Immersive View Surgical Plan (IVSP®) is intended for use as a software system for the transfer of imaging information from a medical scanner such as a CT based system. The is processed by the ImmersiveView Surgical Plan (IVSP®) system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical splints, and surgical guides for use in maxillofacial surgery. The Immersive View Surgical Plan (IVSP®) system is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

Device Description

The ImmersiveView Surgical Plan (IVSP®) system is a software based pre-surgical planning system. It is intended for use as a software system for the transfer of imaging information from a medical scanner such as CT based system. Physical outputs include surgical splints, and surgical guides that will be used in maxillofacial surgery. Surgical marking guides and surgical splints are not intended to come in contact with surgical cutting or drilling tools and therefore should not interface with surgical cutting or drilling tools.

ImmersiveTouch receives patient specific medical imaging information which is further utilized by ImmersiveTouch trained employees within the ImmersiveView Surgical Plan (IVSP®) system. This includes software to extract anatomical areas of interest from 3D medical scan images and create patient-specific physical and digital outputs. Throughout the process, a physician reviews and approves the plan prior to delivery of the final outputs.

Physical model outputs include surgical splints, and surgical guides for use in maxillofacial surgery. Surgical splints and surgical guides are designed and manufactured by ImmersiveTouch trained employees. Trained employees utilize the ImmersiveTouch additive manufacturing workflow to design and manufacture surgical guides, and, surgical splints using polymer resin. Surgical splints and surgical guides are provided in a NON-sterile condition and instructions for use provide the steps for cleaning and sterilization prior to use in surgery. Surgical splints and surgical guides are manufactured based on recommendations outlined in the FDA Guidance Document "Technical Considerations for Additive Manufactured Medical Devices."

Prior to use in surgery, the physician confirms the accuracy and level of precision by attaching surgical splints and surgical guides to the anatomical models are designed and manufactured using similar workflow and materials as the subject devices.

Reports are generated for each patient specific case illustrating the plan and accompany the physical outputs that are delivered once verified and approved by the physician.

AI/ML Overview

The provided document is a 510(k) summary for the ImmersiveView Surgical Plan (IVSP®) system. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific clinical study with acceptance criteria and device performance metrics in the way a clinical trial report would.

Therefore, the information you've requested regarding acceptance criteria and a study proving the device meets them, including sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in this 510(k) summary.

Here's what can be extracted and what is explicitly not available based on the provided text:

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

Not explicitly provided as a quantifiable table with specific performance metrics (e.g., accuracy, sensitivity, specificity) against defined acceptance criteria.
The document states: "The performance data indicates that the verification and validation testing performed on the ImmersiveView Surgical Plan (IVSP®) system successfully demonstrates that design outputs meet design inputs." This is a high-level statement but doesn't offer specific numerical acceptance criteria or performance results.
Mechanical Strength Testing: "The result of the testing concluded that subject device was in accordance with the pre-defined acceptance criteria." This implies criteria existed, but they are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided. The document refers to "patient specific medical imaging information" but does not give any details on the number of cases or their origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not provided. The document mentions "a physician reviews and approves the plan prior to delivery of the final outputs" and that "ImmersiveTouch trained employees" utilize the system. It also notes that "the physician confirms the accuracy and level of precision by attaching surgical splints and surgical guides to the anatomical models." However, this does not detail ground truth establishment in a study context, expert numbers, or qualifications.

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

Not provided.

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

Not provided. The document focuses on the system as a pre-surgical planning tool and highlights "Human Intervention for Interpretation of images: Yes" for both the subject and predicate devices, indicating a human-in-the-loop approach. However, a comparative effectiveness study measuring improvement with AI assistance is not mentioned.

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

Not directly addressed in terms of formal performance metrics. The device description indicates human involvement in the planning process: "ImmersiveTouch receives patient specific medical imaging information which is further utilized by ImmersiveTouch trained employees within the ImmersiveView Surgical Plan (IVSP®) system." And "Throughout the process, a physician reviews and approves the plan prior to delivery of the final outputs." This implies it's not a standalone, algorithm-only device in its clinical workflow.

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

Not explicitly stated in a study context. The closest mention to "ground truth" or verification is a physician confirming the accuracy of physical outputs against anatomical models.

