· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The Trident® Tritanium® PST® Acetabular Shell is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

Device Description

The subject Trident® Tritanium® PST® Acetabular Shell is the predicate PST® Acetabular Shell, which has been modified to incorporate the acetabular bearing mating features of the predicate Trident® Tritanium®, Trident® PSL®, and Trident® Hemispherical Shells, to allow compatibility with existing Stryker Orthopaedics acetabular bearings including the Trident polyethylene and Modular Dual Mobility (MDM) bearing families.

The subject Trident® Tritanium® PST® Acetabular Shells are manufactured from titanium alloy and feature a porous structured surface. The subject shells feature a dome hole, and are available either in a solid shell (no screw holes) configuration, or in a cluster screw hole configuration for optional supplemental bone screw fixation. The subject Tritanium® PST® Acetabular Shells are compatible with the optional predicate PST Acetabular Shell system bone screws (titanium alloy), with the optional predicate Stryker Orthopaedics Torx head acetabular dome hole occluder (CP titanium), and with an optional new hex head acetabular dome hole occluder (titanium alloy).

AI/ML Overview

The provided text is a 510(k) Summary for the Trident® Tritanium® PST® Acetabular Shells. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way an AI/software device would.

This document describes a medical device (an acetabular shell for hip replacement), not a software or AI product. The "Performance Testing" section refers to comparisons of materials, manufacturing methods, design features, and disassembly testing per ASTM F1820 (including push-out, and torsional testing) to demonstrate substantial equivalence to predicate devices.

Therefore, most of the requested information (related to AI performance, sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) is not applicable to this type of regulatory submission for a physical medical device.

I can only extract the following relevant information:

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

Based on the document, specific acceptance criteria and reported device performance in terms of quantifiable metrics like sensitivity, specificity, accuracy, etc., are not applicable as this is a physical medical device, not an AI/software device with such performance metrics.

The performance testing mentioned is mechanical in nature, focused on demonstrating substantial equivalence to predicate devices.

Acceptance Criteria Category	Reported Device Performance / Evaluation Method
Mechanical Performance	- Comparison of materials: Same materials as predicate PST® Acetabular Shells.- Comparison of manufacturing methods: Same manufacturing methods as predicate PST® Acetabular Shells.- Comparison of design features: Same outer profile and porous structured surface as predicate PST® Acetabular Shells.- Disassembly Testing: Per ASTM F1820, including push-out and torsional testing (for worst-case style and size of compatible Stryker Orthopaedics acetabular bearings).
Compatibility	- Incorporates acetabular bearing mating features of predicate Trident® Tritanium®, Trident® PSL®, and Trident® Hemispherical Shells.- Compatible with existing Stryker Orthopaedics acetabular bearings, including Trident polyethylene and Modular Dual Mobility (MDM) bearing families.
Sterilization	Same sterilization methods as predicate PST® Acetabular Shells.
Packaging	Similar packaging to predicate PST® Acetabular Shells.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this device. The testing described is mechanical performance (e.g., disassembly testing per ASTM F1820) of physical components, not data analysis or clinical studies in the typical sense of AI/software device evaluation.

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)

This information is not applicable. Ground truth, in the context of expert review for AI/software, is not relevant for the mechanical testing of a physical implant.

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

This information is not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations for ground truth establishment, which is not relevant here.

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

This information is not applicable. MRMC studies are for evaluating human performance with and without AI assistance for tasks like image interpretation, which is not relevant for an orthopedic implant.

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

This information is not applicable. This describes a physical medical device, not an algorithm.

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

This information is not applicable. The "ground truth" for a physical device is its adherence to specified material properties, mechanical strength characteristics, and design specifications as evaluated through engineering tests, not clinical or pathological outcomes in the context of expert consensus as described for AI/software.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/software device.

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

This information is not applicable. There is no "training set."

