The Equinoxe Humeral Augmented Tray is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in skeletally mature individuals with an intact medial calcar for whom the rotator cuff is irreparable or grossly deficient, a functional deltoid muscle is present, and proximal humeral bone loss is present in cases of:

· 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 arthrodesis or resectional arthroplasty of the humeral head are not acceptable
Revisions of humeral prostheses when other treatments or devices have failed (where adequate humeral stem fixation can be achieved)
· Displaced three- and four-part upper humeral fractures
· Failed ORIF requiring rTSA with an absent or deficient greater tuberosity
Revision of failed previous reconstructions when distal anchorage is required
· Treatment of unplanned proximal bone loss during a revision
· To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Humeral Augmented Tray can be used in either primary or revision arthroplasty procedures.

Device Description

The Exactech Equinoxe Humeral Augmented Trays are intended for use in total shoulder arthroplasty in skeletally mature patients with proximal humeral bone loss. Specifically, Equinoxe Humeral Augmented Trays are used in combination with Equinoxe Reverse Shoulder System components to compensate for proximal humeral bone loss in presence of an intact medial calcar, irreparable or grossly deficient rotator cuff and a functional deltoid muscle. One of the overall goals of the anatomically designed Equinoxe Humeral Augmented Trays is to improve joint mechanics and stability by providing increased deltoid muscle wrapping and adequate soft tissue tensioning in patients with proximal humeral bone loss.

The Equinoxe Humeral Augmented Trays are consisted of a humeral tray component, a modular extension (augment) and a universal locking screw for use in primary and revision cases. To accommodate patients' various anatomical needs. Equinoxe Humeral Augmented Trays are anatomically designed with two offsets/thicknesses and multiple lateralizations of left and right humeral trays and left and right modular extensions. Per surgeon evaluation, the modular extension secured with a locking screw is used to replace greater and more severe proximal humeral bone loss than can be adequately addressed with use of humeral tray component alone. When the modular extension is used, the locking screw must be used to secure it to the humeral tray component. All three components of the Equinoxe Humeral Augmented Trays are manufactured from Titanium Alloy (Ti-6Al-4V).

AI/ML Overview

The provided text describes a medical device submission (K191561) for Exactech® Equinoxe® Humeral Augmented Trays. This document is a regulatory filing, and as such, it does not contain acceptance criteria or study results in the manner typically associated with AI/ML device performance. The device described is a physical implant for shoulder arthroplasty, not an AI or software device that would have performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested points are not applicable to this document. I will extract the relevant information from the provided text.

Here's an analysis based on the assumption that the request is looking for "acceptance criteria" and "study results" related to the mechanical performance and regulatory clearance of this physical implant, rather than an AI/ML diagnostic system.

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

The document describes non-clinical testing performed to demonstrate substantial equivalence, but it does not explicitly state quantitative "acceptance criteria" with numerical targets and then report performance against those targets. Instead, it lists the types of tests done to ensure the product performs as intended and is comparable to previously cleared devices.

Acceptance Criteria (Implied)	Reported Device Performance (Non-Clinical Testing)
Mechanical Performance:
- Sufficient fatigue strength under worst-case lateral loading	- Fatigue strength testing under worst-case lateral loading was performed. (Result: Demonstrates substantial equivalence)
- Sufficient fatigue strength under worst-case medial loading	- Fatigue strength testing under worst-case medial loading was performed. (Result: Demonstrates substantial equivalence)
- Maintain acceptable Range of Motion	- Range of Motion Analysis was performed. (Result: Demonstrates substantial equivalence)
- Biomechanical compatibility and functional performance in situ	- Cadaveric evaluation was performed. (Result: Demonstrates substantial equivalence)
Biocompatibility/Sterility:
- Meet pyrogen limits for sterile devices	- Pyrogen testing was conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72. (Result: Meets recommended limits per FDA's Guidance Document Submission and Review of Sterility Information in Premarket (510(k)) Submission for Devices Labeled as Sterile, demonstrating substantial equivalence)
Overall substantial equivalence to predicate devices	- Results of these non-clinical tests (mechanical testing, engineering analysis, and cadaveric evaluation) demonstrate that the proposed device is substantially equivalent to the previously cleared Humeral Adapter Trays (K063569, K082702).

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 a quantifiable manner typical for clinical trials or AI/ML studies. The device underwent non-clinical testing, which includes:

Mechanical testing: Likely involved a specified number of devices tested on a test rig, but the specific sample size for each test (e.g., how many augmented trays underwent fatigue testing) is not detailed.
Engineering analysis: This is a computational/design review rather than a "sample."
Cadaveric evaluation: This would involve a certain number of cadaver specimens, but the exact count is not specified in the document.

The provenance (country of origin, retrospective/prospective) is not relevant for these types of non-clinical tests.

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 section is not applicable. The device is a physical implant, and its performance is assessed through mechanical tests and cadaveric evaluation, not through interpretation by human experts to establish "ground truth" for a diagnostic purpose.

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

This is not applicable. Adjudication methods like "2+1" are used in diagnostic consensus for things like image interpretation, which is not relevant to the mechanical and cadaveric testing of a shoulder implant.

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 is not applicable. An MRMC study is designed for evaluating diagnostic devices, particularly AI/ML systems that assist human readers. This document concerns a physical orthopedic implant.

