The Wright Total Hip Implant Stems for use with these instruments are 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; and,
revision procedures where other treatments or devices have failed
Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty.

Device Description

The design features of the Anterior Approach Hip Surgery Instruments are summarized below:

Manufactured from Stainless Steel .
Modular PROFEMUR® Starter Broach provides means to begin preparation of . proximal femur; overall size envelope is smaller than any existing PROFEMUR® stem, allowing usage with all designs; curvature of lateral surface allows insertion without interfering with greater trochanter; engagement with broach handle allows usage in familiar orientation
Modular PROFEMUR® Box Chisel provides means to remove bone in calcar region, . creating opening for other instruments; curvature of lateral surface allows insertion without interfering with greater trochanter; engagement with broach handle allows usage in familiar orientation
Modular PROFEMUR® Dimple Stem Inserter provides means by which implant may . be impacted via engagement of dimple on lateral shoulder; engagement with broach handle allows usage in familiar orientation
Modular PROFEMUR® Pocket Stem Inserter provides means by which implant may . be impacted via engagement of modular neck pocket; engagement with broach handle allows usage in familiar orientation
Lateralizing Rasp provides rigid, aggressively-toothed surface at end of handle that . can be used to contour the proximal region of the femoral canal.
Dual-Offset Broach Handles Right and Left broach handles provide improved access . to the proximal femur

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Anterior Approach Hip Surgery Instruments." This document focuses on establishing substantial equivalence to predicate devices for surgical instruments, rather than presenting a study proving a device meets specific performance acceptance criteria through quantitative metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or explicitly stated in this type of submission. This 510(k) is for surgical instruments, which are generally subject to different types of evaluation than diagnostic devices or active implants that would have performance metrics like sensitivity, specificity, or object detection accuracy. Without a study detailing specific performance metrics, the other requested information like sample size, ground truth, and expert qualifications are also not provided.

Here's an analysis based on the provided text, indicating where information is present versus not applicable or missing:

Acceptance Criteria and Device Performance Study Analysis

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

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (Summary of Substantial Equivalence)
Material Composition Equivalence: Instruments should be manufactured from materials equivalent to predicate devices.	Met: "Manufactured from Stainless Steel." And "Materials for the Anterior Approach Hip Surgery Instruments are identical to instruments used with implants cleared by PROFEMUR® TL Hip Stem."
Design Features Equivalence: Design features should enable similar function and use as predicate devices.	Met: Design features include elements like "Modular PROFEMUR® Starter Broach," "Modular PROFEMUR® Box Chisel," "Modular PROFEMUR® Dimple Stem Inserter," "Modular PROFEMUR® Pocket Stem Inserter," "Lateralizing Rasp," and "Dual-Offset Broach Handles." The document states, "The design features of the Anterior Approach Hip Surgery Instruments are substantially equivalent to the predicate devices."
Intended Use Equivalence: Instruments should be indicated for the same or similar intended uses as predicate devices.	Met: The intended use for the hip implant stems used with these instruments is identical to those used with cleared PROFEMUR® LX 5/8 Hip Stem and PROFEMUR® TL Hip Stem. The conditions for use are listed.
Fundamental Scientific Technology Equivalence: The underlying technology should not have fundamentally changed from predicate devices.	Met: "The fundamental scientific technology of the modified device has not changed relative to the predicate devices."
Safety and Effectiveness: The device must be safe and effective for its intended use.	Met (by substantial equivalence): "The safety and effectiveness of the Anterior Approach Hip Surgery Instruments are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification."

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 for this type of submission. This 510(k) does not describe a performance study with a test set in the traditional sense (e.g., for AI/diagnostic devices). The nonclinical testing mentions "Prototypes were used and further evaluated by the design surgeons in a surgical setting," which implies some form of qualitative evaluation but no quantified test set or sample size is provided.

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. No formal "ground truth" establishment from experts for a quantitative test set is described. The "design surgeons" mentioned in the nonclinical testing section serve as evaluators, but their number and specific qualifications beyond being "design surgeons" are not detailed.

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

Not applicable. No formal adjudication method is mentioned as there is no specifically defined test set with quantitative endpoints requiring adjudication.

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. This is a submission for surgical instruments, not an AI-assisted diagnostic or decision support device. An MRMC study is not relevant here.

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

No. This is for physical surgical instruments. There is no algorithm involved.

