Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis;
rheumatoid arthritis;
arthritis secondary to a variety of diseases and anomalies and correction of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
revision procedures where other treatment or devices have failed; and
treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

Device Description

The Global Bipolar System consists of a bipolar liner, full lock ring liner, and a metal retaining ring. The system is to be used with existing femoral heads distributed by Smith & Nephew.

AI/ML Overview

The provided text is a 510(k) summary for the "Global Bipolar System," a hip joint femoral prosthesis. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data in the way one would expect for a diagnostic or AI-driven device.

Therefore, many of the requested points regarding acceptance criteria, study design, expert involvement, and ground truth are not applicable to this type of regulatory submission for a mechanical implant. The evaluation here hinges on material, design, and intended use comparison.

Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:

Acceptance Criteria and Device Performance (Not Applicable - Substitution with Equivalence Claim)

The document does not detail specific quantitative acceptance criteria or a "reported device performance" in the typical sense for a diagnostic device (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criterion for regulatory approval is the demonstration of substantial equivalence to predicate devices.

Acceptance Criterion (Implicit for device approval)	Reported Device Performance (Claimed for approval)
Mechanical equivalence to predicate devices	"capable of withstanding expected in vivo loading without failure"
Similarity in intended use	"The system is to be used with existing femoral heads distributed by Smith & Nephew."
Similarity in materials	(Implied by equivalence claim and statement "The components share the same intended use, material, and design features...")
Similarity in design features	(Implied by equivalence claim and statement "The components share the same intended use, material, and design features...")

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as quantitative metrics (e.g., "Must achieve X% accuracy"). The implicit acceptance criterion is substantial equivalence to predicate devices in terms of intended use, materials, design features, and mechanical performance.
- Reported Device Performance: The document states that a "review of the mechanical test data indicated that the Global Bipolar System is equivalent to devices currently on the market and are capable of withstanding expected in vivo loading without failure." No specific numerical performance values (e.g., shear strength, fatigue life cycles) are provided in this summary.
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 mention a test set sample size in the context of clinical or diagnostic performance. The evaluation is based on mechanical testing and comparison to predicate devices, not clinical studies with patients.
- Data Provenance: The mechanical test data would typically be generated in a lab setting, likely in the US where Smith & Nephew is based. No specific country of origin or retrospective/prospective nature is stated for this mechanical testing data.
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):
- Not Applicable. This is a mechanical implant, not a diagnostic device where "ground truth" is established by experts interpreting images or clinical data. The "ground truth" for mechanical performance would be established by standardized engineering tests and specifications.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. There is no "test set" requiring adjudication by human experts in this type of submission.
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 mechanical implant, not an AI-driven or diagnostic device that would involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a mechanical implant; there is no algorithm or standalone performance to evaluate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the mechanical performance, the "ground truth" would be engineering specifications and mechanical testing standards (e.g., ISO, ASTM standards for orthopedic implants), which determine if the device meets strength, fatigue, and other biomechanical requirements. No clinical ground truth (pathology, outcomes) is discussed in the context of this submission's evidence for performance.
The sample size for the training set:
- Not Applicable. There is no "training set" as this is not a machine learning or diagnostic device.
How the ground truth for the training set was established:
- Not Applicable. There is no "training set" for this device.

Summary

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K02 3743

Smith & Nephew, Inc. Summary of Safety and Effectiveness :Global Bipolar System

Contact Person and Address

Date of Summary: November 6, 2002

Janet Akil Director, Clinical and Regulatory Affairs Smith & Nephew, Inc., Orthopaedics Division 1450 East Brooks Road Memphis, TN 38116 (901) 399-5153

JAN 2 3 2003

Name of Device: Global Bipolar System Common Name: Bipolar System

Device Classification Name

21 CFR 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis

Substantial Equivalence Information

The Global Bipolar System is substantially equivalent to the following: Smith & Nephew Bipolar System, Centrax Bipolar System; Multipolar Bipolar System; Self-Centering Bipolar System; and the Ringloc Bipolar System.

Device Description

The Global Bipolar System consists of a bipolar liner, full lock ring liner, and a metal retaining ring. The system is to be used with existing femoral heads distributed by Smith & Nephew.

Indications for Use

The Global Bipolar System is indicated for the following:

Non-inflammatory degenerative joint disease including osteoarthritis, 1. osteonecrosis, avascular necrosis and post traumatic arthritis;
1. rheumatoid arthritis;
arthritis secondary to a variety of diseases and anomalies and correction of 3. functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
revision procedures where other treatment or devices have failed; and ধ:
treatment of proximal femoral non-union, femoral neck fracture, and trochanteric న. fractures of the proximal femur with head involvement.

Technological & Performance Characteristics:

The Global Bipolar System is similar to currently marketed bipolar systems. The components share the same intended use, material, and design features of one or more of the above mentioned predicates. A review of the mechanical test data indicated that the Global Bipolar System is equivalent to devices currently on the market and are capable of withstanding expected in vivo loading without failure.

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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 depiction of a bird or abstract human figure, composed of curved lines, within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 2003

Ms. Janet J. Akil Director, Regulatory Affairs Orthopaedic Division Smith & Nephew, Inc. 1450 Brooks Road. Memphis. Tennessee 38116

Re: K023743

Trade Name: Global Bipolar System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: II Product Code: KWY Dated: November 6, 2002 Received: November 7, 2002

Dear Ms. Akil:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 – Ms. Janet J. Akil

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

sincerely yours,

Mark A. Milkerss

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

Enclosure

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2374/3

Global Bipolar System Indications Statement

The Global Bipolar System is indicated for the following:

1. Non-inflammatory degenerative joint disease including osteoarthritis, osteonecrosis, avascular necrosis and post traumatic arthritis;
1. rheumatoid arthritis;
arthritis secondary to a variety of diseases and anomalies and correction 3. of functional deformity such as congenital hip dysplasia or ankylosing spondylitis;
revision procedures where other treatment or devices have failed; and 4.
న్. treatment of proximal femoral non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement.

****************************************************************************************************************************************************************************** Concurrence of CDRH, Office of Device Evaluation Prescription Use OR Over-The Counter Use (Per 21 CFR 801.109) Division Sign-Off) Division of General, Restorative and Neurological Devices (023743 10(k) Number -

Regulation Number and Section

§ 888.3390 Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis.

(a)
Identification. A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (§ 888.3027) or implanted by impaction.(b)
Classification. Class II.