The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.

TKA Pro software application is specifically indicated for Total Knee Arthroplasty.

Device Description

The ExactechGPS® System proposed in this submission is a modification of the ExactechGPS® System cleared per 510(k) #K193618.

The ExactechGPS® System is an image-quided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons during arthroplasty. The ExactechGPS® System enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals.

The ExactechGPS® System works with ExactechGPS® hardware trackers that communicate intraoperative data to the ExactechGPS® hardware station to provide surgeons with real-time information on the positions of patient anatomical structures and instrumentation used to prepare bone during stereotaxic surgery.

The proposed modifications do not change the ExactechGPS® System general intended use, general design features, or basic fundamental scientific technology.

AI/ML Overview

This document describes the ExactechGPS® System, a surgical navigation system, and its modifications. While the document mentions general performance tests, electrical safety, EMC compatibility, photobiological safety, biocompatibility, and cleaning/sterilization validation, it does not provide the specific details required to fully address your request regarding acceptance criteria and a study proving the device meets these criteria in the context of an AI/human-in-the-loop system.

The device described is a "stereotaxic instrument" and mentions a "TKA Pro software application" for Total Knee Arthroplasty, aiding surgeons in locating anatomical structures and aligning endoprostheses. This implies a core functionality related to precise surgical guidance.

Given the information provided in the document, here's what can be extracted and what is missing:

Information Provided:

Device Name: ExactechGPS® System
Intended Use: "intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. TKA Pro software application is specifically indicated for Total Knee Arthroplasty."
Modifications: New set of ExactechGPS Trackers V2 (different architecture, updated electronic card, InfraRed bandpass filter) and compatibility with only the TKA Pro clinical software application (whereas the predicate was compatible with TKA Pro and TKA Plus).
Claimed Impact of Modifications: "Based on test bench testing, the proposed changes do not alter significantly the performances of the devices and the way it is used: The proposed ExactechGPS Trackers V2 have the same general features and dimensions, with the same technology and performances. The redesigned electronic card only resolves obsolescence issues with no impact on user, performance and safety. The new InfraRed bandpass filter only improves communication reliability."
Non-Clinical Testing: General Functions tests, Electrical Safety (IEC 60601-1), EMC Compatibility (IEC 60601-1-2), Photobiological Safety (EN 62471), Biocompatibility (ISO 10993-1:2018), Cleaning and Sterilization Validation (ISO 17664:2017, ISO 17665-1:2006, AAMI TIR12:2020, AAMI TIR30:2011/(R) 2016).

Information NOT Provided (or not in sufficient detail):

Specific Acceptance Criteria and Performance Data for Surgical Accuracy/Clinical Outcome: While "General Functions tests" are mentioned, no quantitative acceptance criteria for surgical accuracy (e.g., angular or translational precision of component placement) or specific performance results (e.g., mean angular deviation, success rate) are presented in a table format as requested. The document states "the proposed changes do not alter significantly the performances," implying a comparison to the predicate, but no specific performance metrics are given.
Sample Size for Test Set and Data Provenance: Not specified for any study related to the device's functional performance in surgical guidance. The document mentions "test bench testing" but no details on the size or nature of the test set.
Number of Experts and Qualifications for Ground Truth: Not applicable as no reader study or expert-based ground truth establishment is described for the device's performance. The device is a navigation system, so its "ground truth" would presumably be the physical reality of component alignment or anatomical structure location, measured by highly accurate metrology, rather than expert interpretation of images.
Adjudication Method for Test Set: Not applicable.
MRMC Comparative Effectiveness Study: Not mentioned or implied. This device is a navigation system, not an AI diagnostic tool primarily assisting human readers in interpreting images.
Standalone Performance (Algorithm Only): The device functions as a system with hardware and software; standalone algorithm-only performance is not directly relevant in the way it might be for an AI diagnostic algorithm.
Type of Ground Truth Used: For a navigation system, ground truth would typically come from highly accurate metrological measurements of physical objects or cadaveric studies, not expert consensus on images or pathology. This exact type of ground truth is not explicitly detailed.
Sample Size for Training Set: Not specified. It's unclear if "training" in the machine learning sense applies to this system's development, or if it refers to calibration/validation data for the navigation system.
How Ground Truth for Training Set was Established: Not specified.

