A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
Avascular necrosis of the femoral head.
Non-union of femoral neck fractures.
Certain high subcapital and femoral neck fractures in the elderly.
Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.

The Actis DuoFix Hip Prosthesis is indicated for cementless use only.

Device Description

The DePuy Actis DuoFix prostheses are manufactured from forged titanium alloy (Ti-6Al-4V) and have a sintered commercially pure titanium bead porous coating (Porocoat®) and thin layer of plasma-sprayed hydroxyapatite (HA) coating.
The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hemi-arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty.

AI/ML Overview

This document is a 510(k) premarket notification for the DePuy Actis DuoFix Hip Prosthesis. As such, it focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than establishing new performance criteria for a novel device or AI algorithm.

Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, and ground truth establishment, which are typical for assessing new medical devices or AI algorithms, is not explicitly present in the provided text.

Here's why and what information is available:

Type of Device: The "DePuy Actis DuoFix Hip Prosthesis" is a physical medical device (an uncemented hip implant), not an AI-powered diagnostic or therapeutic tool.
Purpose of Submission: This is a 510(k) submission, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing technological characteristics and non-clinical performance data (e.g., mechanical tests, biocompatibility) rather than new clinical effectiveness studies with explicit acceptance criteria for diagnostic accuracy, sensitivity, or specificity.
No Clinical Tests: The document explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence." This directly negates the possibility of finding information about clinical test sets, ground truth, expert adjudication, or MRMC studies.

However, I can provide the information that is available from the document regarding the non-clinical tests conducted.

Based on the provided document, here's what can be inferred and what information is not present:

A table of acceptance criteria and the reported device performance:

Acceptance Criteria: Not explicitly stated as pass/fail thresholds in the context of comparative performance as would be for an AI device. The acceptance is based on demonstrating substantial equivalence to the predicate devices through non-clinical testing.
Reported Device Performance: The document only lists the types of non-clinical tests performed. It does not provide the numerical results of these tests or specific performance metrics against an acceptance criterion. It simply states that these tests were "conducted for determination of substantial equivalence."

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Mechanical properties (e.g., fatigue strength) comparable to predicate devices.	Non-clinical tests were conducted for: - Distal fatigue - Neck fatigue - Range of motion - Biocompatibility
Biocompatibility comparable to predicate devices.

Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the non-clinical tests.
- Data Provenance: Not applicable as no clinical data or test sets are mentioned. The testing would be laboratory-based on the physical devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set or ground truth (in the diagnostic sense) was established. The "truth" for mechanical integrity is inherent in material science and engineering standards.
Adjudication method for the test set:
- Not applicable, as no clinical test set requiring expert adjudication was used.
If a multi reader multi case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. The document explicitly states, "No clinical tests were conducted to demonstrate substantial equivalence." An MRMC study is a type of clinical study involving human readers.
- Effect size: Not applicable, as no such study was performed.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical hip prosthesis, not a software algorithm.
The type of ground truth used:
- Not applicable in the context of diagnostic/AI devices. For this physical device, "ground truth" for non-clinical testing would refer to established engineering standards, material properties, and biocompatibility protocols.
The sample size for the training set:
- Not applicable. This is a physical device, not an AI model requiring a training set.
How the ground truth for the training set was established:
- Not applicable. This is a physical device, not an AI model.

Summary of available information:

Non-Clinical Tests Conducted: Distal fatigue, neck fatigue, range of motion, biocompatibility.
Clinical Tests Conducted: None.
Comparison Basis: Substantial equivalence to predicate devices (DePuy Summit DuoFix Hip Prosthesis (K011489) and DePuy Corail AMT Hip Prosthesis (K123991)) based on technological characteristics and non-clinical performance.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & 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 a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

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

DePuy Orthopaedics, Incorporated Correne Ramy Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46582

September 25, 2015

Re: K150862 Trade/Device Name: DePuy Actis DuoFix Hip Prosthesis 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: MEH, LPH, KWL, KWY Dated: September 2, 2015 Received: September 4, 2015

Dear Ms. Ramy:

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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use Statement

K150862

510 (k) Number (if known):

Device Name: DePuy Actis DuoFix Hip Prosthesis

Indications for Use:

Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
1. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
1. Avascular necrosis of the femoral head.
1. Non-union of femoral neck fractures.
1. Certain high subcapital and femoral neck fractures in the elderly.
1. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
1. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.

The Actis DuoFix Hip Prosthesis is indicated for cementless use only.

Prescription Use X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

(Please do not write below this line. Continue on another page if needed.)

