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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Device Description

The subject devices are a line extension to the existing range of Articul/Eze 36mm Femoral Heads and represent additional taper sizes and offsets to allow surgeons more flexibility in the choice of femoral hip stem. Specifically, the tapers include 12/14 Articul/Eze taper with +15.5mm offset, 11/13 S-ROM taper with -3mm, 0mm, +3mm, +6mm, +9mm and 12mm offsets, and 14/16 taper with 0mm, +3mm, +5mm, +8mm and +11mm offsets. The tapers are designed to mate with femoral hip stems which have matching neck taper sizes. The offsets vary to allow the surgeon flexibility in lateralization of the hip joint.

AI/ML Overview

There is no information in the provided text about acceptance criteria or a study proving that a device (in the context of AI or diagnostic algorithms) meets such criteria. The document is a 510(k) summary for DePuy M-Spec 36mm Femoral Heads, which are medical devices used in total hip arthroplasty (hip replacement), not a "device" in the sense of an AI/ML algorithm.

The document states that a dimensional analysis was conducted to demonstrate substantial equivalence to predicate devices, but this is a characteristic of the physical product, not a performance metric that would typically have "acceptance criteria" in the way an AI algorithm does (e.g., sensitivity, specificity thresholds).

Here's an analysis based on the provided text, highlighting what is and is not present:

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

Not Applicable. The document describes a physical medical device (femoral heads) and its substantial equivalence to previously cleared devices. It does not contain acceptance criteria or performance metrics (like sensitivity, specificity, or AUC) typically associated with diagnostic AI or similar software devices. The "performance data" section only mentions "dimensional analysis" to show substantial equivalence.

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. There is no "test set" in the context of an AI/ML device. The "dimensional analysis" would involve measuring the physical characteristics of the femoral heads. Information on the number of units measured or their origin is not 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. There is no "ground truth" establishment by experts because this is not an AI/ML device requiring such validation.

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

Not Applicable. No adjudication method is described as it's not relevant for this type of device submission.

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. This is not an AI-assisted device, so no MRMC study was conducted or is relevant.

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

Not Applicable. This is a physical medical implant, not an algorithm.

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

Not Applicable. No ground truth, as typically defined for AI/ML devices, was used. The demonstration of substantial equivalence relied on a "dimensional analysis" comparing the new device's physical dimensions to those of predicate devices.

8. The sample size for the training set

Not Applicable. There is no training set for a physical medical device like this.

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

Not Applicable. There is no training set or ground truth for this type of device.

In summary: The provided text is a 510(k) summary for a physical medical device (femoral heads) and does not relate to an AI/ML device or software. Therefore, most of the requested information about acceptance criteria for AI performance studies is not present or applicable. The submission focused on demonstrating "substantial equivalence" through dimensional analysis rather than performance metrics typically associated with AI/ML algorithms.

Summary

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Section 5: 510 (k) Summary

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

APR 3 0 2013

Submitter Information
Name	DePuy Orthopaedics, Inc.
Address	700 Orthopaedic Drive, Warsaw, IN 46582
Phone number	(574)
Fax number	(574) 371-4987
EstablishmentRegistrationNumber	1818910
Name ofcontact person	Correne Ramy
Date prepared	February 27, 2013
Name of device
Trade orproprietaryname	DePuy M-Spec 36mm Femoral Heads
Common orusual name	Femoral heads
Classificationname	Hip joint metal/polymer/metal, semi-constrained, porous-coated, uncementedprosthesisHip joint metal/polymer, semi-constrained cemented prosthesis
Classification panel	87 Orthopedics
Regulation	21 CFR 888.3358 and 21 CFR 888.3350
Product Code(s)	LPH, JDI
Legally marketeddevice(s) to whichequivalence is claimed	36mm Articul/eze Femoral Heads (K980513, cleared April 14, 1998)DePuy M-Spec Femoral Heads (K060031, cleared January 31, 2006)DePuy LCS Femoral Hip Prosthesis (K880269, cleared May 6, 1988)DePuy ASphere M-Spec Femoral Heads (K082585, cleared December 4, 2008)
Reason for 510(k)submission	Line extension
Device description	The subject devices are a line extension to the existing range of Articul/Eze 36mmFemoral Heads and represent additional taper sizes and offsets to allow surgeons moreflexibility in the choice of femoral hip stem. Specifically, the tapers include 12/14Articul/Eze taper with +15.5mm offset, 11/13 S-ROM taper with -3mm, 0mm, +3mm,+6mm, +9mm and 12mm offsets, and 14/16 taper with 0mm, +3mm, +5mm, +8mmand +11mm offsets. The tapers are designed to mate with femoral hip stems whichhave matching neck taper sizes. The offsets vary to allow the surgeon flexibility inlateralization of the hip joint.
Intended use of thedevice	Total hip arthroplasty

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K120599 (Page 2 of 2) Total hip replacement is indicated in the following conditions: Indications for use A severely painful and/or disabled joint from osteoarthritis, traumatic l . arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. Failed previous hip surgery including joint reconstruction, internal 4. arthrodesis, hemiarthroplasty, surface replacement fixation, arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. Porous-coated Pinnacle Acetabular Cups are indicated for cementless applications Summary of the technological characteristics of the device compared to the predicate device Characteristic | DePuv M-Spec 36mm | Modular M-Spec | ASphere M-LCS

	DePuy M-Spec36mm FemoralHeads	36mmArticul/ezeFemoralHeads(K980513)	Modular M-SpecFemoral Heads(K060031)	Aspire M-Spec FemoralHeads(K082585)	LCSFemoral HipProsthesis(K880269)
Material	Cobalt-chromium-molybdenum	Cobalt-chromium-molybdenum	Cobalt-chromium-molybdenum	Cobalt-chromium-molybdenum	Cobalt-chromium-molybdenum
Head diameter	36mm	36mm	40, 44, 48mm	36, 40, 44mm	32mm
Offsets (taperstyle)	+15.5mm (12/14)-3, +0, +3, +6, +9,+12mm (11/13)+0, +3, +5, +8,+11mm (14/16)	-2, +1.5, +5,+8.5, +12mm(12/14)	-2, +1.5, +5, +8.5,+12, +15.5mm(12/14)-3, +0, +3, +6, +9,+12mm (11/13)	-2, +1.5, +5,+8.5, +12,+15.5mm(12/14)-3, +0, +3, +6,+9, +12mm(11/13)	+0, +5, 11mm(14/16)
SterilizationMethod	Gamma radiation	Gamma radiation	Gamma radiation	Gamma radiation	Gamma radiation

PERFORMANCE DATA

SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

Dimensional analysis of femoral heads included in K980513, K060031, K880269, and K082585 compared to the subject devices was conducted to show substantial equivalence.

SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

No clinical testing was required to demonstrate substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around the perimeter. In the center of the seal is a stylized emblem, consisting of a symbol that resembles a caduceus or a staff with a serpent entwined around it.

Public Health Service

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

Letter dated: April 30, 2013

DePuy Orthopaedics, Inc. % Ms. Correne Ramy Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46582

Re: K120599

Trade/Device Name: DePuy M-Spec 36mm Femoral Heads Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, JDI Dated: February 25, 2013 Received: March 4, 2013

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

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Page 2 - Ms. Correne Ramy

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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/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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Section 4: Indications for Use Statement

K120599 510 (k) Number (if known):

Device Name: DePuy M-Spec 36mm Femoral Heads

Indications for Use:

Total hip replacement 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, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

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.)

DOD-DIVISION SIGN-OFF
Division of Orthopedic Devices	Elizabeth L. Frank - S
510(k) Number:	K120599

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.