The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter and electrode insertion, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.

Device Description

The ClearPoint System is comprised of a workstation laptop with software, the SMARTGrid™ MRI-Guided Planning Grid, the SMARTFrame™ MRI-Guided Trajectory Frame, the SMARTFrame™ Accessory Kit and the SMARTFrame™ Thumbwheel Extension.

The SMARTGrid and associated Marking Tool are designed to assist the physician to precisely position the entry hole as called out in the traiectory planning software. The SMARTFrame is an Adjustable Trajectory Frame (ATF) that provides the quidance and fixation for neurosurqical tools. The MRI visible fluids of the Targeting Cannula along with the fiducial markers in the base of the frame allows for trajectory feedback when the physician views the MRI images, makes changes and confirms with subsequent MR images.

The ClearPoint System can be used with any MRI-compatible head fixation frame to immobilize the patient's head with respect to the scanner table, as well as with any imaging coil(s) (supplied by scanner manufacturers) that meet the physician's desired imaging quality. MRI Interventions also supplies an optional head fixation frame that can be used with the ClearPoint System.

The ClearPoint Workstation includes the following:

ClearPoint Workstation Software (for trajectory planning and monitoring)
Laptop Computer

The hardware components of the current ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following:

SMARTGrid MRI Planning Grid (interacts with the software to determine the desired location of the burr hole)
a. Marking Grid
b. Marking Tool
SMARTFrame Pack (SMARTFrame or SMARTFrame XG)
a. SMARTFrame ("ATF") with Base
b. Centering Device and Wharen Centering Guide
c. Dock
d. Device Lock (2 different diameters)
e. Screwdriver
f. Roll Lock Screw and Washer
Rescue Screws (Extra Titanium Screws)
Thumbwheel Extension
Accessory Kit
a. Peel-away Sheath
b. Stylet
c. Lancet
d. Depth Stop
e. Ruler
Scalp Mount Base
Guide Tubes and Device Guide Packs (Guide Cannulas)

In addition, the ClearPoint System is used with the following separately cleared or Class I, 510(k)exempt products:
SmartTip MRI Hand Drill and Drill Bit Kit
MRI Neuro Procedure Drape, with Marker Pen and Cover
SmartFrame MR Fiducial
Camera Fiberscope Accessory Kit

AI/ML Overview

The provided text is a 510(k) summary for the ClearPoint System, focusing on software updates. It describes the device, its intended use, and comparative technological characteristics with a predicate device. The "Performance Data" section outlines the verification testing performed.

Here's an analysis of the provided information to answer your questions, with the caveat that detailed study methodologies are often abridged in 510(k) summaries:

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

The summary doesn't explicitly present a table of acceptance criteria for each test with numerical targets, but it states "Pass. The design has been verified to satisfy all acceptance criteria" and provides performance details within the results.

Here's a table attempting to construct this from the provided "Performance Data":

Test	Implied Acceptance Criteria (Inferred from outcomes)	Reported Device Performance
Integrated System Test	Correct interoperation with scanner and disposable hardware kit; satisfactory accuracy for device placements (Likely predefined numerical accuracy target, although not explicitly stated).	Pass. The design has been verified to satisfy all acceptance criteria. All functional requirements necessitating interfacing with a live MR scanner were satisfied and validated using the software. Nine device placements were evaluated and had accuracy of 1.0 mm or less.
Regression Test	Output consistent with the previously released software version (predicate device) for underlying system components.	Pass. The design has been verified to satisfy all acceptance criteria. The following underlying system components still produce output that is consistent with the previously released software version: image display/visualization, image transfer, network communication verification, segmentation library output, scan plane parameter computations, hardware adjustment computations and low-level math utilities.
Verification Test	All functional areas within the software behave as described in the requirements.	Pass. The design has been verified to satisfy all acceptance criteria. All functional areas within the software behaved as described in the requirements.
Automated UI Test	Software functions correctly when simulating user input.	Pass. The design has been verified to satisfy all acceptance criteria. The ClearPoint 2.0 Software has passed the Automated UI test protocol.

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

Integrated System Test: "Nine device placements were evaluated."
Regression Test: "This test used data from the predicate device..."
Verification Test: "This test used data from the predicate device..."
Automated UI Test: No specific sample size of "data" is mentioned, as it simulates user input to test functionality.

The data provenance is not specified regarding country of origin, nor is it explicitly stated whether the tests were retrospective or prospective, though "live scanner connection" and "data from the predicate device" suggest a mix of methodologies, likely a combination of new prospective testing for the integrated system and retrospective analysis of existing data for regression/verification.

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

The 510(k) summary does not provide any information on the number or qualifications of experts used to establish ground truth for the test set. The tests described are primarily focused on software and system functionality (e.g., accuracy of device placement, consistency with previous versions), rather than clinical performance based on expert interpretation of medical images.

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

The summary does not describe any adjudication methods. This type of detail is typically relevant for studies involving human interpretation or subjective assessments, which are not the primary focus of the engineering verification tests described 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 involving human readers and AI assistance is mentioned or implied. The study focuses on the device's functional performance, not its impact on human reader performance.

