The SuRgical Planner (SRP) BrainStorm is intended for use as a software interface and image segmentation system for the transfer of image information from a CT, MR, or X-ray 3D Angiography (XA) medical scanner to an output file. It can also be used for pre-operative planning and surgical training in a virtual environment.

Device Description

The SuRgical Planner (SRP) BrainStorm is not intended to be used for diagnosis.

The SRP BrainStorm software has the ability of creating 3D models of the patient data from 2D scan slices. Additionally, it provides the user with the ability to input, display, color, and manipulate the 2D scan slices via a 3D representation. The software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views on a high-definition (HD) touch screen monitor. The use of a virtual reality (VR) or augmented reality (AR) headset provides the surgeon a 3D stereoscopic display of the same scene inside the VR / AR headset. While wearing the VR / AR headset, the surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controllers to perform such actions as rotate, zoom in and zoom out. The use of the SuRgical Planner (SRP) BrainStorm with VR / AR headset and controllers is not intended for use during surgery. The SRP BrainStorm is intended for use for pre-operative planning.

The SRP BrainStorm software includes additional features to facilitate the review of relevant data by a multidisciplinary team that includes neurosurgeons and neurologists for pre-operative surgical planning.

The SRP BrainStorm product does not include any custom hardware and is a software-based device that runs on a high-performance desktop PC assembled using "commercial off-the-shelt" components that meet minimum performance requirements. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process medical images in DICOM format, and an image generator software engine.

AI/ML Overview

This 510(k) premarket notification describes a software device, SuRgical Planner (SRP) BrainStorm, which is intended for use as a software interface and image segmentation system for the transfer of image information from medical scanners to an output file. It is also used for pre-operative planning and surgical training in a virtual environment. The submission focuses on demonstrating substantial equivalence to a predicate device, SuRgical Planner (SRP) (K170793), rather than presenting a study to prove the device meets specific performance acceptance criteria for a new clinical task.

Therefore, much of the requested information regarding acceptance criteria and performance study specifics (like sample size, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth detailed establishment for training/test sets) is not applicable or not explicitly detailed in the provided document. The document describes a verification and validation (V&V) plan to confirm the device meets its intended use and performance requirements, implying internal testing rather than a clinical effectiveness study against predefined criteria like sensitivity or specificity.

Here's a breakdown of the available information:

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

The document does not provide a table of acceptance criteria with numerical performance targets (e.g., sensitivity, specificity, accuracy) or quantitative performance results. Instead, it states:

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence: The SuRgical Planner (SRP) BrainStorm performs its intended functions (image segmentation, 3D model creation, 3D scene display, VR/AR integration, pre-operative planning, surgical training) as described in the device description.	"A formal verification and validation plan was executed to confirm that the SRP BrainStorm meets its intended use and performance requirements." "Verification and validation tests demonstrated the SRP BrainStorm is as safe and effective as the predicate SRP, and performs as intended in the specified use conditions."
Safety and Effectiveness Equivalence: The modifications implemented in SRP BrainStorm do not raise any new questions regarding safety and effectiveness compared to the predicate device.	"The differences between the subject and predicate device do not raise any new questions regarding safety and effectiveness." "Based on the information provided in this 510(k) submission, the SRP BrainStorm is considered substantially equivalent to the predicate SRP in terms of fundamental scientific technology." "Any differences between the subject and predicate device do not raise any new concerns regarding safety and effectiveness."
Usability/Human Factors: The modifications to the device (e.g., AR support, simplified planner mode features) conform to user needs and the intended use.	"In addition, simulated use human factors and usability validation was performed to validate the modifications conform to the user needs and the intended use of the device."
Design Control Compliance: Software design verification and validation testing followed internal design control requirements and methods.	"Software design verification and validation testing was performed per the same internal design control requirements and methods used for the predicate device."

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

Sample Size: Not specified. The document only mentions "a formal verification and validation plan was executed" and "verification and validation tests were performed."
Data Provenance: Not specified. The source or nature of the data used for the V&V tests (e.g., type of medical images, number of cases, patient demographics, country of origin) is not provided.

