Bullsai Confirm provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.

Device Description

Bullsai Confirm is intended to assist medical professionals in planning the programming of deep brain stimulation (DBS) by visualizing the Volume of Tissue Activated (VTA) relative to patient anatomy. It is used to visualize patient-specific information within the patient's anatomy. Integrated magnetic resonance imaging (MRI) and computed tomography (CT) images are uploaded to Bullsai Confirm and can be navigated through in multiple 2D projections and 3D reconstructions. Abbott DBS lead models are positioned in the corresponding artifacts and potential stimulation settings and electrode configurations entered. Bullsai Confirm mathematically combines finite element (FE) based electric field model of the lead with an axon based neural activation model to translate potential stimulation settings and electrode configurations into a visualized VTA field to indicate the shape and the area or volume of anatomy that will be activated by the stimulation. Results, including input image quality assessments, are shared in an output PDF report and visualized in a web-based software interface.

Bullsai Confirm is used to do the following:

Import DICOM images from a picture archiving and communication system (PACS), including . MRI and CT DICOM images.
. Import preoperative planning outputs (including tractography, structural ROIs, etc.) from AWS S3 Cloud Storage
. Combine MR images, CT images, and patient specific 3D structures for more detail
Localize graphical compatible DBS lead models (based on preoperative imaging) .
. Visualize VTA fields relative to structures of interest in the patient anatomy or lead position

The software provides a workflow for clinicians to:

Create patient-specific stimulation plans for DBS programming .
. Export reports that summarize stimulation plans for patients (PNG screenshot)

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for Bullsai Confirm, based on the provided FDA 510(k) summary:

Device: Bullsai Confirm
Indication for Use: To assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't present a specific table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, or accuracy for the Bullsai Confirm product itself. Instead, the acceptance criteria are described in terms of compliance with regulatory requirements and the fulfillment of specific software functionalities as special controls.

The "Performance Data" section states the device meets the special controls under 21 CFR 882.5855, which are:

Acceptance Criteria (Special Controls - 21 CFR 882.5855)	Reported Device Performance
1. Software verification, validation, and hazard analysis must be performed.	A hazard analysis and software verification and validation testing were performed for Bullsai Confirm.
2. Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.	Bullsai Confirm underwent formative usability testing.
3. Labeling must include: a. The implanted brain stimulators for which the device is compatible. b. Instructions for use. c. Instructions and explanations of all user-interface components. d. A warning regarding use of the data with respect to not replacing clinical judgment.	The User Manual for Bullsai Confirm contains the labeling statements in accordance with the special controls. (Implies compliance with all sub-points a-d).

Note: The document also mentions "technical performance evaluation of the lead artifact detection and registration between image types" but does not provide specific acceptance criteria or performance metrics (e.g., accuracy, precision) for these evaluations. This is a common practice in 510(k) submissions where specific quantitative performance for a planning software like this might not be required in the public summary if the primary claim is substantial equivalence and compliance with special controls.

Study Proving Device Meets Acceptance Criteria

The document outlines that the device's performance was evaluated through various tests to meet the special controls.

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

The document does not explicitly state the number of cases or sample sizes used for the "formative usability testing" or the "technical performance evaluation of the lead artifact detection and registration between image types."

Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While it mentions importing from PACS and AWS S3, this doesn't detail the origin of the data used for testing.

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

The document does not specify the number of experts or their qualifications involved in establishing ground truth for any test sets. The nature of this software (DBS planning assistant) suggests that "ground truth" would likely relate to the accuracy of lead localization, VTA calculation, and anatomical registration, typically assessed by neurosurgeons or neurologists specializing in DBS.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating device performance. This would typically be detailed if a reader study or performance validation against a consensus "gold standard" was performed and the results reported as part of the summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of an MRMC comparative effectiveness study being performed, nor any data on how much human readers improve with AI vs. without AI assistance. The device is described as an assistant for planning, implying a human-in-the-loop, but without a comparative study.

6. Standalone (Algorithm Only) Performance

The document does not provide standalone (algorithm only, without human-in-the-loop) performance metrics. The software is explicitly described as assisting "medical professionals," indicating it's designed for human-in-the-loop use.

7. Type of Ground Truth Used

The specific "type of ground truth" (e.g., expert consensus, pathology, outcomes data) is not explicitly stated for any of the performance evaluations mentioned. For "technical performance evaluation of the lead artifact detection and registration between image types," the ground truth would likely be derived from expert manual localization or highly accurate imaging methods, but this is not detailed.

8. Sample Size for the Training Set

The document provides no information regarding the size of the training set used for any machine learning components (if applicable) within the Bullsai Confirm software. Given the description focusing on finite element models and neural activation models, it's possible the core algorithms are physics-based rather than exclusively data-driven, or that details of data-driven components (if any) are not disclosed in this summary.

9. How Ground Truth for the Training Set Was Established

As no training set size is provided, there is consequently no information on how ground truth for a training set was established.