Based on the provided document, here's a structured response indicating available information and significant gaps:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion	Reported Device Performance
Functional Performance (e.g., Surgical Accuracy, Precision)	NOT SPECIFIED QUANTITATIVELY. The document states: - "General Functions tests to ensure design is fully verified and validated." - "The proposed changes do not alter significantly the performances of the devices and the way it is used." There are no specific metrics (e.g., angular deviation, translational error) or numerical results provided to define acceptance criteria or demonstrate performance.
Electrical Safety (IEC 60601-1)	Compliant with requirements of the standard.
EMC Compatibility (IEC 60601-1-2)	Compliant with requirements of the standard.
Photobiological Safety (EN 62471)	Compliant with requirements of the standard.
Biocompatibility (ISO 10993-1:2018)	Compliant with requirements of the standard.
Cleaning and Sterilization Validation (ISO 17664:2017, ISO 17665-1:2006, AAMI TIR12:2020, AAMI TIR30:2011/(R) 2016)	Compliant with requirements of the standards.
Compatibility with Tracker V2 Performance	"The proposed ExactechGPS Trackers V2 have the same general features and dimensions, with the same technology and performances."
Electronic Card Redesign Impact	"redesigned electronic card only resolves obsolescence issues with no impact on user, performance and safety."
Infrared Bandpass Filter Impact	"new InfraRed bandpass filter only improves communication reliability."

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

Sample Size: Not specified. The document only mentions "test bench testing."
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing was conducted "in-house and by accredited testing laboratories."

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

Not applicable as no expert-based ground truth establishment or reader study is described for the performance claims. The device is a navigation system; its performance would likely be evaluated against physical measurements.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No evidence of an MRMC study. The device is a surgical navigation system, not a diagnostic AI tool for image interpretation by human readers. Its primary function is to provide real-time guidance during surgery, not to enhance human interpretation of medical images.

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

The document describes the device as a system of hardware (trackers, station) and software. The listed "performance data" refers to general system functions and regulatory compliance (electrical safety, EMC, etc.). It does not detail a standalone algorithm-only performance study related to its core navigation accuracy. The "TKA Pro software application" is part of the system, not presented as a standalone AI for diagnosis.

7. The Type of Ground Truth Used:

For a surgical navigation system, the ground truth for functional performance (like accuracy of component placement) would typically be established using highly accurate metrological measurements on physical models, cadavers, or potentially intraoperative measurements. This document does not specify the exact type of ground truth used for "General Functions tests" or "test bench testing" related to the navigation's accuracy. It is not expert consensus, pathology, or outcomes data in the traditional sense for diagnostic devices.

8. The Sample Size for the Training Set:

Not specified. It's unclear if "training set" refers to a machine learning training set or calibration data for the navigation system. The document does not describe an AI model that would require a distinct "training set" in the context of deep learning.

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

Not specified and likely not applicable in the context of an AI training set as described in the prompt, as the device is not presented as a deep learning AI diagnostic tool.

Summary

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Image /page/0/Picture/0 description: The image shows 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

May 2, 2022

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

Re: K213877

Trade/Device Name: ExactechGPS® System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 25, 2022 Received: February 1, 2022

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

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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: 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) K213877

Device Name ExactechGPS® System

Indications for Use (Describe)

The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.

TKA Pro software application is specifically indicated for Total Knee Arthroplasty.

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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Image /page/3/Picture/0 description: The image shows the logo for BlueOrtho, a company specializing in augmented orthopedics. The logo features a stylized blue "C" shape on the left, followed by the text "BlueOrtho" in a clean, sans-serif font. Below "BlueOrtho" is the tagline "AUGMENTED ORTHOPAEDICS" in smaller, uppercase letters. The overall design is modern and professional, conveying a sense of innovation and expertise in the field of orthopedics.

