The REPIPHYSIS Limb Salvage Proximal Femur and REPIPHYSIS Limb Salvage Total Femur are indicated for cemented procedures where radical resection and replacement of the proximal or total femur is required in skeletally immature patients (weighing up to 67 lbs) with osteosarcoma.

REPIPHYSIS Limb Salvage Proximal and Total Femur devices are intended for cemented use only.

Device Description

The REPIPHYSIS® Limb Salvage Proximal Femur is designed to replace the proximal femur with an expansion mechanism that has the identical internal components as the expansion mechanism in the previously cleared REPIPHYSIS® Limb Salvage System. The REPIPHYSIS® Limb Salvage Total Femur is designed to replace the entire femur with an expansion mechanism in the distal femoral portion that is identical to the expansion mechanism in the previously cleared REPIPHYSIS® Limb Salvage System.

REPIPHYSIS® Limb Salvage Proximal Femur

The REPIPHYSIS® Limb Salvage Proximal consists of a femoral stem, a femoral housing with expansion mechanism, and a femoral neck designed to be used with all previously cleared WMT 12/14 taper femoral heads. The components of the REPIPHYSIS® Proximal Femur are substantially equivalent to the components of the GUARDIAN™ Limb Salvage System for proximal femur replacement. The REPIPHYSIS® Limb Salvage Proximal Femur is custom assembled for each patient.

REPIPHYSIS® Limb Salvage Total Femur

The REPIPHYSIS® Limb Salvage Total Femur consists of a tibial base, axial bushing, axial pin, distal hinge femur housing with expansion mechanism, and a proximal femoral component. The components of the REPIPHYSIS® Total Femur are substantially equivalent to the components of the GUARDIAN™ Limb Salvage System for total femur replacement. The tibial base, axial bushing, axial pin, and distal hinge femur housing with expansion mechanism are identical to the components of the REPIPHYSIS® Limb Salvage System. The REPIPHY SIS® Limb Salvage Total Femur is custom assembled for each patient.

AI/ML Overview

The provided text is a 510(k) summary for the REPIPHYSIS® Limb Salvage Proximal Femur and Total Femur. This document details the device's intended use, description, and claims of substantial equivalence to previously cleared devices.

Crucially, this document does not describe a study with acceptance criteria and reported device performance in the way a clinical trial or AI/software validation study would. Instead, it focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical device approval.

Therefore, I cannot extract the information required for items 1-9 in your request, as the provided text does not contain a study with acceptance criteria, test sets, ground truth establishment, or performance metrics in that context.

Here's what I can provide based on the given document, addressing the spirit of your request where possible by noting what information is not present:

A table of acceptance criteria and the reported device performance
- N/A. The document does not describe a study with specific acceptance criteria and reported numerical performance data. The regulatory pathway here is based on substantial equivalence.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- N/A. This document does not describe a "test set" in the context of a performance study on humans or a software algorithm. The "test" here is a regulatory review based on comparing the new device to predicate devices.
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)
- N/A. There is no "ground truth" establishment in the context of a performance study on a test set mentioned in this document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No test set or adjudication method is described.
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
- N/A. This device is a physical implant (limb salvage system), not an AI or imaging diagnostic tool. Therefore, an MRMC study is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device, not an algorithm, so this concept does not apply.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A. No ground truth in the context of a performance study is described. The "truth" in this regulatory submission relies on the established safety and effectiveness of the legally marketed predicate devices.
The sample size for the training set
- N/A. No training set is mentioned as this is not a machine learning or AI device.
How the ground truth for the training set was established
- N/A. No training set or ground truth for it is mentioned.

Summary of the Acceptance Criteria and Study as Implied by the 510(k) Process (Not a Clinical Performance Study):

The acceptance criteria for this device are inherently tied to demonstrating substantial equivalence to predicate devices. The "study" proving this is the 510(k) submission itself, which presents information to the FDA for review.

Acceptance Criteria (Implied by 510(k) Substantial Equivalence):

