The Equinoxe Mega Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
· Rheumatoid arthritis
· Revision where other devices or treatments have failed
· Correction of functional deformity
Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
· Traumatic arthritis
· Oncology applications including bone loss due to tumor resection.
· Significant humeral resection which are unmanageable using other treatment methods

The Equinoxe Mega Prosthesis System can be used in either primary or revision arthroplasty procedures.

The Equinoxe Mega Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreparable and grossly deficient, and a functional deltoid muscle is present.

The Equinoxe Mega Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.

The Equinoxe Mega Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Mega Prosthesis Distal Fixation Rings are only for uncemented, press-fit use.

Device Description

The Equinoxe Mega Prosthesis differs from conventional Total Shoulder Arthroplasty implants in that it is intended to replace both the articulating surface (humeral head) as well as the resected humerus. The modular design allows for the surgeon to construct the middle and proximal segments of the prosthesis in various lengths in order to match the length of resected bone, and to maintain the patient's natural arm length.

The prosthesis is manufactured from Ti-6A1-4V and has both Titanium Plasma Spray and HA coated regions. The proximal bodies are available in four sizes (Small, Medium, Large, Extra-Large) and two lengths (+0mm, +12.5mm). The middle segments are available in 3 lengths (25mm, 50mm, 75mm) with one diameter (20mm). The distal stems are available in 3 lengths (80mm, 120mm, 200mm) and 6 diameters (6mm, 7mm, 8mm, 9mm, 11mm, 13mm). The distal fixation rings are available in 17 diameters (17.5mm-33.5mm, 1mm increments). The distal fixation rings are intended for press-fit fixation. The proximal bodies and middle segments have suture through holes to facilitate soft tissue attachment.

AI/ML Overview

This document is a 510(k) premarket notification for the Exactech Equinoxe Mega Prosthesis, which is a medical device. The primary purpose of this type of submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its effectiveness or safety through extensive clinical trials as would be required for a PMA. Therefore, the information typically requested for acceptance criteria and studies (especially those involving human subjects, ground truth, experts, and statistical analysis with sample sizes) for AI/ML devices is not explicitly detailed in this type of submission for a traditional medical implant.

However, I can extract the relevant information regarding the non-clinical testing performed to support substantial equivalence.

Here's an attempt to fill in the requested table and information based on the provided document, acknowledging the limitations for a traditional medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Implied/General)	Reported Device Performance
Indications for Use	Similar to predicate device; new indications do not create a new intended use.	The proposed Exactech Equinoxe Mega Prosthesis has similar indications for use to the predicate device. Added hemi- and reverse shoulder arthroplasty indications, but these "do not create a new intended use" as stability is achieved comparably (dynamic muscle balancing for hemi/total; inverted articular concavities for reverse without rotator cuff dependence).
Materials/Surface Finish/Coatings	Composed of similar, biocompatible materials and similar surface finish/coatings to predicate.	Composed of Ti-6A1-4V with Titanium Plasma Spray and HA coated regions, similar to the predicate device, and are biocompatible.
Design Features	Similar design features to predicate device; design differences addressed by bench testing.	Shares similar design features. Design differences (distal fixation ring, different sizes of distal stems and proximal bodies, hemi/reverse shoulder indications) were considered and addressed via bench testing.
Dimensions	Dimensionally comparable to predicate device.	Dimensionally comparable to the predicate device.
Sterilization	Provided sterile for single use, consistent with predicate.	Provided sterile for single use only.
Performance Requirements	Conform to recognized performance standards for shoulder replacement devices.	"The proposed Exactech Equinoxe Mega Prosthesis and the predicate device conform to recognized performance standards for shoulder replacement devices." This is a general statement rather than specific quantitative criteria, common for a 510(k) where equivalence to existing standards is key.
Plasma Spray Coating Characterization	Coating properties meet specifications for permanent implants.	Performed. Implied performance met industry standards for coating integrity and adhesion. (No specific quantitative data provided in the summary).
Fatigue Testing	Device withstands cyclic loading without failure for expected lifespan.	Performed. Implied performance met industry standards for fatigue strength and durability under simulated physiological loads. (No specific quantitative data provided in the summary).
Torsion Testing	Device withstands torsional forces without failure.	Performed. Implied performance met industry standards for torsional strength. (No specific quantitative data provided in the summary).
Taper Analysis	Taper connections maintain integrity.	Performed. Implied performance met design specifications for taper security. (No specific quantitative data provided in the summary).
Axial Pull-Off Testing	Components remain securely connected under axial pull-off forces.	Performed. Implied performance met design specifications for resistance to axial decoupling. (No specific quantitative data provided in the summary).
Suture Abrasion Testing	Suture through-holes do not significantly abrade sutures.	Performed. Implied performance ensured that the suture through-holes did not cause excessive abrasion to sutures used for soft tissue attachment. (No specific quantitative data provided in the summary).
Cadaveric Study	Confirms proper surgical technique, fit, and biomechanical interaction in a simulated environment.	Performed. The study was part of validating the device's performance in a simulated surgical setting. (Details on specific outcomes or quantitative results are not provided in the summary). This would typically assess surgical handling, fit, range of motion, and stability characteristics.

