The STarFix Designer Software is part of the WayPoint Stereotactic System. The WayPoint Stereotactic System is intended to be used with commercially available stereotactic system for neurological procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

Device Description

FHC, Inc. STarFix™ Designer software is an advanced image-based neurosurgical planning software application designed for generating patient specific frames (FHC, Platform) primarily for Deep Brain Stimulation (DBS) Proedures and stereo-electroencephalography (SEEG) by means of the WayPoint™ Stereotactic platforms.

The STarFix™ Designer offers the following core features:

Image import and registration
- Open and manipulate CT and MR images for surgical planning
- . Rigid registration between CT and MR images, with user-selected reference scan of either modality.
Automatic localizer extraction
- Extract localizers from preoperative CT manually or automatically
- I Manually place localizers on MR scans
- Manual refinement of localizer position
- Patient specific 2D and 3D visualization of anatomical landmarks: AC, PC, MP
Trajectory planning ●
●
DBS STarFix™ Platform frame modeling ●
. Multi-Oblique STarFix™ Platform frame modeling
. Export and import planning data, including images, for transfer on another computer or to be saved for easy reference during the surgery
Save the plan any time during the planning session

The STarFix™ Designer provides a modern design, built to ease user interaction, and allow fast and efficient planning for the WayPoint™ Platforms and ultimately, the implantation of DBS electrodes. With safety as a primary concern, all planning elements need to be verified and marked explicitly before a platform model can be built. The user interface is guiding the necessary planning steps, by using numbered menus and intuitive labeling, along with a minimum of application settings and common actions arranged in the form of a toolbar dedicated to either 2D or 3D operations.

AI/ML Overview

The provided document, a 510(k) Summary for the STarFix Designer Software, describes the acceptance criteria and the study used to demonstrate that the device meets those criteria. However, it specifically states that the performance data for the STarFix Designer Software is documented in verification and validation reports, which are not included in this publicly available 510(k) summary. The summary itself only provides a high-level overview of the testing conducted.

Here's an attempt to extract the requested information based on the provided text, with explicit notes where information is not available from this document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from test method)	Reported Device Performance (Summary from 510k)
Software functionality consistent with predicate device's workflow (Usability Specification)	All major areas of software functionality were confirmed for the subject device.
Risk level of remaining bugs no greater than "Acceptable" as defined by the risk management plan.	No remaining bugs had a risk level of greater than Acceptable as defined by risk management plan.
Effectiveness of bug fixes confirmed.	Bug fixes assessed for effectiveness and risk. (Implied: effective and acceptable risk).
Substantive equivalence to predicate device maintained throughout its life-cycle (including bug fixes, risk acceptance, software releases, and regression testing).	Substantive equivalence is established.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "All major and minor software functions were tested iteratively" and refers to "software regression test protocol... based on the workflow established in the Usability specification of the predicate device." This suggests testing across a range of functionalities and scenarios, but no specific number of test cases or patient datasets used for validation is provided in this summary.
Data Provenance: Not explicitly stated. For software testing, this would typically involve synthetic data, anonymized real patient data, or a combination. The document doesn't specify the origin or type of data used for testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not mentioned. For software regression testing, adjudication is often performed by software quality assurance teams or subject matter experts comparing actual output to expected output. No specific method (e.g., 2+1 consensus) is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The performance data presented focuses on software regression testing to demonstrate substantial equivalence to a predicate device, rather than human performance with and without AI assistance.
Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable, as no such study was performed or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance: The testing described is primarily focused on the standalone software's functionality and adherence to the established workflow of the predicate device. It confirms that "All major areas of software functionality were confirmed for the subject device" and that bug risks are acceptable. While not explicitly termed "standalone performance" in the typical AI/CAD context, the software regression testing inherently evaluates the algorithm's functions independent of real-time human interaction during a clinical procedure, verifying its computational accuracy and reliability in generating plans. However, it's crucial to note this is within the context of surgical planning software, where the output is used by a human, not a diagnostic AI system making a direct independent diagnosis.

