The SL-PLUS° Standard Femoral Stem with Ti/HA is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.

The SL-PLUS* Lateralized Stem with Ti/HA is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).

These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Device Description

The SL-PLUS Standard and Lateral Stems with Ti/HA are based on the uncoated design of SL-PLUS® Standard and Lateral Femoral Stems cleared via K072852. The subject stems are made from forged titanium alloy Ti-6Al-4Nb 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) summary for the SL-PLUS® Standard and Lateral Femoral Stems with Ti/HA. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical effectiveness studies with explicit acceptance criteria for performance metrics like sensitivity, specificity, or reader improvement with AI.

Therefore, many of the requested elements (sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth types and establishment methods) are not applicable or not explicitly stated in this document as it pertains to a medical device clearance process for a hip implant, not an AI/algorithm-based diagnostic device.

However, I can extract the information relevant to the substantial equivalence determination for this device, which serves as its "acceptance criteria" in the context of this 510(k) submission.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Outcome	Reported Device Performance (Summary of Study Results)
Material & Design	Overall design, materials, and indications for use substantially equivalent to predicate.	"Based on the similarities to the predicate components..."
Mechanical Strength	Capable of withstanding expected in vivo loading without failure.	"A review of the mechanical data indicates that the SL-PLUS® Standard and Lateral Femoral Stems with Ti/HA are capable of withstanding expected in vivo loading without failure."Specific tests performed: Stem Fatigue Testing, Neck Fatigue Testing.
Surface Characterization	Physical, chemical, or mechanical properties of the Ti/HA coating meet established standards.	"...discussed in detail in the Ti/HA Coating Master File MAF – 1762, Amendment 1 and are not included in this dossier." (Implies satisfactory data exists in the master file).

2. Sample size used for the test set and the data provenance:

Not Applicable. This document describes a mechanical device (femoral stem). The "test set" in this context refers to the physical devices subjected to mechanical testing, not a dataset of patient samples or images for an AI/diagnostic algorithm. The document does not specify the number of stems tested, only the types of tests performed.
Data Provenance: The tests are likely laboratory-based mechanical tests conducted at Smith & Nephew Orthopaedics AG or a contracted lab. Country of origin for the data is not specified but implicitly related to the manufacturing/testing location of Smith & Nephew (stated as Cordova, Tennessee, and Smith & Nephew Orthopaedics AG, which suggests global operations).

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

Not Applicable. No experts (e.g., radiologists) were used to establish "ground truth" in the context of a diagnostic test set, as this is a hip implant. The "ground truth" for a mechanical device is its ability to meet engineering specifications and withstand forces, which is assessed through standardized mechanical testing, not expert consensus.

4. Adjudication method for the test set:

Not Applicable. As there's no expert consensus or diagnostic test set, an adjudication method is not relevant. Mechanical test results are typically evaluated against pre-defined engineering standards.

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. This is a medical device (hip implant), not an AI diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not Applicable. This is a mechanical device, not an algorithm.

7. The type of ground truth used:

Engineering Specifications and Industry Standards: For the mechanical aspects (fatigue testing), the "ground truth" is adherence to established engineering specifications and industry standards for orthopedic implants, ensuring the device can withstand in vivo loading.
Predicate Device Characteristics: For substantial equivalence, the "ground truth" is the established safety and effectiveness profile of the legally marketed predicate devices (SL-PLUS® Standard and Lateral Femoral Stems K072852, and POLARCUP® Dual Mobility System K110135). The new device is compared directly to these.

8. The sample size for the training set:

Not Applicable. No training set exists as this is a mechanical device, not an AI algorithm.

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

Not Applicable. As there is no training set, there is no ground truth established for it.

Summary

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K120211 (pg 1/2)

JUL 1 9 2012

510(k) Summary SL-PLUS® Standard and Lateral Femoral Stems with Ti/HA

Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
Date of Summary:	January 23, 2012
Contact Person.	John Connor, Regulatory Affairs SpecialistT (901) 399-5944 F (901) 566-7961
Name of Device:	SL-PLUS° Standard and Lateral Femoral Stemwith 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-hip)metal/polymer cemented or uncementedprosthesis21 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

Device Description

Intended Use

The SL-PLUS Standard Femoral Stem with Ti/HA is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.

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The SL-PLUS Lateralized Stem with Ti/HA is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).

These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Technological Characteristics

A review of the mechanical data indicates that the SL-PLUS® 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 SL-PLUS° Standard and Lateral Femoral Stems with Ti/HA are substantially equivalent to the following commercially available predicate devices.

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & NephewOrthopaedics AG	SL-PLUS® Standard and Lateral Femoral Stems	K072852	2/9/09
Smith & NephewOrthopaedics AG	POLARCUP® Dual Mobility System	K110135	10/14/11

The following 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, Amendment 1 and are not included in this dossier.

Conclusion

As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the SL-PLUS 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 above.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

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

JUL 19 2012

Smith & Nephew, Inc. % Mr. John Connor Regulatory Affairs Specialist 1450 Brooks Rd. Memphis, TN 38116

Re: K120211

Trade/Device Name: SL-PLUS Standard and Lateral Femoral Stem with TifHA Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/polymer/metal semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, KWY, LWJ Dated: July 12, 2012 Received: July 13, 2012

Dear Mr. Connor:

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 r ou may, are severy hims of the Act include requirements for annual registration, listing of general only is provisitive, 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 r lease be deviloed a determination that your device complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must or any I edolul statutes and equirements, including, but not limited to: registration and listing (21

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Page 2 – Mr. John Connor

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
for Nat Nolin.

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

Enclosure

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Premarket Notification Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

SL-PLUS Standard and Lateral Femoral Stem with Ti/HA Device Name:

Indications for Use:

The SL-PLUS° Standard Femoral Stem with Ti/HA is intended for advanced hip joint wear due to degenerative, post-traumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.

The SL-PLUS* Lateralized Stem with Ti/HA is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).

These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801.109)

AND/OR

Over-the-Counter Use _ (Optional Format 1-2-96)

(Please Do NoT WRITE BELOW THIS LINE – Continue on Another Page if Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ASh

(Division Sign-Oft) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120211

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.