The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.

Device Description

The Stealth-Midas MR8 consists of electric and pneumatic drill handpieces that feature an optical navigation tracker, enabling navigation in conjunction with the StealthStation S8 System and the Integrated Power Console (IPC). The system allows the navigation of a selection of currently available surgical dissecting tools. The navigated handpieces are provided non-sterile and are reusable. The associated attachments are provided non-sterile and are reusable. The associated surgical dissecting tools and MR8 ClearView burs are provided sterile and are single-use.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Medtronic Stealth-Midas MR8 System. The information provided outlines the device, its intended use, and comparative testing to establish substantial equivalence to predicate devices. However, the document does NOT contain a detailed study proving the device meets specific acceptance criteria with reported device performance metrics in the format requested. The document primarily focuses on establishing substantial equivalence based on technological characteristics and functional testing, not a formal clinical efficacy or diagnostic performance study with specific quantitative acceptance criteria typically seen for AI/ML-driven devices.

Therefore, many of the requested items (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, effect sizes, standalone performance, type of ground truth) are not explicitly present in the provided text. The device described is a surgical instrument with navigation capabilities, not an AI/ML-driven diagnostic or prognostic tool.

Despite this, I will describe what is present and indicate what is missing based on the prompt's requirements.

Device Name: Stealth-Midas MR8 System
Device Type: Stereotaxic Instrument (Surgical Navigation System with Drill)

The provided document describes the Stealth-Midas MR8 System, which combines an electric and pneumatic drill handpiece with an optical navigation tracker for computer-assisted surgery. The purpose of the 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices, not necessarily to prove the device meets specific quantitative performance acceptance criteria in the context of an efficacy study as might be conducted for an AI/ML diagnostic algorithm.

Here's a breakdown of the requested information based on the provided document:

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

The document focuses on "Navigational Accuracy Analysis" as a key performance test.

Acceptance Criteria (from predicate)	Reported Device Performance (Stealth-Midas MR8 System)
StealthStation System Accuracy Requirements (Predicate Stealth-Midas with StealthStation S7):	Stealth-Midas MR8 with StealthStation S8:
3D Accuracy Testing: < 2.27 mm	3D Accuracy Testing: < 2.00 mm
2D Accuracy Testing: < 2.98 mm	2D Accuracy Testing: < 3.00 mm
Conclusion: The document states, "Accuracy validation testing conducted on the subject device confirms the Stealth-Midas MR8 when used with StealthStation S8 is equivalent in accuracy as the predicate Stealth-Midas when used with StealthStation S7."

Other "performance testing" mentioned includes:

CAD Model Evaluation: Verified that CAD models are accurately reflected in the application software. (No quantitative acceptance criteria or reported performance given beyond "verified").
Formative Usability: Confirmed users can follow the navigated workflow and assemble the device. (No quantitative acceptance criteria or reported performance given beyond "confirmed").
Summative Testing: Confirmed users can safely and effectively use the Stealth-Midas MR8 navigated drill handpiece with the StealthStation S8 software. (No quantitative acceptance criteria or reported performance given beyond "confirmed").

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

Sample Size for Test Set: Not specified in the provided document. The document refers to "Accuracy validation testing" but does not detail the number of tests performed or the nature of the samples (e.g., phantom, cadaver, pre-clinical/clinical data).
Data Provenance: Not specified. It can be inferred that testing was conducted internally by Medtronic, but no country of origin or whether it was retrospective/prospective is mentioned.

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

This information is not provided in the document. The accuracy testing refers to comparing the device's measured accuracy against a predicate device's established accuracy requirements. It's likely that "ground truth" for navigational accuracy pertains to physical measurements using precision instruments, not expert-derived labels.

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

This information is not provided and is generally not applicable to the type of engineering/physical accuracy testing described for a surgical navigation system. Adjudication methods are typically used for establishing ground truth in image interpretation or clinical outcomes, which is not the primary focus of the performance tests detailed here.

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 MRMC comparative effectiveness study was done or mentioned. This type of study is relevant for AI-assisted diagnostic tools, not for a surgical drill and navigation system like the Stealth-Midas MR8. The device assists surgeons in locating anatomical structures, but it does not analyze images or provide diagnoses that human "readers" would interpret.

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

The concept of "standalone performance" for an algorithm is not applicable in the context of this device. The Stealth-Midas MR8 System is an instrument that functions in conjunction with a human surgeon and the StealthStation S8 System. Its "performance" is inherently linked to its ability to accurately track and display the position of surgical tools relative to patient anatomy, as used by a human, rather than an independent algorithmic output. The "Navigational Accuracy Analysis" seems to be a form of standalone technical performance assessment of the navigation component.

