MAKO SURGICAL UNICONDYLAR KNEE SYSTEM by MAKO SURGICAL CORP.

The MAKO Surgical Unicondylar Knee is a single use device intended for cemented reconstruction of the medial or lateral femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis provided there is evidence of sufficient bone to seat the implant. Indications for use include moderate joint impairment from painful arthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy in patients with unicompartmental arthritis.

Device Description

The MAKO Surgical Unicondylar Knee System is for use in reconstruction of either the medial or lateral femoral and corresponding tibial surface. The MAKO Surgical Unicondylar Knee System consists of the following basic components. These components are intended for cemented, one-time use.

CoCr distal femoral component.
UHMWPE tibial resurfacing component -- includes radiographic pin.
Standard unicondylar knee instrumentation is also provided with the system. This includes for example femoral sizers, femoral templates with handles & peg drill assembly, tibial instrument tray, tibial sizers, tibial leveling guide, impactor, inserters, extractors, etc. Essentially, the instrumentation is the same as that of the predicate device.

AI/ML Overview

This document describes the MAKO Surgical Unicondylar Knee System and its substantial equivalence to a predicate device, as part of a 510(k) submission to the FDA. The information provided heavily focuses on the device's characteristics and intended use rather than a study proving its performance against specific acceptance criteria.

Therefore, many of the requested categories (acceptance criteria, specific study details, sample sizes, ground truth establishment methods, MRMC studies, standalone performance, expert involvement) cannot be extracted from the provided text as they are not present. The document is a regulatory submission for substantial equivalence based on material and design similarities, not a clinical study report.

Here's a summary of what can be extracted and a clear indication of what cannot.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Criterion	Acceptance Criteria (Explicitly Stated in Document)	Reported Device Performance (Explicitly Stated in Document)
Intended Use / Indications for Use	Not explicitly stated as an "acceptance criterion" in a quantitative sense, but rather as statements of intended use that the device meets.	The MAKO Surgical Unicondylar Knee System is "a single use device intended for cemented reconstruction of the medial or lateral femur and corresponding tibial surface of moderately disabled and/or painful knee resulting from osteoarthritis, traumatic arthritis provided there is evidence of sufficient bone to seat the implant. Indications for use include moderate joint impairment from painful arthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy in patients with unicompartmental arthritis." This matches the predicate device's intended use, indicating equivalence.
Implant Components	Implied: Components should be equivalent to predicate.	Consists of CoCr femoral component, UHMWPE tibial component with a radiographic marker pin.
Sizes	Implied: Sizes should provide adequate range.	Femoral components available in 5 sizes (left and right for each). Tibial components in 5 sizes with 3 thicknesses (6.5mm, 7.5mm, 8.5mm). Thinnest section of 6.5mm tibial component is 6.0mm.
Congruency	Implied: Congruency should be within an acceptable range.	20 – 27% congruency.
Materials	Implied: Materials should be biocompatible and meet standards.	Femoral component – CoCr per ASTM F-75. Tibial component – UHMWPE per ASTM F-648 Type 2. Radiographic marker pin – titanium wire per ASTM F-1341. "Both devices are made of materials for surgical implant applications per ASTM standards listed above."
Sterilization & Packaging	Implied: Sterilization and packaging methods should be effective.	Implants and tibial components – gamma radiation. Instrumentation – prevacuum steam. Packaging: double sealed containers maintaining double sterile barriers; tibial component packaged in Argon gas environment.
Biocompatibility	Implied: Biocompatible.	"Both devices are made of materials for surgical implant applications per ASTM standards listed above."

2. Sample size used for the test set and the data provenance

Not provided. This document is a 510(k) summary, not a clinical study report. It focuses on demonstrating substantial equivalence based on design, materials, and intended use to a predicate device (Stelkast Corporation's Unicondylar Knee System, K032824), rather than presenting results from a performance study with a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. No test set or ground truth establishment by experts is mentioned as part of this 510(k) submission document.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or adjudication method is mentioned.