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

Not applicable. For this type of mechanical surgical instrument, "ground truth" typically relates to manufacturing specifications, material properties, and ergonomic/functional performance validated through engineering tests and surgical evaluations. No specific "ground truth" in the context of clinical endpoints (like pathology or outcomes data from a study) is presented. The "evaluation by design surgeons in a surgical setting" acts as a form of qualitative validation against functional expectations.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" or corresponding ground truth establishment process described.

Summary

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K102565 (pg 1/2)

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

DEC 2 2 2010

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 Anterior Approach Hip Surgery Instruments.

(a)(1) Submitted BySubmitter's Name:	Wright Medical Technology, Inc.5677 Airline Rd. Arlington, TN 38002800-238-7188 (phone), 901-867-4190 (fax)
Date:Contact Person:	December 20, 2010Gregory NealRegulatory Affairs Specialist II
(a)(2) Device NameProprietary Name:Common Name:	Anterior Approach Hip Surgery InstrumentsBroach, Inserter/Impactor, Chisel, Rasp
Classification Name and Reference:	21 CFR 888.3330 Hip joint metal/ metalsemi-constrained, with an uncementedacetabular component prosthesis - Class III
Subject Device Product Code and Panel Code:	Orthopedics/87/KWA, JDI, JDL, LWJ, LZO
(a)(3) Predicate DevicePredicate Proprietary Name:	PROFEMUR® LX 5/8 Hip Stem (K081090)PROFEMUR® TL Hip Stem (K060358)
Predicate Classification and Number:	Orthopedics/87/ KWA, 888.3330

(a)(4) Device Description

The design features of the Anterior Approach Hip Surgery Instruments are summarized below:

Manufactured from Stainless Steel .
Modular PROFEMUR® Starter Broach provides means to begin preparation of . proximal femur; overall size envelope is smaller than any existing PROFEMUR® stem, allowing usage with all designs; curvature of lateral surface allows insertion without interfering with greater trochanter; engagement with broach handle allows usage in familiar orientation
Modular PROFEMUR® Box Chisel provides means to remove bone in calcar region, . creating opening for other instruments; curvature of lateral surface allows insertion without interfering with greater trochanter; engagement with broach handle allows usage in familiar orientation

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Modular PROFEMUR® Dimple Stem Inserter provides means by which implant may . be impacted via engagement of dimple on lateral shoulder; engagement with broach handle allows usage in familiar orientation
Modular PROFEMUR® Pocket Stem Inserter provides means by which implant may . be impacted via engagement of modular neck pocket; engagement with broach handle allows usage in familiar orientation
Lateralizing Rasp provides rigid, aggressively-toothed surface at end of handle that . can be used to contour the proximal region of the femoral canal.
Dual-Offset Broach Handles Right and Left broach handles provide improved access . to the proximal femur

(a)(5) Intended Use

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; and,
1. revision procedures where other treatments or devices have failed

(a)(6) Technological Characteristics of the Device

The indications for implants used with the Anterior Approach Hip Surgery Instruments are identical to instruments used with implants cleared by PROFEMUR® LX 5/8 Hip Stem and PROFEMUR® TL Hip Stem. Materials for the Anterior Approach Hip Surgery Instruments are identical to instruments used with implants cleared by PROFEMUR® TL Hip Stem. The design features of the Anterior Approach Hip Surgery Instruments are substantially equivalent to the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices.

(b)(1) Nonclinical Testing

Prototypes were used and further evaluated by the design surgeons in a surgical setting.

(b)(2) Clinical Testing

Clinical data was not provided for the Class I instruments.

(b)(3) Conclusions

The safety and effectiveness of the Anterior Approach Hip Surgery Instruments 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 & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the graphic.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Wright Medical Technology, Inc. % Mr. Gregory M. Neal Regulatory Affairs Specialist II 5677 Airline Road Arlington, TN 38002

DEC 2 2 2910

K102565 Trade/Device Name: Anterior Approach Hip Surgery Instruments Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, JDI, JDL, LWJ, LZO Dated: November 24, 2010 Received: November 26, 2010

Dear Mr. Neal:

Re:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Gregory M. Neal

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

A.S. B. R.
fu

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEC 2 2 2010

Indications for Use

510(k) Number (if known):

Device Name: Anterior Approach Hip Surgery Instruments

Indications For Use:

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; and,
1. revision procedures where other treatments or devices have failed

Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty. .

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)

for M. Melkersm

(Diviston/Sign-Oft) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102565

Page 1 of 1

Regulation Number and Section

§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.

(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.