Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
inflammatory degenerative joint disease such as rheumatoid arthritis;
correction of functional deformity;
revision procedures where other treatments or devices have failed; and,
treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Device Description

The PRO-FEMUR Hip with plasma spray coating is a modular prosthesis comprising of four principal parts:

Distal Stem
Proximal Body
Extension Adapter
Modular Neck

The PRO-FEMUR distal stem with plasma spray coating will be available in three different lengths, namely SHORT, MEDIUM, and LONG, in increments of Irum from 10mm to 22mm in diameter. The SHORT distal stem (135mm) is straight, and the MEDIUM (175mm) and LONG (215mm) are both anatomically curved. All distal stems are cylindrical with plasma spray coating and a bullet shaped distal tip.

The PRO-FEMUR Proximal Body with plasma spray coating will be available in seven different sizes: Extra Small, Small, 4x Standard, and Large. The four standard components have the same length but became progressively wider.

The distal stem is secured to the proximal body by a morse taper and secondly by a fixation screw.

To further lengthen the implant by either 26 or 52 mm, extension adapters are available. They are positioned between the selected proximal body and distal stem and secured by morse taper and a longer fixation screw.

The proximal body has a specific oblong housing for the insertion of the twelve modular necks.

The design features of PRO-FEMUR Hip System with plasma spray coating are substantially equivalent to the design features of competitive devices previously cleared for market.

AI/ML Overview

The provided document, a 510(k) summary for the PRO-FEMUR Hip System, does not describe the acceptance criteria, or a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study would for a diagnostic device.

Instead, this document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, which is the primary mechanism for clearance under a 510(k) premarket notification. The "study" in this context is the submission itself, which primarily relies on comparative analysis and materials testing rather than clinical performance data against predefined acceptance criteria for accuracy, sensitivity, or specificity.

Here's why the structured information cannot be fully provided based on the input:

No "acceptance criteria" for performance metrics: The 510(k) pathway does not typically require the device manufacturer to establish and meet specific performance acceptance criteria (like sensitivity, specificity, accuracy percentages) from a clinical study for Class II devices. Instead, the focus is on showing the device is as safe and effective as a predicate device.
No "study" in the traditional sense: There isn't a prospective or retrospective clinical study of the PRO-FEMUR Hip System described with patient outcomes, expert ground truth, or statistical analysis of performance against a benchmark. The "study" is the submission of materials data and a comparison to predicate devices, which are deemed safe and effective.
No AI component: The PRO-FEMUR Hip System is a physical orthopedic implant, not an AI/ML-driven device. Therefore, questions about human-in-the-loop performance, standalone algorithm performance, or training set details are not applicable.

However, I can extract information related to the demonstration of safety and effectiveness as presented in the document, framed within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion/Requirement (Implied for 510(k))	Device Performance/Demonstration (PRO-FEMUR Hip System)
Intended Use Equivalence	Indicated for total hip arthroplasty for similar conditions (non-inflammatory/inflammatory degenerative joint disease, deformity correction, revision, proximal femur fractures) as predicate devices.
Material Equivalence	Utilizes materials comparable to predicate devices (metal/polymer, metal/ceramic/polymer, plasma spray coating). Specific material data mentioned as provided.
Type of Interface Equivalence	Designed for uncemented total hip arthroplasty, similar to predicate devices. Features modular components (distal stem, proximal body, extension adapter, modular neck).
Design Features Equivalence	Design features (e.g., modularity, tapering, sizing, plasma spray coating) are "substantially equivalent to the design features of competitive devices previously cleared for market."
Safety and Effectiveness	"Adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification." (Implies the testing and comparison demonstrate equivalent safety/effectiveness).

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This is a 510(k) submission for an orthopedic implant. There is no "test set" of patient data in the sense of a diagnostic algorithm or image analysis. The "testing results" refer to material and mechanical tests (e.g., fatigue, wear) on the device components, not clinical performance on a patient cohort. The document does not specify the number of units tested.
Data Provenance: Not applicable in the context of clinical patient data. The "data" primarily refers to engineering and material testing data, and comparative design analyses.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No ground truth in the clinical diagnostic sense is established by external experts for this type of submission. The safety and effectiveness are established by the manufacturer through comparison to predicate devices and mechanical testing, and then reviewed by FDA scientific/regulatory experts.

4. Adjudication method for the test set

Not Applicable. No clinical test set or adjudication process for interpreting patient outcomes is described in this 510(k) summary.

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

Not Applicable. The PRO-FEMUR Hip System is a physical orthopedic implant, not an AI device.

