The ImmersiveTouch is software based pre-surgical planning system. It is intended for use as a software interface. It is also intended as pre-operative software for simulation and evaluation of surgical treatment options.

The ImmersiveTouch software has the capability of displaying 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.

The 3D models of patient data are combined with the use of haptics. This provides the user with ability to modify the haptic properties, creating the sensation of feeling specific tissues.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it relies on successful testing, verification, and validation against specifications, as well as adherence to established medical device standards. The performance is reported as meeting these standards.

Acceptance Criteria Category	Acceptance Criteria (as implied)	Reported Device Performance
Safety and Effectiveness	Meets specifications to ensure device is safe and effective for its intended use.	"Successfully tested, verified and validated to ensure that it meets specifications." "Results of performance tests conducted on the pre-operative software clearly demonstrate the device is safe and effective for its intended use."
Electrical Safety	Compliance with electrical safety standards.	"CE certified by Underwriters Laboratories under the standard IEC 60950-1:2005 (2005 (2005); Am 1:2009." "Also been tested in accordance with IEC 60601-1 and IEC 60601-1-2 standards."

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

The document does not provide details on the sample size used for any specific test set, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective) for any clinical or performance data. It discusses general testing and validation, but not the specifics of a test set with patient data.

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

The document does not mention the use of experts to establish ground truth for a test set. The focus is on technical compliance with standards rather than clinical performance evaluated against expert-derived ground truth.

4. Adjudication Method for the Test Set:

Given that no experts or ground truth establishment are described, there is no mention of an adjudication method.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the provided document. The document describes the device as a pre-operative software for simulating and evaluating surgical treatment options, and its substantial equivalence is based on technological characteristics compared to predicate devices, not on a human-in-the-loop performance study.

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

The document describes the "ImmersiveTouch" as "software based pre-surgical planning system" and clarifies that it is "intended for use as a software interface." It focuses on its technical capabilities (displaying 3D models, manipulating 2D scan slices, haptic properties). While it implies standalone function for generating simulations, it does not explicitly detail a standalone performance study with metrics suitable for an algorithm-only evaluation (e.g., accuracy against a defined ground truth for specific tasks). The performance data cited refers to technical and electrical safety standards.

7. The Type of Ground Truth Used:

The document does not specify the type of ground truth used for performance evaluation in the context of clinical accuracy or decision-making. The "performance data" mentioned refers to compliance with safety and electrical standards (IEC 60950-1, IEC 60601-1, IEC 60601-1-2) which are general engineering and safety truths, not patient-specific clinical ground truths (like pathology, expert consensus, or outcomes data).

8. The Sample Size for the Training Set:

The document does not provide any information about a training set since it focuses on the device's technical specifications and safety standards rather than a machine learning or AI algorithm trained on data.

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

As no training set is mentioned or implied, there is no information on how ground truth for a training set was established.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

December 16, 2014

Immersive Touch, Inc. % Prashant Banerjee, Ph.D. President 708 Kristin Court WESTMONT IL 60559

Re: K140860

Trade/Device Name: ImmersiveTouch3 and MicrovisTouch Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 17, 2014 Received: November 21, 2014

Dear Dr. Banerjee:

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.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

Robert A Ochs

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration
Indications for Use
	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K140860
Device Name	ImmersiveTouch3MicrovisTouch
Indications for Use (Describe)	The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options.
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)	Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
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."

FORM FDA 3881 (8/14)Page 1 of 1	PSC Publishing Services (301) 443-6740
-------------------------------------	----------------------------------------

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

Chapter 2: Item 2, 3, and 4

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

ImmersiveTouch, Inc. 708 Kristin Court Westmont, Illinois 60559 Phone # 1-630-570-5943

Contact Person:

P. Pat Banerjee CEO ImmersiveTouch Date Prepared: August 12th, 2014

Name of Device and Classification Name.

Device Name: ImmersiveTouch3 Device Name: MicrovisTouch Regulation Name: Picture archiving and communications system Regulation Number: 892.2050 Product Code: LLZ Classification Panel: Radiology

Predicate Device

Surgical Theater Surgery Rehearsal Platform (K123023) Simbionix PROcedure Rehearsal Studio (K112387)

Intended Use

The ImmersiveTouch simulators are intended as pre-operative software for simulating and evaluating surgical treatment options.

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

Technological Characteristics and Substantial Equivalence

A. Device Description

The 3D models of patient data are combined with the use of haptics. This provides the user with ability to modify the haptic properties, creating the sensation of feeling specific tissues.

B. Substantial Equivalence

The ImmersiveTouch is substantially equivalent to the Surgery Rehearsal Platform (K123023) and Simbionix PROcedure Rehearsal Studio (K112387). The ImmersiveTouch is substantially equivalent to its predicate devices in that it uses a PC workstation that allows for the viewing of CT and MRI images. These images can be used in pre-operative software for simulating and evaluating surgical treatment options.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Characteristic	ImmersiveTouch	Surgery RehearsalPlatform	SimbionixPROcedure
510(k) AccessionNumber	K140860	K123023	K112387
Clearance Date	TBD	2/8/2013	12/27/2011
Computer	PC Workstation	Same	Same
Image Sources	CT and MRI	Same	Same
Indications for Use	The ImmersiveTouch simulatorsare intended as pre-operativesoftware for simulating andevaluating surgical treatmentoptions.	Software interface andimage segmentationsystem for the transfer ofimaging information fromCT or MR medical scannerto output file. Intended aspre-operative software forsimulating and evaluatingsurgical treatment options	Same asSurgeryRehearsalPlatform
Patient Contact	No	No	No

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

C. Performance Data

The ImmersiveTouch has been successfully tested, verified and validated to ensure that it meets specifications. The ImmersiveTouch was CE certified by Underwriters Laboratories under the standard IEC 60950-1:2005 (2005 (2005); Am 1:2009.

The ImmersiveTouch has also been tested in accordance with IEC 60601-1 and IEC 60601-1-2 standards.

D. Conclusions

ImmersiveTouch, Inc. believes the ImmersiveTouch is substantially equivalent to and is as safe and effective as its predicate devices. While they have different indications for use, all devices are constructed from similar materials and incorporate similar operational principles. Results of performance tests conducted on the pre-operative software clearly demonstrate the device is safe and effective for its intended use.

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).