Blueprint® Mixed Reality system is indicated for use during Total Shoulder Arthroplasty using Stryker's FDA cleared implants that are also implants cleared for pre-operative planning with the Blueprint® Software. Blueprint® Mixed Reality system is intended to allow surgeons to visualize the Blueprint® 3D preoperative planning intra-operatively. Blueprint® Mixed Reality system is also indicated for stereotaxic surgery to guide the placement of a glenoid pin provided that registration between the patient's anatomical landmarks / surfaces can be established on the preoperative CT based plan. Blueprint® Mixed Reality system is to be only used for skeletally matured adult patients.

Device Description

The Blueprint® Mixed Reality system is used to intraoperatively display stereoscopic threedimensional images of the Blueprint shoulder arthroplasty preoperative plan and to guide and enable the insertion of a pin following the reaming axis aimed at preparing the glenoid fossa surface to facilitate the placement of the implant. The Blueprint Mixed Reality system allows the user to both see the patient in real-time and their internal boney anatomy displayed on seethrough screens of a head-mounted device (goggles).

The Blueprint Mixed Reality system assists surgeons in visualizing stereoscopic threedimensional images of the patient's boney anatomy and intraoperatively aid by guiding the pin during placement through real-time feedback.

The Blueprint Mixed Reality system is composed of three main components including the HOLOBLUEPRINT software, Microsoft® HoloLens 2 Goggles, and Instrumentation.

The Blueprint Mixed Reality system runs the HOLOBLUEPRINT software application on the Microsoft HoloLens 2 using Microsoft Windows Holographic Operating System. The Blueprint Mixed Reality system leverages the reference device by receiving planned glenoid cases as input for visualizing and guiding the placement of the pin during the shoulder arthroplasty procedure. The digital components of the system interface with specialized surgical instrumentation to enable intra-operative guidance through real-time feedback to the surgeon.

The components of the subject device are as follows:

HOLOBLUEPRINT™ Software
HOLOBLUEPRINT is designed and written by Tornier SAS specifically for use on the Microsoft HoloLens 2 goggles (hardware). The HOLOBLUEPRINT software is to be installed on the hardware to be used by the surgeon as part of the Blueprint Mixed Reality system.

HoloLens 2 goggles (HoloLens 2)
The HoloLens 2 is a Microsoft hardware that runs Microsoft Windows 10 Holographic Operating System. HoloLens 2 is a see-through, mixed reality headmounted smart glasses.

Instrumentations (Instruments)
There are four reusable instruments and one single-use (sterile) instrument designed specifically for use with the Blueprint Mixed Reality system (subject device). The subject device system instruments include a Glenoid Pin Guide, Glenoid Digitizer, Instruments Check Block, Coracoid Clamp, and a Depth Stop Pin (Sterile).

The subject device is compatible with all Tornier (Stryker) commercially FDA-cleared glenoid implants (Except Patient Matched Implants) available in the reference device (K211359). The compatibility of implants with the reference device was validated and verification was performed for glenoid guidance and visualization of the patient's boney anatomy.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Blueprint Mixed Reality system. It describes the device's indications for use, technological characteristics, and non-clinical performance evidence to demonstrate substantial equivalence to a predicate device.

Based on the content, here's a description of the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily focused on the accuracy and repeatability of the system, and that the software performs as per requirements and specifications. The document states that the system was validated through cadaver testing to demonstrate its accuracy and establish performance equivalency to the predicate device.

