the indications.

All forms of osteoarthritis
Patients with hips at risk of dislocation
Femoral neck fracture or proximal fracture to hip joint

Technological Characteristics

A review of the mechanical data indicates that the POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA is capable of withstanding expected in vivo loading without failure.

Substantial Equivalence Information

The overall design, materials, and indications for use for the POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA are substantially equivalent to the following commercially available predicate devices. The Ti/HA coating on the POLARSTEM Collared and Valgus femoral stem is identical in composition, properties, and manufacturing location (Smith & Nephew AG) to the predicate below.

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & NephewOrthopaedics AG	POLARSTEM Standard and Lateral FemoralStems with Ti/HA	K130728	10/10/2013

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

. Hip Stem Fatigue Testing
. Range of Motion Analysis

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 Amendment 1 and 2 and are not included in this 510(k).

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Conclusion

As previously noted, this 510(k) Premarket Notification is being submitted to request clearance for the POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA coated by Smith & Nephew AG. Based on the similarities to the predicate component and a review of the mechanical testing performed, the devices are substantially equivalent to the commercially available predicate device listed above.

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.