inVisionOS by PrecisionOS Technology Inc.

inVisionOS is a software-based medical image viewing system intended for use as a software interface for the preoperative evaluation of surgical treatment options of bone pathologies imaged using CT scans.

Device Description

inVisionOS is a software-based pre-surgical planning system with a virtual reality (VR) headset. It is intended as pre-operative planning software for the evaluation of orthopedic surgical treatment options. The inVisionOS software displays virtual reality 3D models of patient data by uploading and converting Computed Tomography (CT) data into a 3-Dimensional (3D) format to be used with a virtual reality (VR) headset. It provides the user with the ability to manipulate the 3D model from multiple points of view through translation, rotation, and scaling. The user can position the Slice Plane Tool in the sagittal, coronal, axial, and oblique planes over the 3D model. This permits the user to view a CT-based 2D image at intersecting points along the plane. The inVisionOS software with a VR headset and controllers is not intended for use during surgery. The inVisionOS software is not intended to be used for diagnosis.

AI/ML Overview

The provided text describes PrecisionOS Technology Inc.'s inVisionOS device, a software-based medical image viewing system for the preoperative evaluation of surgical treatment options of bone pathologies imaged using CT scans. It is a Class II device with product code LLZ and regulation number 21 CFR 892.2050 (Medical image management and processing system).

However, the provided text does not contain specific acceptance criteria, detailed study results, or the information requested for a comprehensive description of the device's performance. The document is a 510(k) summary for the FDA, focusing on substantial equivalence to predicate devices and general performance testing.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information. The document states that "Performance Testing: Verification and validation activities, driven by risk analysis guided by ISO 14971:2007, were conducted and documentation is provided. These activities included software verification and validation, unit testing, cybersecurity, image accuracy and system testing. Usability testing was conducted in a simulated-use environment by appropriately trained health care providers. All testing activities demonstrated that the device met all design requirements and intended use, and that it is both safe and effective."

Below is a summary of the available information and a notation on what is missing:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the provided document	The document states that "All testing activities demonstrated that the device met all design requirements and intended use, and that it is both safe and effective." However, no specific performance metrics or thresholds are provided. Specific metrics for image accuracy, system speed, usability scores, etc., are not detailed.

Study Information

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document mentions "usability testing was conducted," but no details on the sample size of cases/patients or the origin/nature (retrospective/prospective) of the data are provided.
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 specified. The document mentions "appropriately trained health care providers" for usability testing, but does not detail how ground truth for performance evaluation (e.g., image accuracy) was established or by whom.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 specified. The document describes inVisionOS as a "software-based medical image viewing system intended for use as a software interface for the preoperative evaluation." It is implicitly an AI-assisted system (as it processes CT data into 3D VR models for planning), but no MRMC study comparing human readers with and without this specific AI assistance or the effect size of such assistance is detailed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not specified. The device is described as a "software interface," implying human-in-the-loop use. Standalone performance (e.g., accuracy of automatic measurements) is not explicitly detailed.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not specified.
The sample size for the training set
- Not specified.
How the ground truth for the training set was established
- Not specified.

Summary of what is known from the provided text:

Device Name: inVisionOS
Description: A software-based pre-surgical planning system with a virtual reality (VR) headset. It converts CT data into 3D format for VR viewing, allowing manipulation (translation, rotation, scaling) and viewing of 2D CT images via a "Slice Plane Tool."
Intended Use: As a software interface for the preoperative evaluation of surgical treatment options of bone pathologies imaged using CT scans. Not for use during surgery or for diagnosis.
Regulatory Status: Class II medical device, 510(k) cleared (K210344).
Predicate Devices: K201465 - SuRgical Planner (SRP) BrainStorm and K182464 - PeekMed.
Performance Testing Mentioned: "Software verification and validation, unit testing, cybersecurity, image accuracy and system testing. Usability testing was conducted in a simulated-use environment by appropriately trained health care providers." All testing "demonstrated that the device met all design requirements and intended use, and that it is both safe and effective."
Software Level of Concern: "Moderate" (since a failure could indirectly result in minor injury to the patient or user).
Animal/Clinical Testing: "No animal or clinical testing was required to support safety and effectiveness of the subject device."

The document focuses on establishing substantial equivalence based on intended use and technological characteristics, and notes that general verification and validation activities were conducted according to regulatory standards (ISO 14971:2007, 21 CFR Part 820.30) without providing specific performance metrics or detailed study methodologies.