Summary

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

January 26, 2015

MAKO Surgical Corporation % Terry Sheridan Powell M Squad Associates, Incorporated 575 Eighth, Avenue, Suite 1212 New York City, New York 10018

Re: K142606 Trade/Device Name: Trident® Tritanium® PST® Acetabular Shells 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: December 22, 2014 Received: December 29, 2014

Dear Terry Sheridan Powell:

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

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Page 2 - Terry Sheridan Powell

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 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/Resourcesfor You/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 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,

Lori A. Wiggins -S

for 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

510(k) Number (if known) K142606

Device Name

Trident® Tritanium® PST® Acetabular Shells

Indications for Use (Describe)

The Trident® Tritanium® PST® Acetabular Shell System is in skeletally mature individuals undergoing surgery for total hip replacement due to:

· A severely painful and/or disabled joint from osteoarthritis, theumatoid arthritis, avascular necrosis, or congenital hip dysplasia;

· Acute traumatic fracture of the femoral head or neck;

· Failed previous hip surgery including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty or total hip replacement.

The Trident® Tritanium® PST® Acetabular Shell is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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This 510(k) Summary is provided in accordance with the requirements of 21 CFR 807.92.

1.1. Device Name and Classification

Device Trade Name:	Trident® Tritanium® PST® Acetabular Shells
Device Common Name:	Artificial Total Hip Replacement
Regulation Number and Description:	888.3358 - Hip joint metal/polymer/metal semi-constrained porous-coated uncementedprosthesis; and 888.3350 - Hip jointmetal/polymer semi-constrained cementedprosthesis
Device Class:	II
Product Codes:	LPH - prosthesis, hip, semi-constrained,metal/polymer, porous uncementedJDI - prosthesis, hip, semi-constrained,metal/polymer, cemented
Advisory Panel:	Orthopedic

1.2. Address and Registration

Submitter's Name:	MAKO Surgical Corp.
Address:	3 Wing Drive Suite 102 Cedar Knolls, NJ 07927
Establishment Registration Number:	3009701876
Contact Person:	Jonathan Reeves
Telephone Number:	954-628-0665
Fax Number:	954-927-0446
Date Summary Prepared:	January 8, 2015

1.3. Purpose of Submission

The Trident® Tritanium® PST® Acetabular Shell is a new device.

1.4. Identification of Legally Marketed Device to which Submitter Claims Equivalence

The subject device is substantially equivalent to the following predicate devices:

Device Description	510(k) Numbers
PST® Acetabular Shells (and dome hole plug)	K112802
Trident® Tritanium®, Trident® PSL® and Trident®Hemispherical Shells	K081171, K983382, K013676

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1.5. Device Description

1.6. Intended Use

The Trident® Tritanium® PST® Acetabular Shell System is indicated for use in skeletally mature individuals undergoing surgery for total hip replacement due to:

. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital hip dysplasia;
. 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.

The Trident® Tritanium® PST® Acetabular Shell is intended for cemented fixation. The porous structured surface provides biological fixation when used in a cementless application.

1.7. Comparison of Technological Characteristics

The subject Trident® Tritanium® PST® Acetabular Shells have the same indications for use, same outer profile, same porous structured surface, and are made from the same materials using the same manufacturing, similar packaging, and same sterilization methods as the predicate PST® Acetabular Shells. The subject Trident® PST® Acetabular Shells incorporate the acetabular bearing mating features of the predicate Trident® Trident® PSL® and Trident® Hemispherical Shells, and are therefore compatible with existing Stryker acetabular bearings, including the Trident polyethylene and Modular Dual Mobility (MDM) bearing families.

1.8. Performance Testing

Comparisons of materials, manufacturing methods, and design features, as well as disassembly testing per ASTM F1820 (including push-out, and torsional testing) for the subject shells with the worst case style and size of compatible Stryker Orthopaedics acetabular bearings, were relied upon to demonstrate the substantial equivalence of the modified subject device to the predicate devices.

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1.9. Clinical Testing

Clinical testing was not required to demonstrate substantial equivalence to the predicates.

1.10.Conclusions

The subject Trident® Tritanium® PST® Acetabular Shells share indications for use, same outer profile, same porous structured surface, and are made from the same materials using the same manufacturing, similar packaging, and same sterilization methods as the predicate PST® Acetabular Shells. The subject Trident® Tritanium® PST® Acetabular Shells share the acetabular bearing mating features of the predicate Trident® Trident® PSL® and Trident® Hemispherical Shells, for compatibility with the same predicate Trident polyethylene and Modular Dual Mobility (MDM) bearing families. Therefore, the subject Trident® Tritanium® PST® Acetabular Shells are substantially equivalent to the identified predicate acetabular shells.

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.