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

Not specified. The document does not describe the use of experts to establish ground truth for a test set in the context of a performance study. Given the nature of the device (software interface and planning tool for pre-operative use), the "ground truth" might refer to the accurate representation of anatomical structures or functional software execution, which would be validated internally rather than through expert clinical review against specific diagnostic criteria.

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

Not specified. No adjudication method is mentioned, as there is no description of a performance study involving comparison to a ground truth established by multiple experts.

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 is mentioned. The device's purpose is not described as an AI-assisted diagnostic tool for human readers but rather as a planning and training tool.

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

Not explicitly detailed, but the context of "verification and validation tests" implies testing of the software's functionality and performance as an algorithm. The device's primary function is a standalone software system for image processing, 3D modeling, and visualization, with human interaction being part of its intended use (e.g., surgeons using VR/AR headsets). It can be inferred that the software's ability to perform its core functions (e.g., segment images, create 3D models) independently was evaluated.

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

Not explicitly defined in the document. For a device like SRP BrainStorm, "ground truth" during verification and validation would likely involve:
- Reference Image Data: Comparing segmented 3D models against known anatomical structures from original medical images.
- Functional Specification Compliance: Ensuring that the software performs its specified functions (e.g., correct import/export, proper 3D rendering, accurate display of electrode detections) as designed.
- Usability/User Interface Testing: Confirming that the user interface and interactions (e.g., with VR/AR headsets) meet design requirements and user expectations for pre-operative planning.

8. The sample size for the training set:

Not applicable. This device is described as an image processing and visualization tool, not an AI/ML algorithm that is trained on a specific dataset for diagnostic or predictive purposes. The "training" mentioned in the context of the device is for surgical training using the virtual environment, not algorithm training.

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

Not applicable for algorithm training set ground truth. For the surgical training aspect, the "ground truth" is typically the anatomical and physiological accuracy of the virtual environment, which would be established through careful modeling based on medical imaging data and validated by anatomical expertise. However, this is not a training set for the algorithm itself.

Summary

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July 17, 2020

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Surgical Theater, Inc. % Mr. Kevin Murrock Sr. Director of Quality and Regulatory 781 Beta Drive MAYFIELD VILLAGE OH 44143

Re: K201465

Trade/Device Name: SuRgical Planner (SRP) BrainStorm Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 2, 2020 Received: June 3, 2020

Dear Mr. Murrock:

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/cfpmp/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 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

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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).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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)

K201465

Device Name SuRgical Planner (SRP) BrainStorm

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 D)

ounter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Surgical Theater. The logo features a stylized, three-dimensional shape that resembles a curved, metallic ribbon or band. Part of the ribbon is silver, while another section is gold. Below the shape, the words "SURGICAL" and "THEATER" are stacked on top of each other in a sans-serif font.

Special 510(k) Premarket Notification

SuRgical Planner (SRP) BrainStorm

510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 8807.92.

Date Prepared: July 15, 2020

Manufacturer/Submitter:

Surgical Theater, Inc. 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (216) 496-7884 Fax: (216) 916-3806

Establishment Registration Number: 3010197287

Contact Person:

Kevin M. Murrock Sr. Director of Quality and Regulatory Surgical Theater, Inc. 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (330) 472-6520 Email: kmurrock@surgicaltheater.net

Name of Device

Trade Name: SuRgical Planner (SRP) BrainStorm
LLZ

21 CFR 892.2050

Common Name: System, Image Processing, Radiological ● Classification Name: Picture Archiving and Communications System
Regulation Number: ●
Product Code:
Regulatory Classification: ●
Device Panel: Radiology

Predicate Device

SuRgical Planner (SRP), 510(k) Number: K170793

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Image /page/4/Picture/0 description: The image shows a logo for "Surgical Theater". The logo features a stylized, abstract shape resembling a curved, metallic structure with a gold accent on one side. Below the shape, the words "SURGICAL" and "THEATER" are stacked on top of each other in a simple, sans-serif font. The text is in a color that complements the metallic tones of the abstract shape above.

Special 510(k) Premarket Notification

Indications for Use:

The only differences in the Indications for Use statement between the subject device and the predicate are the removal of "Surgical Theater, LLC" and the change from "SuRgical Planner (SRP)" to "SuRgical Planner (SRP) BrainStorm". While the Indications for Use statement of the subject device is not identical to that of the predicate device, these modifications do not alter the intended use nor do they affect the safety and effectiveness of the device.

