Surgery Theater, LLC Surgery Rehearsal Platform is intended for use as a software interface and image segmentation system for the transfer of imaging information from CT or MR medical scanner to an output file. It is also intended as pre-operative software for simulating surgical treatment options.

Device Description

The Surgery Rehearsal Platform (SRP) is software based medical image management system. It is intended for use as a software interface and image segmentation system. for the transfer of imaging information from a CT or MR medical scanner, to an output file. It is also intended as pre-operative software for simulation and evaluation of surgical treatment options.

The SRP software has the capability of creating 3D models of patient data from 2D scan slices. Additionally, it provides the user with ability to input, display, color, and manipulate the 2D scan slices via a 3D representation.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the Surgical Theater Surgery Rehearsal Platform (K123023) based on the provided text:

Important Note: This 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve a traditional clinical study with detailed performance metrics and ground truth establishment in the way typically seen for diagnostic AI/ML devices. The "acceptance criteria" here are essentially the requirements for demonstrating substantial equivalence and functional performance.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance
Intended Use	"Software interface and image segmentation system for the transfer of imaging information from CT or MR medical scanner to an output file. It is also intended as pre-operative software for simulating/evaluation surgical treatment options." (Matches predicate)
Technological Characteristics	- Computer: PC Workstation (Matches predicate) - Image Sources: CT and MRI (Matches predicate) - Data Transfer Method: CD or USB (Matches predicate) - Preoperative Planning: Yes (Matches predicate) - Patient Contact: No (Matches predicate) - Human Intervention for Interpretation of Images: Yes (Matches predicate) - Capability of creating 3D models of patient data from 2D scan slices: Yes (Matches predicate) - Provides the user with ability to input, display, color, and manipulate the 2D scan slices via a 3D representation: Yes (Matches predicate) - Image tools such as rotation, scaling and coloring: Yes (Matches predicate)
Functional Verification	Design outputs met design input requirements (confirmed internally by Quality personnel).
Functional Validation (User Needs)	Met user needs and intended use (confirmed internally by Quality personnel, and subsequently by surgeons).
Risk Analysis Compliance	Performed in accordance with ISO 14971 (2007). Risk management file verification and validation conducted (desk audit and system testing).
Overall Safety and Effectiveness	Demonstrated to be "as safe and effective as its predicate device" based on matching indications for use, construction, operational principles, and performance test results.

Study Information

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document mentions "documented software test procedures" and testing on "each supported system configuration (e.g. 2D vs. 3D Stereoscopic)." However, a specific number of cases or datasets used for testing is not provided.
- Data Provenance: Not specified. It's likely that synthetic or anonymized clinical data was used for functional testing, but this is not confirmed. The document does not mention the country of origin or whether the data was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated for the test set's "ground truth."
- Qualifications of Experts: The document states that "the system was validated by surgeons to ensure the system meets end-user requirements." While these surgeons were involved in functional validation, their role in establishing a formal "ground truth" for specific medical findings is not described.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable or not described in the context of this submission. The validation involved internal quality personnel and surgeons assessing the system's functionality and meeting user needs, not typically a "ground truth" adjudication process for medical findings.
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:
- MRMC Study: No. This submission does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device is for "pre-operative software for simulating/evaluation surgical treatment options," not primarily a diagnostic AI tool meant to improve human reader accuracy.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The device itself is a standalone software, but its performance is measured against its functional requirements and substantial equivalence to a predicate, not against a specific diagnostic or clinical outcome metric. The "Human Intervention for Interpretation of Images" characteristic is listed as "Yes," indicating it is an assistive tool, not fully autonomous.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the "test set" in the context of traditional AI evaluation, a formal ground truth (e.g., pathology, expert adjudicated labels) is not described. The "ground truth" for this device's validation appears to be adherence to design specifications and user requirements, as confirmed by internal quality personnel and surgeons.
The sample size for the training set:
- Training Set Sample Size: Not applicable. This document describes a software device that performs image segmentation and 3D modeling from existing CT/MR scans, and provides tools for simulation. It is not presented as an AI/ML device that requires a training set in the typical sense for learning patterns from labeled data to make predictions.
How the ground truth for the training set was established:
- Training Set Ground Truth: Not applicable, as no training set for an AI/ML model is described.

Summary of Approach:

The K123023 submission for the Surgical Theater Surgery Rehearsal Platform focuses on demonstrating substantial equivalence to an existing predicate device (Simbionix PROcedure Rehearsal Studio K112387). The "performance data" describes:

Internal test plans and execution to confirm the device meets specified requirements (functional verification).
Functional validation testing by quality personnel and surgeons to ensure the system meets user needs and intended use.
Compliance with risk analysis standards (ISO 14971).