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

The ground truth for the "Navigational Accuracy Analysis" would likely be physical measurements from a highly accurate measurement system (e.g., optical tracking system with known fiducials, coordinate measuring machine) in a controlled laboratory setting, rather than expert consensus, pathology, or outcomes data. The document implies a technical performance measurement against established benchmarks, not a clinical outcome.

8. The sample size for the training set

Not applicable / Not provided. The Stealth-Midas MR8 System is a mechanical and optical medical device, not an AI/ML system that requires a "training set" in the computational sense. The device's design and operating parameters are based on engineering principles and validated through testing, not machine learning.

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

Not applicable / Not provided. As the device is not an AI/ML system, there is no "training set" or corresponding ground truth establishment process in the way it's understood for AI/ML.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Medtronic Powered Surgical Solutions Jenna Groves Regulatory Affairs Manager 4620 North Beach Street Fort Worth, Texas 76137

Re: K183644

Trade/Device Name: Stealth-Midas MR8 System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW Dated: December 21, 2018 Received: December 26, 2018

Dear Jenna Groves:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 (21 CFR Part 807); labeling (21 CFR Part

May 22, 2019

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For: CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183644

Device Name Stealth-Midas MR8 System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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K183644

510(k) Summary

December 17, 2018

I. Company: Medtronic Powered Surgical Solutions 4620 North Beach Street Fort Worth, TX 76137 Telephone Number: (817) 788-6400
- Contact: Jenna Groves Regulatory Affairs Manager Telephone Number: (817) 788-6686 Fax: (817) 788-6222 Email: Jenna.a.groves@medtronic.com
II. Proprietary Trade Name: Stealth-Midas MR8 System
III. Common Name: Orthopedic, Neurologic Stereotaxic Instrument
IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
Classification: Class II V.
VI. Product Code(s): OLO, HAW

VII. Product Description:

VIII. Indications for Use:

IX. Identification of Legally Marketed Devices (Predicate Devices):

Stealth-Midas System (K160713) ●

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. MR8 Drill System (K183515)

X. Comparison of the Technological Characteristic:

The only significant difference between the subject navigated handpieces and the currently cleared navigated handpieces are minor changes to the optical tracker geometry.

The passive optical tracking technology is identical to that employed in the use of the predicate navigated instrument. Navigational accuracy testing confirms that the subject navigated drill system is as accurate as the predicate system.

The currently cleared MR8 Drill System consists of pneumatic and electric handpieces, attachments, and surgical dissecting tools that are indicated for various cranial and spinal procedures. There are no changes to any of the attachments or surgical dissecting tools. The only significant difference between the subject handpiece and the currently available MR8 handpiece is the addition of a passive optical tracker to the hind to enable navigation of a selection of dissecting tool. As a drill, the Stealth-Midas MR8 is identical to the MR8 drill system, with the exception, as stated, an optical tracker has been attached to the hind of the handpiece to allow navigation. The addition of the tracker does not impact the ability of the drill system to perform to their intended use as a drill system. See below table for a comparison of qualitative characteristics.

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Feature	Stealth-Midas SystemMR8 (subject devices)	Stealth Midas System(primary predicate)K160713	MR8 Drill System and MR8ClearView (secondary predicate)K183515	Equivalence Discussion
Regulation	21 CFR 882.4560(Stereotaxic Instrument)	21 CFR 882.4560 (StereotaxicInstrument)	21 CFR 882.4360 (Motor, Drill,Electric)21CFR 882.4370 (Motor, Drill,Pneumatic)21 CFR 882.4310 (Drills, Burs,Trephines & Accessories	SameAs a navigated drill, the Stealth-MidasMR8 falls into the same regulation numberas the primary predicate Stealth-Midas andhas the same intended use.SimilarThe Stealth-Midas MR8 operates andperforms the same as the predicate MR8drill and falls into a similar regulation.
Product Code	OLO, HAW	OLO	HBC, HBB, HBE, ERL, HSZ	EquivalentThe Stealth-Midas MR8 System isindicated for use in navigated cranial andspinal procedures. As such, it carries thesame OLO product code (orthopedicstereotaxic instrument) as predicateStealth-Midas spine instruments and alsoincludes product code HAW (neurologicalstereotaxic). HAW falls within the sameregulation number 21 CFR 882.4560 andhas the same intended use as OLO.
Intended Use	Incision / cutting, removal,drilling, and sawing of softand hard tissue, bone, andbiomaterials.	Incision / cutting, removal,drilling, and sawing of soft andhard tissue, bone, andbiomaterials.	Incision / cutting, removal,drilling, and sawing of soft andhard tissue, bone, and biomaterials.	EquivalentThe Navigated Electric and PneumaticStealth-Midas MR8 motors, with thetracker on the hind of the motor, allow foroptical tracking of the -tip at the surgicalsite. The subject Stealth-Midas MR8 andthe predicate devices have the sameintended use.As a drill system the subject systemintended use is identical to that of thepredicate drill system. The only differencebetween the subject and the predicate MR8

