The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.

Device Description

The Exactech Equinoxe Small Reverse Shoulder System is a reverse shoulder system that provides small reverse glenoid plates, small reverse glenospheres, screw components, humeral liners, and surgical instrumentation for use in reverse total shoulder arthroplasty. The modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Reverse Shoulder System; these geometry modifications are the entire basis for the proposed Exactech Equinoxe Small Reverse Shoulder System.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Exactech® Equinoxe® Small Reverse Shoulder System." It describes the device, its intended use, and provides evidence of its substantial equivalence to previously cleared predicate devices.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or categorical format for performance metrics that would typically be expected for a diagnostic or AI-driven device. Instead, the "acceptance criteria" for this implantable device are demonstrated through mechanical and biological testing to show it performs as intended and is substantially equivalent to predicate devices. The "reported device performance" is essentially the successful outcome of these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance: - Glenoid Plate Fixation Strength - Glenoid Plate/Glenosphere Fixation Strength - Range of Motion	- Equinoxe Small Glenoid Plate Fixation Testing: Performed in accordance with ASTM F2028 for Reverse Total Shoulder Arthroplasty. Results indicate adequate fixation strength.- Equinoxe Small Glenoid Plate/Glenosphere Fixation Testing: Performed in accordance with ASTM F2028 for Reverse Total Shoulder Arthroplasty. Results indicate adequate fixation strength.- Range of Motion Evaluation: Performed in accordance with ASTM F1378. Results demonstrate appropriate range of motion for the intended application.
Biocompatibility/Sterility: - Absence of Pyrogens	- Pyrogen Testing: Conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72. Components met recommended limits as per FDA guidance for sterile devices.
Substantial Equivalence: - Same Indications for Use, Intended Use, Materials, Design Features, and Basic Fundamental Scientific Technology as predicate devices.	- The proposed and predicate devices share: The same Indications for Use, the same intended use, the same materials, the same design features and basic fundamental scientific technology, the same compression screws, glenosphere locking screw, humeral liners, humeral adapter trays, and humeral stem compatibility.

2. Sample size used for the test set and the data provenance

The document describes non-clinical laboratory testing (mechanical and pyrogen testing) rather than a test set of patient data. Therefore, this information is not applicable in the context of typical AI/diagnostic device studies using patient data. The "sample size" refers to the number of test articles (implants) used in the mechanical and pyrogen tests. The document does not specify exact numbers of test articles, but it does reference specific ASTM and USP standards for these tests, which would dictate appropriate sample sizes.

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

This information is not applicable. The device is an implantable shoulder system, not a diagnostic or AI-enabled device requiring expert interpretation of results for ground truth establishment. The "ground truth" for this device's performance is established through standardized engineering and biological tests conducted by qualified laboratory personnel following established protocols.

4. Adjudication method for the test set

This information is not applicable as there is no test set in the sense of a collection of patient cases requiring expert adjudication. The "adjudication" of the device's performance is based on meeting the quantitative criteria specified by the referenced ASTM and USP standards during laboratory testing.

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

This information is not applicable. This device is an implantable medical device, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or would be relevant for this type of device.

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

This information is not applicable. There is no algorithm or AI component in this device, so no standalone algorithm performance study was done.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily mechanical performance data against industry standards and biological safety data (pyrogenicity). This means:

Mechanical Ground Truth: Adherence to the specified mechanical properties (e.g., strength, range of motion) as defined by ASTM F2028 and ASTM F1378.
Biological Ground Truth: Absence of pyrogens within specified limits as defined by USP <161>, USP <85>, and ANSI/AAMI ST72.

8. The sample size for the training set

This information is not applicable. There is no AI component in this device, and thus no training set was used.

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

This information is not applicable. As there is no training set for an AI/algorithm, no ground truth needed to be established in this context.

Summary

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July 25, 2018

Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

Exactech, Inc. Zach Sharrah Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

Re: K180632

Trade/Device Name: Exactech® Equinoxe® Small Reverse Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWS, KWT Dated: June 21, 2018 Received: June 25, 2018

Dear Zach Sharrah:

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 manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

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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 comprehensive regulatory information about mediation-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,

Peter G. Allen -S 2018.07.25 11:15:28 -04'00'

for 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K180632

Device Name

Exactech® Equinoxe® Small Reverse Shoulder System

Indications for Use (Describe)

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.

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Exactech® Equinoxe® Small Reverse Shoulder System Special 510(k) - 510(k) Summary of Safety and Effectiveness

Sponsor:	Exactech®, Inc.2320 NW 66th CourtGainesville FL, 32653
	Phone: (352) 377-1140Fax: (352) 378-2617
	FDA Establishment Number 1038671
Contact Person:	Zach SharrahRegulatory Affairs SpecialistTelephone: (352) 377-1140Fax: (352) 378-2617
Date:	March 5, 2018
Proprietary Name:	Exactech® Equinoxe® Small Reverse Shoulder System
Common Name:	Reverse Shoulder Arthroplasty

Classification Name:

. Shoulder Prosthesis, Reverse Configuration (21 CFR Section 888.3660, Class II, Product Code PHX
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer cemented (21 ● CFR Section 888.3660, Class II, Product Code KWS
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer cemented (21 ● CFR Section 888.3650, Class II, Product Code KWT

		Legally Marketed Device to Which Substantial Equivalence Is Claimed:

Name	Manufacturer	510(k) Number
Equinoxe Reverse Shoulder System	Exactech, Inc.	K063569
Equinoxe Reverse Shoulder Line Extensions	Exactech, Inc.	K110708
Equinoxe Reverse Shoulder System 36mm Glenosphere and Humeral Liners	Exactech, Inc.	K093275
Equinoxe Total Shoulder – Fixed Angle Replicator Plates, Cast Humeral Heads, and Cast Glenosphere	Exactech, Inc.	K102951
Equinoxe Superior/Posterior Augment Reverse Shoulder Glenoid Baseplate	Exactech, Inc.	K131575

Indications for Use:

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Exactech® Equinoxe® Small Reverse Shoulder System Special 510(k) - 510(k) Summary of Safety and Effectiveness

Device Description:

Both the proposed and predicate devices share the following similarities:

The same Indications for Use ●
. The same intended use
The same materials
. The same design features and basic fundamental scientific technology
The same compression screws. glenosphere locking screw. humeral liners. . humeral adapter trays, and humeral stem compatibility

Non-Clinical Testing:

The following non-clinical testing and engineering analyses were performed to demonstrate that the Exactech Equinoxe Small Reverse Shoulder System performs as intended and is substantially equivalent to the identified predicate devices:

Equinoxe Small Glenoid Plate Fixation Testing in accordance with ASTM F2028 for Reverse Total Shoulder Arthroplasty
Equinoxe Small Glenoid Plate/ Glenosphere Fixation Testing in accordance . with ASTM F2028 for Reverse Total Shoulder Arthroplasty
Range of Motion Evaluation of the Equinoxe Small Reverse Shoulder ● Implants in accordance with ASTM F1378

Pyrogen testing was conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72 to ensure the proposed Equinoxe Small Reverse Shoulder components meet recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile.

Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Equinoxe Small Reverse Shoulder System devices are substantially equivalent to the cited cleared predicate Equinoxe devices.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”