Total 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, 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 and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; 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 Hip System components are designed for single use only.

Device Description

The Smith & Nephew Hip System is comprised of cross-linked UHMWPE acetabular liners and cobalt chrome femoral heads. The acetabular liners are designed to mate to previously cleared Smith & Nephew Reflection metal acetabular shells. The cobalt chrome femoral heads are designed to function with the subject acetabular liners and to mate with Smith & Nephew femoral hip stems identified in this Special 510(k) Premarket Notification. The intended use, type of interface, and design features of the components comprising the Smith & Nephew Hip System are identical to other Smith & Nephew predicate devices identified in this submission.

AI/ML Overview

The provided document pertains to a 510(k) premarket notification for the Smith & Nephew Hip System, specifically focusing on cross-linked UHMWPE acetabular liner components and cobalt chrome femoral heads.

Based on the information provided in this 510(k) summary, the device is a medical implant, not an AI/ML powered device. Therefore, the questions regarding acceptance criteria, study details, human reader performance, ground truth, and training sets that are typically applicable to AI/ML powered medical devices are not relevant for this submission.

The "study" that proves the device meets acceptance criteria for this type of medical device is typically a demonstration of substantial equivalence to a predicate device, supported by "test data, material information, and substantial equivalence information."

Here's an interpretation based on the provided text, modified to fit the context of a non-AI/ML device:

Acceptance Criteria and Study for Smith & Nephew Hip System (Non-AI/ML Device)

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as stated in the 510(k) summary)
Material Composition Equivalence: Materials used are comparable to those in legally marketed predicate devices.	The Smith & Nephew Hip System is comprised of cross-linked UHMWPE acetabular liners and cobalt chrome femoral heads. The components are similar to predicate devices manufactured by Smith & Nephew and previously cleared for market. The "material" (and design features) are identical to the predicate devices identified in this submission.
Design Feature Equivalence: Design features are comparable to those in legally marketed predicate devices.	The acetabular liners are designed to mate to previously cleared Smith & Nephew Reflection metal acetabular shells. The cobalt chrome femoral heads are designed to function with the subject acetabular liners and to mate with Smith & Nephew femoral hip stems. The "design features" of the components are identical to other Smith & Nephew predicate devices identified in this submission.
Intended Use Equivalence: The intended use is comparable to that of legally marketed predicate devices.	The intended use is identical to other Smith & Nephew predicate devices identified in this submission. The indications for use are clearly stated for primary and revision surgery for various hip conditions.
Performance (Mechanical/Biocompatibility) Equivalence: Device performance (e.g., wear, strength, biocompatibility) is comparable to predicate devices and meets relevant standards.	"The safety and effectiveness for the subject devices are adequately supported by test data, material information, and substantial equivalence information provided in this Special 510(k) Premarket Notification." "Tests results indicate that the subject devices meet the requirements of the applicable guidance documents." (Specific tests or standards are not detailed in this summary, but this statement confirms their completion and positive outcome).

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

The document indicates that "test data" was used. For mechanical and material testing of orthopedic implants, a "test set" typically refers to the number of physical samples of the device and its components subjected to various biomechanical tests (e.g., fatigue, wear, strength, corrosion) and material characterization tests. The specific sample size for these tests is not specified in the provided 510(k) summary.

Data Provenance: The data would be derived from laboratory bench testing (e.g., in vitro mechanical testing) and material characterization performed according to established standards. The summary does not specify the country of origin for the testing, but it would presumably be in compliance with FDA requirements for medical devices marketed in the USA. Given the nature of mechanical testing, it is prospective in the sense that new samples are tested to demonstrate performance.

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

This question is not applicable as the device is a physical implant, not an AI/ML diagnostic or prognostic tool that relies on expert interpretation to establish a "ground truth" for a test set of data. "Ground truth" for this device would be established through engineering specifications, material standards, and biomechanical performance metrics.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in cases of diagnostic disagreement for image-based or clinical data. For an orthopedic implant, performance is assessed against predefined engineering and material standards, not through adjudication of expert opinions on a "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

This question is not applicable. This device is a physical orthopedic implant and does not involve AI assistance, human readers, or image interpretation. Therefore, an MRMC study is irrelevant.

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

This question is not applicable. The device is an orthopedic implant, not an algorithm.

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

For this medical implant, the "ground truth" is fundamentally based on:

Engineering Specifications and Standards: Compliance with recognized international and national standards for orthopedic implants (e.g., ISO, ASTM for materials, mechanical properties, wear resistance).
Biocompatibility Standards: Demonstration that materials are safe for implantation in the human body.
Predicate Device Performance: The primary "ground truth" for a 510(k) submission is often the established safety and effectiveness of a legally marketed predicate device. The new device must perform comparably.

8. The sample size for the training set

This question is not applicable as there is no "training set" in the context of an AI/ML algorithm for this physical orthopedic implant.

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

This question is not applicable as there is no "training set" for an AI/ML algorithm.

Summary

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K022902

OCT 02 2002

510(k) SUMMARY Smith & Nephew Hip System

In conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the Smith & Nephew Hip System.

Submitter's name:Submitter's address:	Smith & Nephew, Inc., Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Submitter's telephone number:	901-399-6487
Contact person:Date Summary prepared:	David HenleyAugust 30, 2002
Trade or proprietary name:	Smith & Nephew Hip System
Common or usual name:	Cross-Linked UHMWPE Acetabular Liner Components;Cobalt Chrome Femoral Heads
Classification name:	21 CFR 888.3358 Hip Joint metal/polymer/metal semi-constrained porous-coated uncemented prostheses, Class I
Device Product Code and Panel Code:	Orthopedics/87

Substantially Equivalent Legally Marketed Devices

Components comprising the Smith & Nephew Hip System are substantially equivalent to Sulzer Inter-Op Durasul Acetabular Liner Inserts and femoral heads that were cleared for market under K993259 and K002575.

Device Description

Device Intended Use

Technological and Performance Characteristics

The components comprising the Smith & Nephew Hip System are similar to predicate devices manufactured by Smith & Nephew and previously cleared for market. Thus, the intended use, material, and design features of these components are identical to the predicate devices identified in this submission. The safety and effectiveness for the subject devices are adequately supported by test data, material information, and substantial equivalence information provided in this Special 510(k) Premarket Notification Tests results indicate that the subject devices meet the requirements of the applicable guidance documents.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. The text is written in a simple, sans-serif font.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 02 2002

Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, Tennessee 38116

Re: K022902

Trade/Device Name: Linked UHMWPE Acetabular Liner Components and Cobalt Chrome Femoral Head 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: August 30, 2002 Received: September 3, 2002

Dear Mr. Henley:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Mr. David Henley

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

lo Mark N Milbersa

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Premarket Notification Indications Enclosure

022902 510(k) Number (if known):

Device Name: Smith & Nephew Hip System

Indications for Use:

Total 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, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJ) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; 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 Hip System components are intended for single use only.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

le Mark A Miller

Division Sion-Off Division of General, Restorative and Neurological Devices

510(k) Number .

K 0 22902

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use __ No (Optional Format 1-2-96)

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.