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

The "Integrated System Test" involves "interoperation with scanner and disposable hardware kit," and the "Regression" and "Verification" tests analyze software output. While not explicitly framed as "algorithm only" performance, these tests evaluate the software's functional output and accuracy without explicitly describing a human-in-the-loop scenario for primary performance evaluation. The "accuracy of 1.0 mm or less" in the Integrated System Test is a measure of the system's precision in device placement.

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

For the Integrated System Test, the "ground truth" for evaluating accuracy (1.0 mm or less) would likely be based on physical measurements of the actual device placement in reference to a target, possibly confirmed through imaging, but the exact method isn't detailed. It's an engineering ground truth related to physical-system accuracy.

For Regression and Verification Tests, the "ground truth" is the expected behavior and output based on the software's requirements and the previously released predicate device's performance.

8. The sample size for the training set

The 510(k) summary does not provide information on training set sample size. This is because the submission is for an updated version of a stereotactic guidance system software, which typically relies on established algorithms and engineering principles rather than a "trained" machine learning model in the sense of deep learning that requires large training datasets. The changes are described as modifications to visualization toolkits, DICOM handling, image fusion, and UI workflow.

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

As there is no mention of a traditional "training set" in the context of machine learning, there is no information on how its ground truth was established. The "ground truth" for the software's development would be based on engineering specifications, medical imaging physics, and clinical requirements for stereotactic accuracy.

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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 2, 2018

MRI Interventions, Inc. % John Smith Partner Hogan Lovells US LLP 555 Thirteenth St. NW Washington, District of Columbia 20004

Re: K181195

Trade/Device Name: ClearPoint System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ORR, HAW Dated: October 5, 2018 Received: October 5, 2018

Dear John Smith:

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 mav, 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 avare 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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.

Matthew C. Krueger -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181195

Device Name ClearPoint 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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510(k) SUMMARY MRI Intervention. Inc.'s ClearPoint Device

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Hogan Lovells, US LLP 555 Thirteenth Street. NW Washington, DC 20004 Phone: 202-637-5600 Fax: 202-637-5910

Contact Person: John J. Smith. M.D., J.D.

Date Prepared: October 5, 2018

Name of Device and Name/Address of Sponsor

ClearPoint System™ MRI Interventions, Inc. 5 Musick Irvine, CA 92618

Common or Usual Name: Neurological Stereotaxic Instrument

Classification: 21 C.F.R. §882.4560

Product Code: ORR, HAW

Predicate Device: MRI Interventions, Inc. ClearPoint System (K171257)

Indications for Use

Device Description

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The ClearPoint Workstation includes the following:

1. ClearPoint Workstation Software (for trajectory planning and monitoring)
1. Laptop Computer

The hardware components of the current ClearPoint System are the SMARTFrame and Accessories. They are all single use devices that are provided sterile. They include the following:

1. SMARTGrid MRI Planning Grid (interacts with the software to determine the desired location of the burr hole)
- a. Marking Grid
- b. Marking Tool
1. SMARTFrame Pack (SMARTFrame or SMARTFrame XG)
- a. SMARTFrame ("ATF") with Base
- Centering Device and Wharen Centering Guide ﻓ
- c. Dock
- d. Device Lock (2 different diameters)
- e. Screwdriver
- f. Roll Lock Screw and Washer
1. Rescue Screws (Extra Titanium Screws)
1. Thumbwheel Extension
1. Accessory Kit
- a. Peel-away Sheath
- b. Stylet
- c. Lancet
- d. Depth Stop
- e. Ruler
1. Scalp Mount Base
1. Guide Tubes and Device Guide Packs (Guide Cannulas)

In addition, the ClearPoint System is used with the following separately cleared or Class I, 510(k)exempt products:

SmartTip MRI Hand Drill and Drill Bit Kit
MRI Neuro Procedure Drape, with Marker Pen and Cover ●
SmartFrame MR Fiducial .
Camera Fiberscope Accessory Kit ●

Purpose of 510(k)

The primary purpose of this 510(k) is to modify the ClearPoint System software to version 2.0 by (1) changing the underlying software visualization toolkit used to display reformatted and threedimensional image renderings; (2) introducing the ability to provide three-dimensional model renderings of the MRI Interventions SMARTGrid and SMARTFrame disposable hardware in combination with 3D volumetric renderings of images that are loaded into the software; (3) changing the DICOM toolkit used to receive images from the MR scanner and loading images from media; (4) adding the ability to fuse/register images together that were not acquired in the same frame of reference; (5) introducing the ability to define three-dimensional volumes of interest within image sets that are loaded into the software; and (6) modifying the software workflow to include new software features and make the existing workflow outlined in the predicate device more flexible.

The table below presents a detailed comparison of the technological characteristics of the updated ClearPoint System and those of the predicate device.