Detailed Study Information (Based on provided text, acknowledging this is a mechanical device, not AI/ML):

The document describes a submission for a traditional medical device (Exactech Equinoxe Mega Prosthesis), not an AI/ML device. Therefore, many of the requested categories like "test set," "training set," "ground truth," "experts," and "MRMC comparative effectiveness study" are not applicable in the context of an AI/ML diagnostic system. The evaluation here is based on non-clinical (bench and cadaveric) testing and comparison to a predicate device for substantial equivalence.

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

Sample Size (Test Set): Not explicitly stated in the summary for each test. For mechanical tests like fatigue, torsion, pull-off, etc., sample sizes would typically be determined by relevant ASTM or ISO standards but are not reported in this summary. For the cadaveric study, the sample size (number of cadavers or specimens) is not specified.
Data Provenance: The studies are non-clinical (bench and cadaveric). Country of origin is not specified, but the applicant (Exactech, Inc.) is based in Gainesville, Florida, USA. The studies are prospective in the sense that they were conducted specifically for this submission.

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)

Number of Experts/Qualifications: Not applicable in the context of this traditional device submission. For a cadaveric study, surgeons might be involved in evaluating surgical technique or fit, but they are not "establishing ground truth" in the diagnostic sense. The "ground truth" for mechanical testing is derived from engineering principles and standards.

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

Adjudication Method: Not applicable. This concept belongs to expert review of diagnostic cases, which is not the nature of these non-clinical tests.

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

MRMC Study: No. This is a traditional medical device, not an AI/ML diagnostic.

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

Standalone Study: Not applicable. This is a physical implant, not an algorithm.

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

Type of Ground Truth:
- For mechanical tests (Fatigue, Torsion, Taper, Axial Pull-Off, Suture Abrasion, Plasma Spray Characterization): The "ground truth" is adherence to established engineering standards (e.g., ASTM, ISO) and successful demonstration of mechanical integrity and performance under simulated physiological conditions.
- For the Cadaveric Study: The "ground truth" would be the observed biomechanical performance, surgical fit, and handling characteristics within the cadaveric specimen, assessed against expected anatomical and surgical outcomes.
- For Clinical Literature Review: The "ground truth" is established medical knowledge and previous clinical outcomes reported in peer-reviewed literature for similar devices or surgical approaches.

8. The sample size for the training set

Sample Size (Training Set): Not applicable. There is no AI/ML model being trained. The design of the device is based on engineering principles and existing knowledge.

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

Ground Truth Establishment (Training Set): Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.

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

April 9, 2015

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

Re: K143659

Trade/Device Name: Exactech® Equinoxe® Mega Prosthesis Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Class: Class II Product Code: KWT, KWS, PHX, HSD Dated: January 8, 2015 Received: January 12, 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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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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Indications for Use

510(k) Number (if known) K143659

Device Name

Exactech® Equinoxe® Mega Prosthesis

Indications for Use (Describe)

The Equinoxe Mega Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
· Rheumatoid arthritis
· Revision where other devices or treatments have failed
· Correction of functional deformity
Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
· Traumatic arthritis
· Oncology applications including bone loss due to tumor resection.
· Significant humeral resection which are unmanageable using other treatment methods

The Equinoxe Mega Prosthesis System can be used in either primary or revision arthroplasty procedures.

The Equinoxe Mega Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.

The Equinoxe Mega Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Mega Prosthesis Distal Fixation Rings are only for uncemented, press-fit use.

