The ADVANCE® Double High Insert is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint discase including osteoarthritis, traumatic arthritis, or avascular necrosis;
1. inflammatory degencrative joint diseasc including rheumatoid arthritis;
1. correction of functional deformity;
1. revision proccdures where other treatments or devices have failed; and
1. treatment of fractures that are unmanageable using other techniques.
  The ADVANCE® Double High Insert is for single cemented use.

Device Description

The design features of the ADVANCE® Double High Insert are summarized below:

Manufactured from UHMWPE ●
Offered in left and right designs, sizes 0-6, thicknesses of 10mm-25mm .
Allows for medial-pivot rotation
Allows for the retention of the cruciate retaining ligament .
Allows for higher flexion .

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device, the ADVANCE® Double High Insert, which is a tibial insert for knee arthroplasty. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a de novo study with acceptance criteria and a detailed study report.

Therefore, many of the requested details about acceptance criteria, specific study designs, sample sizes, expert qualifications, and ground truth establishment are not present in the provided text.

Here's an attempt to answer the questions based only on the provided information, noting where information is absent:

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

Acceptance Criteria	Reported Device Performance
Material Equivalence: Materials of the ADVANCE® Double High Insert are identical to predicate devices.	Achieved: The ADVANCE® Double High Insert uses UHMWPE, which is identical to the ADVANCE® Medial Pivot Insert and AXIOM® Standard Tibial Insert.
Indications for Use Equivalence: Indications for use are identical to predicate devices.	Achieved: The ADVANCE® Double High Insert's indications for use are identical to the ADVANCE® Medial Pivot Insert and AXIOM® Standard Tibial Insert.
Articulating Surface Equivalence: Articulating surface is substantially equivalent to predicate devices.	Achieved: The articulating surface of the ADVANCE® Double High Insert is substantially equivalent to the ADVANCE® Medial Pivot Insert and AXIOM® Standard Tibial Insert.
Overall Safety and Effectiveness: Safety and effectiveness are adequately supported by substantial equivalence information, materials information, and analysis data.	Achieved: The FDA found the device substantially equivalent to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: The submission is for substantial equivalence, not a performance study requiring a test set of data in the manner typically associated with AI/diagnostic devices. The safety and effectiveness are supported by comparing design features and materials to existing devices.

3. 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 / Not Provided: As this is a submission based on substantial equivalence for a physical medical implant, there is no "test set" requiring expert-established ground truth in the context described (e.g., for diagnostic accuracy).

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

Not Applicable / Not Provided: No test set or expert adjudication is described for this type of submission.

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

No: No MRMC study was performed or described. This type of study is not relevant for a knee implant based on substantial equivalence.

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

No: This is not an AI or algorithm-based device.

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

Not Applicable / Not Provided: The "ground truth" for this submission revolves around demonstrating that the device's design, materials, and intended use are sufficiently similar to predicate devices that have established their safety and effectiveness. This is based on engineering analysis, material specifications, and regulatory comparison rather than clinical "ground truth" derived from patient data.

8. The sample size for the training set

Not Applicable / Not Provided: As this is a submission for a physical medical implant based on substantial equivalence, there is no "training set" in the context of an AI/machine learning device.

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

Not Applicable / Not Provided: There is no training set mentioned in this submission.

Summary

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Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a stylized graphic consisting of three horizontal lines that converge to a point on the right side, resembling a wing or a stylized checkmark. The letters "TM" are located at the bottom right corner of the graphic.

KO33890 (Pg1 of 2 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information scrves as a Summary of Safety and Effectiveness for the use of the ADVANCE® Double High Insert.

Submitted By:	Wright Medical Technology, Inc.
Date:	December 15, 2003
Contact Person:	Katie Logerot
	Regulatory Affairs Associate
Proprietary Name:	ADVANCE® Double High Insert
Common Name:	Tibial Insert
Classification Name and Reference:	21 CFR 888.3560 Knce, Patellofemorotibial, Semi-constrained, cemented, Polymer/ metal/polymer
Device Product Code and Panel Code:	Orthopedics/87/JWH

DEVICE INFORMATION

A. INTENDED USE

The ADVANCE® Double High Insert is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint discase including osteoarthritis, traumatic arthritis, or avascular necrosis;
1. inflammatory degencrative joint diseasc including rheumatoid arthritis;
1. correction of functional deformity;
1. revision proccdures where other treatments or devices have failed; and
1. treatment of fractures that are unmanageable using other techniques.

B. DEVICE DESCRIPTION

The design features of the ADVANCE® Double High Insert are summarized below:

Manufactured from UHMWPE ●
Offered in left and right designs, sizes 0-6, thicknesses of 10mm-25mm .
Allows for medial-pivot rotation

headquarters 901.867.9971 phor 5677 Airline Road Arlington, TN 38002 Wright Medical Technology, Inc.

www.wmt.com

international subsidiarie 011.32.2.378.3905 Belgium 011.39.0250.678.227 Italy

011.81.3.3538.0474 Janar

011.33.1.45.13.24.40 France 011.44.1483.721.404 Uk

011.49.4161.745130 Germany

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K033890 (fg 2 of 2)

Allows for the retention of the cruciate retaining ligament .
Allows for higher flexion .

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use and materials of the ADVANCE® Double High Inscrt are identical to the ADVANCE® Medial Pivot Insert and AXIOM® Standard Tibial Insert. The articulating surface of the ADVANCE® Double High Insert is substantially equivalent to the ADVANCE® Medial Pivot Insert and AXIOM® Standard Tibial Insert. The safety and effectiveness of the ADVANCE® Double High Insert are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2004

Ms. Katic Logerot Regulatory Affairs Associate Wright Medical Technology, Inc. 5677 Airline Road Arlington, Tennessec 38002

Re: K033890

Trade/Device Name: ADVANCE® Double High Insert Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: December 15, 2003 Received: December 16, 2003

Dear Ms. Legerot:

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 I'DA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 ClFR 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. Donna Heraty

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,

Mail N. Millican

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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Indications for Use

510(k) Number (if known): 11 033890

Device Name: ADVANCE® Double High Insert

Indications For Use:

The ADVANCE® Double High Insert is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis;
inflammatory degenerative joint disease including theumatoid arthritis; 2)
correction of functional deformity; 3)
revision procedures where other treatments or devices have failed; and 4)
treatment of fractures that are unmanageable using other techniques. 5)

The ADVANCE® Double High Insert is for single cemented use.

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)

for Mark N. Melkerson

(Sign-Off)
Division of General, Restorative

in Neurological Devices

Page 1 of 1

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.