Acceptance Criteria Category	Specific Criteria (Implied from the document)	Reported Device Performance (Implied from the document)
Accuracy and Repeatability	The system must demonstrate accuracy and repeatability in guiding the placement of a glenoid pin and visualizing the 3D preoperative planning intra-operatively.	"The accuracy and repeatability were tested." and "The system was validated through cadaver testing to determine its accuracy to establish the performance equivalency of the predicate device." (Specific numerical values are not provided in this public summary).
Software Performance	The HOLOBLUEPRINT™ software must perform as per the system requirements and specifications.	"Bench Testing conducted to demonstrate the HOLOBLUEPRINT™ software performs as per the systems requirements and specifications."
Software Design Output Compliance	All software design outputs must meet specified requirements.	"Software Verification testing was performed to ensure all design outputs meet specified requirements."
User Needs & Intended Use Conformance	Software specifications must conform to user needs and intended uses.	"User needs Validation performed to ensure software specifications conform to user needs and intended uses."
Instrument Functional & Performance Requirements	All instruments must satisfy functional and performance requirements.	"Systems Instruments testing was performed to confirm that all instruments satisfy functional and performance requirements."
Safety & Effectiveness (Overall)	The device should not raise new questions of safety or effectiveness compared to the predicate device.	"All requirements were met, and no new question of safety and effectiveness was raised." and "The results of performance testing for the subject device support substantial equivalence to the predicate device."

Study Details:

Sample Size and Data Provenance:
- Test Set Sample Size: The document mentions "cadaver testing" and "simulated use cases" for validation. It does not specify the numerical sample size (e.g., number of cadavers or simulated cases) used for the test set.
- Data Provenance: The document does not explicitly state the country of origin of the data. The company is based in France, but the testing locations are not specified. The studies were non-clinical, involving cadavers and simulated use. It is a prospective study in the sense that the testing was performed specifically to evaluate this device.
Number of Experts and Qualifications:
- The document does not provide details on the number of experts used or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing ground truth or evaluating performance. The testing involved "cadaver testing" and "simulated use cases," implying technical personnel or surgeons would be involved in assessing accuracy, but their roles and expertise are not elaborated upon.
Adjudication Method for the Test Set:
- The document does not specify an adjudication method (e.g., 2+1, 3+1) for the test set. Given it's a technical accuracy and performance study on a medical device system, it's more likely that technical measurements and predefined tolerance limits were used for "ground truth" rather than subjective expert consensus requiring adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not explicitly done. The document states, "Clinical testing was not deemed necessary for the determination of substantial equivalence." The evaluation was based on non-clinical performance evidence (bench testing, system accuracy validation through cadaver testing, functional and performance testing, software verification/validation). Therefore, there is no reported effect size of how much human readers improve with AI vs. without AI assistance.
Standalone (Algorithm Only) Performance:
- Yes, a form of standalone performance was assessed. The "Bench Testing conducted to demonstrate the HOLOBLUEPRINT™ software performs as per the systems requirements and specifications" can be considered an assessment of the algorithm's performance in isolation from the full human-in-the-loop use case, focusing on its computational accuracy and adherence to specifications. The "System Accuracy Validation... through cadaver testing" also evaluates the system's (including the software) ability to provide accurate guidance measurements, independent of a specific surgeon's subjective interpretation (though a surgeon would utilize the output).
Type of Ground Truth Used:
- The ground truth for the accuracy studies (cadaver testing) would likely be established through highly precise measurements using a gold-standard reference system (e.g., coordinate measuring machine, highly accurate optical tracking system, or direct physical measurements) to verify the device's reported position and orientation accuracy against the true anatomical features. For software performance, the ground truth would be defined by the pre-defined system requirements and specifications.
Training Set Sample Size:
- This document describes the validation of a medical device system, not specifically a machine learning model where a distinct "training set" for an AI algorithm would be relevant. While the system incorporates "HOLOBLUEPRINT™ Software," the text does not indicate that this software is an adaptive AI model requiring a separate training phase with a specific data set size. Therefore, no sample size for a training set is provided or implied.
How Ground Truth for Training Set was Established:
- Given that the document does not describe the use of an adaptive AI model with a training set, the concept of establishing ground truth for a training set is not applicable here. The software validation is against pre-defined specifications and requirements, not against an annotated training dataset for learning.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

January 20, 2023

Tornier SAS Moyees Kamara Staff Specialist, Regulatory Affairs 161 rue LAVOISIER Montbonnot Saint Martin, 38330 France