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

Not Applicable. The PRO-FEMUR Hip System is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used

Not Applicable in the clinical diagnostic sense (e.g., expert consensus, pathology, outcomes data). The "ground truth" for this device's clearance is its demonstrated substantial equivalence to legally marketed predicate devices, supported by engineering design specifications, material properties, and mechanical testing data that confirm its performance characteristics (e.g., strength, durability, wear resistance) are comparable to those predicates.

8. The sample size for the training set

Not Applicable. The device is not an AI/ML system that requires a "training set."

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

Not Applicable. The device is not an AI/ML system.

In summary, the provided document is a 510(k) summary for a physical medical device. The "acceptance criteria" are regulatory requirements for demonstrating substantial equivalence to a predicate device, primarily through comparative analysis of intended use, technology, materials, and design features, along with non-clinical testing (e.g., mechanical testing). It does not involve performance metrics like sensitivity/specificity derived from a clinical study with patient data and expert-established ground truth.

Summary

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OCT - 3 2001

lord

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 serves as a Summary of Safety and Effectiveness for the use of the PRO-FEMUR Hip System.

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc.

July 3, 2001

Ehab M. Esmail Manager, Regulatory Affairs

PRO-FEMUR

TOTAL HIP SYSTEM

PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENT - Class II

PROSTHESIS. HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED- Class II

Device Product Code and Panel Code:

Orthopedics/87/ LWJ and LZO

DEVICE INFORMATION

A. INTENDED USE

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity;
1. revision procedures where other treatments or devices have failed; and,
1. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Image /page/0/Picture/29 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol above the word "WRIGHT" in a bold, sans-serif font. Below the name is the text "MEDICAL TECHNOLOGY, INC." in a smaller, sans-serif font with a line above it.

Image /page/0/Picture/30 description: The image shows a black and white graphic of a globe. The globe is partially obscured by a dark, irregular shape, possibly representing a landmass or cloud cover. The globe is surrounded by a circular border, which is also partially obscured. The image has a grainy texture, suggesting it may be a low-resolution scan or a photocopy.

510(K) SUMMARY

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The PRO-FEMUR Hip System are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

B. DEVICE DESCRIPTION

The PRO-FEMUR Hip with plasma spray coating is a modular prosthesis comprising of four principal parts:

Distal Stem 해
Proximal Body 미
에 Extension Adapter
용 Modular Neck

5107RT SUMMARY " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

The distal stem is secured to the proximal body by a morse taper and secondly by a fixation screw.

The proximal body has a specific oblong housing for the insertion of the twelve modular necks.

The design features of PRO-FEMUR Hip System with plasma spray coating are substantially equivalent to the design features of competitive devices previously cleared for market.

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, material, type of interface, and design features of PRO-FEMUR Hip System are substantially equivalent to the competitive devices previously cleared for market. The safety and effectiveness of the PRO-FEMUR Hip System are adequately supported by the substantial equivalence information, materials data, and testing results provided within the Premarket Notification.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized symbol that resembles an abstract eagle or bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 3 2001

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

Re: K012091

Trade/Device Name: PRO-FEMUR Hip System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, LWJ, MAY Dated: July 3, 2001 Received: July 5, 2001

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 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. Ehab M. Esmail

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 Mulkern

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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Image /page/4/Picture/0 description: The image shows the logo for Wright Medical Technology, Inc. The logo features a stylized "W" symbol on the left, followed by the word "WRIGHT" in large, bold letters. Below "WRIGHT" is the text "MEDICAL TECHNOLOGY, INC." in a smaller font. The address "5677 AIRLINE ROAD ARLINGTON, TN 38002" and phone number "901-867-9971" are printed below the company name.

PRO-FEMUR HIP SYSTEM

INDICATIONS STATEMENT

Indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
1. inflammatory degenerative joint disease such as rheumatoid arthritis;
1. correction of functional deformity;
1. revision procedures where other treatments or devices have failed; and,
1. treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General Restorative Devices 510(k) Number

Prescription Use
(Per21 CFR 801.109)

Mark n Milkuson

Over-The Counter Use (Optional Format 1-2-96)

Restorative

5100k) Number

Image /page/4/Picture/17 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the words "WRIGHT MEDICAL TECHNOLOGY" stacked on top of each other. Below the logo is the text "A Wright Medical Group Company".

INDICATIONS STATEMENT

Image /page/4/Picture/19 description: The image shows a black and white drawing of a globe. The globe is tilted on its axis and is sitting on a stand. The continents of Asia and Australia are visible on the globe. The drawing is simple and has a vintage look.

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.