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Indications for Use	The Stealth-Midas MR8	The Stealth-Midas System is	The Medtronic MR8	Handpieces is that the proposed Stealth-Midas MR8 Handpieces are supplied witha Tracker on the hind of the Handpieces.Equivalent
The Stealth-Midas MR8System is indicated for thedrilling, burring andremoval of hard tissue andbone in spinal and cranialsurgical procedures.Computer-assisted surgeryand its associatedapplications are intendedas an aid for preciselylocating anatomicalstructures in either open orpercutaneous procedures.Their use is indicated forany medical condition inwhich the use ofstereotactic surgery may beappropriate, and wherereference to a rigidanatomical structure, suchas a long bone, or vertebra,can be identified relative toa CT- or MR-based model,fluoroscopic images, ordigitized landmarks ofthe anatomy.	indicated for the incision /cutting, removal, drilling, andsawing of soft and hard tissue,bone, and biomaterials in spinalsurgical procedures. Computer-assisted surgery and itsassociated applications areintended as an aid for preciselylocating anatomical structuresin either open or percutaneousprocedures. Their use isindicated for any medicalconditionin which the use of stereotacticsurgery may be appropriate,and where reference to a rigidanatomical structure, such as along bone, or vertebra, can beidentified relative to a CT- orMR-based model, fluoroscopicimages, or digitized landmarksof the anatomy.	Drill System is indicatedfor the incision/cutting,removal, drilling, andsawing of soft and hardtissue, bone, andbiomaterials inNeurosurgical (Cranialand Craniofacialincluding craniotomy);Ear, Nose and Throat(ENT), Maxillofacial,Orthopedic,Arthroscopic, Spinal,Sternotomy, and GeneralSurgical Procedures.Additionally, the MR8Drill System is indicatedfor the incision/cutting,removal, drilling, and sawing ofsoft and hardtissue, bone, andbiomaterials during openand minimally invasivespine procedures, whichmay incorporateapplication of varioussurgical techniquesduring the followinglumbar spinalprocedures:• LumbarMicrodiscectomy• Lumbar StenosisDecompression• Posterior LumbarInterbody Fusion (PLIF)	The Navigated Electric and PneumaticStealth-Midas MR8 motors, with thetracker on the hind of the motor, allow foroptical tracking of the tool-tip at thesurgical site. The subject Stealth-MidasMR8 and the predicate devices have thesame intended use, but the subject deviceis indicated for both cranial and spinalapplications and the predicate Stealth-Midas is indicated for spinal applications.As a drill system the subject systemintended use is identical to that of thepredicate MR8 drill system. The onlydifference between the subject motor andthe predicate motor is the Stealth-MidasMR8 motors are supplied with a tracker orthe hind of the handpieces/motor. Thesubject motor and the predicate motor areboth indicated for spinal and cranialapplications.