Re: K222510

Trade/Device Name: Blueprint Mixed Reality system Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: December 20, 2022 Received: December 21, 2022

Dear Moyees Kamara:

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

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

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,

Shumava Ali -S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K222510

Device Name Blueprint® Mixed Reality system

Indications for Use (Describe)

Blueprint® Mixed Reality system is indicated for use during Total Shoulder Arthroplasty using Stryker's FDA cleared implants that are also implants cleared for pre-operative planning with the Blueprint® Mixed Reality system is intended to allow surgeons to visualize the Blueprint® 3D preoperative planning intra-operatively. Blueprint® Mixed Reality system is also indicated for stereotaxic surgery to guide the placement of a glenoid pin provided that registration between the patient's anatomical landmarks / surfaces can be established on the preoperative CT based plan. Blueprint® Mixed Reality system is to be only used for skeletally matured adult patients.

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)

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."

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

Image /page/3/Picture/0 description: The image shows the word "TORNIER" in a blue serif font, followed by a blue hexagon containing a stylized letter "T". The font is a classic serif style, with the letters evenly spaced and sized. The hexagon is a geometric shape with six sides, and the stylized "T" inside it is designed to complement the overall logo.

K222510

Date Prepared: August 17, 2022

Administrative Information

Name:	Tornier SAS
Address:	161 rue Lavoisier38330 Montbonnot Saint MartinFrance
Contact Person:	Moyees Kamara, Jr.
Title:	Staff Specialist, Regulatory Affairs
Phone:	+1 240-869-8849

Device Information

Name of Device:	Blueprint® Mixed Reality system
Common Name (s):	Orthopedic Stereotaxic Instrument
Regulatory Class:	II
Regulation:	21 CFR 882.4560, Stereotaxic instrument
Product Codes:	OLO, LLZ

Predicate Device Information

Predicate:	ExactechGPS® Total Shoulder Application (K173372)
Reference Device:	Tornier Perform™ Patient-Matched Primary Reversed Glenoid andBLUEPRINT™ Patient Specific Instrumentation (K211359)

Device Description

The Blueprint Mixed Reality svstem assists surgeons in visualizing stereoscopic threedimensional images of the patient's boney anatomy and intraoperatively aid by guiding the pin during placement through real-time feedback.

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

Image /page/4/Picture/0 description: The image shows the word "TORNIER" in a large, sans-serif font, colored in blue. To the right of the word is a logo consisting of a stylized letter "T" inside a hexagon. The logo is also colored in blue and has a modern, geometric design.

The Blueprint Mixed Reality system is composed of three main components including the HOLOBLUEPRINT software, Microsoft® HoloLens 2 Goggles, and Instrumentation.

The components of the subject device are as follows:

HOLOBLUEPRINT™ Software

. HOLOBLUEPRINT is designed and written by Tornier SAS specifically for use on the Microsoft HoloLens 2 goggles (hardware). The HOLOBLUEPRINT software is to be installed on the hardware to be used by the surgeon as part of the Blueprint Mixed Reality system.

HoloLens 2 goggles (HoloLens 2)

. The HoloLens 2 is a Microsoft hardware that runs Microsoft Windows 10 Holographic Operating System. HoloLens 2 is a see-through, mixed reality headmounted smart glasses.

Instrumentations (Instruments)

There are four reusable instruments and one single-use (sterile) instrument designed specifically for use with the Blueprint Mixed Reality system (subject device). The subject device system instruments include a Glenoid Pin Guide, Glenoid Digitizer, Instruments Check Block, Coracoid Clamp, and a Depth Stop Pin (Sterile).

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

Image /page/5/Picture/0 description: The image shows the word "TORNIER" in a large, blue, serif font. To the right of the word is a blue hexagon with a stylized "T" inside. The "T" is also blue and has a smaller hexagon inside of it.

