The ExactechGPS is intended for use during preoperative planning and during orthopedic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.

The ExactechGPS Total Shoulder Planning Application is specifically indicated for pre-operative planning of Total Shoulder Arthroplasty using the Equinoxe system. The ExactechGPS Total Shoulder Planning Application permits to visualize, measure and reconstruct anatomical structures in order to select and place the glenoid and humeral components.

The Exacted GPS Total Shoulder Navigation is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.

Device Description

The ExactechGPS Total Shoulder Application proposed in this submission is a modification of the ExactechGPS Total Shoulder Application cleared per 510(k) #K173372.

The ExactechGPS Total Shoulder Application is an Image Guided Surgery, or Navigation, system designed to quide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure. The ExactechGPS Total Shoulder Application also offers a preoperative planning feature that enables surgeons to plan a surgical intervention by evaluating implant size, type, and positioning using reconstructed patient bone models in a virtual environment. The ExactechGPS Total Shoulder Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model, for both navigation and planning.

In the predicate device, the planning step was only indicated for pre-operative planning of the dlenoid part of the Equinoxe system. This submission proposes the addition of the humeral component. Therefore, the proposed ExactechGPS Total Shoulder Planning Application permits to visualize, measure and reconstruct anatomical structures in order to select and place the glenoid and humeral components.

The proposed ExactechGPS Total Shoulder Planning and Navigation Applications integrate some other modifications compared to the predicate device. These modifications are documented in Letter to Files.

The proposed modifications do not change the ExactechGPS System general intended use, general design features, or basic fundamental scientific technology. No changes to the hardware platform or system accessories are proposed by this submission.

AI/ML Overview

The provided text is a 510(k) summary for the ExactechGPS Total Shoulder Application. It describes a medical device and its proposed modifications, claiming substantial equivalence to a predicate device. However, it does not include detailed performance data, acceptance criteria, or study methodologies that would allow for a comprehensive description as requested. It only broadly states that "testing information demonstrating safety and effectiveness... is supported by testing that was conducted in-house" and lists general types of software testing (verification and validation).

Therefore, I cannot provide a complete answer to all parts of your request based solely on the provided document. I will focus on what can be inferred or directly stated from the text.

Here's an attempt to answer your questions based on the provided document, highlighting where information is missing:

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

The document states: "Software verification testing to ensure all design outputs meet all specified requirements" and "Software validation to ensure software specifications conform to user needs and intended uses."
However, the specific acceptance criteria and the reported device performance metrics (e.g., accuracy, precision, sensitivity, specificity, etc.) are not provided in this 510(k) summary.

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

This information is not provided in the document. The text only mentions "testing that was conducted in-house."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document.

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

This information is not provided in the document.

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

The document describes a "surgical navigation system" and "preoperative planning feature," but does not indicate that an MRMC comparative effectiveness study was performed or that human readers' improvement with AI assistance was measured. The focus is on the device's functionality in aiding surgical planning and navigation. Therefore, this information is not applicable or not provided in the context of this 510(k) summary.

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

The document mentions "software verification testing" and "software validation" which would typically involve testing the algorithm's performance in a standalone manner (e.g., accuracy of bone model reconstruction, implant placement) before integration with the surgeon's input. However, the specific results or detailed methodology for these standalone tests are not provided.

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

This information is not explicitly provided. Given the nature of a surgical planning and navigation system, ground truth would likely involve highly accurate imaging (e.g., high-resolution CT scans), anatomical measurements, and potentially expert anatomical review for validation of the reconstructed bone models and implant placements. However, the specific method for establishing this ground truth (e.g., expert consensus based on imaging, cadaveric studies with known anatomical landmarks) is not detailed in this summary.

8. The sample size for the training set

The document describes modifications to an existing device and its functionalities (e.g., extending planning to the humeral component, extending segmentation capabilities). It does not explicitly mention a deep learning or machine learning system that would require a distinct "training set" in the common AI sense. If the "software" relies on rule-based programming or image processing algorithms, a traditional "training set" might not be applicable in the same way as for a neural network. If there was any machine learning involved, the training set size is not provided.

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

As the existence or nature of a training set is unclear, the method for establishing its ground truth is also not provided.

Summary

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January 6, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Blue Ortho Matthieu Coic QA RA Director 22 Chemin du Vieux Chene Meylan, 38240 France

Re: K213546

Trade/Device Name: ExactechGPS Total Shoulder Application, Equinoxe Planning Software Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: October 29, 2021 Received: November 8, 2021

Dear Matthieu Coic:

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

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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 (OS) 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,

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

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Indications for Use

510(k) Number (if known) K213546

Device Name ExactechGPS® Total Shoulder Application

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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 is a logo for Blue Ortho. The logo consists of a blue square with a white "C" inside of it. To the right of the square is the text "Blue Ortho" in blue, with the words "Augmented Orthopaedics" in smaller letters underneath.