Summary

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PrecisionOS Technology Inc. % Danny P. Goel, M.D. CEO & Cofounder 500-319 West Hastings Street Vancouver, British Columbia V6B 1H6 CANADA

November 10, 2021

Re: K210344

Trade/Device Name: inVisionOS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: Septeber 22, 2021 Received: October 6, 2021

Dear Dr. Goel:

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 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

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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 mediation-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) K210344

Device Name inVisionOS

Indications for Use (Describe)

in VisionOS is a software-based medical image viewing system intended for use as a software interface for the preoperative evaluation of surgical treatment options of bone pathologies imaged using CT scans.

X 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 contains a logo with a blue geometric shape on the left and the text "precision os" on the right. The geometric shape is a three-dimensional object with multiple faces, resembling a stylized cube or diamond. The text "precision" is in a bold, blue sans-serif font, while "os" is in a lighter shade of blue and a slightly smaller font size. The overall design is clean and modern, suggesting a technology-related company or product.

INVISIONOS

VOLUME #	TITLE
5	510(K) SUMMARY	K210344
510(k) Applicant:	PrecisionOS Technology Inc.500 - 319 West Hastings StreetVancouver, British ColumbiaCanada V6B 1H6
Contact Person:	Danny GoelCEO & Co-founderPhone: +1 (877) 673-0176danny@precisionostech.com
Date Prepared:	January 27, 2021
Device Trade Name:	inVisionOS™
Common Name:	System, Image Processing, Radiological
Classification Name:	Picture Archiving and Communications System
Regulation Number:	21 CFR 892.2050
Product Code:	LLZ
Classification:	II
Panel:	Radiology
Primary Predicate Device:	K201465 - SuRgical Planner (SRP) BrainStorm
Predicate Device:	K182464 - PeekMed

Device Description: inVisionOS is a software-based pre-surgical planning system with a virtual reality (VR) headset. It is intended as pre-operative planning software for the evaluation of orthopedic surgical treatment options. The inVisionOS software displays virtual reality 3D models of patient data by uploading and converting Computed Tomography (CT) data into a 3-Dimensional (3D) format to be used with a virtual reality (VR) headset. It provides the user with the ability to manipulate the 3D model from multiple points of view through translation, rotation, and scaling. The user can position the Slice Plane Tool in the sagittal, coronal, axial, and oblique planes over the 3D model. This permits the user to view a CT-based 2D image at intersecting points along the plane. The inVisionOS software with a VR headset

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Image /page/4/Picture/0 description: The image shows the logo for PrecisionOS. The logo consists of a blue geometric shape resembling a multifaceted gem or crystal, positioned to the left of the company name. The text "precisionos" is written in a sans-serif font, with the word "precision" in a darker blue and "os" in a lighter shade of blue.

and controllers is not intended for use during surgery. The inVisionOS software is not intended to be used for diagnosis.

Indications for Use: inVisionOS is a software-based medical image viewing system intended for use as a software interface for the pre-operative evaluation of surgical treatment options of bone pathologies imaged using CT scans.

Substantial Equivalence: The indicated use, design, and technological characteristics for inVisionOS are the same as the predicate devices: software-based 3D medical image viewing system for the preoperative evaluation of surgical treatment options imaged using CT scans. The indicated use for inVisionOS is consistent with the indicated use of the primary predicate device, with the exception of the field of intended use. The indicated use for inVisionOS is consistent with the indicated use of the secondary predicate device and is used to view the same field of intended use. Software verification and usability validation demonstrates that inVisionOS may be used for the same indicated uses as the predicate devices and any technological differences do not raise any safety or effectiveness concerns.

Performance Testing: Verification and validation activities, driven by risk analysis guided by ISO 14971:2007, were conducted and documentation is provided. These activities included software verification and validation, unit testing, cybersecurity, image accuracy and system testing. Usability testing was conducted in a simulated-use environment by appropriately trained health care providers. All testing activities demonstrated that the device met all design requirements and intended use, and that it is both safe and effective. No animal or clinical testing was required to support safety and effectiveness of the subject device.

The software for inVisionOS was deemed to be "moderate" level of concern since a failure or latent flaw in the software could indirectly result in minor injury to the patient or user.

Conclusion: The design and development of inVisionOS according to 21 CFR Part 820.30 Design Controls and FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" provide objective evidence that inVisionOS is as safe, effective and performs, at least, as well as the predicate devices.

Moreover, based on the shared intended use and technological characteristics, inVisionOS is substantially equivalent to the predicate devices. Though there are slight differences in the technological characteristics between inVisionOS and the predicate devices, these differences do not introduce additional questions concerning the safety and/or effectiveness of inVisionOS. The verification, validation and usability studies conducted with inVisionOS provide objective of its safety and effectiveness for its indicated 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).