The Cofield2 Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are indicated for use as orthopaedic implants for the partial replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively.

The Cofield2 Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are intended for the following:

Proximal Humeral Prosthesis - (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonunion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.

Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) - severe destruction of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, osteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis avascular necrosis with secondary glenoid changes, radiation necrosis, and other failed reconstructive procedures. The subject all poly glenoid components are intended for cemented fixation only and for single use only.

The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all polyethylene glenoid components manufactured from UHMWPE material in the following product systems:

Cofield Total Shoulder System (all polyethylene glenoid components) .
Neer II Total Shoulder System (all polyethylene glenoid components) .
Neer III Total Shoulder System (all polyethylene glenoid components)

Device Description

There have been no changes in indications for use, design, or material property changes to any Cofield2, Neer II, or Neer III Total Shoulder System UHMWPE all polyethylene glenoid components that will be sterilized using the VHP® process.

The VHP sterilization process uses hydrogen peroxide (H2O2) vapor for sterilization of Coffeld2, Neer II, and Neer III Total Shoulder System components (all polyethylene glenoids) manufactured from UHMWPE using the Century SL VHP® Sterilizer. Sterilization is achieved by a series of H2O2 gas injections at deep vacuum set points. Aeration of the medical devices after sterilization is conducted by a series of chamber evacuations.

AI/ML Overview

The provided text describes the 510(k) summary for the UHMWPE Components of the Cofield2, Neer II, and Neer III Total Shoulder Systems sterilized with the VHP® Sterilization Process. The focus of the acceptance criteria and study here is on the sterilization process itself, not on the performance of the shoulder systems as medical devices. The document aims to demonstrate that the VHP® sterilization process achieves a required sterility assurance level (SAL) and does not negatively affect the material properties of the UHMWPE components.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for VHP® Sterilization Process)	Reported Device Performance (VHP® Sterilization Process)
Microbicidal effectiveness of the vaporized hydrogen peroxide to achieve a Sterility Assurance Level (SAL) of 10⁻⁶.	Test results demonstrated that the VHP® sterilization process is capable of terminally sterilizing UHMWPE orthopaedic implants and verifies achievement of a SAL of 10⁻⁶.
No detrimental effects of the VHP® sterilization cycle on UHMWPE materials.	The effects of the VHP® sterilization cycle on UHMWPE materials in which the product is packaged were evaluated. (No specific adverse effects reported, implying acceptance criteria met).
Process validation to demonstrate that the VHP® sterilization process is effective and reproducible.	Process validation efforts demonstrated that the VHP® sterilization process is effective and reproducible.
Safety, reproducibility, predictability, and effectiveness in sterilizing UHMWPE orthopaedic implants packaged and sealed in Tyvek®/Mylar® pouches.	The VHP sterilization process was also demonstrated to be safe, reproducible, predictable, and effective in sterilizing UHMWPE orthopaedic implants packaged and sealed in Tyvek®/Mylar® pouches.

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

The document does not explicitly state the specific sample sizes (e.g., number of UHMWPE components or test runs) used for the sterilization validation tests. It refers to "numerous tests."

Sample Size for Test Set: Not explicitly stated (referred to as "numerous tests").
Data Provenance: Not explicitly stated. The document is from Smith & Nephew, Inc., an orthopaedic division, implying the data would come from their internal testing or commissioned labs. Given the date (2002), it is likely retrospective or conducted specifically for this submission.

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

The concept of "experts" and "ground truth" in the typical medical imaging or diagnostic sense is not applicable here. The "ground truth" for sterilization is established through scientific and industry standards (e.g., SAL of 10⁻⁶), which are validated through microbiological and material science testing methods. Experts in sterilization science and material compatibility would be involved in designing and interpreting these tests, but their number and specific qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1) are typically used for subjective assessments by multiple human readers, common in medical imaging studies. Sterilization validation involves objective laboratory testing against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This type of study (MRMC) is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This submission is about the validation of a sterilization process, which does not involve human readers interpreting cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Yes, in essence, the sterilization validation studies are "standalone" in that they evaluate the performance of the process (VHP® sterilization) directly against established criteria, without human intervention in the outcome of the sterilization itself (though humans operate the sterilizer and conduct the tests). The tests assess the microbicidal effectiveness and material compatibility of the process independently.

7. The Type of Ground Truth Used

The ground truth used for this device (sterilization process) is primarily based on:

Microbiological Standards: Achieving a Sterility Assurance Level (SAL) of 10⁻⁶, which is a widely accepted industry standard for terminal sterilization indicating a probability of one in a million contaminated units. This is objectively measured and verified through biological indicators and process challenge devices.
Material Compatibility Standards: Demonstrating no adverse effects on the mechanical or chemical properties of the UHMWPE material due to the sterilization process. This is assessed through physical, chemical, and mechanical testing.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for a sterilization process involves developing and optimizing the process parameters through experiments, but this is not referred to as a "training set" in the context of this 510(k) summary.

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

Not applicable, as there is no "training set" in the AI/machine learning sense. The "ground truth" during the development and optimization of the VHP® sterilization process would have been established through a rigorous scientific and engineering approach, using microbiological assays and material characterization techniques to determine effective and safe process parameters.