Device Description:

The SuRgical Planner (SRP) BrainStorm is not intended to be used for diagnosis.

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Image /page/5/Picture/0 description: The image shows a logo for "Surgical Theater". The logo features a stylized, abstract design above the text. The design appears to be a curved, metallic shape with a gold accent on one side. The text "SURGICAL THEATER" is written in a simple, sans-serif font, with each word on a separate line.

Technological Characteristics

The proposed SRP BrainStorm has similar technological characteristics compared to the predicate device.

The subject and predicate devices are based on the following same technological characteristics:

The ability to create 3D models of the patient data from 2D scan slices. Additionally, it provides the user with the ability to input, display, color, and manipulate the 2D scan slices via a 3D representation. The software transforms 2D medical images into a dynamic interactive 3D scene with multiple point of views on a high-definition (HD) touch screen monitor.
The use of a virtual reality (VR) headset provides the surgeon a 3D stereoscopic display . of the same scene inside the VR headset. While wearing the VR headset, the surgeon can perform a virtual / simulated "fly-through" inside the 3D scene using controllers to perform such actions as rotate, zoom in and zoom out.
. Except for the modifications described below, all other functions are available on both the predicate and proposed devices.

The following modifications were implemented in SRP BrainStorm to provide additional features to be used by a multidisciplinary team that includes neurosurgeons and neurologists for pre-operative surgical planning for neurological disorders:

. Support for augmented reality (AR) headset display and controller to enable the surgeon to experience a 3D stereoscopic view of the same scene displayed on the LED monitor, and also perform actions previously available with a VR headset.
. A simplified planner mode that includes additional features that may be used to facilitate multidisciplinary communication for planning neurosurgery:
- Tools to detect electrodes from the post electrodes implantation CT and display O the results in the 3D scene.
- Import file containing brain wave recordings that shows the EEG graph output о detected during stimulation of each inserted electrode contact.
- Provide a 360° representation of the locations and intensities of the EEG о recordings over time, enabling the team to visually correlate between a physical position of an electrode to the graph readings detected by it in the 3D scene. No analysis is done on the brain wave recordings, all display and visualization are based on the raw voltage values saved in the imported data file.

The differences between the subject and predicate device do not raise any new questions regarding safety and effectiveness. Based on the information provided in this 510(k) submission, the SRP BrainStorm is considered substantially equivalent to the predicate SRP in terms of fundamental scientific technology.

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Image /page/6/Picture/0 description: The image shows a logo for "Surgical Theater". The logo features a stylized, three-dimensional shape resembling a curved, metallic structure with a gold accent on one side. Below the shape, the words "SURGICAL THEATER" are written in a simple, sans-serif font, stacked vertically.

Special 510(k) Premarket Notification

Summary of Non-Clinical Performance Data

Non-clinical performance testing was performed in support of the substantial equivalence determination. A formal verification and validation plan was executed to confirm that the SRP BrainStorm meets its intended use and performance requirements. In addition, simulated use human factors and usability validation was performed to validate the modifications conform to the user needs and the intended use of the device. Software design verification and validation testing was performed per the same internal design control requirements and methods used for the predicate device.

Verification and validation tests demonstrated the SRP BrainStorm is as safe and effective as the predicate SRP, and performs as intended in the specified use conditions.

Substantial Equivalence Conclusion

Based on the information provided in this 510(k) submission, the SRP BrainStorm is substantially equivalent to the predicate SRP in terms of indications for use, technological characteristics, and safety and effectiveness. Any differences between the subject and predicate device do not raise any new concerns regarding safety and effectiveness.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Indications for Use

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510(k) SUMMARY

Manufacturer/Submitter:

Contact Person:

Name of Device

Common Name: System, Image Processing, Radiological ● Classification Name: Picture Archiving and Communications System

Predicate Device

Special 510(k) Premarket Notification

Indications for Use:

Device Description:

Technological Characteristics

Summary of Non-Clinical Performance Data

Substantial Equivalence Conclusion

§ 892.2050 Medical image management and processing system.