8. The sample size for the training set

Not applicable/Not provided. This document describes a surgical planning system that utilizes medical images as input to create patient-specific outputs and does not describe an AI or machine learning algorithm that requires a "training set" in the conventional sense. The "image segmentation system" mentioned is part of the overall workflow but no details on its AI/ML training are given.

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

Not applicable/Not provided. (See point 8)

Summary of available "performance data" categories from the document:

The "Performance Data" section primarily addresses verification and validation activities related to manufacturing and quality control, ensuring the physical outputs meet certain standards, rather than clinical performance metrics of the software itself.

Device Performance Validation: "processes validation methods such as IQ, OQ, and PQ to ensure that the manufacturing process can effectively produce patient matched devices." Also, "Equipment used for production purposes have been qualified to ensure the equipment used for manufacturing of surgical guides, surgical splints and, anatomical models meet production needs."
Sterilization Validation: Conducted in accordance with ISO 17665 and FDA guidance to a Sterility Assurance Level (SAL) of 1x10^-6.
Biocompatibility Validation: Conducted in accordance with ISO 10993-1 and FDA guidance.
Mechanical Strength Testing: "The result of the testing concluded that subject device was in accordance with the pre-defined acceptance criteria." (Specific criteria and results not detailed).

In conclusion, the document provides evidence for the safety and substantial equivalence of the device through manufacturing process validation, sterilization validation, biocompatibility validation, and mechanical strength testing of the physical outputs. However, it does not include the type of detailed performance study you've asked for, which typically involves comparing diagnostic or functional output capabilities against a ground truth using specific metrics and sample sizes. This level of detail is often found in clinical study reports, which are usually separate from the 510(k) summary focused on substantial equivalence.

Summary

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June 9, 2020

ImmersiveTouch P. Pat Banerjee CEO 708 Kristin Court Westmont, Illinois 60559

Re: K181813

Trade/Device Name: ImmersiveView Surgical Plan (IVSP®) Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument And Accessories Regulatory Class: Class II Product Code: DZJ, LLZ Dated: May 8, 2020 Received: May 13, 2020

Dear P. Pat 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. 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/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.

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

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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 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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181813

Device Name ImmersiveView Surgical Plan (IVSP®)

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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510(K) Summary – K181813

Submitter

Name:	ImmersiveTouch, Inc.
Address:	910 West Van Buren, Suite 715, Chicago, IL 60607 US
Contact Person:	Dr. P. Pat Banerjee
Date Prepared:	June 8th , 2020

Name of Device and Classification Name

Device Name: ImmersiveView Surgical Plan (IVSP®) Regulation Name: Bone Cutting Instrument and Accessories Regulation Number: 872.4120 Product Code: Primary – DZJ; Secondary – LLZ Classification Panel: Dental

Predicate Device

VSP® System, Medical Modeling, Inc. (K120956).

Indications for Use

ImmersiveView Surgical Plan (IVSP®) is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ImmersiveView Surgical Plan (IVSD®) system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical splints, and surgical guides for use in maxillofacial surgery. The ImmersiveView Surgical Plan (IVSP®) system is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.

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Device Description

Reports are generated for each patient specific case illustrating the plan and accompany the physical outputs that are delivered once verified and approved by the physician.

Performance Data

The performance data indicates that the verification and validation testing performed on the ImmersiveView Surgical Plan (IVSP®) system successfully demonstrates that design outputs meet design inputs.

Device Performance Validation

The performance testing for the device includes processes validation methods such as IQ, OQ, and PQ to ensure that the manufacturing process can effectively produce patient matched devices. Equipment used for production purposes have been qualified to ensure the equipment used for manufacturing of surgical guides, surgical splints and, anatomical models

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meet production needs. Surgical splints, and surgical guides are manufactured based on recommendations outlined in the FDA Guidance Document "Technical Considerations for Additive Manufactured Medical Devices."

Sterilization Validation

Sterilization validation was conducted in accordance with international standard ISO 17665 and FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." to a sterility Assurance Level (SAL) of 1x10 . All test method acceptance criteria were met.

Biocompatibility Validation

Biocompatibility validation was conducted in accordance with international ISO 10993-1 and FDA guidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The results of the testing adequately address biocompatibility for the output devices and their intended use.

Mechanical Strength Testing

The subject device was tested for flexural deformation testing. The result of the testing concluded that subject device was in accordance with the pre-defined acceptance criteria.