Summary

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March 28, 2025

Turing Medical Technologies, Inc. Christa Nova Director of Quality Assurance and Regulatory Affairs 393 N Euclid Ave Suite 310 Saint Louis, Missouri 63108

Re: K243520

Trade/Device Name: Bullsai Confirm Regulation Number: 21 CFR 882.5855 Regulation Name: Brain Stimulation Programming Planning Software Regulatory Class: Class II Product Code: OOC Dated: March 14, 2025 Received: November 15, 2024

Dear Christa Nova:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).

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Sincerely,

Jitendra V. Virani -S

CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine 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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K243520

Device Name

Bullsai Confirm

Indications for Use (Describe)

Bullsai Confirm provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

Device Trade Name:	Bullsai Confirm
Manufacturer:	Turing Medical Technologies, Inc.393 N EUCLID AVE STE 310,SAINT LOUIS, MISSOURI 63108 UNITED STATES
Contact:	Christa NovaDirector, QARA419-388-3288
Date Prepared:	March 28, 2025
Classification:	Brain stimulation programming planning software, 21 CFR882.5855
Class:	II
Product Code:	QQC
Primary Predicate:	SureTune4 Software, DEN210003

Indications For Use:

Bullsai Confirm provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.

Device Description:

Bullsai Confirm is used to do the following:

Import DICOM images from a picture archiving and communication system (PACS), including . MRI and CT DICOM images.
. Import preoperative planning outputs (including tractography, structural ROIs, etc.) from AWS S3 Cloud Storage
. Combine MR images, CT images, and patient specific 3D structures for more detail
Localize graphical compatible DBS lead models (based on preoperative imaging) .
. Visualize VTA fields relative to structures of interest in the patient anatomy or lead position

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The software provides a workflow for clinicians to:

Create patient-specific stimulation plans for DBS programming .
. Export reports that summarize stimulation plans for patients (PNG screenshot)

Predicate Device:

Turing Medical Technologies, Inc. submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Bullsai Confirm is substantially equivalent in indications, design principles, and performance to the following predicate device.

Primary Predicate: SureTune4 Software (DEN210003)

Item	Predicate:SureTune4SoftwareDEN210003	Subject Device:Bullsai Confirm	Comparison
Classification	Class II	Class II	Identical
Product Code	QQC	QQC	Identical
DeviceDescription	The SureTune4 Software isintended to assist medicalprofessionals in planning theprogramming of deep brainstimulation (DBS) byvisualizing the Volume ofNeural Activation (VNA)relative to patient anatomy. Itis used to visualize patient-specific information within thepatient's anatomy. Integratedpreoperative andpostoperative magneticresonance imaging (MRI), O-armTM, and computedtomography (CT) images areuploaded to SureTune4 andcan be navigated through inmultiple 2D projections and 3Dreconstructions. MedtronicDBS lead models arepositioned in thecorresponding artifacts andpotential stimulation settingsand electrode configurationsentered. The SureTune4Software mathematicallycombines finite element (FE)based electric field model ofthe lead with an axon basedneural activation model to	Bullsai Confirm is intended toassist medical professionalsin planning the programmingof deep brain stimulation(DBS) by visualizing theVolume of Tissue Activated(VTA) relative to patientanatomy. It is used tovisualize patient-specificinformation within the patient'sanatomy. Integratedmagnetic resonance imaging(MRI) and computedtomography (CT) images areuploaded to Bullsai Confirmand can be navigated throughin multiple 2D projections and3D reconstructions.Abbott DBS lead models arepositioned in thecorresponding artifacts andpotential stimulation settingsand electrode configurationsentered. Bullsai Confirmmathematically combinesfinite element (FE) basedelectric field model of the leadwith an axon based neuralactivation model to translatepotential stimulation settingsand electrode configurations	Similar;1) Bullsai Confirmdoes not import orcombine O-arm™images.2) Bullsai Confirmdoes not import fromphysical media.3) Bullsai Confirmshares results,including input imagequality assessments,in an output PDFreport and visualizedin a web-basedsoftware interface.4) Bullsai Confirmdoes not enterelectrophysiologicalannotations.5) Bullsai Confirmdoes not superimposean anatomical atlas.6) Bullsai Confirmdoes not manuallysegment structures of
	translates potential stimulationsettings and electrodeconfigurations into a visualizedVNA field to indicate theshape and the area or volumeof anatomy that will beactivated by the stimulation.The SureTune4 software isused to do the following:• Import MR, O-armTM, andCT patient images over aDICOM network or fromphysical media (harddrive, USB drive, CD, orDVD)• Import DICOM archivesfrom StealthStationTMS7TM systems withCranial 3.x software andStealthStationTM S8Cranial software systems,and SureTune4 systemsover a DICOM network• Combine MR, O-armTMand CT images for moredetail• Superimpose ananatomical atlas to betterunderstand the position ofstructures of interestrelative to a patient'sanatomy• Manually segmentstructures of interest tohighlight particular brainstructures• Localize graphicalMedtronic DBS leadmodels (based onpreoperative imaging)• Enter electrophysiologicalannotations• Visualize VNA fieldsrelative to structures ofinterest in the patientanatomy or lead position• Create patient-specificstimulation plans for DBSprogramming• Generate reports thatsummarize stimulationplans for patients• Export patient sessions toSureTune4 XLSspreadsheets (inMicrosoftTM Excel format)	into a visualized VTA field toindicate the shape and thearea or volume of anatomythat will be activated by thestimulation. Results, includinginput image qualityassessments, are shared inan output PDF report andvisualized in a web-basedsoftware interface.Bullsai Confirm is used to dothe following:• Import DICOM images froma picture archiving andcommunication system(PACS), including MRI andCT DICOM images.• Import preoperativeplanning outputs (includingtractography, structuralROIs, etc.) from AWS S3Cloud Storage• Combine MR images, CTimages, and patient specific3D structures for moredetail• Localize graphicalcompatible DBS leadmodels (based onpreoperative imaging)• Visualize VTA fields relativeto structures of interest inthe patient anatomy or leadpositionThe software provides aworkflow for clinicians to:• Create patient-specificstimulation plans for DBSprogramming• Export reports thatsummarize stimulationplans for patients (PNGscreenshot)	interest to highlightparticular brainstructures.
Indication for Use	The SureTune4 Software is indicated to assist medical professionals in planning the programming of stimulation for patients receiving approved Medtronic deep brain stimulation (DBS) devices.	Bullsai Confirm provides functionality to assist medical professionals in planning the programming of stimulation for patients receiving approved Abbott deep brain stimulation (DBS) devices.	Similar

