Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, 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 SMP Hip Stem is a straight, tapered, proximally loaded stem designed to match the geometry of the femur. The subject monoblock SMF° femoral stem line additions are offered in sizes 1 - 9. 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 SMF® monoblock 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 the Smith & Nephew SMF® Hip Stem line additions, a medical device for hip replacement. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information, addressing your specific points:

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

The document does not explicitly state numerical "acceptance criteria" in the way one might see for a diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating substantial equivalence to a previously cleared predicate device (K103256).

The "performance" is primarily demonstrated through the similarity of features and material attributes, and a review of performance testing.

Feature / Acceptance Criteria	Reported Device Performance (Subject SMF® Hip Stem Line Additions)	Notes on Meeting Criteria
Indications for Use	Similar to predicate	Verified as similar
Size Offering	Sizes 1-9 (Predicate: -1 and 0)	Expansion of sizes, but maintained design principles
Stem Material	Ti-6Al-4V	Identical to predicate
Tapered Stem Geometry	✓ (yes)	Identical to predicate
Medial Grit-Blasted Surface Finish	✓ (yes)	Identical to predicate
Proximal Porous Coating	✓ (yes)	Identical to predicate
Glass Bead Distal Tip	✓ (yes)	Identical to predicate
Fixed Neck	✓ (yes)	Identical to predicate
Neck Taper	12/14	Identical to predicate
Standard and High Offset Options Available	✓ (yes)	Identical to predicate
Polished Neck Area	✓ (yes)	Identical to predicate
Performance Testing	Conducted in accordance with guidance documents; review demonstrated no new safety/effectiveness issues.	This implies that the tests met the general requirements outlined in the guidance documents, indicating acceptable performance. Specific numerical results are not provided.

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 primarily refers to "performance testing" of the device, not a "test set" in the context of diagnostic algorithm validation. The testing appears to be bench testing or mechanical testing of the physical hip stem components. The specific sample sizes for these tests (e.g., number of stems tested for fatigue strength) are not provided. Similarly, the data provenance (country of origin, retrospective/prospective) is not applicable as it's not a clinical study involving patient data.

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 information is not applicable to this type of device submission. The "ground truth" for a hip stem is its mechanical integrity and biocompatibility, which are evaluated through engineering tests and material science, not through expert review of clinical cases.

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

This is not applicable to the submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or diagnosis. The performance evaluation here focuses on the physical properties of the device.

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

An MRMC study is not applicable as this is a physical implant device, not an AI or diagnostic tool requiring human reader interpretation. No such study was performed or described.

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

This is not applicable as the device is a physical hip stem, not an algorithm or AI.

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

The "ground truth" for this device's performance is established through compliance with recognized standards and guidance documents for orthopedic implants, material specifications (Ti-6Al-4V), and mechanical testing results (e.g., fatigue strength). The goal is to demonstrate that the expanded sizes of the hip stem maintain the safety and effectiveness characteristics proven for the predicate device.

8. The sample size for the training set

This is not applicable as this is a physical medical device, not an AI or machine learning model that requires a "training set."

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

This is not applicable for the reasons stated in point 8.

Summary

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OCT 24 2012

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

Date of Summary: 9/27/2012

Contact Person and Address

Natalie P. Williams Senior Regulatory Affairs Specialist Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 (901) 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

Hip components are indicated for.individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.

Smith & Nephew SMP 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:

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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.

Substantial Equivalence Information

The materials, intended use, indications for use, sterilization, and overall design of the Smith & Nephew SMF° Hip Stem line additions are substantially equivalent to the SMP Hip Stems cleared in premarket notification K103256. 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 SMF® Hip StemLine Additions	Predicate SMF® Hip Stems(K103256)
Similar Indicationsfor Use	✓	✓
Size Offering	1 - 9	-1 and 0
Stem Material	Ti-6Al-4V	Ti-6Al-4V
Tapered StemGeometry	✓	✓
Medial Grit-BlastedSurface Finish	✓	✓
Proximal PorousCoating	✓	✓
Glass Bead Distal Tip	✓	✓
Fixed Neck	✓	✓
Neck Taper	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 Special 510(k) Premarket Notification is being submitted to request clearance for the sizes 1 - 9 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 the femoral stem components currently marketed under K103256.

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Image /page/2/Picture/1 description: The image is a logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that converge at the bottom.

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

OCT 24 2012

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

Re: K123012

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: September 27, 2012

Received: September 28, 2012

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.

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. Natalie P. Williams

CFR Part 807); labeling (21 CFR Part 801); medical device 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,

fee Duth lind.

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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K1230126pg1117

510(k) Number (if known): K123012

Device Name: Smith & Nephew SMF Hip Stem

Indications for Use:

Smith & Nephew SMF° Hip Stem components are intended for single use only and are to be implanted without bone cement.

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)

AND/OR

Concurrence of CDRH/Office of Device Evaluation (ODE)

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

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Labels	Values
510(k) Number	K123012

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.