The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

The Tactile Guidance System v2.0 is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.

Device Description

The TGS v2.0 is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and a robotic arm. TGS v2.0 uses patient CT data to assist the physician with presurgical planning and interpretive navigation. The robotic arm serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The robotic arm, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the robotic arm and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as drills and awls.

The TGS v2.0 consists of the following basic components:

Robotic Arm
Guidance Module
Camera Stand
Tool and accessories
Preoperative planning laptop

AI/ML Overview

The provided text is a 510(k) summary for the MAKO Surgical Corp. Tactile Guidance System v2.0. This document focuses on establishing substantial equivalence to previously cleared devices for regulatory approval, rather than presenting a detailed study proving the device meets specific performance acceptance criteria in a clinical or technical context like an AI/ML device.

Therefore, the requested information cannot be fully extracted from this document, especially regarding acceptance criteria and a study design to prove it in the context of device performance as typically understood for AI/ML.

However, I can provide the available information and highlight what is missing:

Information Available from the Document:

Device Name: Tactile Guidance System v2.0
Intended Use/Indications for Use: To assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures, specifically unicondylar knee replacement and/or patellofemoral knee replacement.
Regulatory Classification: Class II, Stereotaxic Instrument (21 CFR 882.4560).
Predicate Devices: MAKO Surgical's Tactile Guidance System (K072806), Voyager/Tactile Guidance System-CT (K052851), and Biomet's Acumen™ Surgical Navigation System (K031454 and K031337). The basis for "proving acceptance" is substantial equivalence to these predicates, not performance against specific, quantifiable acceptance criteria presented as part of a novel study.

Missing Information (and why it's missing from this type of document):

The 510(k) summary is a regulatory document focused on demonstrating substantial equivalence to a predicate device, not typically a publication of a clinical trial or technical performance study with detailed acceptance criteria and results. Therefore, the document does not contain:

A table of acceptance criteria and reported device performance: This document does not describe specific numerical performance metrics or acceptance criteria for accuracy, precision, or other performance aspects. It establishes equivalence based on similar technological characteristics and intended use.
Sample size used for the test set and data provenance: No "test set" in the context of a performance study is mentioned. Performance is assumed to be similar to predicate devices.
Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as there is no performance study described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance: Not applicable. This device is a robotic surgical assistant, not an AI diagnostic or interpretive system that "improves human readers."
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not explicitly detailed, as the device is designed to assist a human surgeon.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not detailed as no specific performance study with ground truth is described.
The sample size for the training set: Not applicable, as this is not an AI/ML device in the modern sense that requires a large training set for model development (though software development would involve testing).
How the ground truth for the training set was established: Not applicable.

Conclusion:

This 510(k) summary is a regulatory filing demonstrating that a new version of a robotic surgical assistance system is substantially equivalent to existing, legally marketed devices. It does not provide the kind of detailed performance study and acceptance criteria typically found for a novel device or AI/ML system seeking to prove its own efficacy or performance against specific, quantifiable benchmarks. The "study" here is the comparison to predicate devices, focusing on technological characteristics and intended use, rather than a clinical trial with specific performance endpoints.

Summary

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1401001

.KORIS67

Image /page/0/Picture/2 description: The image shows the logo for MAKO Surgical Corp. The logo consists of the word "MAKO" in large, bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font below it. Above the word "MAKO" is a stylized graphic element that resembles a curved, abstract shape. The logo is in black and white.

NOV 2 5 2008

2555 davie road ________________ fort lauderdale, florida 33317 tel 954.927.2044 fax 954 927 0446

EXHIBIT L 510(K) SUMMARY

Submitter:	MAKO Surgical Corp.
Address:	2555 Davie Road, Fort Lauderdale, FL, 33317
Phone number:	954-927-2044 x. 605
Fax number:	954-927-0446
Contact Person:	William F. Tapia
Date Prepared:	June 30 2008
Device Trade Name:	Tactile Guidance System v2.0
Common Name:	Stereotaxic Instrument
Classification Name:	Class II
Classification #:	21 CFR 882.4560

Substantial Equivalence Claimed To: The Tactile Guidance System (TGS) v2.0 is substantially equivalent to the MAKO Surgical's Tactile Guidance System (K072806) and Voyager/Tactile Guidance System-CT (K052851) and Biomet's Acumen™ Surgical Navigation System (K031454 and K031337).

Description: The TGS v2.0 is a stereotaxic instrument that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and a robotic arm. TGS v2.0 uses patient CT data to assist the physician with presurgical planning and interpretive navigation. The robotic arm serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The robotic arm, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the robotic arm and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as drills and awls.

Summary of Technological Characteristics:

The TGS v2.0 consists of the following basic components:

1. Robotic Arm
- . User Panel
- Computer .
- CRISIS software application .
- QNX operating system .
- . Power components
- . Uninterruptible Power Supply (UPS)
- Cable panel .
- Positioning lever .
- Integrated cutting system .
- Isolation transformer
1. Guidance Module
- . High Resolution Color Liquid Crystal Display (LCD) Monitor
- � Computer
- . Software drivers for video grabber, standard components (keyboard, mouse, monitor, etc.)
- Knee software application .
- Linux operating system .
- Keyboard and Mouse
1. Camera Stand
- Second High Resolution LCD screen that shows an identical image to the primary touch . screen

Exhibit L - 1

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Image /page/1/Picture/0 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in a bold, sans-serif font, with the words "SURGICAL CORP." in a smaller font underneath. Above the word "MAKO" is a stylized graphic that resembles a shark fin. The logo is black and white.

fort lauderdale, florida 33317 2555 davie road ______________________________________________________________________________________________________________________________________________________________

tel 954.927.2044

fax 954.927.0446

Optical Detector .
1. Tool and accessories
- Optically tracked surgical tools and accessories such as probes and arrays .
- Non-tracked tools and accessories such as drill guides, drill adapters, and screw drivers .
1. Preoperative planning laptop
- Runs only the preoperative planning portion of the application (up to the first implant planning . step). Dicom CDs of CT scans with patient data can be loaded and surgical plans can be created on this laptop and downloaded (in an encrypted format) to a USB memory stick to be transferred to the TGS System

Intended Use/Indications for Use: The Tactile Guidance System v2.0 is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

8/g

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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, USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mako Surgical Corporation % Mr. William F. Tapia VP, Regulatory 2555 Davie Road Davie, Florida 33317

NOV 2 5 2008

Re: K081867

Trade/Device Name: Tactile Guidance System v2.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 18, 2008 Received: November 20, 2008

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 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.

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 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 - Mr. William F. Tapia

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N Wilkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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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 below. Above the word "MAKO" is a stylized graphic that resembles a shark fin or a wave. The graphic is filled with a textured pattern, giving it a three-dimensional appearance.

fort lauderdale, florida 33317 2555 davie road tel 954.927.2044 fax 954.927 D446

EXHIBIT K

INDICATIONS FOR USE

K081867 510(k) Number (if known):

Device Name: Tactile Guidance System v2.0

Indications for Use:

Prescription Use _ X

OR 1 Over-the-Counter Use

(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

(Division Sign-O Restorative, Division of Ger and Neurologic

10(k) Number K081867

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).