1. pathological fractures of the femoral neck
1. non-union of femoral neck fractures
1. aseptic necrosis of the femoral head and neck
1. primary pathology in the young involving the femoral head but with a non-deformed acetabulum.

Device Description

The design features of the GLADIATOR™ Bipolar System are summarized below:

. Shells manufactured from cast CoCr allov
. Shells available in O.D. sizes 36-65mm
. Bearing insert manufactured from cross-linked UHMWPE
Bearing insert available in I.D. (femoral head) sizes 22, 28, 32, 36mm .
Locking and support rings manufactured from UHMWPE .
All components permanently assembled during production .

AI/ML Overview

The provided document is a 510(k) summary for the GLADIATOR™ Bipolar System, a Class II medical device. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of performance metrics (like sensitivity, specificity, accuracy, etc.) typically associated with AI/software devices.

Instead, this 510(k) focuses on demonstrating substantial equivalence to existing predicate devices. This means the manufacturer is asserting that their device is as safe and effective as a legally marketed device that does not require premarket approval (PMA).

Here's why the requested information is absent and what the document does provide:

Type of Device: The GLADIATOR™ Bipolar System is a hip prosthesis, a physical implant. The questions you've asked are most relevant to software-as-a-medical-device (SaMD) or AI-powered diagnostic/prognostic devices, which rely on data analysis for performance measurement.
Regulatory Pathway: The 510(k) pathway for substantial equivalence does not typically require the type of clinical performance study to establish specific numerical acceptance criteria (e.g., sensitivity, specificity) for a physical implant device in the same way it would for a diagnostic algorithm. Instead, it relies on demonstrating similar design features, materials, and intended use as a predicate device, along with verification and validation (V&V) testing to ensure the device performs as intended and is safe. The document states, "The indications for use of the GLADIATOR™ Bipolar System are identical to the previously cleared predicate device. The design features and materials of the subject device are substantially equivalent to those of the respective predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices."

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an AI/software device, as this information is not present in the provided submission for a physical hip implant.

What the document does confirm is that the GLADIATOR™ Bipolar System was deemed "substantially equivalent" to a legally marketed predicate device by the FDA (K062693). This regulatory determination is the primary "acceptance criterion" for this type of device and submission.

Summary

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K062643

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

SEP 2 9 2006

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 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the GLADIATOR™ Bipolar System.

Submitted By:	Wright Medical Technology, Inc.
Date:	September 8, 2006
Contact Person:	Matt PaulRegulatory Affairs Specialist
Proprietary Name:	GLADIATOR™ Bipolar System
Common Name:	Bipolar Hip System
Classification Name and Reference:	21 CFR 888.3390 Prosthesis, hip, hemi-, femoral,metal/polymer, cemented or uncemented - Class II
Device Product Code and Panel Code:	Orthopedics/87/KWY

DEVICE INFORMATION

A. Intended Use

The GLADIATOR™ Bipolar System is indicated for the following conditions:

1. pathological fractures of the femoral neck
1. non-union of femoral neck fractures
1. aseptic necrosis of the femoral head and neck
1. primary pathology in the young involving the femoral head but with a non-deformed acetabulum.

B. Device Description

The design features of the GLADIATOR™ Bipolar System are summarized below:

. Shells manufactured from cast CoCr allov
. Shells available in O.D. sizes 36-65mm
. Bearing insert manufactured from cross-linked UHMWPE
Bearing insert available in I.D. (femoral head) sizes 22, 28, 32, 36mm .
Locking and support rings manufactured from UHMWPE .
All components permanently assembled during production .

C. Substantial Equivalence Information

The indications for use of the GLADIATOR™ Bipolar System are identical to the previously cleared predicate device. The design features and materials of the subject device are substantially equivalent to those of the respective predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Mr. Matt Paul Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

Re: K062693

Trade/Device Name: GLADIAFOR ""Bipolar System Regulation Number: 21 CFR 888.3390 Regulation Name: Hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWY Dated: September 8, 2006 Received: September 11, 2006

Dear Mr. Paul:

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. Matt Paul

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 (240) 276-0120. 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 with ber (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

N. Molkerson

Mark N. Melkerson 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):

Device Name: GLADIATOR™ Bipolar System

Indications For Use:

The GLADIATOR™ Bipolar System is indicated for the following conditions:

1. pathological fractures of the femoral neck
1. non-union of femoral neck fractures
1. aseptic necrosis of the femoral head and neck
1. primary pathology in the young involving the femoral head but with a non-deformed acetabulum.

Prescription Use X (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)

Sig. Off

(Division Sign-Division of General, Restorative, and Neurological Devices

Page 1 of 1

510(k) Number 11062643

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.