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 proposed Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere represents a modification of the predicate Exactech Equinoxe Reverse Shoulder 46x25mm Glenosphere cleared in K063569. Both the predicate and proposed devices have the same intended use, general design features and basic fundamental scientific technology. The only difference between the predicate and the proposed device are the following dimensional modifications:

1. Reduced Lateral Offset The proposed glenosphere has a lateral offset of 21mm, which is 4mm shorter than the predicate 46x25mm glenosphere.
  These modifications are proposed to provide another glenosphere option to the existing glenospheres cleared in K063569.

AI/ML Overview

This document discusses a 510(k) premarket notification for the "Exactech® Equinoxe® Reverse Shoulder 46x21mm Glenosphere." This is a medical device, specifically a component of a shoulder prosthesis. The document is a letter from the FDA to Exactech, Inc., indicating that the device has been found substantially equivalent to a legally marketed predicate device.

The "device" in question is not an AI/ML powered device, but a physical medical implant. Therefore, most of the requested information regarding AI/ML study design, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, or MRMC studies, is not applicable. The provided text describes engineering tests performed to demonstrate substantial equivalence for this physical product.

Here's an analysis based on the provided text, addressing the relevant sections of your request:

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

Since this is a physical medical device and not an AI/ML algorithm, the "acceptance criteria" are related to mechanical performance and the "reported device performance" are the results of engineering analyses demonstrating equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Demonstrated mechanical equivalence to predicate device for glenoid loosening, cyclic fatigue, deltoid abductor moment arms, and range of motion.	Engineering analyses (Glenoid Loosening and Cyclic Fatigue Testing, Analysis Of Deltoid Abductor Moment Arms, Range of Motion Analysis) were conducted and results demonstrated substantial equivalence to the cleared predicate device.

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

This question is not applicable as the submission is for a physical medical device. The "test set" here refers to the actual physical devices or components tested in engineering analyses, not a dataset for an AI/ML model. The document does not specify the number of physical components tested in the engineering analyses. Data provenance in this context would refer to the testing facility and procedures, which are not detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience).

This question is not applicable. "Ground truth" in the context of physical device testing would refer to established engineering standards and methodologies, not expert consensus on medical images or patient outcomes. The engineering analyses are likely performed by qualified engineers following established protocols.

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

This question is not applicable. Adjudication methods like 2+1 are used for resolving disagreements among human reviewers of cases, typically in clinical studies or for establishing ground truth for AI/ML. Engineering tests typically follow standardized protocols, and results are measured objectively, not through adjudication.

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 question is not applicable. An MRMC study is relevant for evaluating the clinical utility of an AI/ML-powered diagnostic or assistive tool. This device is a physical shoulder implant, and no AI component is described.

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

This question is not applicable. The device is a physical implant, not an algorithm.

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

This question is not applicable for a physical device in the AI/ML sense. The "ground truth" for the engineering tests would be established engineering principles, material science properties, and established benchmarks for mechanical performance of similar medical implants.

8. The sample size for the training set.

This question is not applicable. There is no AI/ML model being trained for this physical device.

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

This question is not applicable. There is no AI/ML model being trained for this physical device.

Summary of what can be gleaned about the "study" (engineering analyses) for the device:

Device: Exactech® Equinoxe® Reverse Shoulder 46x21mm Glenosphere (a physical shoulder implant component).
Purpose of "Study": To demonstrate substantial equivalence of the new 46x21mm glenosphere to a predicate 46x25mm glenosphere, primarily due to a dimensional modification (reduced lateral offset).
Methodology: "Engineering analyses" were conducted.
- Glenoid Loosening and Cyclic Fatigue Testing
- Analysis Of Deltoid Abductor Moment Arms
- Range of Motion Analysis
Conclusion: The engineering studies demonstrated substantial equivalence to the predicate device.
Data Provenance: Not specified in terms of country or retrospective/prospective, but implies laboratory-based engineering testing.

In essence, the document details the regulatory approval process for a physical medical device based on engineering tests, not an AI/ML algorithm or software.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 14, 2015

Exactech, Incorporated Mr. Thomas McNamara Regulatory Affairs Specialist 2320 North West 66th Court Gainesville, Florida 32653

Re: K150458

Trade/Device Name: Exactech® Equinoxe® Reverse Shoulder 46x21mm Glenosphere Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX Dated: April 14, 2015 Received: April 16, 2015

Dear Mr. McNamara:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Thomas McNamara

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150458

Device Name

Exactech® Equinoxe® Reverse Shoulder 46x21mm Glenosphere

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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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:

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"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."

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Sponsor:	Exactech®, Inc2320 NW 66th CourtGainesville FL, 32653Phone: (352) 377-1140Fax: (352) 378-2617
FDA Establishment Number	1038671
Date:	April 14, 2015
Contact Person:	Thomas McNamaraRegulatory Affairs SpecialistTelephone: (352) 327-1140Fax: (352) 378-2617
Proprietary Name:	Exactech® Equinoxe® Reverse Shoulder 46x21mmGlenosphere
Common Name:	Reverse Shoulder Arthroplasty

Classification Name:

Shoulder Prosthesis, Reverse Configuration (21 CFR Section 888.3660, Class II, Product Code PHX).

Legally Marketed Device to Which Substantial Equivalence Is Claimed:

Name	Manufacturer	510(k) Number
Equinoxe Reverse Shoulder System	Exactech, Inc	K063569

Indication for Use:

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

1. Reduced Lateral Offset The proposed glenosphere has a lateral offset of 21mm, which is 4mm shorter than the predicate 46x25mm glenosphere.

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These modifications are proposed to provide another glenosphere option to the existing glenospheres cleared in K063569.

Testing:

The following engineering analyses were conducted to demonstrate substantial equivalence of the proposed Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere to the predicate Exactech Equinoxe Reverse Shoulder Glenospheres:

Glenoid Loosening and Cyclic Fatigue Testing ●
Analysis Of Deltoid Abductor Moment Arms ●
Range of Motion Analysis

Substantial Equivalence Conclusion:

Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere are substantially equivalent to the cleared Exactech Equinoxe Reverse Shoulder 46x25mm Glenosphere.

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.”