StealthStationOperatingPrinciple(TrackingMethod)	Optical (infra-red)	Optical (infra-red)	• Transforaminal LumbarInterbody Fusion (TLIF)• Anterior LumbarInterbody Fusion (ALIF)• Direct LateralInterbody Fusion (DLIF)The Midas Rex MR8ClearView Tools areused only in conjunctionwith the MR8 DrillSystem to perform asintended. Please refer to the MidasRex MR8Drill System andassociated User's Guidesfor the Indications ofUse.	IdenticalThe Operating Principle of the subjectStealth-Midas MR8 device is identical tothe predicate Stealth-Midas
StealthStationSystemAccuracyRequirements	3D Accuracy Testing:<2.00 mm2D Accuracy Testing:<3.00 mm	3D Accuracy Testing:<2.27 mm2D Accuracy Testing:<2.98 mm	N/A	EquivalentThe StealthStation S8 System accuracyrequirements are equivalent to theStealthStation S7 System accuracyrequirements. Accuracy validation testingconducted on the subject device confirmsthe Stealth-Midas MR8 when used withStealthStation S8 is equivalent in accuracyas the predicate Stealth-Midas when usedwith StealthStation S7.
SystemComponents	• Electric Handpiece w/Passive Optical Tracker• Pneumatic Handpiece w/Passive Optical Tracker• Attachments• Surgical DissectingTools	• Electric Handpiece w/Passive Optical Tracker• Pneumatic Handpiece w/Passive Optical Tracker• Attachments• Surgical Dissecting Tools	• Electric Handpiece• Pneumatic Handpiece• Attachments• Surgical Dissecting Tools	EquivalentAs a drill system the components areidentical to those of the predicate MR8drill system. The only difference is animprovement to the secondary lockmechanism that requires a ¼ turn insteadof multiple rotations. Additional markings
				were added to the subject handpiece toprovide a visual aid when locking.Navigation compatibility is enabled by useof a passive optical tracker, which is nearlyidentical to the tracker of the predicatenavigated drills. The only difference is thetracker on the subject device has a slightlydifferent geometry to allow differentiationfrom the predicate Stealth-Midas device.The Stealth-Midas MR8 offers a singledownward orientation for angledattachments versus the Stealth-Midaspredicate device that offered a right or leftdownward orientation angled attachment.The single downward orientation versus aright/left orientation has no impact onfunctionality, performance or accuracy ofthe Stealth-Midas MR8 device
SurgicalDissecting Tools– Overall Length	3-42 cm	3-42 cm	3-42 cm	SimilarAs a drill system there are no changes tocurrently marketed components. Selectsurgical dissecting tools, identified in thedevice description, will be compatible withspinal and/or cranial navigation.
SurgicalDissecting Tools– Head Diameter	0.5 – 25 mm	0.5 – 25 mm	0.5 – 25 mm	SimilarAs a drill system there are no changes tocurrently marketed components. Selectsurgical dissecting tools and MR8ClearView burs, as identified in the devicedescription, will be compatible with spinaland/or cranial navigation.
AttachmentLength	2 – 40 cm	2 – 40 cm	2 – 40 cm	Similar
				As a drill system there are no changes tocurrently marketed components. Selectcombinations of surgical dissecting tools,MR8 ClearView burs and attachments, asidentified in the device description, will becompatible with spinal or cranialnavigation.
Drill SystemOperatingPrinciple	• Electric (Powered byIPC)• Pneumatic (Powered byPneumatic Pressure)	• Electric (Powered by IPC)• Pneumatic (Powered byPneumatic Pressure)	• Electric (Powered by IPC)• Pneumatic (Powered byPneumatic Pressure)	IdenticalThe operating principle of the subjecthandpiece and the predicate handpieces areidentical.
System Interface	• IPC• StealthStation System	• IPC• StealthStationSystem	• Electric (Powered by IPC)• Pneumatic (N/A)	EquivalentBoth the subject Stealth-Midas MR8 andthe predicate Stealth-Midas interface withthe StealthStation. The predicate deviceinterfaces with the StealthStation S7System and the subject device interfaceswith the StealthStation S8 System.
Sterilization &Cleaning	• Non-sterile (Handpieces,Attachments)• Sterile (SurgicalDissecting Tools andMR8 ClearView burs)	• Non-sterile (Handpieces,Attachments)• Sterile (Surgical DissectingTools and ClearView burs)	• Non-sterile (Handpieces,Attachments)• Sterile (Surgical DissectingTools and MR8 ClearViewinstrument)	SimilarThe subject system will be used withcurrently cleared Attachments as well asSurgical Dissecting Tools and MR8ClearView burs available with the MR8Drill System. The sterilization andcleaning parameters for the handpieces aresimilar to those of the predicatehandpieces.
Materials	Attachments: StainlessSteel, Aluminum, Ceramic,Phenolic, Epoxy, ChromeCoated Brass, Torlon 4301Surgical Dissecting Tools:Stainless Steel, Tool Steel,Alloy Steel, Carbide, TDCCoating, Diamond Coating	Attachments: Stainless Steel,Aluminum, Ceramic, Phenolic,Epoxy, Chrome Coated Brass,Torlon 4301Surgical Dissecting Tools:Stainless Steel, Tool Steel,Alloy Steel, Carbide, TDCCoating, Diamond Coating in	Attachments: Stainless Steel,Aluminum, Ceramic, Phenolic,Epoxy, Chrome Coated Brass,Torlon 4301Surgical Dissecting Tools:Stainless Steel, Tool Steel, Alloy Steel, Carbide, TDC	IdenticalThe subject device uses identical materialsto the primary and secondary predicate.

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in Nickel Substrate,Titanium NitrideTracker: Aluminum	Nickel Substrate, TitaniumNitrideTracker: Aluminum	Coating, Diamond Coating inNickel Substrate, Titanium NitrideTracker: N/A
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XI. Discussion of the Performance Testing

Testing was completed to ensure the functionality and compatibility with the identified Medtronic products. The following table summarizes the performance testing completed:

Test	Description
Navigation Accuracy Analysis	Confirmed navigated instrument accuracy
CAD Model Evaluation	Verified that CAD models are accurately reflected in the application software
Formative Usability	Confirmed users can follow the navigated workflow and assemble the device
Summative Testing	Confirmed users can safely and effectively use the Stealth-Midas MR8 navigated drill handpiece with the StealthStation S8 software.

XII. Conclusions

The Stealth-Midas MR8 System has been shown through comparison and testing to be substantially equivalent to the identified predicate devices.

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).