Substantial Equivalence:

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Bullsai Confirm is substantially equivalent to the identified predicate (legally marketed) device. Bullsai Confirm has the same intended use and technological characteristics as the predicate device and or different intended use and technological characteristics that do not raise different questions of safety and effectiveness.

At a high level, Bullsai and predicate device are based on the following same elements:

Bullsai Confirm is intended to assist medical professionals in planning the programming of . deep brain stimulation (DBS).
Bullsai Confirm visualizes neural activation tissue through Volume of Tissue Activated (VTA). •
Bullsai Confirm visualizes relative to patient anatomy.
Bullsai Confirm is used to visualize patient-specific information within the patient's anatomy.
. Bullsai Confirm imports preoperative and postoperative MR and CT images.
Bullsai Confirm displays integrated preoperative and postoperative MR and CT images.
Bullsai Confirm accepts uploaded images which can be navigated through in multiple 2D projections and 3D reconstructions.
. Bullsai Confirm positions DBS lead models in the corresponding artifacts, and potential stimulation settings and electrode configurations are displayed.
. Bullsai Confirm mathematically combines finite element (FE) based electric field model of the lead with an axon based neural activation model to translates potential stimulation settings and electrode configurations into a visualized field to indicate the shape and the area or volume of anatomy that will be activated by the stimulation.
. Bullsai Confirm imports patient images.
Bullsai Confirm uses DICOM networks (PACS). •
Bullsai Confirm uses DBS lead models. •
Bullsai Confirm combines images for more detail.
Bullsai Confirm localizes graphical DBS lead models based on preoperative imaging.
. Bullsai Confirm visualizes fields relative to structures of interest in the patient anatomy or lead position.
. Bullsai Confirm provides a workflow for clinicians to create and export patient-specific summary stimulation plans.

At a high level, Bullsai Confirm and predicate device have the following different elements:

Bullsai Confirm does not import or combine O-arm™ images. .
Bullsai Confirm does not import from physical media.
Bullsai Confirm shares results, including input image quality assessments, in an output PDF . report and visualized in a web-based software interface.
Bullsai Confirm does not enter electrophysiological annotations.
. Bullsai Confirm does not superimpose an anatomical atlas.
Bullsai Confirm does not manually segment structures of interest to highlight particular brain ● structures.

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Performance Data:

The subject device meets the special controls under 21 CFR 882.5855 for brain stimulation programming planning software, which include the following:

1. Software verification, validation, and hazard analysis must be performed.
1. Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
1. Labeling must include:
- a. The implanted brain stimulators for which the device is compatible.
- b. Instructions for use.
- c. Instructions and explanations of all user-interface components.
- d. A warning regarding use of the data with respect to not replacing clinical judgement.

A hazard analysis and software verification and validation testing were performed for Bullsai Confirm. Bullsai Confirm also underwent formative usability testing and technical performance evaluation of the lead artifact detection and registration between image types. The User Manual for Bullsai Confirm contains the labeling statements in accordance with the special controls.

Conclusion:

The subject device and the predicate devices have the same intended use and have similar technological characteristics. The data included in this submission demonstrates substantial equivalence to the predicate device listed above.

Regulation Number and Section

§ 882.5855 Brain stimulation programming planning software.

(a)
Identification. The brain stimulation programming planning software is a prescription device intended to assist in planning stimulation programming for implanted brain stimulators.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Software verification, validation, and hazard analysis must be performed.
(2) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(3) Labeling must include:
(i) The implanted brain stimulators for which the device is compatible.
(ii) Instructions for use.
(iii) Instructions and explanations of all user-interface components.
(iv) A warning regarding use of the data with respect to not replacing clinical judgment.