The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:

P	L	F	Indications
√	√		Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
√	√		Congenital abnormalities in the skeletally mature
√			Primary and secondary necrosis of the humeral head.
√		√	Humeral head fracture with displacement of the tuberosities
√	√		Pathologies where arthodesis or resectional arthroplasty of the humeral head are not acceptable
√	√		Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
		√	Displaced three-part and four-part upper humeral fractures
	√		Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
	√		Revision of failed previous reconstructions when distal anchorage is required
√	√		To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, i rreparable 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.

The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fractures Stein is indicated for cemented use only.

Device Description

The Exactech Equinoxe Platform Fracture Stem is a cemented humeral stem designed for use with the Equinoxe primary shoulder components and the Equinoxe reverse shoulder components. The Equinoxe Platform Fracture Stem is intended to be used in cemented applications for repair of acute fracture of the proximal humerus.

The proposed and predicate (K092900) fracture stems have identical design features. However, the proposed stems will be made from forged titanium alloy (per ASTM F136 and ASTM F620), as opposed to the wrought titanium alloy (ASTM F1472) used in the predicate stems.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the Exactech® Equinoxe® Platform Fracture Stem. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in a clinical or AI context.

Therefore, much of the requested information regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, ground truth establishment, adjudication methods, and MRMC/standalone studies, cannot be found in this document.

The document describes material and mechanical testing to support substantial equivalence, not a study evaluating clinical performance or AI algorithm performance.

Here's what can be extracted from the provided text:

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

The document describes engineering evaluations for substantial equivalence, not a clinical performance study with acceptance criteria for performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI.

Acceptance Criteria (from this document)	Reported Device Performance (from this document)
Constructs must meet criteria without failure in dynamic compression test.	All constructs met the criteria without failure.
Device must be sufficient to sustain clinically relevant loads during its expected life under worst-case conditions.	An engineering evaluation determined that the proposed device is sufficient to sustain clinically relevant loads during its expected life.

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 "tests" described are engineering and mechanical evaluations of the device itself (compression test, engineering evaluation), not a study involving patient data.

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 information is not provided in the document. The "ground truth" for the engineering tests would be the physical properties and performance characteristics of the materials and device design, established by engineering principles and testing standards, not by medical experts.

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

This information is not provided in the document. Adjudication methods are relevant for clinical assessments or expert consensus, not for the mechanical testing described here.

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

There was no MRMC comparative effectiveness study and therefore no effect size reported. This document is for a physical implantable device, not an AI-powered diagnostic tool.

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

There was no standalone algorithm performance study. This document is for a physical implantable device, not an AI-powered diagnostic tool.

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

For the mechanical tests, the ground truth would be based on engineering and material science principles and standards (e.g., ability to withstand specified loads, material properties conforming to ASTM standards). There is no mention of expert consensus, pathology, or outcomes data as ground truth for the evaluations presented.

8. The sample size for the training set

This information is not applicable and is not provided. There is no "training set" as this is not an AI/machine learning study.

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

This information is not applicable and is not provided. There is no "training set" as this is not an AI/machine learning study.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health and Human Services.

Public Health Service

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

November 2, 2016

Exactech, Incorporated Mr. Graham L. Cuthbert Regulatory Affairs Specialist II 2320 N.W. 66th Court Gainesville, Florida 32653

Re: K101909

Trade/Device Name: Exactech® Equinoxe® Platform Fracture Stem Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWT, KWS Dated: July 7, 2010 Received: July 8, 2010

Dear Mr. Cuthbert:

This letter corrects our substantially equivalent letter of August 2, 2010.

