The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty, anatomic hemi-arthroplasty, or reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment.

Clinical indications for anatomic total arthroplasty and anatomic hemi-arthroplasty are as follows:

· Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
· Congenital abnormalities in the skeletally mature
· Primary and secondary necrosis of the humeral head.
· Pathologies where arthrodesis 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)
· To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Preserve Stems are additionally indicated for use in reverse total arthroplasty in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff or a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Equinoxe Preserve Stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon.

Device Description

The Exactech Equinoxe Preserve Stem is a line extension to the range of humeral stems marketed by Exactech under the Equinoxe brand name. The subject device is intended to provide surgeons with a short-stem, distal bone preserving option that is compatible with minimally invasive surgical techniques. The proposed device is manufactured from Ti-6Al-4V and has Titanium Plasma Spray, grit blasted, and polished regions. The stems are available in 10 sizes, with distal stem diameters between 6mm and length of 70mm.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the Exactech® Equinoxe® Preserve Stem, a humeral stem for shoulder replacement surgery. It establishes substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the context of AI/algorithm performance. Therefore, I cannot extract the requested information regarding acceptance criteria and studies in the way you've outlined, as this document pertains to a physical orthopedic implant and its regulatory clearance process based on substantial equivalence, not an AI/software as a medical device.

The document discusses:

Indications for Use: What the device is intended for.
Technological Characteristics: How the device is similar to predicate devices (materials, design, dimensions, sterilization).
Non-Clinical Testing: Engineering analyses performed to demonstrate performance (Fatigue Testing, Subsidence and Pull-out Testing, Pyrogen testing).

It does not contain information about:

A table of acceptance criteria and reported device performance (in terms of AI metrics).
Sample size for a test set, data provenance, or ground truth.
Number of experts or their qualifications for establishing ground truth.
Adjudication method.
Multi-reader multi-case (MRMC) comparative effectiveness studies.
Standalone (algorithm only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

This document is a regulatory submission for a physical medical device, not an AI/ML-driven diagnostic or therapeutic device that would require the specific types of studies and acceptance criteria you're asking about.

Summary

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

February 1, 2017

Exactech Inc Thomas McNamara Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

Re: K162726

Trade/Device Name: Exactech® Equinoxe® Preserve Stem Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWS, HSD, KWT Dated: December 22, 2016 Received: December 27, 2016

Dear Thomas 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 devicerelated 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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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" (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.

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,

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

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

510(k) Number (if known) K162726

Device Name

Exactech® Equinoxe® Preserve Stem

Indications for Use (Describe)

Clinical indications for anatomic total arthroplasty and anatomic hemi-arthroplasty are as follows:

· Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
· Congenital abnormalities in the skeletally mature
· Primary and secondary necrosis of the humeral head.
· Pathologies where arthrodesis 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)
· To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Preserve Stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon.

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.

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Exactech® Equinoxe® Preserve Stem Traditional 510(k) - 510(k) Summary

Company:	Exactech®, Inc2320 NW 66th CourtGainesville, FL 32653
Date:	January 26, 2017
Contact Person:	Thomas McNamara, RACRegulatory Affairs Specialist
	Phone: (352) 377-1140Fax: (352) 378-2617
Proprietary Name:	Exactech® Equinoxe® Preserve Stem
Common Name:	Humeral Stem
Classification Name:	Shoulder Joint Metal/Polymer Semi-Constrained CementedProsthesis, 21 CFR 888.3660, Class II, Product Code PHX,Shoulder Joint Metal/Polymer Semi-Constrained CementedProsthesis, 21 CFR 888.3660, Class II, Product Code KWS,Shoulder Joint Humeral (Hemi-Shoulder) MetallicUncemented Prosthesis, 21 CFR 888.3690, Class II,Product Code HSD, Shoulder Joint Meta/Polymer Non-Constrained Cemented Prosthesis, 21 CFR 888.3650, ClassII, Product code KWT

Legally Marketed Device to Which Substantial Equivalence Is Claimed:

Biomet Comprehensive Primary Shoulder Micro Stem (K060692) ●
Exactech Equinoxe Press-Fit Primary Humeral Stem (K042021) ●
. Biomet Comprehensive Reverse Shoulder (K080642)

Device Description

Indications for Use

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Clinical indications for anatomic total arthroplasty and anatomic hemi-arthroplasty, are as follows:

. Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
Congenital abnormalities in the skeletally mature ●
Primary and secondary necrosis of the humeral head.
Pathologies where arthrodesis 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)
To restore mobility from previous procedures (e.g. previous fusion) ●

The Equinoxe Preserve Stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon.

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 Equinoxe Preserve Stems and the predicate devices have similar indications for use.
. Materials/Surface Finish/Coatings. The proposed Equinoxe Preserve Stems and the predicate devices are composed of the same biocompatible substrate materials, and the same or similar surface finish/coatings for permanent implants.
. Design Features. The proposed Equinoxe Preserve Stems and the predicate devices share the same design features.
. Dimensions. The proposed Equinoxe Preserve Stems and the predicate devices are dimensionally comparable.
Sterilization. The proposed Equinoxe Preserve Stems and the predicate devices are provided sterile for single use only.
Performance Requirements. The proposed Equinoxe Preserve Stems and the predicate devices conform to recognized performance standards for total shoulder replacement devices.

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Exactech® Equinoxe® Preserve Stem Traditional 510(k) - 510(k) Summary

Non-Clinical Testing

The following engineering analyses were performed to demonstrate that the Equinoxe Preserve Stems perform as intended and are substantially equivalent to the identified predicate devices:

. Fatigue Testing
Subsidence and Pull-out Testing .

Pyrogen testing was conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72 to 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

Based on consideration of indications for use, technological characteristics, and results of non-clinical testing, it was concluded that the Equinoxe Preserve Stems demonstrates substantial equivalence to the referenced predicate 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.”