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 not an AI-powered device. This is a medical implant (knee replacement system). Therefore, MRMC studies and AI assistance are not relevant to this device.

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

No, this is not an AI-powered device. This is a medical implant.

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

Not applicable/Not provided. The document describes a medical implant system and its characteristics for substantial equivalence, not a diagnostic or AI device requiring ground truth.

8. The sample size for the training set

Not applicable/Not provided. This is not an AI/algorithm-based device that would require a training set.

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

Not applicable/Not provided. As above, no training set or ground truth establishment for a training set is relevant or mentioned.

Summary

{0}------------------------------------------------

FEB 2 3 2006

Image /page/0/Picture/2 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, sans-serif font, with the words "SURGICAL CORP" in a smaller font size underneath. Above the word "MAKO" is a graphic element that resembles a stylized mountain range or a shark fin, created with a pixelated effect. The overall design is simple and modern, conveying a sense of precision and innovation.

2901 simms street

lei 954 927 2044

fax 954.927.0446

EXHIBIT E - 510(K) SUMMARY

hollywood, florida 33020

Submitter:	MAKO Surgical Corp.
Address:	2901 Simms Street, Hollywood, FL, 33020
Phone number / Fax Number:	(Ph) 954-927-2044 x105; (F) 954-927-0446
Contact Person:	William F. Tapia
Date Prepared:	December 30, 2005
Proprietary Name:	MAKO Surgical Unicondylar Knee System
Common Name:	Knee joint femorotibial metal/polymer non-constrained cemented prosthesis
Classification Name / #:	Class II; 21 CFR 888.3520
Product Code:	87 HSX – Knee joint femorotibial metal/polymer non-constrained cemented prosthesis

Substantial Equivalence: The MAKO Surgical Unicondylar Knee System is substantially equivalent to Stelkast Corporation's Unicondylar Knee System (K032824).

Feature	Stelkast Unicondylar Knee System (K032824) / MAKO Surgical Corp.'sUnicondylar Knee System
Intended Use/Indications forUse	The MAKO Surgical Unicondylar Knee is a single use device intended forcemented reconstruction of the medial or lateral femur and corresponding tibialsurface of moderately disabled and/or painful knee resulting from osteoarthritis,traumatic arthritis provided there is evidence of sufficient bone to seat theimplant. Indications for use include moderate joint impairment from painfularthritis (osteo and/or post-traumatic), and as an alternative to tibial osteotomy inpatients with unicompartmental arthritis.
Implant Components	CoCr femoral component. UHMWPE tibial component. Radiographic marker pin in tibial component
Sizes	Femoral components available in 5 sizes (left and right component for each size). Tibial components available in 5 sizes with 3 thicknesses (6.5mm, 7.5mm, 8.5mm). Thinnest section of 6.5mm tibial component is 6.0mm.
Congruency	20 – 27% congruency
Materials	Femoral component – CoCr per ASTM F-75 Tibial component – UHMWPE per ASTM F-648 Type 2. Radiographic marker pin – titanium wire per ASTM F-1341.
Instrumentation	Provided separately in a re-usable/sterilizable tray. Tray includes various tools(e.g., sizers, templates, trials, drill, gage, impactors, inserters, extractors) usedduring surgery.
Sterilization and Packaging	Sterilization: Implant and tibial components – gamma radiation Instrumentation – prevacuum steam Packaging: Both femoral and tibial components are supplied in double sealed containers maintaining double sterile barriers. Tibial component is packaged in Argon gas environment.
Biocompatibility	Both devices are made of materials for surgical implant applications per ASTMstandards listed above.

Description: The MAKO Surgical Unicondylar Knee System is for use in reconstruction of either the medial or Description. The MANO Ourface. The MAKO Surgical Unicondylar Knee System consists of the following basic components. These components are intended for cemented, one-time use.

