The ExactechGPS is intended for use during preoperative planning and during stereotaxic 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 Application 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

This submission proposes modifications to the ExactechGPS Total Shoulder Application cleared per #K162567.

The ExactechGPS Total Shoulder Application is an Image Guided Surgery, or Navigation, system designed to guide 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.

At initial release, the segmentation step was manually conducted by Blue Ortho. This submission proposes the addition of a semi-automatic segmentation option, where surgeons can elect to not send the CT exams to Blue Ortho for segmentation but employ a semiautomatic segmentation process to virtually reconstruct the bony anatomy of the patient in three dimensions. The use of semi-automatic segmentation to virtually recreate patient bone is available for planning only, and not for use during a navigated surgical procedure.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ExactechGPS Total Shoulder Application. It focuses on a modification to the device, specifically the addition of a semi-automatic segmentation option for preoperative planning.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria in a table format and corresponding reported device performance values. It discusses the changes in a qualitative manner. The primary acceptance criterion appears to be demonstrating that the modified device, particularly the semi-automatic segmentation, does not negatively impact the overall performance and maintains substantial equivalence to the predicate device.

Acceptance Criteria (Inferred)	Reported Device Performance
Software Verification: All design outputs meet specified requirements.	The submission includes software verification testing to ensure all design outputs meet all specified requirements, confirming compliance.
System Accuracy Verification: Comparison of system outputs to CT-scan data collected during clinical use.	The submission references system accuracy verification via comparison of system outputs to CT-scan data collected during clinical use, indicating the system's output aligns with real clinical data.
Software Validation: Software specifications conform to user needs and intended uses.	The submission includes software validation to ensure software specifications conform to user needs and intended uses, confirming the software meets user and purpose requirements.
No Effect on Intended Use: Modifications do not affect device intended use.	The modifications do not affect device intended use.
No Effect on General Design Features and Dimensions: Modifications do not affect general device features and dimensions.	The modifications do not affect general device features and dimensions.
No Change in Basic Fundamental Scientific Technology: Modifications do not change the device computer language or other basic fundamental technologies.	The modifications do not change the device computer language or other basic fundamental technologies.
No Effect on Performance Specifications: Modifications do not affect device accuracy and/or performance.	The modifications do not affect device accuracy and/or performance.
No Changes to Hardware Platform: No changes to the hardware platform or system accessories proposed.	No changes to the hardware platform or system accessories are proposed by this submission.
Substantial Equivalence to Predicate Device: The modified device is substantially equivalent to the predicate (K162567).	The report concludes that the proposed ExactechGPS Total Shoulder Application is substantially equivalent to the cited predicate, sharing identical indications for use, intended use, stereotaxic surgery technology, and similar/equivalent preoperative planning technology.

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

The document mentions "CT-scan data collected during clinical use" for system accuracy verification. However, it does not specify:

The sample size used for this test set.
The country of origin of the data.
Whether the data was retrospective or prospective.

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

The document does not provide any information regarding the number of experts used, their qualifications, or their role in establishing ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance. The focus is on the device's performance in preoperative planning and stereotaxic surgery, specifically the new semi-automatic segmentation feature.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

The document refers to "software verification testing" and "software validation," which imply standalone algorithm testing. The semi-automatic segmentation is a feature of the algorithm designed for "planning only, and not for use during a navigated surgical procedure," suggesting its performance as an algorithmic tool is evaluated. However, specific performance metrics for the standalone algorithm are not detailed.

7. Type of Ground Truth Used

The document states "comparison of system outputs to CT-scan data collected during clinical use." This suggests the ground truth for validating system accuracy might be derived from:

Clinical CT-scan data: Potentially representing actual patient anatomy or expert-verified segmentations based on these scans.
The initial "manually conducted" segmentations by Blue Ortho could also serve as a ground truth baseline for comparison with the new semi-automatic method.

However, the specific nature of how "ground truth" was established (e.g., expert consensus on CT, pathology, or outcomes) is not explicitly detailed.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set (if any was used for the semi-automatic segmentation algorithm).

9. How the Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for the training set was established. It only mentions that the "segmentation step was manually conducted by Blue Ortho" at initial release, which implies manual segmentation could have been used for training data, but this is not explicitly stated.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym followed by the words "U.S. Food & Drug Administration" on the right. The Department of Health and Human Services logo is a stylized human figure, while the FDA text is in blue.

November 24, 2017

Blue Ortho Anthony Boyer President and CEO 6 Allee de Bethleem Gieres, 38610 France

Re: K173372

Trade/Device Name: ExactechGPS Total Shoulder Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: October 26, 2017 Received: October 27, 2017

Dear Anthony Boyer:

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. 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K173372

Device Name

ExactechGPS® Total Shoulder Application

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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Image /page/3/Picture/1 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 similar blue color. Below "BlueOrtho" is the text "AUGMENTED ORTHOPAEDICS" in a smaller font size.

6 Allée de Bethléem 38610 Gières France

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

Submission date:

October 26, 2017

Sponsor:

BLUE ORTHO 6 Allée de Bethléem 38610 Gières France Phone: +33 (0) 4 58 00 35 25

Contact:

Anthony BOYER Phone: +33 (0) 4 76 54 95 46 Cell: +33 (0)6 30 39 50 66 anthony.boyer@blue-ortho.com

US Local Agent

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

Trade or Proprietary or Model Name(s):

ExactechGPS® Total Shoulder Application

Common Name:

Surgical navigation system and preoperative planning tool

Classification Number 21 CFR 882.4560

Classification Name: Orthopedic Stereotaxic Instrument, Picture Archiving & Communications System

Classification Class II

Product Code OLO (21 CFR 882.4560), LLZ (21CFR 892.2050)

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Image /page/4/Picture/1 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, lighter font.

6 Allée de Bethléem 38610 Gières France

Information on Devices to which Substantial Equivalence is Claimed:

Primary Predicate

510(k) Number	Trade or Proprietary Model Name	Manufacturer
#K162567	ExactechGPS® Total Shoulder Application	Blue Ortho

Indications for Use:

The ExactechGPS is intended for use during preoperative planning and during stereotaxic 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.

Device Description:

This submission proposes modifications to the ExactechGPS Total Shoulder Application cleared per #K162567.

Testing:

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

Software verification testing to ensure all design outputs meet all specified requirements
System accuracy verification via comparison of system outputs to CT-scan data collected during clinical use
Software validation to ensure software specifications conform to user needs and intended uses

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Image /page/5/Picture/1 description: The image shows the logo for BlueOrtho, a company specializing in augmented orthopedics. The logo features a stylized letter "C" in blue, followed by the company name "BlueOrtho" in a similar blue color. Below the company name, the words "AUGMENTED ORTHOPAEDICS" are written in smaller font, indicating the company's focus. The logo is clean and professional, conveying a sense of innovation and expertise in the field of orthopedics.

Testing demonstrates the modified ExactechGPS Total Shoulder Application is substantially equivalent to the cited predicate.

Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics:

Intended use: the modifications do not affect device intended use. -
-General design features and dimensions: the modifications do not affect general device features and dimensions.
-Basic fundamental scientific technology: the modifications do not change the device computer language or other basic fundamental technologies.
-Performance specifications: the modifications do not affect device accuracy and / or performance.
-Hardware platform: no changes to the hardware platform or system accessories are proposed by this submission.

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. The devices share:

Identical Indications for Use statements
Identical intended use
Identical technology for stereotaxic surgery
Similar, equivalent technology for preoperative planning

The information provided by Blue Ortho in this application confirms the proposed ExactechGPS Total Shoulder Application is substantially equivalent to the predicate cleared per #K162567.

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).