7. The Type of Ground Truth Used

Type of Ground Truth: For the software regression testing, the "ground truth" is largely defined by the "workflow established in the Usability specification of the predicate device" and expected system behavior based on these specifications. This would involve comparing the output of the STarFix Designer Software (e.g., image registration, localizer extraction, trajectory planning, platform modeling) against the expected output or behavior of the predicate device or a golden standard derived from the predicate's known performance. It is a functional and performance ground truth based on prior validated software.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is described as "advanced image-based neurosurgical planning software" that performs functions like "Image import and registration," "Automatic localizer extraction," and "Trajectory planning." It is a rule-based or algorithmic software, not a machine learning/AI model that typically requires a training set. The comparison is to older versions of planning software.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set Establishment: Not applicable, as there is no mention of a training set for a machine learning model.

Summary

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September 8, 2023

Image /page/0/Picture/1 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.

FHC, Inc. Kelly Moeykens QSO & Quality/Regulatory Manager 1201 Main Street Bowdoin, Maine 04287

Re: K231141

Trade/Device Name: STarFix Designer Software (C0265) Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: QRI, HAW Dated: August 9, 2023 Received: August 10, 2023

Dear Kelly Moeykens:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

Image /page/1/Picture/5 description: The image shows a digital signature. The signature includes the name "Adam D. Pierce - S". The signature indicates that the document was digitally signed on September 8, 2023, at 11:37:42 -04'00'.

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices 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) K231141

Device Name STarFix Designer Software (C0265)

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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K231141 Page 1 of 7

510(K) Summary

Submitter's name, address, telephone number, a contact person, and the date the summary was prepared:

FHC, Inc. 1201 Main Street Bowdoin, ME-04287 Tel: 207-666-5651 Fax: 207-666-8292

Contact: Kelly Moeykens Date: 04/20/2023

2. Name(s) of the Device:

Proprietary/Trade Name:	STarFix™Designer
	STarFix™Designer, SFD or C0265 or Stereotaxis
Common Name:	Planning Software
Regulation Number
Regulation Name:	Neurological Stereotaxic Instrument
Classification Panel	Neurology
Product Code:	QRI
Regulatory Class:	II

3. Legally Marked Predicate Device to which the submitter claims substantial equivalence:

The STarFix™Designer is substantially equivalent to FHC, Inc.'s Voxim and WayPoint™ Planning Software, part of the WayPoint™ Stereotactic System (K092192); decision date: February 12™ 2010, product code: HAW

4. Description of device:

The STarFix™ Designer offers the following core features:

Image import and registration
- Open and manipulate CT and MR images for surgical planning
- . Rigid registration between CT and MR images, with user-selected reference scan of either modality.

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K231141

Page 2 of 7

Automatic localizer extraction
- Extract localizers from preoperative CT manually or automatically
- I Manually place localizers on MR scans
- Manual refinement of localizer position
- Patient specific 2D and 3D visualization of anatomical landmarks: AC, PC, MP
Trajectory planning ●

●

DBS STarFix™ Platform frame modeling ●
. Multi-Oblique STarFix™ Platform frame modeling
. Export and import planning data, including images, for transfer on another computer or to be saved for easy reference during the surgery
Save the plan any time during the planning session

Image /page/4/Figure/13 description: The image shows a medical imaging interface with multiple views of a brain scan. The interface is divided into sections for imaging, fiducials, anatomy, trajectories, and platform. The brain scans are displayed in 2D and 3D views, with green lines indicating trajectories or points of interest. The display orientation is set to 'Original' with L: 2.75, P: 0.82, and S: -1.93.

Figure 1 : DBS planning session using the bilateral platform.

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5. Statement of Intended Use:

STarFix™Designer software is intended to be used by a neurosurgeon, neurologist or clinical neurophysiologist to plan and monitor positioning of microelectrodes, stimulating electrodes, or other instruments in specific anatomical structures in brain or nervous system.

Statement of Indications for Use:

The STarFix™Designer is part of the WayPoint™ Stereotactic System. The WayPoint™ Stereotactic System is intended to be used with commercially available stereotactic systems for neurosurgical procedures which require the accurate positioning of microelectrodes, stimulating electrodes, or other instruments in the brain or nervous system.

6. Comparison of Technological Characteristics to Predicate Device

The technological characteristics of the STarFix™ Designer are the same as those in the predicate device. There is no new technology, materials or method of manufacture introduced. A summary of similarities in the specifications between the STarFix™ Designer and its predecessor is provided below.