22 Chemin du Vieux Chêne 38240 Meylan France

ExactechGPS® System 510(k) Summary of Safety and Effectiveness

I. SUBMISSION DATE

December 10, 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

510(k) Number Trade or Proprietary Model Name Manufacturer #K193618 EXACTECH GPS Blue Ortho This predicate has not been subject to a design-related recall.

V. PROPOSED DEVICE DESCRIPTION

Trade or Proprietary or Model Name(s): ExactechGPS® System Common Name: Surgical navigation system Classification Name: Orthopedic Stereotaxic Instrument (21 CFR 882.4560, product code OLO) Classification: Class II Device Description: The ExactechGPS® System proposed in this submission is a modification of the ExactechGPS® System cleared per 510(k) #K193618.

The ExactechGPS® System is an image-quided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist

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Image /page/4/Picture/0 description: The image shows the logo for BlueOrtho, a company specializing in augmented orthopedics. The logo features a blue square with a stylized "C" inside, followed by the text "BlueOrtho" in a light blue sans-serif font. Below "BlueOrtho" is the text "AUGMENTED ORTHOPAEDICS" in a smaller font size. A registered trademark symbol is located to the right of the word "Ortho".

surgeons during arthroplasty. The ExactechGPS® System enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals.

The proposed modifications do not change the ExactechGPS® System general intended use, general design features, or basic fundamental scientific technology.

VI. INDICATIONS FOR USE

The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.

TKA Pro software application is specifically indicated for Total Knee Arthroplasty.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

This submission proposes the following hardware modifications to the ExactechGPS® system:

A new set of ExactechGPS Trackers V2 with a different architecture, an updated electronic card and an InfraRed bandpass filter
The ExactechGPS® system cleared per 510(k) #K193618 is compatible with the Knee Clinical Applications Software suite (which includes ExactechGPS® TKA Pro and ExactechGPS® TKA Plus clinical software applications).

The proposed ExactechGPS® system that includes changes listed hereabove is compatible only with the ExactechGPS® TKA Pro clinical software application.

Based on test bench testing, the proposed changes do not alter significantly the performances of the devices and the way it is used:

The proposed ExactechGPS Trackers V2 have the same general features and . dimensions, with the same technology and performances.
The redesigned electronic card only resolves obsolescence issues with no . impact on user, performance and safety.
The new InfraRed bandpass filter only improves communication reliability. ●

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Image /page/5/Picture/0 description: The image shows the logo for BlueOrtho. The logo consists of a blue square with a stylized "C" shape inside, followed by the text "BlueOrtho" in a light blue sans-serif font. Below the text is the phrase "AUGMENTED ORTHOPAEDICS" in a smaller font.

VIII. PERFORMANCE DATA

Testing information demonstrating safety and effectiveness of the ExactechGPS® System in the intended environment of use is supported by testing that was conducted in-house and by accredited testing laboratories.

This submission includes or references the following non-clinical testing:

General Functions tests to ensure design is fully verified and validated.
Electrical safety testing per IEC 60601-1 determined the proposed ● ExactechGPS® System is compliant with the requirements of the standard.
EMC Compatibility testing per IEC 60601-1-2 Determined the proposed ● ExactechGPS® System is compliant with the requirements of the standard.
Photobiological safety testing per EN 62471 determined the proposed . ExactechGPS® System is compliant with the requirements of the standard.
. Biocompatibility testing per ISO 10993-1:2018 and associated standards determined the proposed ExactechGPS® System is compliant with the requirements of the standard.
Cleaning and sterilization validation per ISO 17664:2017, ISO 17665-1:2006, . AAMI TIR12:2020 and AAMI TIR30:2011/(R) 2016 determined the proposed ExactechGPS® System is compliant with the requirements of the standard.

IX. SUBSTANTIAL EQUIVALENCE CONCLUSION

A comparison of specific features included in this submission demonstrates the proposed ExactechGPS® System is substantially equivalent to the cited predicate cleared per #K193618. 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).