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

This 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)

For the non-clinical testing mentioned:

Mechanical Testing: The "ground truth" would be the engineering standards for fatigue, strength, and range of motion.
Cadaveric Evaluation: The "ground truth" would relate to anatomical fit, surgical procedure, and biomechanical function as observed by the evaluating surgeons/researchers in the cadaver models.

8. The sample size for the training set

This is not applicable. This is a physical medical device; there is no "training set" in the context of machine learning. The design and manufacturing process would involve iterative development and testing, analogous to "training" in an engineering sense, but not a data-driven training set.

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

This is not applicable for the same reason as point 8.

Summary

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August 20, 2019

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

Exactech, Inc Shing Jen Tai Principal Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

Re: K191561

Trade/Device Name: Exactech® Equinoxe® Humeral Augmented Trays 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: June 11, 2019 Received: June 13, 2019

Dear Shing Jen Tai:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

FOR Vesa Vuniqi Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

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

510(k) Number (if known) K191561

Device Name

Exactech® Equinoxe® Humeral Augmented Trays

Indications for Use (Describe)

· 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 arthrodesis or resectional arthroplasty of the humeral head are not acceptable
Revisions of humeral prostheses when other treatments or devices have failed (where adequate humeral stem fixation can be achieved)
· Displaced three- and four-part upper humeral fractures
· Failed ORIF requiring rTSA with an absent or deficient greater tuberosity
Revision of failed previous reconstructions when distal anchorage is required
· Treatment of unplanned proximal bone loss during a revision
· To restore mobility from previous procedures (e.g. previous fusion)

The Equinoxe Humeral Augmented Tray can be used in either primary or revision arthroplasty procedures.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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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Exactech®Equinoxe® Humeral Augmented Trays Traditional 510(k) - 510(k) Summary

Sponsor:	Exactech®, Inc2320 N.W. 66th CourtGainesville, FL 32653
	Phone: (352) 377-1140Fax: (352) 378-2617
	FDA Establishment Number 1038671
Contact Person:	Shing Jen Tai, PhDPrincipal Regulatory Affairs Specialist
Date:	August 8, 2019
Proprietary Name:	Exactech® Equinoxe® Humeral Augmented Trays
Common Name:	Reverse shoulder prosthesis
Regulation Number:	21 CFR 888.365021 CFR 888.3660
Classification Name:	Shoulder joint metal/polymer non-constrained cementedprosthesisShoulder joint metal/polymer semi-constrained cementedprosthesis
Device Class:	Class II
Product Code:	PHX, KWT, KWS
Classification Panel:	Orthopedic

Information on devices to which substantial equivalence is claimed:

510(k) Number	Trade or Proprietary Model Name	Manufacturer
K063569	Equinoxe Reverse Shoulder System (HumeralAdapter Trays)	Exactech, Inc
K082702	Equinoxe Reverse Shoulder System + 15mmHumeral Adapter Tray	Exactech, Inc

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Exactech® Equinoxe® Humeral Augmented Trays Traditional 510(k) - 510(k) Summary

Information on reference device:

510(k) Number	Trade or Proprietary Model Name	Manufacturer
K143659	Equinoxe Humeral Reconstruction Prosthesis	Exactech, Inc

Indications for Use

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 arthrodesis or resectional arthroplasty of the humeral head are ● not acceptable
Revisions of humeral prostheses when other treatments or devices have failed (where adequate humeral stem fixation can be achieved)
Displaced three- and four-part upper humeral fractures
Failed ORIF requiring TTSA with an absent or deficient greater tuberosity ●
Revision of failed previous reconstructions when distal anchorage is required ●
Treatment of unplanned proximal bone loss during a revision
To restore mobility from previous procedures (e.g. previous fusion) ●

The Equinoxe Humeral Augmented Tray can be used in either primary or revision arthroplasty procedures.

De vice De scription

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Exactech® Equinoxe® Humeral Augmented Trays Traditional 510(k) - 510(k) Summary

surgeon evaluation, the modular extension secured with a locking screw is used to replace greater and more severe proximal humeral bone loss than can be adequately addressed with use of humeral tray component alone. When the modular extension is used, the locking screw must be used to secure it to the humeral tray component. All three components of the Equinoxe Humeral Augmented Trays are manufactured from Titanium Alloy (Ti-6Al-4V).

Non-Clinical Testing

The following mechanical testing, engineering analysis, and cadaveric evaluation were performed to demonstrate that the Exactech Equinoxe Humeral Augmented Trays perform as intended and are substantially equivalent to the identified predicate Equinoxe Humeral Adapter Trays previously cleared in K063569 and K082702:

Fatigue strength testing under worst-case lateral loading
Fatigue strength testing under worst-case medial loading ●
Range of Motion Analysis ●
Cadaveric evaluation

Pyrogen testing was conducted in accordance with USP <161>, USP <85>, and ANSI/AAMI ST72 to ensure the proposed Equinoxe Humeral Augmented Trays 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 the non-clinical testing including mechanical testing, engineering analysis and cadaveric evaluation demonstrate the proposed Exactech Equinoxe Humeral Augmented Trays are substantially equivalent to the previously cleared Humeral Adapter Trays in the Exactech Equinoxe Reverse Shoulder System.

Regulation Number and Section

N/A