The Surgical Theater, LLC SuRgical Planner (SRP) 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) is intended for use as a software interface and image segmentation system for the transfer of imaging 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.

The SuRgical Planner is not intended to be used for diagnosis.

The SRP 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) 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. The SRP with VR headset and controllers is not intended for use during surgery. The SRP is intended for use for pre-operative planning.

The SRP 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-shelf" 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

The provided text is a 510(k) summary for the Surgical Theater, LLC SuRgical Planner (SRP) software. It describes the device, its intended use, comparison to a predicate device, and performance data. However, the document primarily focuses on regulatory compliance and substantial equivalence rather than a detailed study evaluating the device's performance against specific acceptance criteria.

Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not available in the provided text. The document states that "Software verification and validation testing were conducted" and that "A formal verification and validation plan was executed to confirm that the modified SRP continues to meet its intended use and performance requirements." However, it does not provide the specifics of these plans or their results in a way that directly answers the questions about acceptance criteria and performance metrics.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Study Details for SuRgical Planner (SRP)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance (as per document)
Functional Equivalence to Predicate Device	The modified SRP is determined to be substantially equivalent to the predicate SRP (K123023). Modifications do not alter intended use, safety, or effectiveness, or fundamental scientific technology.
Image Modality Support (XA scans)	SRP supports input for X-Ray 3D Angiography (XA) scans, provided they are exported as DICOM CT image storage type. DICOM data verification includes checking Image Modality file type (CT, MR, or XA) and Media Storage SOP Class/UID (CT or MR).
Electromagnetic Compatibility (EMC)	Device found to be in compliance per IEC 60601-1-2:2007 Third Edition by a 3rd party test laboratory.
Software Verification and Validation (Functional and Safety)	"Fully tested, verified and validated by Surgical Theater as part of its own internal design control requirements." "A formal verification and validation plan was executed to confirm that the modified SRP continues to meet its intended use and performance requirements." "Software for this device was considered a 'moderate' level of concern." Product risk management activities (EN ISO 14971:2012) included desk audit and software testing to ensure implementation of all risk mitigations.
DICOM Import Library Functionality	fo-DICOM library replaces mDCM, supports all mDCM functionalities, and adds support for the latest DICOM standard (NEMA PS3.1 - 2006) and future developments.
Multi-Layer Overlay and Registration	Ability to overlay up to two secondary data sets over the primary 3D model, with tools to align/register images and define segmentation for each layer. Up to five secondary layers definable and savable.
Brain Atlas Functionality	Ability to superimpose a "generic" brain atlas tissue model over the patient-specific 3D model, with tools to align and scale the brain atlas model.

2. Sample Size for Test Set and Data Provenance

Sample Size: Not specified in the provided document. The document mentions "Software verification and validation testing were conducted," but details on the number of cases or images used in these tests are absent.
Data Provenance: Not specified. The document states the device processes DICOM images from CT, MR, or X-ray 3D Angiography (XA) medical scanners, but does not indicate the source (e.g., country, hospital, retrospective/prospective) of the data used for testing.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document states the device is for "pre-operative planning and surgical training in a virtual environment," implying surgical expertise might be relevant, but this is not confirmed for ground truth establishment.

4. Adjudication Method for Test Set

Adjudication Method: Not specified. The document outlines general software verification and validation but does not detail how ground truth was established or if an adjudication process was involved for performance evaluation.

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

MRMC Study: No, an MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on the device's technical specifications and regulatory equivalence, not on evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Standalone Study: Yes, implicitly. The document states that the "SRP was fully tested, verified and validated by Surgical Theater as part of its own internal design control requirements" to "meet its intended use and performance requirements." While details on specific metrics are missing, this implies a standalone evaluation of the software's functionality and accuracy in image segmentation and 3D model generation, which are core algorithmic tasks. However, explicit performance metrics (e.g., segmentation accuracy, speed) are not provided.

7. Type of Ground Truth Used

Type of Ground Truth: Not specified. Given the device's function involves image segmentation and 3D model generation, ground truth would likely relate to the accuracy of these outputs against a reference. However, the method for establishing this reference (e.g., manual segmentation by experts, phantom scans with known anatomy) is not detailed.

8. Sample Size for the Training Set

Sample Size: Not specified. The document does not provide information about a training set, as the SRP functions primarily as an image processing and visualization tool, rather than a machine learning model that requires explicit training data in the traditional sense. It processes existing medical images.

