The Restoris® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:

. Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
. Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis.
. As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

The Restoris® Porous Femoral Component and PST Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application.

Device Description

The Restoris® Porous Partial Knee System is a unicompartmental knee system that includes porous coated, cast CoCr, asymmetric femoral components in sizes 1 – 8; and Ti6Al4V, asymmetric, porous tibial baseplate components in sizes 1 - 8. The subject femoral and tibial baseplate components are compatible and are intended for use with predicate MAKO Restoris MCK Tibial Onlay Inserts in standard UHMWPE or highly crosslinked vitamin E UHMWPE (K090763, K133039). The sagittal articular surface of the femoral condyle has an extended posterior radius that accommodates flexion up to 155%.

AI/ML Overview

The provided text is a 510(k) summary for the Restoris® Porous Partial Knee System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study to establish new performance criteria. Therefore, the information you're requesting regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI device evaluation metrics (like sensitivity, specificity, etc.) is not present in this document.

This document describes a traditional medical device (a knee implant), not an AI/ML diagnostic or predictive device. The "performance testing" mentioned refers to mechanical and material testing to ensure structural integrity and functional similarity to existing devices.

However, I can extract information related to the device's performance testing and how it relates to demonstrating substantial equivalence, which is the regulatory standard for this type of device.

Here's a breakdown of what is available in the document, framed as closely as possible to your request, but acknowledging the difference in device type:

1. Table of Acceptance Criteria and Reported Device Performance:

For a traditional medical device like a knee implant, "acceptance criteria" are not reported as statistical metrics like sensitivity or specificity. Instead, the "acceptance criteria" are implied by demonstrating that the device performs equivalently or acceptably in terms of mechanical strength, material compatibility, and design features compared to predicate devices. The "reported device performance" refers to the results of these engineering tests.

Performance Metric (Implied Acceptance Criteria: Substantial Equivalence to Predicate)	Reported Device Performance (Summary of Testing)
Mechanical Performance:
Femoral Component Fatigue	Tested; capable of withstanding expected in vivo loading.
Tibial Baseplate Fatigue	Tested; capable of withstanding expected in vivo loading.
Tibial Insert/Baseplate Locking Mechanism Strength	Previously tested (K090763 or K133039); capable of withstanding expected in vivo loading.
Femorotibial Congruency	Previously tested (K090763 or K133039); demonstrated substantial equivalence.
Femorotibial Contact Area	Previously tested (K090763 or K133039); demonstrated substantial equivalence.
Range of Motion	Previously tested (K090763 or K133039); demonstrated substantial equivalence.
Material/Design Characteristics:
Porous Surface Characterization (Femoral and Tibial Baseplate)	Tested; shown equivalent to predicate device porous coatings.
Indications for Use	Same as one or more predicate knee systems.
Materials	Same as one or more predicate knee systems.
Design Features	Similar to one or more predicate knee systems.

Explanation of "Acceptance Criteria" for this device: The primary "acceptance criterion" for a 510(k) submission is Substantial Equivalence (SE) to a legally marketed predicate device. This means the new device must have the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, these differences must not raise new questions of safety and effectiveness, and the device must be as safe and effective as the predicate. The performance testing outlined above is designed to demonstrate this substantial equivalence, primarily through mechanical testing and material characterization.

The following points are typically relevant for AI/ML device evaluations and are not applicable to this 510(k) summary for a traditional knee implant. I will explicitly state "Not Applicable" where the information is not provided because it pertains to a different type of device or study.

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. This document does not describe a clinical study with a "test set" in the context of AI/ML data. The "testing" refers to benchtop mechanical and material characterization. "Data provenance" such as country of origin or retrospective/prospective is not relevant for this type of engineering performance testing.

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 medical experts for a "test set" described in this submission. The "truth" for engineering tests is based on established standards, mechanical properties, and comparison to predicate device performance.

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

Not Applicable. No expert adjudication method is described.

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. No MRMC study was conducted.

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

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

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

Not Applicable. "Ground truth" in the AI/ML sense is not relevant here. The "truth" for the engineering performance tests is adherence to engineering standards and demonstration of comparable mechanical performance to predicate devices.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no training set.

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

Not Applicable. No training set is involved.

In summary: The provided document is a regulatory submission (510(k)) for a traditional medical device (a knee implant), focusing on demonstrating substantial equivalence to already marketed devices. It details engineering performance testing (fatigue, material characterization) to ensure the device's physical and mechanical properties are comparable to its predicates, thereby establishing its safety and effectiveness. The questions you've posed are highly specific to the evaluation of AI/ML medical devices, which operate under a different set of performance and validation criteria.