Summary

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K012788

10F2

MAR 1 5 2002

Orthopaedic Division

Smith & Nephew, Inc. 1450 Brooks Rd., Memphis, TN 38116 901-396-2121, For information: 1-8 orders and order incomes: 1-80

Smith - Nephew

510(k) Summary of Safety and Effectiveness

Submitter's name:	Smith & Nephew, Inc., Orthopaedic Division
Submitter's address:	1450 Brooks Road, Memphis, TN 38116
Submitter's telephone number:	Direct phone: 901-399-6487 or FAX: 901-398-5146
Contact person:	David Henley, Senior Clinical/Regulatory Affairs Specialist
Date summary prepared:	March 15, 2002
Trade or proprietary device name:	UHMWPE Components of the Cofield2, the Neer II, and theNeer III Total Shoulder Systems Sterilized with the VHP®Sterilization Process
Common or usual name:	Cofield2, Neer II, and Neer III Total Shoulder SystemUHMWPE Components
Classification name:	21 CFR 888.3660, shoulder joint metal/polymer, semi-constrained cemented prosthesis

Substantially Equivalent Legally Marketed Devices

Cofield Total Shoulder System Smith & Nephew, Inc. �
Neer II Total Shoulder System Smith & Nephew, Inc. .
Neer III Total Shoulder System Smith & Nephew, Inc. �

Device Description

Device Intended Use

VHPCofNIN3510kSumS&E

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The Cofield2 Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are indicated for use as orthopaedic implants for the partial or total replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively.

The Cofield2 Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are intended for the following:

Proximal Humeral Prosthesis -- (1) complex, acute fractures or fracture-dislocations of the humeral head (e.g. trauma - three and four-part injuries in the Neer classification, or head splitting, or head impression fractures); (2) complex, chronic fractures or fracture-dislocations of the humeral head with malunion, nonumion of a small osteoporotic head fragment, or chronic dislocation with loss of humeral head cartilage, or large impression fractures; (3) avascular necrosis with intact glenoid cartilage; and (4) selected patients with arthritis who do not have adequate scapular bone to support a glenoid component or must engage in moderately heavy activities.

Total Shoulder Arthroplasty (when used in conjunction with a compatible glenoid component) - severe I out Dion of the glenohumeral articular surfaces with intractable chronic pain in rheumatoid arthritis, asteoarthritis, traumatic arthritis, cuff tear arthroplasty, ancient septic arthritis avascular necrosis with scoondary glenoid changes, radiation necrosis, and other failed reconstructive procedures. The subject all poly glenoid components are intended for cemented fixation only and for single use only.

The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to term ally sterilize all orthopaedic implant components manufactured from UHMWPE material in the Cofield Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System (all polyethylene glenoids).

Technological Characteristics

The VHP sterilization process is similar to the predicate sterilization processes listed above. Both of these predicate sterilization processes are intended to terminally sterilize orthopaedic implants/medical devices to a Sterility Assurance Level (SAL) of 10 . When compared to the VHP® process, the predicate processes also have similar technological characteristics.

Performance Characteristics

The Orthopaedic Division of Smith & Nephew, Inc. has conducted numerous tests as supporting evidence that the VHP® sterilization process is qualified for sterilization of all UHMWPE orthopaedic implants in the Coffeld', Neer II, and Neer III Total Shoulder Systems by demonstrating the following:

Microbicidal effectiveness of the vaporized hydrogen peroxide �
The effects of the VHP® sterilization cycle on UHMWPE materials in which the . product is packaged
Process validation efforts to demonstrate that the VHP® sterilization process is effective and � reproducible resulting in a SAL of at least 10-6

Test results demonstrated that the VHP® sterilization process is capable of terminally sterilizing UHMWPE orthopaedic implants and verifies achievement of a SAL of 10d. The VHP sterilization process was also demonstrated to be safe, reproducible, predictable and effective in sterilizing UHMWPE orthopaedic implants packaged and sealed in Tyvek®/Mylar® pouches.

1012788

20F2

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Image /page/2/Picture/1 description: The image is a black and white 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, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The caduceus is positioned in the center of the logo, with the text encircling it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2002

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

Re: K012788

Trade/Device Name: UHMWPE Components of the Cofield, the Neer II, and the Neer III Total Shoulder Systems Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer, Semi-constrained Cemented Prosthesis Regulatory Class: Class II Product Code: KWS Dated: December 14, 2001 Received: December 17, 2001

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,

Mark A Milken

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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Premarket Notification Indications Enclosure

510(k) Number (if known): Ko127888

Device Name: UHMWPE Components of the Cofield', Neer III Total Shoulder Systems Sterilized with the VHP® Sterilization Process

Indications for Use:

The Cofield' Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are indicated for use as orthopaedic implants for the partial replacement of the human shoulder joint articulating either directly against the glenoid face or a compatible glenoid component, respectively.

The Cofield2 Total Shoulder System, the Neer II Total Shoulder System, and the Neer III Total Shoulder System are intended for the following:

Cofield Total Shoulder System (all polyethylene glenoid components) .
Neer II Total Shoulder System (all polyethylene glenoid components) .
Neer III Total Shoulder System (all polyethylene glenoid components) �

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K012788

Prescription Use
CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)
(Per 21

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”