Total hip components are 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; 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 SMF Hip Stem components are intended for single use only and are to be implanted without bone cement.

Device Description

The Smith & Nephew SMF® Stem, previously marketed by Smith & Nephew as the MIS Hip Stem, is a straight, tapered, proximally loaded stem designed to match the geometry of the subject monobloc SMP femoral stem line additions are offered in sizes -1 and 0. The subject devices have fixed, non-modular necks with a 12/14 neck taper to accept currently available Smith & Nephew femoral heads, and are available in standard and high offset. The SMP monobloc femoral stems are manufactured from titanium alloy (Ti-6Al-4V) and are proximally coated with Smith & Nephew's Stiktite porous coating.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a hip stem device (Smith & Nephew SMF® Hip Stem line additions). This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, rather than conducting a full clinical study with specific acceptance criteria and detailed performance data like those typically found for novel devices or AI/software-as-a-medical-device.

Therefore, many of the requested elements (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size) are not applicable to this type of submission.

Here's a breakdown of what can be extracted and how it relates to the request:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) of this nature, the "acceptance criteria" revolve around demonstrating that the new device (SMF Hip Stem line additions - sizes -1 and 0) is substantially equivalent to predicate devices (SMF Hip Stem cleared in K080625 and Anthology Hip Stem cleared in K052792). The "performance" is demonstrated through a comparison of features and review of non-clinical testing.

Acceptance Criteria (Demonstrates Substantial Equivalence)	Reported Device Performance (Comparison)
Similar Indications for Use	✓ (Subject device has similar indications for use to predicates)
Similar Stem Material	Ti-6Al-4V (Same as predicates)
Similar Tapered Stem Geometry	✓ (Same as predicates)
Similar Medial Grit-Blasted Surface Finish	✓ (Same as predicates)
Similar Proximal Porous Coating	✓ (Same as predicates)
Similar Glass Bead Distal Tip	✓ (Same as predicates)
Similar Neck Taper	12/14 (Same as predicates)
Similar Standard and High Offset Options	✓ (Same as predicates)
Similar Polished Neck Area	✓ (Same as predicates)
Review of Performance Testing	"Fatigue strength testing has also been evaluated. A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices." Specific thresholds or numerical results are not provided in this summary.
No significant changes in overall design philosophy, intended use, and material choices	"Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate devices."

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

Not Applicable. This submission relies on demonstrating substantial equivalence through a comparison of device features and non-clinical performance testing (e.g., fatigue strength), not clinical test sets with patient data.

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

Not Applicable. No ground truth from experts on clinical data is mentioned as this is a device modification based on substantial equivalence and non-clinical testing. The "experts" would likely be the engineers and regulatory personnel involved in the design and testing, and the FDA reviewers.

4. Adjudication method for the test set

Not Applicable. No clinical test set.

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 physical medical device (hip stem), not an AI/software device.

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

Not Applicable. This is a physical medical device, not an algorithm/AI.

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

The "ground truth" here is the established performance and safety of the predicate devices and the results of non-clinical engineering tests (e.g., fatigue strength). The expectation is that because the new device is structurally and functionally equivalent to the predicate (with only minor changes to size offerings and neck type), it will perform safely and effectively in the same manner. This is based on engineering testing standards and comparison to legally marketed devices.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of this physical device submission.

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

Not Applicable. There is no "training set" for this submission type.

In summary: The provided document is a 510(k) submission for substantial equivalence. It is not an AI/software or novel device submission that would typically involve the detailed clinical study and performance metrics you've asked for. The "acceptance criteria" and "proof" are fulfilled by demonstrating that the new device is essentially the same as already cleared devices, supported by review of standard non-clinical performance data.

Summary

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K103256 (pg 1/2)

JAN 3 1 2011

Smith & Nephew, Inc. Summary of Safety and Effectiveness SMF® Hip Stem Line Additions

Date of Summary: 11/02/2010

Contact Person and Address Natalie P. Williams Regulatory Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 1901/399-5161

Name of Device: Smith & Nephew SMF® Hip Stem Common Name: Hip Stem Device Classification Name and Reference: 21 CFR 888.3358 Hip joint metal/polymer/metal semiconstrained porous-coated uncemented prosthesis Device Class: II Panel Code: Orthopaedics/87 LPH

Device Description

Intended Use

Total hip components are 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 (NID) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; 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 SMF Hip Stem components are intended for single use only and are to be implanted without bone cement.

Performance Data

Performance testing has been conducted for the subject devices in accordance with the following guidance documents:

Guidance Document for Testing Orthopaedic Implants with Modified Metallic Surfaces Apposing . Bone or Bone Cement, dated April 1994
Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked" Modular Implant . Components dated May 1995
Non-Clinical Information for Femoral Stem Prostheses, dated September 2007 .

Fatigue strength testing has also been evaluated. A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices.

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Substantial Equivalence Information

The materials, intended use, indications for use, sterilization, and overall design of the Smith & Nephew SMP Hip Stem line additions are substantially equivalent to the SMP Hip Stems cleared in premarket notification K080625 and the Anthology Hip Stems cleared via K052792. Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate devices.

Feature	Subject Size -1 and 0SMF © Hip Stems withStiktite	S&N SMF ©Hip Stem with Stiktite(K080625)	S&N AnthologyStem (K052792)
Similar Indicationsfor Use	✓	✓	✓
Size Offering	-1 and 0	1 - 9	1-14
Stem Material	Ti-6Al-4V	Ti-6Al-4V	Ti-6Al-4V
Tapered StemGeometry	✓	✓	✓
Medial Grit-BlastedSurface Finish	✓	✓	✓
Proximal PorousCoating	✓	✓	✓
Glass Bead Distal Tip	✓	✓	✓
Neck Options
Fixed orModular Neck	Fixed	Modular	Fixed
Neck Taper	12/14	12/14	12/14
Standard and HighOffset OptionsAvailable	✓	✓	✓
Polished Neck Area	✓	✓	✓

Table 1: Comparison of Size -1 and 0 Femoral Stems to Predicate Device

Conclusion

This Abbreviated 510(k) Premarket Notification is being submitted to request clearance for the size -1 and 0 SMF° Hip Stem line addition components. Based on the similarities to the predicate device and a review of the testing, the devices are substantially equivalent to femoral stem components currently marketed under K080625 and K052792.

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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 features a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

Smith & Nephew, Inc. % Natalie P. Williams Regulatory Affairs Specialist 1450 Brooks Road Memphis, TN 38116

JAN 3 1 2011

Re: K103256

Trade/Device Name: Smith & Nephew SMF Hip Stem Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH Dated: November 2, 2010 Received: November 3, 2010

Dear Ms. Williams:

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.

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Page - 2 - Ms. Natalie P. Williams

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 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 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.

Sincerely yours,

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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Indications for Use

510(k) Number (if known): K (03256 (rg 1/1)

Device Name: Smith & Nephew SMF Hip Stem

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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)

M. Mikkerson

(Division Division of Surgical, Orthopedic, and Restorative Device

510(k) Number K103256

Page 1 of _

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.