The Voyager Linux is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

The Voyager Linux is indicated for any medical condition in which the use of stereotactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:

Intra-cranial surgical procedures involving space occupying lesions or malformations (including soft tissue, vascular and osseous)
Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms
ENT Procedures
Orthopedic surgical procedures

Device Description

The Voyager Linux is an image guided surgical device that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and the TGS. Voyager Linux uses patient data to assist the physician with presurgical planning and interpretive navigation. The TGS, which is an add-on to the Voyager Linux, serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the TGS and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as drills, awls, and 300 party drill systems.

The Voyager Linux consists of the following basic components:

High Resolution color liquid crystal display (LCD) touch screen monitor
Uninterruptible Power Supply (UPS)
Central Processing Unit (CPU)
Isolation Transformer
Keyboard and Mouse
Optical Detector
Operating Room Cart
Tool and accessories surgical tools and accessories instrumented with reflective markers.
TGS connected to the Voyager Linux platform to enable stereotactic guidance of standard surgical tools.
Software application specific software provided as part of system or via standard media (e.g., CD-ROM)

AI/ML Overview

The provided document for the MAKO Surgical Corp. "Voyager Linux" device (K050973) is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device. This type of document typically does not contain detailed information about specific acceptance criteria, a comprehensive study report with quantitative performance data against those criteria, or the methodology for establishing ground truth, as would be found in a full clinical or validation study report.

Therefore, much of the requested information cannot be extracted directly from the provided text.

Here is what can be inferred or explicitly stated from the document, and what is missing:

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

Missing: The document does not specify quantitative acceptance criteria (e.g., accuracy thresholds, precision measurements) for the device's performance, nor does it provide a table of reported device performance against such criteria. The "performance" described is primarily in terms of demonstrating substantial equivalence to a predicate device and confirming the functionality of the added Tactile Guidance System (TGS).

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

Missing: The document does not describe a "test set" in the context of a validation study with specified sample sizes or data provenance. The 510(k) summary states, "As required by risk analysis, all verification and validation activities performed to date by designated individuals and the results demonstrated substantial equivalence." This is a high-level statement without details on the specific data used for these activities.

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)

Missing: This information is not present. The document mentions "designated individuals" performing verification and validation, but does not detail how ground truth was established for any test data, nor the number or qualifications of experts involved.

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

Missing: No information on an adjudication method for a test set is provided.

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

Missing: The document does not mention an MRMC study or any comparative effectiveness study involving human readers with or without AI assistance. The device (Voyager Linux with TGS) is an image-guided surgical device that provides "stereotactic guidance," not an AI-based diagnostic tool that assists human readers in interpreting images.

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

Missing: The device is described as an "image-guided surgical device" and an "intelligent tool holder or tool guide used by a surgeon." This implies a human-in-the-loop system, where the TGS assists the surgeon. The document does not present any standalone algorithm performance separate from its use by a surgeon.

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

Missing: The document does not specify the type of ground truth used for any validation activities. Given the device's function (surgical guidance), ground truth would typically relate to the accuracy of tool placement or anatomical registration, but this is not detailed.

8. The sample size for the training set

Missing: The document does not discuss a "training set" as it would for a machine learning or AI-driven system. The device primarily uses patient diagnostic images for "presurgical planning and interpretive navigation" and provides software-defined spatial boundaries. This implies programmed instructions and image processing, rather than a system trained on a large dataset in the modern AI sense.

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

Missing: As no training set is discussed, there is no information on how its ground truth might have been established.

Summary based on available information:

The provided document is a 510(k) summary for a medical device (Voyager Linux with Tactile Guidance System). Its purpose is to demonstrate substantial equivalence to a previously cleared predicate device, rather than to present a detailed study proving performance against specific acceptance criteria for an AI or diagnostic application. The document states that "all verification and validation activities performed to date by designated individuals and the results demonstrated substantial equivalence," but it does not elaborate on the specifics of these activities, including sample sizes, ground truth establishment, or detailed performance metrics.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for MAKO Surgical Corp. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters underneath. To the left of the logo is the text "K050973" with a line drawn underneath it.

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IMPORTANT

INSTRUCTIONS

READ the entire label carefully.
FOLLOW all directions and precautions.
USE only as directed.
STORE in original container.
DISPOSE of empty container properly.