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

Ground Truth Establishment for Training Set: Not applicable, as detailed training set information is not provided and the device description does not explicitly mention machine learning components that require a training set with established ground truth in the context of predictive or diagnostic tasks. The "training" aspect mentioned in the document refers to surgical training in a virtual environment using the device, not training of the device itself.

In summary, the provided document serves as a regulatory submission emphasizing substantial equivalence and general safety/effectiveness through internal verification and validation processes. It lacks the quantitative performance data and detailed study designs typically found in clinical efficacy studies that would address specific acceptance criteria with measured outcomes.

Summary

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February 12, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The Department of Health and Human Services logo features a stylized depiction of a human figure embracing a sphere. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.

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

Re: K170793

Trade/Device Name: SuRgical Planner (SRP) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 6, 2018 Received: February 8, 2018

Dear Mr. Murrock:

We have reviewed vour 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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Michael D.'Hara For

Robert Ochs. Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170793

Device Name SuRgical Planner (SRP)

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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Image /page/3/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, with each word stacked on top of the other.

SuRgical Planner (SRP)

510(K) SUMMARY AS REQUIRED BY SECTION 807.92

Purpose of Submission.

Surgical Theater, LLC hereby submits this 510(k) premarket notification to obtain a determination of substantial equivalence for our SuRgical Planner (SRP) software that was formerly known as the Surgery Rehearsal Platform (SRP) (K123023).

510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person and Date Prepared.

Submitter:

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

Establishment Registration Number: 3010197287

Contact Person:

Kevin M. Murrock Director of Quality and Regulatory Surgical Theater, LLC 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (330) 472-6520 Fax: (216) 916-3806 Email: kmurrock@surgicaltheater.net

Date Prepared: February 9, 2018

Name of Device

Trade Name:	SuRgical Planner (SRP)
• Other Device Trade Names:	Surgery Rehearsal Platform, SRP Clinic Viewer
• Common Name:	System, Image Processing, Radiological
• Classification Name:	Picture Archiving and Communications System
• Regulation Number:	21 CFR 892.2050
• Product Code:	LLZ
• Regulatory Classification:	II
• Device Panel:	Radiology

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Image /page/4/Picture/0 description: The image shows a logo for "Surgical Theater". The logo features a stylized, three-dimensional metallic shape, with the top portion appearing silver and the bottom right corner colored gold. Below the shape, the words "SURGICAL" and "THEATER" are stacked on top of each other in a simple, sans-serif font.

Predicate Device

Surgical Theater, LLC Surgery Rehearsal Platform, 510(k) Number: K123023

Device Description:

The SuRgical Planner is not intended to be used for diagnosis.

Indications for Use:

The change in the Indications for Use (IFU) of the subject device was due to the addition of the support for X-Ray 3D Angiography (XA) scans. In addition, the phrase "It is also intended as pre-operative software for simulating/evaluating surgical treatment options" was replaced with "It can also be used for pre-operative planning and surgical training in a virtual environment" to clarify that the device is not intended to simulate and evaluate treatment performance and to ensure the device remains under the correct regulation / product code LLZ.

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Image /page/5/Picture/0 description: The image shows a logo for "Surgical Theater". The logo features a stylized, three-dimensional metallic object with a gold accent. Below the object, the words "SURGICAL" and "THEATER" are stacked on top of each other in a simple, sans-serif font. The overall design is clean and modern.

to the predicate device. Both the subject and predicate devices share intended use for pre-operative planning and surgical training in a virtual environment.

Comparison of Technological Characteristics

The primary technological differences between the predicate and modified device are as follows:

1. Added input support for X-Ray 3D Angiography (XA) scans. To be usable by the SRP, the XA scan must be exported by the originating system as a DICOM CT image storage type. During case preparation, the SRP software verifies DICOM data meets the following acceptance criteria; otherwise, data is rejected: 1) Image Modality file type is CT, MR or XA and 2) Media Storage SOP Class and SOP Class UID are CT or MR.
The change in the Indications for Use (IFU) of the subject device was due to the addition 2. of the support for X-Ray 3D Angiography (XA) scans as described above in Note 1. In addition, the phrase "It is also intended as pre-operative software for simulating/evaluating surgical treatment options" was replaced with "It can also be used for pre-operative planning and surgical training in a virtual environment" to clarify that the device is not intended to simulate and evaluate treatment performance. While the Indications for Use statement of the subject device is not identical to that of the predicate device, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices share the same intended use for pre-operative planning.
1. The addition of a virtual reality (VR) headset to enable the surgeon to view the scene displayed on the LED monitor in the 3D stereoscopic display of the VR headset.
1. A change in DICOM import library from mDCM to fo-DICOM. The fo-dicom library replaces the obsolete mDCM library and supports all the mDCM library functionalities, as well as adding support for the latest DICOM standard (NEMA PS3.1 - 2006) and future DICOM standard developments.
1. The ability to overlay up to two (2) secondary data sets (i.e. layers) of images over the primary data set of images in the 3D model. This includes tools to align/register images from a secondary data set to the primary data set, and define image segmentation for each secondary layer. Up to five (5) secondary layers may be defined and saved to the case file. The merging of image data sets from different modalities provides additional information to aid surgery planning. For example, CT images are used more often to ascertain differences in tissue density while MR images are typically used to visualize and diagnose tumors.
1. Incorporation of a licensing mechanism consisting of a USB dongle programmed with software features to be enabled, and a software manager that enables or disables features per the programming of the dongle.
1. The ability to launch the FDA cleared (K163324) NNL BrainEx Neuro-Imaging Software for functional MRI installed on the SRP computer from within the SRP application. The

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Image /page/6/Picture/0 description: The image shows the logo for Surgical Theater. The logo features a stylized, three-dimensional shape resembling a curved, metallic ribbon or band. The ribbon is primarily silver or gray, with a section on the right side colored gold. Below the ribbon is the text "SURGICAL THEATER" in a simple, sans-serif font, with "SURGICAL" stacked above "THEATER".

DTI functional images generated from the BrainEx application can then be directly imported into the current case on the SRP.

1. Addition of an SRP Clinic Viewer configuration to be used for patient consultation and surgeon review that will be loaded on either a 1) high-performance touch-screen laptop personal computer or 2) All-in-one high-performance touchscreen desktop PC. The Clinic Viewer configuration provides a limited subset of functions as compared to the SRP desktop configuration. The software functionality is controlled by the USB license dongle and the following general functions are not available: new case preparation, 3D controller, brain atlas, IG lights controls, and VR headset
1. Addition of the Brain Atlas function to provide the ability to superimpose a "generic" brain atlas tissue model directly over the patient-specific 3D model, and provide tools to align and scale the brain atlas model to the patient's 3D model.

Performance Data

The following non-clinical performance data were provided in support of the substantial equivalence determination.

Electromagnetic Compatibility (EMC)

In order to ensure that the use of the SRP system does not adversely affect other devices within the patient environment. EMC evaluation per IEC 60601-1-2:2007 Third Edition was performed by a 3rd party test laboratory on the modified device and the SRP was found to be in compliance.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff, "Guidance for Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered a "moderate" level of concern.

The SRP was fully tested, verified and validated by Surgical Theater as part of its own internal design control requirements. A formal verification and validation plan was executed to confirm that the modified SRP continues to meet its intended use and performance requirements. The verification and validation report included with this submission summarizes the results of verification and validation activities for the modified device.

Safety and Effectiveness

Product risk management activities were performed in accordance with EN ISO 14971:2012 throughout the product development process. Risk management verification and validation consisted of both a desk audit and software testing to ensure the implementation of all risk mitigations for the device

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Image /page/7/Picture/0 description: The image shows the logo for Surgical Theater. The logo consists of a stylized, three-dimensional shape that resembles an abstract representation of a surgical theater or operating room. The shape is primarily silver, with a gold accent on one side. Below the shape, the words "SURGICAL THEATER" are written in a stacked format, with "SURGICAL" on top of "THEATER".

Conclusions

Modifications to the SRP do not raise new questions of safety and effectiveness.

While the Indications for Use statement of the subject device is not identical to that of the predicate device, the device modifications do not alter the intended use of the device nor do they affect the safety and effectiveness of the device or the fundamental scientific technology relative to the predicate device. Both the subject and predicate devices share the same intended use for pre-operative planning and surgical training in a virtual environment.

Verification and validation results demonstrate the modified SRP is as safe and effective as the predicate SRP, and performs as intended in the specified use conditions.

In summary, the SRP device described in this submission is, in our opinion, substantially equivalent to the predicate device.

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).