Substantial Equivalence

ImmersiveView Surgical Plan (IVSP®) is substantially equivalent to the identified predicate based on indications for use, principles of operation, technological characteristics, inputs, and outputs. Minor differences in the surgical planning and manufacturing processes are verified and validated in the performance data in accordance with the intended use.

The input is medical scanner images such as CT and CBCT. Outputs are physical and digital that include surgical splints and surgical guides. Biocompatible materials are used in the creation of the subject devices.

All devices are intended to aid in maxillofacial surgeries. These systems are intended to be utilized by trained employees with the approval by the physician.

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
	IVSP® System,ImmersiveTouch, Inc.	VSP® System Medical ModelingInc.
510(k) Number	K181813	K120956
Clearance Date	TBD	12/12/2012
Computer	PC Workstation	PC workstation
Image Sources	CT	CT
Indications for Use	ImmersiveView Surgical Plan (IVSP®) is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the ImmersiveView Surgical Plan (IVSP®) system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, surgical splints, and surgical guides for use in maxillofacial surgery. The ImmersiveView Surgical Plan (IVSP®) system is also intended as a pre-operative software tool for simulating/evaluating surgical treatment options.	The Medical Modeling VSP® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the VSP® system and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating /evaluating surgical treatment options
Preoperative software	Yes	Yes
Human Intervention forInterpretation of images	Yes	Yes
Additive manufacturingof patient specificsurgical splints, surgicalguides and anatomicalmodels	Yes	Yes
Data inputs	Images from medical scanners	Images from medical scanners
Data outputs	Output for surgical splints, surgicalguides and anatomical models	Output for anatomical models, templates, andsurgical guides
Physical Outputs	Surgical splints, surgical guides, andanatomical models	Anatomical models, templates, and surgical guides
Materials	Biocompatible polymers	Biocompatible polymers and surgical stainlesssteel
Sterilization	Subject device is provided NON-sterile and is sterilized by the end-user	Same

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Comparison of Technological Characteristics with the Predicate Device

ImmersiveView Surgical Plan (IVSP®) system is substantially equivalent to and it is as safe and effective as its predicate device (VSP® System, Medical Modeling, Inc. -K120956).

Similarities to Predicate

The ImmersiveView Surgical Plan (IVSP®) and VSP® systems utilizes similar technologies as identified by its predicate device including:

. Software for image transfer, manipulation, and surgical planning. These differences in software were addressed via verification and validation testing of the system.
. Hardware for additive manufacturing of patient specific surgical splints, surgical guides, and anatomical models. These differences in software were addressed via verification and validation testing of the system

ImmersiveView Surgical Plan (IVSP®) and VSP® systems have similar technological characteristics including:

. System inputs: Images from medical scanners
. System Outputs: Physical outputs such as patient specific surgical splints, surgical guides, and anatomical models.
Software: The subject and predicate devices both use similar software components for the digital workflow. Difference in the software used were addressed via verification and validation testing of the system.
. Materials: Biocompatible polymers
Sterility Assurance Level: 1x10-6

The intended use of ImmersiveView Surgical Plan (IVSP®) system and its predicate device is substantially equivalent in the following respect:

. ImmersiveView Surgical Plan (IVSP®) system and the identified predicate device are intended to be used by trained personnel with active support from the surgeon. ImmersiveView Surgical Plan (IVSP®) system and the identified predicate device are intended for use on surgical candidates undergoing maxillofacial surgeries.

Differences to Predicate

The following technological differences exist between the subject and predicate device:

. The subject device does not include surgical stainless-steel inserts because the subject devices are not intended to come in contact with surgical cutting or drilling tools.
. The indications for use statements differ slightly in that the predicate device lists the physical outputs to include "anatomical models, templates, and surgical guides"

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whereas the subject device includes "anatomical models, surgical guides, and surgical splints" The predicate device includes surgical splints in the device description, but surgical splints were included in the indications for use of the subject device to describe all physical outputs..

The subject and predicate device both use biocompatible polymers to manufacture system outputs, but the materials used by the predicate device is different from the material used by the subject device.
. The workflow that both the subject device and predicate device use is different. In order to address the differences IQ, OQ, and PQ testing was conducted along with verification and validation activities.

Conclusion

ImmersiveView Surgical Plan (IVSP®) is substantially equivalent to and is as safe and effective as its predicate device. Both devices incorporate similar inputs, operations, and outputs.

Regulation Number and Section

§ 872.4120 Bone cutting instrument and accessories.

(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.