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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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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

for

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

Enclosure

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Exactech® Equinoxe® Platform Fracture Stem Special 510(k) - Indications for Use

510(k) Number:

AUG 0 % 2010

Device Name: Exactech® Equinoxe® Platform Fracture Stem

INDICATIONS FOR USE:

Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:

P	L	F	Indications
√	√		Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
√	√		Congenital abnormalities in the skeletally mature
√			Primary and secondary necrosis of the humeral head.
√		√	Humeral head fracture with displacement of the tuberosities
√	√		Pathologies where arthodesis or resectional arthroplasty of the humeral head are not acceptable
√	√		Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
		√	Displaced three-part and four-part upper humeral fractures
	√		Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
	√		Revision of failed previous reconstructions when distal anchorage is required
√	√		To restore mobility from previous procedures (e.g. previous fusion)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number

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Exactech® Equinoxe® Platform Fracture Stem Special 510(k) - Indications for Use

Prescription Use X and/or (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

Please do not write below this line -- use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suictu for mxm
(Division Sign off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101909

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Exactech® Equinoxe® Platform Fracture Stem Special 510(k) - Summary of Safety and Effectiveness

Company:
----------	--

Exactech, Inc. 2320 N.W. 66th Court Gainesville, FL 32653

LAUS 02 2010

Phone: (352) 377-1140 Fax: (352) 378-2617

LL101.909

Contact Person: Graham L. Cuthbert, Regulatory Affairs Specialist II

July 6th 2010 Date:

Exactech Equinoxe Platform Fracture Stems II. Proprietary Name:

Fracture Shoulder Prosthesis Common Name:

Classification Name:

Shoulder joint metal/polymer non-constrained cemented prosthesis (21 CFR . 888.3650, Class II, Product Code KWT)
Prosthesis, Shoulder, Semi-constrained, metal/polymer cemented (21 CFR 888.3660, ● Class II, Product Code K WS)

Legally Marketed Devices to Which Substantial Equivalence Is Claimed: III.

510(k) Number	Trade of Proprietary Model Name	Manufacturer
K092900	Equinoxe Platform Fracture Stem	Exactech, Inc

IV. Device Description:

V. Intended Use of the Device

The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemiarthroplasty is determined by the surgeon to be the preferred method of treatment. Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components are as follows:

P	L	F	Indications
√	√		Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumaticdegenerative problems

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Exactech® Equinoxe®Platform Fracture Stem Special 510(k) - Summary of Safety and Effectiveness

√	√	Congenital abnormalities in the skeletally mature
√	√	Primary and secondary necrosis of the humeral head.
√		√ Humeral head fracture with displacement of the tuberosities
√	√	Pathologies where arthodesis or resectional arthroplasty of thehumeral head are not acceptable
√	√	Revisions of humeral prostheses when other treatments or deviceshave failed (where adequate fixation can be achieved)
		√ Displaced three-part and four-part upper humeral fractures
	√	Spiral and other fractures of the mid-humerus (in combination withglenohumeral degenerative diseases)
	√	Revision of failed previous reconstructions when distal anchorage isrequired
√	√	To restore mobility from previous procedures (e.g. previous fusion)

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.

The Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff.resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.

Rationale for Substantial Equivalence VI.

Equinoxe Fixed Angle Replicator Plate:

Intended Use / Indications for Use. The Equinoxe Platform Fracture Stem and the ● predicate device are intended for use in total shoulder joint replacement and have identical indications for use.
Materials. The Equinoxe Platform Fracture Stem and the predicate device are . composed of equivalent biocompatible materials conforming to recognized industry standards for permanent implants.
Design Features. The Equinoxe Platform Fracture Stem and the predicate device . have identical design features.
Dimensions. The Equinoxe Platform Fracture Stem and the predicate device have . identical geometry.
The Equinoxe Platform Fracture Stem and the Packaging and Sterilization. ● I ackaging "and" Stermanson" sterilized using identical materials and processes.

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Exactech® Equinoxe® Platform Fracture Stem Special 510(k) - Summary of Safety and Effectiveness

Device Shelf Life. The Equinoxe Platform Fracture Stem and the predicate device . have the identical shelf life.

Summary of Non-Clinical Performance Data VII.

Sunmal y of Non-Chinearing evaluations were conducted to demonstrate substantial equivalence of the proposed device to the predicate Equinoxe Platform Fracture Stem

A dynamic compression test was conducted. All constructs met the criteria without . failure.
An engineering evaluation determined under worst case conditions that the proposed . device is sufficient to sustain clinically relevant loads during its expected life.

The results demonstrate that the proposed device is as substantially equivalent to the predicate device.

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.”