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 MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.

Device Description

The MDF Revision Hip System is comprised of a stem, modular neck, and modular sleeve component. The components of the revision hip system modularly connect together to form the complete MDF Revision Hip System construct. The Extra Small (XSM) Modular Sleeve line additions mate with similar size femoral stems in the MDF Revision Hip System and lock onto the proximal end of the stem. The XSM Modular Sleeves are manufactured from titanium alloy (Ti-6Al-4V). The XSM MDF Modular Sleeve line additions are grit-blasted and contain a threaded surface with a hydroxylapatite (HA) coating applied by a plasma spray technique.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Smith & Nephew MDF Modular Sleeve" hip implant component, a medical device. The information provided heavily focuses on demonstrating "substantial equivalence" to existing, legally marketed predicate devices, rather than presenting a performance study with detailed acceptance criteria and results against those criteria in the way one might expect for a novel AI device or a device with new functional claims.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or cannot be extracted from this type of regulatory submission. The "performance data" section refers to non-clinical (mechanical) testing, not clinical performance or AI/software performance.

Here's an attempt to answer based on the provided text, noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence of a medical device (hip implant component) and not an AI or software-driven device, the "acceptance criteria" and "reported device performance" are primarily related to mechanical and material characteristics and adherence to established guidance documents for non-clinical testing, rather than metrics like sensitivity, specificity, or accuracy against a ground truth. The acceptance criteria are implicitly met by demonstrating compliance with the referenced guidance documents and by showing that the new device's design, materials, and intended use are comparable to predicate devices.

Acceptance Criteria (Implied by Guidance)	Reported Device Performance (as stated in submission)
Compliance with "Non-Clinical Information for Femoral Stem Prostheses" (2007)	"Performance testing has been conducted for the subject devices in accordance with the following guidance documents..." (including this one)
Compliance with "Draft Guidance Document for Testing Non-Articulating, 'Mechanically Locked,' Modular Implant Components" (1995)	"...Performance testing has been conducted for the subject devices in accordance with the following guidance documents..." (including this one)
Compliance with "Calcium Phosphate (Ca-P) Coating Draft Guidance Document..." (1997)	"...Performance testing has been conducted for the subject devices in accordance with the following guidance documents..." (including this one)
Absence of new issues related to safety or effectiveness post-testing	"A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices."
Substantial equivalence in overall design, intended use, and material choices to predicate devices	"The overall design... is substantially equivalent to the modular sleeves that currently exist as part of the MDF Revision Hip System cleared via K081124. The XSM Modular Sleeves utilize an HA coating on a grit blasted surface... and are substantially equivalent to the Synergy Press Fit Stem (K970337)... no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate devices."
Materials (Substrate, Roughened Coating, HA Coating) matching predicate or accepted standards	Subject K100481: - Substrate: Ti-6Al-4V per ASTM F1472 - Roughened Coating: N/A; substrate is grit-blasted - HA Coating: HA Coated per ASTM F1185 (These align with or are found in predicate devices)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable. This document describes non-clinical performance testing (e.g., corrosion fatigue, dissociation testing of mechanical components), not a clinical study involving patients or a test set of data for an AI algorithm. The "test set" would refer to the physical devices subjected to mechanical testing. The specific number of devices tested is not provided in this summary but would be detailed in the underlying test protocols and reports.
Data Provenance: Not applicable. This refers to non-clinical laboratory testing of hip implant components. No human patient data is discussed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth, in the context of AI or diagnostic studies, is not relevant here. The "ground truth" for mechanical performance is implicitly defined by the physical properties of the materials and the engineering standards (ASTM, guidance documents) against which the device is tested.

4. Adjudication Method for the Test Set

Not applicable. This is not a study assessing human reader performance or diagnostic accuracy.

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 not an AI-driven device or study.

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

Not applicable. This is not an AI-driven device or study.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by engineering standards and guidance documents (e.g., ASTM standards for materials, FDA guidance for non-clinical testing of femoral stems and modular components). The performance data (e.g., environmental corrosion fatigue, pre-fatigue dissociation, post-fatigue dissociation) is evaluated against the requirements set forth in these documents to ensure safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is not an AI-driven device. There is no concept of a "training set" in this context.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set for this type of medical device submission.

Summary

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K100481 *"1/2

Smith & Nephew, Inc. Summary of Safety and Effectiveness MDF Revision Hip System Line Additions JUL 1 5 2010

Date of Summary: 07/14/2010

Contact Person and Address

Natalie P. Williams Regulatory Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 (901)399-5161

Name of Device: Smith & Nephew MDF Modular Sleeve Common Name: Modular Sleeve Device Classification Name and Reference: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Device Class: II Panel Code: Orthopaedics/87 MEH

Device Description

Indications for Use

Performance Data

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

. Non-Clinical Information for Femoral Stem Prostheses, dated September 2007
Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked," Modular Implant Components, dated May 1995

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Calcium Phosphate (Ca-P) Coating Draft Guidance Document for Preparation of FDA Submissions for Orthopaedic and Dental Endosseous Implants, dated February 1997

Environmental corrosion fatigue, pre-fatigue disassociation, and post-fatigue disassociation have 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 overall design of the Smith & Nephew Extra Small MDF Modular Sleeve line additions is substantially equivalent to the modular sleeves that currently exist as part of the MDF Revision Hip System cleared via K081124. The XSM Modular Sleeves utilize an HA coating on a grit blasted surface to achieve comed hiss fixation and are substantially equivalent to the Synergy Press Fit Stem (K970337) also featuring USA coating on a roughened titanium substrate to achieve cementless fixation. Giving coosideration to the evice 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. Additional design detail is provided in Table 1 below.

DeviceComparison	Modular SleevesSubject of K100481	Predicate MDF ModularSleeves Subject ofK081124	Predicate SynergyPress Fit StemsSubject of K970337
	HA on Grit BlastModular Sleeves	Stiktite plus HA CoatedModular Sleeves	HA on Grit BlastPress Fit Stems
Size Offering	Sizes 11 - 26/27; XSM	Sizes 11-25; S, M, L	Sizes 9-18
Materials
Substrate	Ti-6Al-4V per ASTMF1472	Ti-6Al-4V per ASTMF1472	Ti-6Al-4V per ASTMF1472
RoughenedCoating	N/A; substrate is grit-blasted to roughensurface.	CPTi per ASTM F67(StikTite)	N/A; substrate is grit-blasted to roughensurface.
HA Coating	HA Coated per ASTMF1185	HA Coated per ASTMF1185	HA Coated per ASTMF1185

Table 1: Comparison of Subject K100481 Modular Sleeves to Predicate Devices

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

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

JUL 1 5 2010

Smith & Nephew, Inc. % Ms. Natalie P. Williams 1450 Brooks Road Memphis, Tenessee 38116

Re: K100481

Trade/Device Name: Smith & Nephew MDF Modular Sleeve 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: MEH Dated: July 8, 2010 Received: July 9, 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.

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

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Page 2 - Ms. Natalie P. Williams

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.htmr.

Sincerely vours.

Mark N. Melkerso 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

KI00481 510(k) Number (if known):

Device Name: Smith & Nephew MDF Modular Sleeve

Indications for 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 (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 osteolomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.

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)

Omtu for mxn
(Division Sign-Off)

(Division Sign rthopedic, Division of Surgical, O and Restorative Devices

Page 1 of

510(k) Number K100481

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.