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Summary of the Technological Characteristics of the Device Compared to the Predicate Device

	ClearPoint System (Predicate): K171257	ClearPoint System (Subject)
Classification	21 C.F.R. § 882.4560	21 C.F.R. § 882.4560
Product Code	ORR, HAW	ORR, HAW
Intended Use	The ClearPoint System is intended to provide stereotactic guidance and operation of instruments or devices during the planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter, and electrode insertion, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.	The ClearPoint System is intended to provide stereotactic guidance and operation of instruments or devices during the planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging. The ClearPoint System is intended as an integral part of procedures that have traditionally used stereotactic methodology. These procedures include biopsies, catheter, and electrode insertion, including deep brain stimulation (DBS) lead placement. The System is intended for use only with 1.5 and 3.0 Tesla MRI scanners.
Environment	MRI SuiteEO 10 -6 SAL	MRI SuiteEO 10 -6 SAL
Sterilization	MRI Planning Grid & Marking Tool	MRI Planning Grid & Marking Tool
SmartGrid Pack	SmartFrame XG, Scalp Mount Base, BoneScrews, Stand-Off Pins, Screwdriver,Centering Tool, Wharen Centering Guide(packaged and sold separately), Dock andLock, Roll Lock Screw with Washer, RescueScrews (packaged separately)	SmartFrame XG, Scalp Mount Base, BoneScrews, Stand-Off Pins, Screwdriver,Centering Tool, Wharen Centering Guide(packaged and sold separately), Dock andLock, Roll Lock Screw with Washer,Rescue Screws (packaged separately)
SmartFramePack	Thumbwheel Extension (Light HandController)	Thumbwheel Extension (Light HandController)
HandController	Peel-away Sheath, Lancet, Stylet, DepthStop, Ruler	Peel-away Sheath, Lancet, Stylet, DepthStop, Ruler
Accessory Kit	4.5mm & 6.0mm	4.5mm & 6.0mm
Drill Guides	0.0825"	0.0825"
TargetingCannula ID	Ultem and PEEK	Ultem and PEEK
TargetingCannulaMaterial	0.0938, 0.141, 0.191, 0.250"	0.0938, 0.141, 0.191, 0.250"
Guide Tube /Device Guide /Drill Guide ID	Ultem	Ultem
Guide Tube/Device Guide /Drill GuideMaterial	Sterile, Sealed Tray, InsideSterile Tyvek Pouch(Wharen Centering Guide and Drill andDevice Guides are Sterile in a double TyvekPouch Without a Tray; Wharen CenteringGuide Packaging includes PVC)	Sterile, Sealed Tray, InsideSterile Tyvek Pouch(Wharen Centering Guide and Drill andDevice Guides are Sterile in a doubleTyvek Pouch Without a Tray; WharenCentering Guide Packaging includes PVC)
Packaging	±1.5mm @ ≤125mm	±1.5mm @ ≤125mm
TargetingAccuracy	1.6.2	2.0
TargetingSoftware

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Performance Data

The company performed verification testing for all software changes in the ClearPoint 2.0 software release. Specifically, the following tests were performed to support this 510(k) notice:

Test	Test Method Summary	Results
IntegratedSystem Test	This test utilized a live scannerconnection to verify correctinteroperation with scanner anddisposable hardware kit.	Pass. The design has been verified to satisfy allacceptance criteria. All functional requirementsnecessitating interfacing with a live MR scanner weresatisfied and validated using the software. Nine deviceplacements were evaluated and had accuracy of 1.0 mm orless.
RegressionTest	This test used data from thepredicate device and includedhead-to-head comparison withoutput from the predicate deviceto support the claim ofsubstantive equivalence.	Pass. The design has been verified to satisfy allacceptance criteria. The following underlying systemcomponents still produce output that is consistent with thepreviously released software version: imagedisplay/visualization, image transfer, networkcommunication verification, segmentation library output,scan plane parameter computations, hardware adjustmentcomputations and low-level math utilities.
Verificationtest	This test used data from thepredicate device to execute allareas of functionality of theworkstation.	Pass. The design has been verified to satisfy allacceptance criteria. All functional areas within the softwarebehaved as described in the requirements.
AutomatedUI test	This is an automated test thatsimulates user input to theClearPoint software to testfunctionality that is otherwisedifficult or time-consuming toexecute as a manual test.	Pass. The design has been verified to satisfy allacceptance criteria. The ClearPoint 2.0 Software haspassed the Automated UI test protocol.

The ClearPoint System hardware is identical to that of the predicate; no additional tests for biocompatibility or sterility were provided in support of this 510(k) notice. Biocompatibility data in accordance with ISO 10993 and Sterilization Validation using the overkill method of ISO 11135-1:2007 utilizing the half cycle method was provided in support of the predicate device.

Conclusions

The ClearPoint System is as safe and effective as the predicate ClearPoint System. The ClearPoint System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor differences in indications do not alter the intended use of the device and do not affect its safety and effectiveness when used as labeled. In addition, the minor technological differences between the ClearPoint System and its predicate devices raise no new issues of safety or effectiveness. Thus, the ClearPoint System is substantially equivalent.

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).