The validation activities ensure the device functions as intended and is comparable to the predicate. It explicitly states, "Test results confirmed that SRP is substantially equivalent to the predicate." This is a pre-AI/ML era submission, and therefore, the testing and validation criteria do not align with the typical "acceptance criteria" and "ground truth" definitions used for AI/ML diagnostic devices.

Summary

{0}------------------------------------------------

K123023

8 2013 FEB

510(k) SUMMARY (Modified February 4, 2013)

SURGICAL THEATER SURGERY REHEARSAL PLATFORM

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

Surgical Theater, LLC 151 Innovation Drive Elyria, Ohio 44035

Contact Person:

Mordechai Avisar CEO/President Surgical Theater, LLC Date Prepared: January 26, 2013

Name of Device and Name/Address of Sponsor

Device Name: Surgery Rehearsal Platform Regulation Name: Picture archiving and communications system Regulation Number: 892.2050 Product Code: LLZ

Sponsor:

Surgical Theater, LLC 151 Innovation Drive Elyria, Ohio 44035

Predicate Device

Simbionix PROcedure Rehearsal Studio (K112387)

Intended Use

The Surgical Theater, LLC Surgery Rehearsal Platform is intended for use as a software interface and image segmentation system for the transfer of imaging information from CT or MR medical scanner to an output file. It is also intended as pre-operative software for simulating/evaluation surgical treatment options.

{1}------------------------------------------------

Technological Characteristics and Substantial Equivalence

A. Device Description

B. Substantial Equivalence

The Surgical Theater, LLC Surgery Rehearsal Platform is substantially equivalent to the Simbionix PROcedure Rehearsal Studio (K112387)

Performance Data

The Surgery Rehearsal Platform has been successfully tested, verified and validated to ensure that it meet specifications.

Testing Summary:

Test Plans were written and executed internally which confirmed that the SRP meets specified requirements. Specified requirements include equivalent features and technical characteristics as the predicate device. The test results confirmed that SRP is substantially equivalent to the predicate. The submission includes the comprehensive system test plans, the pass/fail criteria and results.

Functional verification testing was conducted to verify that design outputs met design input requirements. The verification effort focused on verifying that design inputs described in system and software requirements specification documents are traceable to design outputs including component specifications, BOMs, and software design documents. Verification activities were performed by Quality personnel.

Functional validation testing was conducted to ensure that the SRP meets user needs and intended use. Validation was performed using SRP system and complete production version software. Testing was performed by Quality personnel on each supported system configuration (e.g. 2D vs. 3D Stereoscopic) using documented software test procedures.

In addition to the functional validation of the SRP system software, the system was validated by surgeons to ensure the system meets end-user requirements. This validation

{2}------------------------------------------------

consisted of both qualitative and quantitative assessments, and confirmed that the SRP meets user needs and intended use.

Risk analysis was performed in accordance with ISO 14971 (2007) standard for risk analysis. A risk management file verification and validation was conducted which included a desk audit and, where applicable, system testing. System testing included any mitigation detailed in software test procedures for individual applications.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Characteristic	Simbionix PROcedure	SurgeryRehearsalPlatform
510(k) Accession Number	K112387	123023
Clearance Date	12/27/2011	TBD
Computer	PC Workstation	Same
Image Sources	CT and MRI	Same
Indications for Use	Software interface and image segmentation system for thetransfer of imaging information from CT or MR medicalscanner to an output file. Pre-operative software forsimulating/evaluation surgical treatment options.	Same
Data Transfer Method	CD or USB	Same
Preoperative Planning	Yes	Yes
Patient Contact	No	No
Human Intervention forInterpretation of Images	Yes	Yes
Capability of creating 3Dmodels of patient datafrom 2D scan slices.	Yes	Yes
Provides the user withability to input, display,color, and manipulate the2D scan slices via a 3Drepresentation.	Yes	Yes
Image tools such asrotation, scaling andcoloring.	Yes	Yes

Comparison of Technological Characteristics

{3}------------------------------------------------

Conclusions:

The Surgery Rehearsal Platform is substantially equivalent to and is as safe and effective as its predicate device. They have the same indications for use, are constructed from the same basic materials and both incorporate the same operational principles. Results of performance tests conducted on the Surgery Rehearsal Platform clearly demonstrate that the device is safe and effective for its intended use. ،

{4}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, facing to the right.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 8, 2013

Surgical Theater, LLC C/O Mordechai Avisar CEO, President and Co-Founder 151 Innovation Drive ELYRIA OH 44035

Re: K123023

Trade/Device Name: Surgical Rehearsal Platform Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: LLZ Dated: September 28, 2012 Received: December 20, 2012

Dear Mr. Avisar:

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. 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 (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.

{5}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sean My Boyd -S for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Indications for Use

510(k) Number (if known):

Device Name: Surgery Rehearsal Platform

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Sean M. Boyd -S

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K123023 510(k)

Page 1 of 1

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).