Summary

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Restoris® Porous Partial Knee System 510(k) Summary

JUL 0882014

Device Proprietary Name:	Restoris Porous Partial Knee System
Common Name:	Artificial Partial Knee System
Classification regulation:	888.3530 (Knee joint femorotibial metal/polymersemi-constrained cemented prosthesis) and888.3535 (Knee joint femorotibial (uni-compartmental) metal/polymer porous-coateduncemented prosthesis)
Device Class:	Class II
Product Codes:	HRY and NJD
Submitter's Name:	MAKO Surgical Corp.
Address:	2555 Davie RoadFort Lauderdale, FL 33317
Contact Person:	Robert C. Cohen
Telephone Number:	(973) 267-8800
Fax Number:	(973) 267-8810
Date Summary Prepared:	December 13, 2013

Device Description:

Intended Use

Restoris® Porous Partial Knee System components are The intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:

. Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
. Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of an unicompartmental knee prosthesis.

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Restoris® Porous Partial Knee System 510(k) Summary

As an alternative to tibial osteotomy in patients with unicompartmental . osteoarthritis.
The Restoris® Porous Femoral Component and PST Tibial Baseplate are intended for cementless or cemented fixation. The Tibial Baseplate may be used in conjunction with ancillary screw fixation. The porous surfaces of both the femoral and tibial tray components provide biological fixation when used in a cementless application.

Predicate Devices:

Restoris® Porous Partial Knee System is similar to the following predicates:

Trade/Proprietary Name	Manufacturer	510(K) #	Clearance Date
Restoris MCK Knee System	MAKO Surgical	K090763	6/17/2009
MMCK Uni Knee System	MAKO Surgical	K082172	11/28/2008
Natural-Knee® II UnicompartmentalKnee System	CenterPulseOrthopedics/Zimmer	K033810	3/5/2004
MAKO Restoris® Hip System(Pipeline Total Hip System)	MAKO (PipelineOrthopedics acquiredby MAKO)	K112802	03/12/2012

Purpose of Submission:

The 510(k) submission is for new unicompartmental knee system femoral and tibial tray . components.

Technological Characteristics:

The Restoris® Porous Partial Knee System has the same indications for use, design features, and materials as one or more of the identified predicate knee systems. The porous surface of the subject Restoris® Porous Partial Knee System tibial baseplates is the same as the porous surface of the predicate MAKO Restoris® Total Hip System (K112802) acetabular shells.

Performance Testing:

The Restoris® Porous Partial Knee System has been evaluated, either by new testing and analysis submitted in this 510(k) for femoral component fatigue, tibial baseplate fatigue, and porous surface characterization, or by testing previously submitted in predicate 510(k) #K090763 or #K133039 for the tibial insert/baseplate locking mechanism strength, femorotibial conguency, femorotibial contact area, and range of motion. The testing demonstrates that the Restoris® Porous Partial Knee System when used as intended with the predicate MAKO Restoris MCK Tibial Onlay Inserts, is capable of withstanding expected in vivo loading and is substantially equivalent to predicate knee systems.

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Restoris® Porous Partial Knee System 510(k) Summary

Conclusions:

The Restoris® Porous Partial Knee System has the same indications for use, is manufactured from the same materials, and has similar design features as compared with one or more of the predicate knee systems. Characterization of the device porous surfaces has shown them equivalent to predicate device porous coatings. Engineering analyses and mechanical testing demonstrate that the performance characteristics of the Restoris® Porous Partial Knee System are equivalent to those of other legally marketed knee systems. Therefore, the Substantial Equivalence of the subject device for the proposed indications for use is demonstrated.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a logo with the words "HUMAN SERVICES - USA" arranged in a circular pattern around a symbol. The symbol is a stylized depiction of an eagle or bird in flight, with its wings spread and feathers suggested by curved lines. The logo appears to be a government or organizational emblem, possibly related to health or social services.

Public Health Service

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

July 8, 2014

MAKO Surgical Corp. % Ms. Terry Sheridan Powell Consultant M Squared Associates, Inc. 575 Eighth Avenue Suite 1212 New York, New York 10018

Re: K133811

Trade/Device Name: Restoris Porous Partial Knee System Regulation Number: 21 CFR 888.3535 Regulation Name: Knee joint femorotibial (uni-compartmental) metal/polymer porouscoated uncemented prosthesis

Class: Class II Product Code: NJD, HRY Dated: May 23, 2014 Received: May 27, 2014

Dear Ms. 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 - Ms. Terry Sheridan Powell

(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 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 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,

Lori A. Wiaains

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 Statement

K133811 510(k) Number: To be assigned -

Device Name: Restoris® Porous Partial Knee System

Indications for Use:

The Restoris® Porous Partial Knee System components are intended for unicompartmental knee arthroplasty to treat one or more of the following conditions:

. Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis.
. Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis.
. As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

AND/OR -Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

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)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3535 Knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint femorotibial (uni-compartmental) metal/polymer porous-coated uncemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surface. It has no linkage across-the-joint. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra-high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial baseplate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.