ExactechGPS® Total Shoulder Application 510(k) Summary of Safety and Effectiveness

I. SUBMISSION DATE

October 29, 2021

II. SUBMITTER

BLUE ORTHO 22 Chemin du Vieux Chêne 38240 Meylan France Phone: +33 (0)4 58 00 35 25 Contact person: Matthieu COIC - Mail: matthieu.coic@blue-ortho.com

III. US LOCAL AGENT

Exactech, Inc. 2320 NW 66th Ct. Gainesville, FL. 32653 Phone: 352-377-1140

IV. INFORMATION ON DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED

Primary Predicate

510(k) Number Trade or Proprietary Model Name #K173372 ExactechGPS® Total Shoulder Application This predicate has not been subject to a design-related recall.

Manufacturer Blue Ortho

Additional Predicates

510(k) Number Trade or Proprietary Model Name BLUEPRINT™ Patient Specific #K203315 Instrumentation

Manufacturer TORNIER SAS

V. PROPOSED DEVICE DESCRIPTION

Trade or Proprietary or Model Name(s): ExactechGPS® Total Shoulder Application Common Name: Surgical navigation system

Classification Name: Orthopedic Stereotaxic Instrument (21 CFR 882.4560, product code OLO); Picture Archiving & Communications System (21CFR 892.2050, product code LLZ)

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Image /page/4/Picture/1 description: The image is a logo for BlueOrtho, a company that specializes in augmented orthopedics. The logo features a stylized letter "C" in blue, followed by the words "BlueOrtho" in a sans-serif font, also in blue. Below "BlueOrtho" are the words "AUGMENTED ORTHOPAEDICS" in a smaller, sans-serif font. The logo is clean and modern, and the use of blue gives it a sense of trustworthiness and professionalism.

Classification: Class II Device Description:

The ExactechGPS Total Shoulder Application proposed in this submission is a modification of the ExactechGPS Total Shoulder Application cleared per 510(k) #K173372.

VI. INDICATIONS FOR USE

The ExactechGPS is intended for use during preoperative planning and during orthopedic surgery to aid the surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures, provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.

The ExactechGPS Total Shoulder Planning Application is specifically indicated for preoperative planning of Total Shoulder Arthroplasty using the Equinoxe system. The ExactechGPS Total Shoulder Planning Application permits to visualize, measure and reconstruct anatomical structures in order to select and place the glenoid and humeral components.

The ExactechGPS Total Shoulder Navigation is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.

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Image /page/5/Picture/1 description: The image is the logo for BlueOrtho. The logo consists of a blue square with a white "C" inside of it, followed by the words "BlueOrtho" in blue. Below the words "BlueOrtho" are the words "AUGMENTED ORTHOPAEDICS" in a smaller font.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

This submission proposes the following modifications to the ExactechGPS Total Shoulder Application:

. Modification of the Indications for Use by proposing an extension of the preoperative feature to the humeral component, and not only the glenoid component. This requires the modification of the ExactechGPS Total Shoulder Planning Application to extend the planning feature to the humeral part and components
. Extension of segmentation capabilities of Blue Ortho to the reconstruction of the humeral humerus
Integration in the ExactechGPS Total Shoulder Planning Application of ● Exactech Equinoxe humeral implants cleared in the following 510(k) submissions:

K042021	Equinoxe Shoulder System
K063569	Equinoxe Reverse Shoulder System
K061454	Exactech Equinoxe Shoulder Stems
K082702	Exactech Equinoxe Reverse Shoulder System+15mm Humeral Adapter
	Tray
K093275	Exactech Equinoxe Reverse Shoulder System 36mm Glenosphere And
	Humeral Liner
K162726	Exactech® Equinoxe® Preserve Stem
K180632	Exactech Equinoxe Small Reverse Shoulder System

Modification of the implementation of the registration algorithm by changing its initialization. This technical change in the registration algorithm has no impact on the global accuracy of the software nor performance.
At a high level, the subject and predicate devices are based on the following same technological elements:
The modifications do not affect device intended use. ●
The modifications do not affect general device features and dimensions.
The modifications do not change the device computer language or other basic ● fundamental technologies.
The modifications do not affect device accuracy and / or performance.
No changes to the hardware platform or system accessories are proposed by . this submission.

VIII. PERFORMANCE DATA

Testing information demonstrating safety and effectiveness of the ExactechGPS Total Shoulder Application is supported by testing that was conducted in-house. This submission includes or references the following non-clinical testing:

Software verification testing to ensure all design outputs meet all specified ● requirements
. Software validation to ensure software specifications conform to user needs and intended uses

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Image /page/6/Picture/1 description: The image is a logo for BlueOrtho Augmented Orthopaedics. The logo features a blue square with a white "C" shape inside. To the right of the square is the text "BlueOrtho" in a blue sans-serif font. Below the text is the phrase "AUGMENTED ORTHOPAEDICS" in a smaller, lighter blue font.

IX. SUBSTANTIAL EQUIVALENCE CONCLUSION

A comparison of specific features included in this submission demonstrates the proposed ExactechGPS Total Shoulder Application is substantially equivalent to the cited predicate cleared per #K173372. The devices share identical intended use, identical general design features and basic fundamental scientific technology.

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).