Argos is intended as an aid to the surgeon for precisely locating anatomical structures on the human body in either open or percutaneous procedures. It links tracked probes to virtual computer image space on a patient's preoperative or intraoperative image data. The system is indicated for any medical condition in which the use of stereotactic surgery may appropriate and where the reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra can be identified relative to medical images such as CT, MR , fluoroscopic or ultrasound images. Example procedures include but are not limited to: Cranial Procedures: Cranial biopsies Tumor resection Craniotomies/Craniectomies Skull base procedures Thalamotomies/Pallidotomies Spinal Procedures: Spinal implant procedures such as pedicle screw placement ENT procedures: Transsphenoidal procedures Intranasal procedures Sinus procedures, such as Maximillary anstrostomies. Ethmoidectomies Sphenoidotomies/Sphenoid explorations, Turbinate resection and Frontal sinusotomies

Device Description

Argos is a system for computer-assisted stereotactic surgery. It is designed to be used as an aid to the location of, and surgical approach to, lesions within the anatomical structures on the human body and to help define the exact anatomical relations of such lesions to surrounding structures. Prior to the brain surgery, the Argos system acquires contiguous MRI or CT scans of the area containing the lesion and uses them to construct an accurate three-dimensional representation of the patient's anatomy used initially to facilitate surgical planning. During the operation the Argos system continuously monitors the position of a pointing instrument, used by the surgeon, and visualizes it on a monitor screen in relation to the three-dimensional virtual anatomy of the patient. It is therefore possible to verify during the operation that the real position of various anatomical reference points, including the lesion, corresponding to those identified during surgical planning.

AI/ML Overview

The provided text is a 510(k) Summary of Safety and Effectiveness for the ARGOS image-guided surgery system. It details the device's description, intended use, and a comparison to a predicate device (VECTORVISION). However, it does not contain any information about specific acceptance criteria, studies proving performance, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The document focuses on establishing substantial equivalence to a legally marketed predicate device, which is a regulatory pathway for medical devices in the United States. This pathway typically relies on demonstrating that the new device is as safe and effective as a predicate device, rather than requiring extensive clinical trials with detailed performance metrics and statistical analyses.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of your detailed questions based on the provided text.

Here's an overview of what can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Information not available in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific performance metrics against defined acceptance criteria.

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

Information not available in the provided text. There is no mention of a test set or data provenance for performance evaluation.

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

Information not available in the provided text. There is no discussion of expert involvement in establishing ground truth for a test set.

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

Information not available in the provided text. No adjudication method is mentioned as a test set is not 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:

Information not available in the provided text. The ARGOS device is an image-guided surgery system, not an AI diagnostic tool primarily involving human readers interpreting images. An MRMC study is not relevant in this context and is not mentioned.

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

The ARGOS system is described as an "aid to the surgeon" that "continuously monitors the position of a pointing instrument, used by the surgeon, and visualizes it on a monitor screen." This clearly indicates a human-in-the-loop system. Therefore, a standalone algorithm-only performance study would not be applicable or described for this type of device.

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

Information not available in the provided text. No ground truth establishment is described. The system utilizes "three-dimensional representation of the patient's anatomy" constructed from "MRI or CT scans," implying that these medical images serve as the basis for anatomical representation.

8. The sample size for the training set:

Information not available in the provided text. There is no mention of a training set as the document does not describe a machine learning or AI model development process with a distinct training phase.

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

Information not available in the provided text. As there is no mention of a training set, the establishment of its ground truth is also not discussed.

Summary of the Study (as described for regulatory purposes):

The "study" presented here is a Substantial Equivalence determination, which is a regulatory review process rather than a scientific performance study. The core of this determination is a comparison between the ARGOS device and a legally marketed predicate device, BRAINLAB VECTORVISION (K003589).

Methodology: The submission compares key characteristics of ARGOS to VECTORVISION, including:
- Indications for Use (found to be similar)
- Device main components (similar components, some differences in physical configuration like camera separability)
- Physical characteristics (differences in dimensions and weight acknowledged, but not considered to affect safety or effectiveness significantly for substantial equivalence)
- Localization technology (both use optical tracking based on infrared cameras and retro-reflective markers for 3D coordinate calculation by triangulation).
Conclusion: Based on this comparison, the FDA concluded that ARGOS is "substantially equivalent" to BRAINLAB VECTORVISION, implying it is as safe and effective as the predicate device for its intended use. This conclusion is documented in the FDA's letter (APR 5 - 2007).

Summary

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APR 5 - 2007 061479

APPENDIX 2 510(k) Summary of Safety and Effectiveness for ARGOS

Submitted By:

3D Line Medical System ,srl Address: via Bernardo Rucellai 23 - 20161 MILAN - ITAL Y Tel.: + 39 02 2550161 Fax: + 39 02 25501642

Contact Person: Marco Luzzara, Director, QA Manager

Summary Date: January 18,2006

Device Trade Name: ARGOS

Common Name: Image guided surgery system

Classification name: instrument, stereotaxic.

Predicate Device:

Vectorvision, (K003589) manufactured by BRAINLAB AG Ammerthalstrasse 8 Heimstetten, GM 85551

Description of the Device:

Prior to the brain surgery, the Argos system acquires contiguous MRI or CT scans of the area containing the lesion and uses them to construct an accurate three-dimensional representation of the patient's anatomy used initially to facilitate surgical planning. During the operation the Argos system continuously monitors the position of a pointing instrument, used by the surgeon, and visualizes it on a monitor screen in relation to the three-dimensional virtual anatomy of the patient. It is therefore possible to verify during the operation that the real position of various anatomical reference points, including the lesion, corresponding to those identified during surgical planning.