ComponentSection	Feature	Subject Device:STarFix™ Designer	Predicate:Waypoint™ Planner	Predicate:Voxim
ImagingLoad images, preview	CT loading	Yes	Yes	Yes, loadpatientdatasets.
	MRI loading	Yes	Yes	Yes, loadpatientdatasets.
Aligning images	Manual pre-align:Align/Rotate	Yes	Yes	Yes
	AutomaticRegistration	RigidRegistration byIntensity	Rigid Registrationby Intensity,Registrationby points,Registrationby device	Yes,automaticmatching,imagingdevicereferential, orframeregistrations.
	Incrementalregistration – usepreviousregistration step asa base for a newregistration step	Yes	Yes	No
Viewing Images -2D	Checkerboard, Lensto check accuratealignment	Yes	Same	Yes, shadefeature
	Brightness/Contrast	Yes	Same	Yes, grayscaletool.
	Measurement	Yes, distance andangles	Same	Yes, distance,angles,surface
Viewing Images -3D	3D volumereconstruction	Yes	Yes	Yes
	Thresholding	Yes, lower andupper limit	Yes, lowerlimit	Yes, lowerand upperlimit
	Solid/ Slice views	Yes	Yes	Yes, solid andsurface cut
	Distancemeasurement	Yes	Same	Yes
FiducialsAnchor Detection	Automatic Anchordetection	Yes	Same	Yes
	Seed and search(semi-automaticsearch)	Yes	Same	No
	Manual placement	Yes	Same	Yes
Anatomy	AC, PC, MP manualpoint placement	Yes	Same	Yes
Point Selection	Display of AC-PCLength	Yes	Yes	Yes
TrajectoriesAdding trajectories	Editing of trajectoryname, entry andtarget coordinates	Yes	Yes	Yes,trajectoryparameterpanel
	Mirroring anexisting trajectorywith respect to themid-plane	Yes	Same	Yes
	Using templates toadd trajectories	Yes	Same	No
	Displaying distanceto target	Yes	No	Yes
	Surgeon's eye view(trajectory view)	Yes	Same	Yes
PlatformSTarFix™ Platform –Unilateral or Bilateral	Select platformmodel	Yes	Same	Yes
	Automatically sortanchors	Yes	Yes	Yes
	Automatically sorttrajectories	Yes	Yes	Yes
	Specifying Platformheight	Yes	Same	Yes
	Building theplatform	Yes	Same	Yes
Multi-Oblique Platform	Select platformmodel	Yes	Same	No
	Edit connections	Yes	Yes	No
		Specifying hub height	Yes	Yes	No
		Building the platform	Yes	Same	No
Data Export	Exporting the production file	Edit the patient details and save the file to disk	Yes	Same	Yes
	Plan files	Save the current plan to disk	Yes	Yes.	Yes.

Table 2: Similarities between STarFix™Designer, Waypoint Planner and Voxim microTargeting™

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8. Substantial Equivalence statement:

The STarFix™ Designer Software System is substantially equivalent in design, construction, materials, intended use and performance characteristics to its predicative devices, FHC, Inc.'s Voxim and WayPoint™ Planner Planning Software, part of the WayPoint™ Stereotactic System (K092192); decision date: February 12th 2010.

9. Performance Data:

Performance data of the STarFix™Designer Software System is documented in the verification and validation reports. Software regression test results show the system to be the equivalent to the predicate system.

Test	Test Method Summary	Results
Softwareregressiontesting	The internally createdsoftware regression testprotocol is based on theworkflow established in theUsability specification of thepredicate device. It isperformed iteratively at eachsoftware release per IEC62304.	All major areas of softwarefunctionality were confirmed for thesubject device. No remaining bugshad a risk level of greater thanAcceptable as defined by riskmanagement plan.
	All major and minor softwarefunctions were testediteratively prior to each	Over the course of its life-cycle, thepredicate device received similartreatment with respect to bug fixes,bug risk acceptance, software

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K231141 Page 7 of 7

release of a new softwarerevision. Additionally, bugsfixed since the previous roundof regression testing wereassessed for effectiveness andrisk.	releases, and regression testing. Assuch, substantive equivalence isestablished.
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10. Conclusion

Based on the non-clinical performance data performed comparing the STarFix™ Designer software to the predicate device (Voxim and WayPoint Planning Software), it is concluded that the subject device is as safe and effective as the predicate device.

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).