The SLR-PLUS Hip Stem is indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Orthopaedics AG SLR-PLUS Hip Stems are intended for single use only.

Device Description

Subject of this Traditional 510(k) premarket notification is the SLR-PLUS Standard and Lateral Femoral Stems. The subject devices are intended for primary hip arthroplasties and to replace previously failed femoral hip arthroplasties. The SLR-PLUS Standard Femoral Stems are designed for prosthetic arthroplasty in primary and revision surgery. The SLR-PLUS Lateral stem has been designed to optimize the lateralization of the femur (offset) in hip arthroplasty surgery. Both stems are manufactured from Ti-6Al-7Nb titanium alloy.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (femoral stems), and it does not describe an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device evaluations, such as ground truth, sample sizes for training/test sets, expert qualifications, adjudication methods, or MRMC studies, are not applicable.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing.

Here's an attempt to answer the questions based solely on the provided text, recognizing the limitations for an AI/ML context:

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

Acceptance Criteria (Standard)	Reported Device Performance	Comments
Neck fatigue testing per ASTM F 2068-03	Implied to meet or exceed.	"A review of the mechanical data indicates that the SLR-PLUS Standard and Lateral Femoral Stems are capable of withstanding expected in vivo loading without failure."
Neck fatigue testing per ISO 7206-6	Implied to meet or exceed.	"A review of the mechanical data indicates that the SLR-PLUS Standard and Lateral Femoral Stems are capable of withstanding expected in vivo loading without failure."
Distal fatigue testing per ISO 7206-4/8	Implied to meet or exceed.	"A review of the mechanical data indicates that the SLR-PLUS Standard and Lateral Femoral Stems are capable of withstanding expected in vivo loading without failure."
Range of Motion per EN ISO 21535	Implied to meet or exceed.	(See above)

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

The document does not specify the sample size for the mechanical tests. The data provenance is not mentioned, but it would typically be from laboratory testing rather than clinical data for this type of device.

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)

This is not applicable for a mechanical device. The "ground truth" for mechanical testing is established by compliance with the specified international standards (ASTM and ISO). No human experts are used to interpret the "ground truth" in this context.

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

Not applicable. Mechanical tests have objective outputs that are compared directly to standard specifications, not adjudicated by human experts.

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 device is a physical hip stem, not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. This device is a physical hip stem, not an algorithm.

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

The "ground truth" for the performance of this device is adherence to mechanical performance standards (ASTM F 2068-03, ISO 7206-6, ISO 7206-4/8, EN ISO 21535). The performance is assessed against the requirements and specifications defined in these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary

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510(k) Summary

Ve are smith&nephew

Submitted by:	Smith & Nephew, Inc.Orthopaedic Division1450 East Brooks RoadMemphis, Tennessee 38116APR 1 5 2010
Date of Summary:	April 8, 2010
Contact Person and Address:	Shereen Myers, Regulatory Affairs SpecialistT (901) 399-6325 F (901) 566-7075
Name of Device:	Smith & Nephew Orthopaedics AG SLR-PLUS Standard andLateral Femoral Stems
Common Name:	Hip Stem
Device Classification Name andReference:	21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncementedprosthesis21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis21 CFR 878.3300 Surgical mesh21 CFR 888.3350 Hip joint metal/polymer semi-constrainedcemented prosthesis
Device Class:	Class II
Panel Code:	Orthopaedics/87
Product Code:	LZO, subsequent LPH, MBL, MEH, JDI, JDJ

Device Description

Technological Characteristics

A review of the mechanical data indicates that the SLR-PLUS Standard and Lateral Femoral Stems are capable of withstanding expected in vivo loading without failure.

Intended Use

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510(k) Summary

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fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Orthopaedics AG SLR-PLUS Hip Stems are intended for single use only.

Substantial Equivalence Information

The substantial equivalence of the SLR-PLUS Femoral Stems is based on its similarities in indications for use, design features, operational principles, and material composition to the following predicate systems:

Smith & Nephew Orthopaedics AG SL-PLUS Standard and Lateral Hip Stems (K072852) .
Smith & Nephew Anthology Hip Stem (K052792) .
SL-PLUS AND SLR-PLUS Stems (K001942) .

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

Neck fatigue testing per ASTM F 2068-03 and ISO 7206-6 .
Distal fatigue testing per ISO 7206-4/8 .
Range of Motion per EN ISO 21535 .

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

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

Smith & Nephew, Inc. Orthopaedic Division % Ms. Shereen Myers Regulatory Affairs Specialist 1450 East Brooks Road Memphis, Tennessee 38116

APR 1 5 2010

Re: K093991

Trade/Device Name: SLR-PLUS Standard and Lateral Femoral Stems Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO, LPH, MBL, MEH, JDI, JDJ Dated: April 8, 2010 Received: April 9, 2010

Dear Ms. Myers:

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

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Page 2 - Ms. Shereen Myers

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 mav 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.

Sincerest yours,

Mark A. Milliceres

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): K093991

Device Name: SLR-PLUS Standard and Lateral Femoral Stems

Indications for Use:

Prescription Use __ X_ (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)

Qoutu for mxn

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

510(k) Number K093991

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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.