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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Exactech® Equinoxe® Mega Prosthesis Traditional 510(k) - 510(k) Summary

Company:	Exactech®, Inc2320 NW 66th CourtGainesville, FL 32653
Date:	April 8, 2015
Contact Person:	Thomas McNamaraRegulatory Affairs SpecialistPhone: (352) 377-1140Fax: (352) 378-2617
Proprietary Name:	Exactech® Equinoxe® Mega Prosthesis
Common Name:	Humeral Stem
Classification Name:	Prosthesis, Shoulder, Non-Constrained, Meta/PolymerCemented, (21 CFR Section 888.3650, Class II, ProductCode KWT), Prosthesis, Shoulder, Semi-Constrainedcemented prosthesis (21 CFR Section 888.3660, Class IIProduct Code KWS), Shoulder Prosthesis, ReverseConfiguration (21 CFR Section 888.3660, Class II ProductCode PHX) Prosthesis, Shoulder, Hemi-, Humeral MetallicUncemented, (21 CFR Section 888.3690, Class II, ProductCode HSD)

Legally Marketed Device to Which Substantial Equivalence Is Claimed:

Biomet Comprehensive Segmental Revision System (K111746) ●

Device Description

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Indications for Use

The Equinoxe Mega Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
. Rheumatoid arthritis
. Revision where other devices or treatments have failed
Correction of functional deformity
. Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
. Traumatic arthritis
. Oncology applications including bone loss due to tumor resection.
. Significant humeral resection which are unmanageable using other treatment methods

The Equinoxe Mega Prosthesis System can be used in either primary or revision arthroplasty procedures.

The Equinoxe Mega Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.

The Equinoxe Mega Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Mega Prosthesis Distal Fixation Rings are only for uncemented, pressfit use.

Summary of Technological Characteristics

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

Indications for Use. The proposed Exactech Equinoxe Mega Prosthesis and the predicate device have similar indications for use. The proposed Exactech Equinoxe Mega Prosthesis is also indicated for use in hemi-shoulder arthroplasty and reverse shoulder arthoplasty. In cases with significant proximal humeral resections, joint stability is the primary concern. The stability of the joint is comparable for hemi and total shoulder indications, because stability is achieved by dynamic muscle balancing. The stability of the joint in a reverse shoulder is achieved via the inverted articular concavities without any requirement for dynamic stability provided by the rotator cuff. The additions of the proposed hemi

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Exactech® Equinoxe® Mega Prosthesis Traditional 510(k) - 510(k) Summary

and reverse shoulder arthroplasty indications do not create a new intended use for the proposed device.

Materials/Surface Finish/Coatings. The proposed Exactech Equinoxe Mega . Prosthesis and the predicate device are composed of similar, biocompatible substrate materials, and the same or similar surface finish/coatings for permanent implants.
. Design Features. The proposed Exactech Equinoxe Mega Prosthesis and the predicate device share similar design features. Design differences between the cited predicate device and the propose Exactech Equinoxe Mega Prosthesis include the use of a distal fixation ring and different sizes of distal stems and proximal bodies, as well as the hemi- and reverse shoulder indications.
Dimensions. The proposed Exactech Equinoxe Mega Prosthesis and the predicate device are dimensionally comparable.
Sterilization. The proposed Exactech Equinoxe Mega Prosthesis and the . predicate device are provided sterile for single use only.
Performance Requirements. The proposed Exactech Equinoxe Mega Prosthesis and the predicate device conform to recognized performance standards for shoulder replacement devices.

Non-Clinical Testing

The following clinical literature review, template studies, mechanical testing, and cadaveric evaluation were performed to demonstrate that the Exactech Mega Prosthesis performs as intended and is substantially equivalent to the identified predicate device:

Clinical Literature Review ●
Cadaveric Study ●
Plasma Spray Coating Characterization ●
Fatigue Testing
. Torsion Testing
Taper Analysis
Axial Pull-Off Testing ●
. Suture Abrasion Testing

Bench testing was conducted to address the design differences between the proposed Exactech Equinoxe Mega Prosthesis and the identified predicate device, including the use of a distal fixation ring and different sizes of distal stems and proximal bodies, as well as the addition of the indication for reverse shoulder arthroplasty.

Substantial Equivalence Conclusion

Based on consideration of indications for use, technological characteristics, and results of combined mechanical testing, cadaveric validation study, and clinical literature review described above, it was concluded that Exactech Equinoxe Mega Prosthesis demonstrates substantial equivalence to the referenced predicate device.

Regulation Number and Section

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”