Indications for Use

Contraindications

Blueprint Mixed Reality system is not to be used for non-adult patients.
Blueprint Mixed Reality system is not to be used for diagnostic purposes. .
. Blueprint Mixed Reality system is not to be used with a range of implants other than commercially authorized and Mixed Reality compatible Stryker/Tornier implants.
. Blueprint Mixed Reality system is not to be used by surgeons with a history of seizures or epilepsy
Blueprint Mixed Reality system is not to be used by surgeons with vision issues that will ● not allow them to visualize the 3D interface clearly and comfortably.
. Blueprint Mixed Reality system is unsuitable to be used on patients with insufficient coracoid bone stock which limits coracoid instrument fixation

Technological Characteristics Comparison to Predicate Device

The subject device, Blueprint Mixed Reality system, and the predicate device, ExactechGPS (K173372) share similar technological characteristics as follows:

Intended Use and Indications for Use ●
Principles of operations ●
Target population and user ●
General technological features
Intraoperative use
Main system components
Surgical instruments for navigation with markers .
. Device accuracy requirements
Environmental use
. Surgical Workflow and tracking system technology

Tornier SAS. Blueprint® Mixed Reality system

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

Image /page/6/Picture/0 description: The image shows the logo for Tornier. The logo consists of the word "TORNIER" in large, blue, serif font, followed by a blue hexagon containing a stylized letter "T". The "T" within the hexagon is also blue and has a unique design, with a smaller hexagon shape inside the larger one.

The differences between the subject device, subject device, and predicate device include:

. The camera positioning is a near-eye, head-mounted device (HoloLens 2) instead of a screen on a desktop monitor, mounted on a platform systems cart to display information to the surgeon.
. The use of an active sensor versus passive sensors
. The tracking system technology is RGB instead of visible images

The Technological differences between the subject and predicate software devices are supported with verification and validation evaluations. The operating principle of the subject device is the same as that of the predicate device.

The differences in technological characteristics do not raise new questions of safety and effectiveness over the predicate device as demonstrated in validation and verification testing performed.

Substantial Equivalence - Non-clinical Performance Evidence

Non-clinical testing was performed to demonstrate substantial equivalence to the predicate device. They include:

Bench Testing conducted to demonstrate the HOLOBLUEPRINT™ software performs . as per the systems requirements and specifications. The accuracy and repeatability were tested.
System Accuracy Validation The system was validated through cadaver testing to . determine its accuracy to establish the performance equivalency of the predicate device.
Functional and Performance Testing the subject device was tested as required by IEC . 62304 standards and FDA Guidance document General Principles of Software Validation issued on January 11, 2002. The goal of the tests was as follows:
- Software Verification testing was performed to ensure all design outputs meet . specified requirements. The software for the subject device was considered a "moderate" level of concern as per the FDA guidance document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued on May 11, 2005).
- User needs Validation performed to ensure software specifications conform to . user needs and intended uses. The system was validated through cadaver and simulated use cases as per IEC 62366-1 standard. All requirements were met, and no new question of safety and effectiveness was raised.
- Systems Instruments testing was performed to confirm that all instruments .

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the word "TORNIER" in a blue serif font, followed by a blue hexagon containing a stylized "T" inside. The font is a classic serif, with a slightly condensed appearance. The hexagon is a simple geometric shape, and the stylized "T" inside is a modern design.

satisfy functional and performance requirements.

Biocompatibility, Cleaning, Sterilization, Packaging, and Shelf life for the subject device . instruments were assessed in accordance with recognized consensus standards.
The subject device components were also assessed in accordance with recognized consensus standards. All tests were successfully completed and passed.

Substantial Equivalence - Clinical Evidence

Clinical testing was not deemed necessary for the determination of substantial equivalence.

Substantial Equivalence - Conclusions

The Blueprint Mixed Reality system (subject device) does not raise new questions of safety or effectiveness. Differences in technological characteristics have been addressed with performance testing. The results of performance testing for the subject device support substantial equivalence to the predicate device, ExactechGPS (K173372, cleared November 24, 2017).

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).