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510 (k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93)

Submitter Information
Name	DePuy Orthopaedics
Address	700 Orthopedic DriveWarsaw, IN 46582
Phone number	574-371-4981
Fax number	574-371-4987
EstablishmentRegistration Number	1818910
Name of contact person	Correne Ramy
Date prepared	March 31, 2015
Trade or proprietaryname	DePuy Actis DuoFix Hip Prosthesis
Common or usual name	Uncemented Hip Prosthesis
Classification name	Hip joint metal/polymer/metal semi-constrained porous-coateduncemented prosthesisHip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesisHip joint femoral (hemi-hip) metallic cemented or uncementedprosthesisHip joint femoral (hemi-hip) metal/polymer cemented oruncemented prosthesis
Class	II
Classification panel	87 Orthopedics
Regulation	21 CFR 888.3358, 888.3353, 888.3360, 888.3390
Product Code(s)	LPH, MEH, KWL, KWY
Legally marketeddevice(s) to whichequivalence is claimed	DePuy Summit DuoFix Hip Prosthesis (K011489, cleared July31, 2001)DePuy Corail AMT Hip Prosthesis (K123991, clearedSeptember 16, 2013)
Reason for 510(k)submission	New hip prosthesis
Device description	The DePuy Actis DuoFix prostheses are manufactured fromforged titanium alloy (Ti-6Al-4V) and have a sinteredcommercially pure titanium bead porous coating (Porocoat®)and thin layer of plasma-sprayed hydroxyapatite (HA) coating.
	The stem consists of a wide range of stem neck designs andsizes allowing an accurate anatomical match for each patient.The stems are compatible with both unipolar and bipolar headsintended for hemi-arthroplasty and with modular metal andceramic femoral heads intended for total hip arthroplasty.
Intended use of thedevice	Total hip arthroplasty and hemi-hip arthroplasty
Indications for use	Total hip replacement or hip arthroplasty is indicated in thefollowing conditions:1. A severely painful and/or disabled joint fromosteoarthritis, traumatic arthritis, rheumatoidarthritis, or congenital hip dysplasia.2. Avascular necrosis of the femoral head.3. Acute traumatic fracture of the femoral head or neck.4. Failed previous hip surgery including jointreconstruction, internal fixation, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, ortotal hip replacement.5. Certain cases of ankylosis.Partial hip replacement or hip hemi-arthroplasty isindicated in the following conditions:1. Acute fracture of the femoral head or neck that cannotbe appropriately reduced and treated with internalfixation.2. Fracture dislocation of the hip that cannot beappropriately reduced and treated with internalfixation.3. Avascular necrosis of the femoral head.4. Non-union of femoral neck fractures.5. Certain high subcapital and femoral neck fractures inthe elderly.6. Degenerative arthritis involving only the femoral headin which the acetabulum does not requirereplacement.7. Pathology involving only the femoral head/neck and/orproximal femur that can be adequately treated by hiphemi-arthroplasty.The Actis DuoFix Hip Prosthesis is indicated forcementless use only.
Characteristics	Subject Device:DePuy Actis DuoFix HipProsthesis	Predicate Device:DePuy Summit DuoFix HipProsthesis (K011489)	Predicate Device:DePuy Corail AMT HipProsthesis (K123991)
Intended Use	Total Hip Arthroplasty,Hemi-Hip Arthroplasty	Total Hip Arthroplasty,	Total Hip ArthroplastyHemi-Hip Arthroplasty
Material	Ti-6AL-4V with Porocoatand plasma sprayed HAcoating	Ti-6AL-4V with Porocoatand plasma sprayed HAcoating	Ti-6AL-4V with plasma sprayedHA coating
Fixation	Uncemented	Uncemented	Uncemented
Stem Size	1, 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12	1, 2, 3, 4, 5, 6, 7, 8, 9, 10	6, 8, 9, 10, 11, 12, 13, 14, 15, 16,18, 20
Neck Offset	Standard, High	Standard, High	Standard, High
Collar	Collared	Collarless	Collared, Collarless
Sterile Method	Gamma	Same	Same
Packaging	Double PETG blister withTyvek peel lid	Same	Same
Shelf Life	10 years	Same	Same
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE
Distal fatigue, neck fatigue, range of motion, biocompatibility
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIALEQUIVALENCE AND/OR OF CLINICAL INFORMATION
No clinical tests were conducted to demonstrate substantial equivalence.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICE

The subject DePuy Actis DuoFix hip stems are substantially equivalent to the predicates Summit DuoFix and DePuy Corail AMT hip prostheses.

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.