ATTACHMENT 17 - 510(K) SUMMARY

Submitter: Address: Phone number: Fax number: Contact Person: Date Prepared: Cleared Device Trade Name: Modified Device Trade Name: Common Name: Classification Name: Classification #:
MAKO Surgical Corp. 2901 Simms Street, Hollywood, FL, 33020 954-927-2044 954-927-0446 William F. Tapia April 15, 2005 Voyager Linux Voyager Linux with the Tactile Guidance System (TGS) Stereotaxic Instrument Class II 21 CFR 882.4560

Substantial Equivalence Claimed To: Voyager Linux; Z-KAT, Inc., K023975 The modification to the Voyager Linux to include the TGS is shown to be substantially equivalent to the cleared system in the previous 510k. As required by risk analysis, all verification and validation activities performed to date by designated individuals and the results demonstrated substantial equivalence.

Description: The Voyager Linux is an image guided surgical device that includes an optical detector, computer, dedicated instrumentation, operating software, tools and accessories, and the TGS. Voyager Linux uses patient data to assist the physician with presurgical planning and interpretive navigation. The TGS, which is an add-on to the Voyager Linux, serves as an "intelligent" tool holder or tool guide used by a surgeon for stereotactic guidance during minimally invasive orthopedic surgical procedures. The TGS, an electromechanical arm, is passively constrained by software-defined spatial boundaries implemented through the use of the TGS and is designed to support a surgeon's preparation of an anatomical site for an orthopedic implant with standard surgical tools such as drills, awls, and 300 party drill systems.

Summary of Technological Characteristics - The Voyager Linux consists of the following basic components:

. High Resolution color liquid crystal display (LCD) touch screen monitor
Uninterruptible Power Supply (UPS) .
Central Processing Unit (CPU)
Isolation Transformer .
Keyboard and Mouse .
Optical Detector ●
Operating Room Cart .
Tool and accessories surgical tools and accessories instrumented with reflective markers. .
TGS connected to the Voyager Linux platform to enable stereotactic guidance of standard . surgical tools.
Software application specific software provided as part of system or via standard media (e.g., . CD-ROM)

Intended Use: The Voyager Linux is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intra-operative procedures.

The Voyager Linux is indicated for any medical condition in which the use of stereofactic surgery may be considered to be safe and effective, and where a reference to a rigid anatomical structure may be made, such as:

Intra-cranial surgical procedures involving space occupying lesions or malformations (including o soft tissue, vascular and osseous)
0 Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of spinal neoplasms

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Image /page/1/Picture/0 description: The image shows the MAKO Surgical Corp. logo. The logo features the word "MAKO" in large, bold letters, with the words "SURGICAL CORP." in smaller letters underneath. Above the word "MAKO" is a black, stylized graphic. The image also contains the number K050973 written in cursive.

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 7 2005

Mr. William F. Tapia Director of Regulatory Affairs MAKO Surgical Corporation 2901 Simms Street Hollywood, Florida 33020

Re: K050973

Trade/Device Name: Voyager Linux Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 29, 2005 Received: May 4, 2005

Dear Mr. Tapia:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because in ad the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the energe, 1976, the enactment date of the Medical Device Amendments, or to coninered pror to that 20, 1978, in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic Ace (110-) that the device, subject to the general controls provisions of the Act. The r our may, therefore, market are as 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 your device is easonned divinal controls. Existing major regulations affecting your device n may be subject to cash of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA our be found in the 'announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised hite i Drivision that your device complies with other requirements of the Act that I Drivias Intactions and regulations administered by other Federal agencies. You must or any I oderal station and sequirements, including, but not limited to: registration and listing (21 comply with an the 110 - 11 CFR Part 801); good manufacturing practice requirements as set CI N Fart 807); and img (21 (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) This letter will anow you to oegin manxoning of substantial equivalence of your device to a legally premarket notification: "The PDs 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 If you uesn't specific davice 10. Jour as 10.1) 276-0115 . Also, please note the regulation entitled, comaci the Office of Complanes as (2 + t notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general information on your response Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octss http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Roh

Miriam C. Provost, Ph.D. Acting 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 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 curved blade. The graphic is black and appears to be slightly textured.

	2018 Sinces
	ATTACHMENT 15
1- 1 - 7	INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Voyager Linux

Indications for Use:

Intra-cranial surgical procedures involving space occupying lesions or malformations (including o soft tissue, vascular and osseous)
Spinal surgical procedures involving spinal stabilization, neural decompression, or resection of O spinal neoplasms
ENT Procedures 0
Orthopedic surgical procedures O

Prescription Use __ × OR

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)

Signature

icrative

ological Devices

K050973

Attachment 15 - 1

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).