Acceptance Criteria Category	Description	Reported Device Performance (as stated in the 510(k))
Intended Use	The intended use of the new device must be the same as or very similar to the predicate device, or if different, must not raise new questions of safety and effectiveness.	REPIPHYSIS® Limb Salvage Proximal Femur and Total Femur: Indicated for cemented procedures where radical resection and replacement of the proximal or total femur is required in skeletally immature patients (weighing up to 67 lbs) with osteosarcoma. This intended use is stated to be substantially equivalent to the GUARDIAN™ Limb Salvage System.
Technological Characteristics	The new device must have technological characteristics (e.g., materials, design, operating principles) that are substantially equivalent to the predicate device. If there are differences, they must not raise new questions of safety and effectiveness.	REPIPHYSIS® Limb Salvage Proximal Femur: Designed to replace the proximal femur with an expansion mechanism identical to the previously cleared REPIPHYSIS® Limb Salvage System. Components (femoral stem, femoral housing with expansion mechanism, femoral neck) are substantially equivalent to GUARDIAN™ Limb Salvage System components.
	REPIPHYSIS® Limb Salvage Total Femur: Designed to replace the entire femur with an expansion mechanism in the distal femoral portion identical to the previously cleared REPIPHYSIS® Limb Salvage System. Components (tibial base, axial bushing, axial pin, distal hinge femur housing with expansion mechanism, proximal femoral component) are substantially equivalent to GUARDIAN™ Limb Salvage System components. Tibial base, axial bushing, axial pin, and distal hinge femur housing with expansion mechanism are identical to the REPIPHYSIS® Limb Salvage System.
Safety and Effectiveness Data	The manufacturer must provide information (e.g., materials information, analysis data) to demonstrate that the device is as safe and effective as the predicate device. This often includes bench testing, biocompatibility data, and sometimes animal or clinical data if substantial equivalence cannot be shown based on technological characteristics alone.	Claimed: "The safety and effectiveness of the REPIPHYSIS® Limb Salvage Proximal Femur and Total Femur are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." (Specific data itself is not presented in this summary, but would have been in the full 510(k) submission to the FDA, likely including mechanical testing to support the design and material equivalence.)
Regulatory Classification	The device must fit into an existing classification that allows for 510(k) clearance (Class II in this case).	Classified as Class II: 21 CFR 888.3510 Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer; 21 CFR 888.3350 Prosthesis, Hip, Semi-Constrained, Metal/Polymer Cemented.

The "Study" Proving Compliance:

The "study" in this context is the premarket notification (510(k) submission) itself. The manufacturer, Wright Medical Technology, Inc., submitted detailed information (including device descriptions, comparison to predicate devices, materials information, and analysis data) to the FDA. The FDA's review of this submission against their regulatory standards for substantial equivalence constitutes the "proof" that the device meets the acceptance criteria for market clearance. The final determination of "Substantial Equivalence" by the FDA (as indicated by the letter from Mark N. Melkerson, Director, Division of General, Restorative and Neurological Devices) is the ultimate demonstration that these criteria have been met.

Summary

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510(K) SUMMARY JAN - 9 2008 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 serves as a Summary of Safety and Effectiveness for the use of the REPIPHYSIS® Limb Salvage Proximal Femur and Total Femur.

Submitted By:	Wright Medical Technology, Inc.
Date:	June 27, 2007
Contact Person:	Ehab Esmail
	Director, Regulatory Affairs
Proprietary Name:	REPIPHYSIS® Limb Salvage Proximal Femur andTotal Femur
Common Name:	Limb Salvage System
Classification Name and Reference:	21 CFR 888.3510 Prosthesis, Knee, Femorotibial,Constrained, Cemented, Metal/Polymer - Class II
	21 CFR 888.3350 Prosthesis, Hip, Semi-Constrained, Metal/Polymer Cemented- Class II
Device Product Code and Panel Code:	Orthopedics/87/JDI
	Orthopedics/87/KRO

DEVICE INFORMATION

A. INTENDED USE

REPIPHYSIS Limb Salvage Proximal and Total Femur devices are intended for cemented use only.

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B. DEVICE DESCRIPTION

REPIPHYSIS® Limb Salvage Proximal Femur

REPIPHYSIS® Limb Salvage Total Femur

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The material and design features of the proposed REPIPHYSIS® Proximal Femur and Total Femur are substantially equivalent to the REPIPHYSIS® Limb Salvage System. The surgical technique and intended use for the REPIPHYSIS® Proximal Femur and Total Femur are substantially equivalent to the GUARDIAN™ Limb Salvage System. The safety and effectiveness of the REPIPHYSIS® Limb Salvage Proximal Femur and Total Femur are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three overlapping wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion around the eagle.

Public Health Service

JAN - 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. % Mr. Ehab M. Esmail Director, Regulatory Affairs 5677 Airline Road Arlington, Tennessee 38002

Re: K072367

Trade/Device Name: REPIPHYSIS® Limb Salvage System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: II Product Code: KRO, JDI Dated: December 18, 2007 Received: December 28, 2007

Dear Mr. Esmail:

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

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Page 2 – Mr. Ehab M. Esmail

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. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Mullan

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): K072367

Device Name:_REPIPHYSIS® Limb Salvage System

Indications For Use:

REPIPHYSIS Limb Salvage Proximal and Total Femur devices are intended for cemented use only.

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)

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Barbave Buehrn

Division of General, Restorative, and Neurological Devices

510(k) Number K072367

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.