CoCr distal femoral component .

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters. Below the word "MAKO" is the text "SURGICAL CORP" in smaller letters. Above the word "MAKO" is a graphic that resembles a mountain range.

fax 954.327.0446 hollywood, florida 35020 lei 954,927 2044

UHMWPE tibial resurfacing component -- includes radiographic pin .
2001 simms street

Standard unicondylar knee instrumentation is also provided with the system. This includes for example femoral Standard unicondylar knee instrumentation is also provides, this leveling guide, impactor,
sizers, femoral templates with handles & peg drill assembly, tibial inotrument trav sizers, femoral templates with handles & peg unlinessentialy, tible in the same of the many of the matrument tray.

Intended Use/Indications for Use: The MAKO Surgical Unicondylar Knee is a single use device intended for Intended Uselindications for USE. The MANO Oulgiour Onloondyna mobile in the materaly disabled cemented reconstruction of the medial of lateral leman and sorrosponding tamily in the sudence of sufficient bone to and/or paintil Knee resulting from osteoarinhis, traditions and a thritis (osted and/or postseal the inipiant. Thurcations for asc inolde moderate your the with unicompartmental arthritis.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stylized lines representing its wings and body. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 3 2006

Mr. William F. Tapia Director of Regulatory/Quality/Clinical Affairs Mako Surgical Corp. 2901 Simms Street Hollywood, California 33020

K060017 Re:

Trade/Device Name: Unicondylar Knee System Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Codes: HSX Dated: February 14, 2006 Received: February 15, 2006

Dear Mr. Tapia:

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 eoniner to pror of they 2011-11-11 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

{3}------------------------------------------------

Page 2 – Mr. William F. Tapia

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set a CFR Part 807), labeling (21 CFR Part 807), good managed and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 GPD 1960 form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Declients of Cevice as described in your Section 510(k)
This letter will allow you to begin marketing your device as described in your a I his letter will anow you to begin mankeling your antial equivalence of your device to a legally premarket notification. The PDA muding of backand of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific acries for your 201) 276-0120. Also, please note the regulation entitled, Comact the Office of Comphance at (210) = i Ecation" (21CFR Part 807.97). You may obtain Misolanding Uy Telefone to premailsonibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-204 or Manufacturers, international and Oolisanhoon varian of the more of the new online with he

Sincerely yours,

Heckin Leuer (w)

Image /page/3/Picture/5 description: The image shows the name and title of Mark N. Melkerson, M.S., who is the Acting Director of the Division of General, Restorative and Neurological Devices. The image also mentions the Office of Device Evaluation and the Center for Devices and Radiological Health. The text is aligned to the left and is written in a clear, readable font.

Enclosure

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold, sans-serif font, with the words "SURGICAL CORP" in a smaller font size underneath. Above the word "MAKO" is a stylized graphic that resembles a shark fin or a wave. The logo is black and white.

... kr 184 827 0449.... .............................................................................................................................................................................. . . . .......? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . #1 12: #RE #MACC . . . . . .

EXHIBIT G

INDICATIONS FOR USE

510(k) Number (if known): K060017

Device Name: MAKO Surgical Unicondylar Knee System

Indications for Use:

The MAKO Surgical Unicondylar Knee is a single use device intented for cemented reconstruction of the resultiv The MAKO Surgical Unicondyial Khee is a single dse act noc rice neable disabled and/or paintil knee resulting
medial or lateral femur and corresponding tibial surface of mode medial or lateral femur and corresportung tible Sunder disable in the implant.
from osteoarthritis, traumatic arthritis provided there is evidence of seat the implic Indications for use include moderate joint impaiment from painfilis (osteo and/or post-traumatic), and molcations for use include moderate joint impartmental arthrilis.

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence(Division Sign-Off) Evaluation (ODE)

Division of General, Restorative.

and Neurological Devices

510(k) Number_

the Countor I lea

Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.