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Intended use of the device:

Example procedures include but are not limited to:

Cranial Procedures: Cranial biopsies Tumor resection Craniotomies/Craniectomies Skull base procedures Thalamotomies/Pallidotomies

Spinal Procedures: Spinal implant procedures such as pedicle screw placement

ENT procedures: Transsphenoidal procedures Intranasal procedures Sinus procedures, such as Maximillary anstrostomies. Ethmoidectomies Sphenoidotomies/Sphenoid explorations, Turbinate resection and Frontal sinusotomies

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Substantial Equivalence to Predicate Device:

ARGOS and VECTORVISION are both image guided surgery systems. They link tracked probes to virtual computer image space on a patient's image. The relevant characteristics are compared below.

	ARGOS	VECTORVISON
Indication forUse	3Dline Argos is intended as an aidto the surgeon for precisely locatinganatomical structures on the humanbody in either open or percutaneousprocedures. It links tracked probesto virtual computer image space on apatient's preoperative orintraoperative image data. Thesystem is indicated for any medicalcondition in which the use ofstereotactic surgery may appropriateand where the reference to a rigidanatomical structure, such as theskull, a long bone, or vertebra can beidentified relative to medical imagessuch as CT, MR, fluoroscopic orultraosund images.	BRAINLAB VectorVision is intended tobe an intraoperative image guidedlocalizaton system to enable minimallyinvasive surgery. It links a freehandprobe, tracked by a passive markersensor system to virtual computer imagespace on a patient's preoperative imagedata being processed by a VectorVisionworkstation. The system is indicated forany medical condition in which the useof stereotactic surgery may beconsidered to be safe and effective andwhere a reference to a rigid anatomicalstructure, such as the skull, a long bone,or vertebra, can be identified relative toa CT, X-ray or MR based model ofanatomy.
Device maincomponents	발Argos Controller, consistingof computers and touch-screen monitor.The Camera System,■consisting of infraredcameras that can be standalone (on wheels), mountedon the controller or mountedon the operating microscope.Localizers and Pointers■트Planning Workstation(optional), that allows thepre-operative planning	IBrainlab VectorVision navigationsystem integrates computers,touch-screen monitors andinfrared cameras. The videocameras cannot be separatedfrom the main unit.트Workstation for pre-operativeplanning에Localizers and pointers
Physicalcharacteristics	Main Unit:Height 152cmWidth 51 cmDepth 54 cmWeight ca. 80KgCamera System (Type SS):Height 12 cm (30cm width thehandle)Width 62cmDepth 16Weight ca. 4.0kgCamera System (Type M):Height 4.6 cmWidth 16cmDepth 9.5Weight ca. 0.8 kg	Main Unit:Height 162cmWidth 95cm (115cm max)Depth72cmWeight ca. 150KgCamera System:Height 9.5 cmWidth 62cmDepth 16.5Weight 2.5kg
	ARGOS	VECTORVISON
Localizationtechnology	Optical tracking, based on infraredcameras and wire-less passiveinstruments (by means of retro-reflective markers).The objects to be tracked are fittedwith retro-reflective markers.The images coming from the videocameras are processed and the 3Dcoordinates of the markers arecalculated by triangulation.	Optical tracking, based on infraredcameras and wire-less passiveinstruments (by means of retro-reflectivemarkers).The objects to be tracked are fitted withretro-reflective markers.The images of the video cameras areprocessed and the 3D coordinates ofthe markers are calculated bytriangulation.

ਾ ।

100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000

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Conclusion: ARGOS has been found to be substantially equivalent to BRAINLAB VECTORVISION, 510/k) No. K003589.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with its head facing left and three stripes representing the three levels of government. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 5 - 2007

3D Line Medical Systems S.R.L. % TUV America, Inc. Mr. Stefan Preiss 1775 Old Highway 8 New Brighton, Minnesota 55112-1891

Re: K061479

Trade/Device Name: ARGOS Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: March 19, 2007 Received: March 21, 2007

Dear Mr. Preiss:

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. Stefan Preiss

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 vours

Paz Pelo Rmz

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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Indication for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ARGOS

Indications for Use:

Argos is intended as an aid to the surgeon for precisely locating anatomical structures on the Argos is intended in an an an apercutaneous procedures. It links tracked probes to virtual computer image space on a patient's preoperative or intraoperative image data. The system is configure mago bpace on condition in which the use of stereotactic surgery may appropriate and where the reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra can be identified relative to medical images such as CT, MR, fluoroscopic or ultrasound images. Example procedures include but are not limited to:

Cranial Procedures: Cranial biopsies Tumor resection Craniotomies/Craniectomies Skull base procedures Thalamotomies/Pallidotomies

Spinal Procedures: Spinal implant procedures such as pedicle screw placement

ENT procedures: Transsphenoidal procedures Intranasal procedures Sinus procedures, such as Maximillary anstrostomies, Ethmoidectomies Sphenoidotomies/Sphenoid explorations, Turbinate resection and Frontal sinusotomies

Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office

(Division

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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).