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 (NDJD) 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; inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of 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.

When used in combination with an appropriately sized Reflection metal acetabular shell, Reflection Acetabular Liners are intended for cemented or uncemented use. Reflection All Polyethylene Cups are intended for cemented use only. Reflection Acetabular Liners and All Polyethylene Cups are intended for single use only.

The Orthopaedic Division of Smith & Nephew, Inc. will utilize the VHP® sterilization process to terminally sterilize all orthopaedic implant components manufactured from UHMWPE material in the Reflection Acetabular System (i.e. acetabular liners and all polyethylene cups)

Device Description

There have been no changes in indications for use, design, or material property changes to any Reflection Acetabular Liner or All Polyethylene Cup components that will be sterilized using the VHP® process.

The VHP® sterilization process uses hydrogen peroxide (H2O2) vapor for sterilization of Reflection Acetabular System components (acetabular liners and all polyethylene cups) 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 Reflection® Acetabular System, focusing on the VHP® sterilization process. This document does not describe a study involving an AI/Machine Learning device or its performance criteria.

Instead, it details the sterilization process validation for medical devices (acetabular liners and all polyethylene cups made from UHMWPE). The "acceptance criteria" and "device performance" in this context refer to the sterilization efficacy and the material's integrity after sterilization, not the diagnostic performance of an AI system.

Therefore, I cannot fulfill your request for information related to AI/Machine Learning device acceptance criteria and study details based on the provided text. The questions you've asked (sample sizes for test sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are specific to AI/ML device validation, which is not what this document addresses.

However, I can extract the information related to the sterilization process validation as it appears in the document:

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

Acceptance Criteria	Reported Device Performance
Microbicidal effectiveness of vaporized hydrogen peroxide	Demonstrated
Effects of VHP® sterilization cycle on UHMWPE materials in which the product is packaged	Demonstrated
Process validation efforts to demonstrate effectiveness and reproducibility, resulting in a Sterility Assurance Level (SAL) of at least 10⁻⁶	Verified achievement of a SAL of 10⁻⁶. Safe, reproducible, predictable, and effective in sterilizing UHMWPE orthopaedic implants packaged and sealed in Tyvek®/Mylar® pouches.

Important Note: The questions related to sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, type of ground truth, training set sample size, and how training set ground truth was established are not applicable to this document, as it concerns the validation of a sterilization process, not an AI/ML diagnostic device.

Summary

{0}------------------------------------------------

MAR 1 5 2002

K012 787
1 OF 2

Orthopaedic Division

Smith & Nephew, Inc 217 Forminer

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 Reflection® Acetabular SystemSterilized with the VHP® Sterilization Process
Common or usual name:	Reflection Acetabular System UHMWPE Components
Classification name:	21 CFR 888.3358, hip joint, metal/polymer/metal, semi-constrained porous-coated, uncemented prosthesis21 CFR 888.3350, hip joint, metal/polymer, semi-constrained,cemented prosthesis

Substantially Equivalent Legally Marketed Devices

Reflection® Acetabular System - Smith & Nephew, Inc. �

Device Description

{1}------------------------------------------------

Device Intended Use

K012787
2 OF 2

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 theumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital eviphysis; fused hip; fracture of the pelvis and diastrophic variant; inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above nonmal danger of infection postoperatively; treatments of 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.

Technological Characteristics

The VHP® sterilization process is similar to the predicate sterilization processes listed above. Both of these predicate sterilization processes are intended to teminally 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 Reflection Acetabular System 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°

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

{2}------------------------------------------------

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 features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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: K012787

Trade/Device Name: UHMWPE Components of the Reflection® Acetabular Systems Regulation Number: 21 CFR 888.3358 and 21CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer/Metal, Semi-constrained Porous Coated Uncemented Prosthesis; and Hip Joint Metal/Polymer/Metal, Semi-constrained Cemented Prosthesis Regulatory Class: Class II Product Code: LPH, JDI 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.

Page 2 - Mr. David Henley

{3}------------------------------------------------

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,

for Mark N. Millerson

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

{4}------------------------------------------------

Premarket Notification Indications Enclosure

510(k) Number (if known): K012787

Device Name: UHMWPE Components of the Reflection® Acetabular System Sterilized with the VHP® Sterilization Process

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milluson

510(k) Number

Over-the-Counter Use $\frac{No}{(Optional Format 1-2-96)}$

Prescription Use non (Per 21 CFR 801.109)

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.