The Equinoxe® Shoulder Proximal Humerus Fracture Plate System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Clinical indications are as follows:

Fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Device Description

The Equinoxe Proximal Humerus Fracture Plate System is for use in the repair of proximal humerus fractures. The system consists of the following components. With the exception of blade locking screws, all components are provided in various sizes.

Proximal Humerus Fracture Plates
Locking Screws, Cancellous and Cortical
Humeral Blades
Blade Locking Screws
Compression Screws, Cortical
Made of 316L Stainless Steel (per ASTM F138-08), all components are supplied nonsterile and must be sterilized in a provided re-usable sterilization container, prior to implantation. Cleaning and Sterilization instructions are provided in the package insert for the Equinoxe® Proximal Humerus Fracture Plate System.

AI/ML Overview

The provided document is a 510(k) Summary for the Exactech® Equinoxe® Proximal Humerus Fracture Plate System. It describes a medical device and its substantial equivalence to predicate devices, rather than a study evaluating a device's performance against acceptance criteria for an AI/CAD system. Therefore, most of the requested information, such as sample sizes, expert qualifications, and ground truth methodologies, is not applicable to this document.

However, I can extract the information related to the device's performance and the "study" (in this context, mechanical and simulated-use tests) that proves it meets acceptance criteria, which are primarily based on equivalence to predicate devices.

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

1. Table of Acceptance Criteria and Reported Device Performance

For this type of medical device (fracture plate system), "acceptance criteria" are generally established through comparison to legally marketed predicate devices and conformity to recognized industry standards (e.g., ASTM standards for materials and biomechanical performance). "Device performance" is then demonstrated through testing to show it meets or exceeds the performance of these predicates.

Acceptance Criteria Category	Specific Criteria (Implicitly based on Predicate Devices & Standards)	Reported Device Performance
Material Composition	Composed of equivalent materials conforming to recognized industry standards (e.g., ASTM F138-08 for 316L Stainless Steel).	"Exactech® Equinoxe® Proximal Humerus Fracture Plate System and predicate devices are composed of equivalent materials conforming to recognized industry standards for orthopedic and trauma implants."
Dimensions/Size Range	Available in equivalent size ranges to predicate devices.	"Equinoxe® Proximal Humerus Fracture Plate System and predicate device components are available in equivalent size ranges."
Sterilization Processes	Utilizes equivalent sterilization processes conforming to recognized industry standards.	"Equinoxe® Proximal Humerus Fracture Plate System and predicate devices are provided non-sterilized prior to implantation, using equivalent sterilization processes conforming to recognized industry standards."
Biomechanical Performance	Withstand clinically relevant biomechanical loads exerted on the humerus during post-operative rehabilitation and fracture healing.	"Equinoxe® Proximal Humerus Fracture Plate System and predicate devices withstand clinically relevant biomechanical loads that are exerted on the humerus during post-operative rehabilitation and fracture healing."
Substantial Equivalence	Demonstrated substantial equivalence to identified predicate devices.	"Results from mechanical tests and simulated-use studies provided within this 510(k) premarket notification demonstrate that Exactech® Equinoxe® Proximal Humerus Fracture Plate System is substantially equivalent to the identified predicate devices."

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not specified in terms of number of plates tested as discreet 'samples'. The "mechanical tests and simulated-use studies" would involve a number of plate configurations tested under various loading conditions, but the exact count isn't given. These are likely in vitro tests.
Data provenance: The tests were conducted internally by Exactech, Inc. (Gainesville, Florida). The data is presumably prospective in nature, generated specifically for this 510(k) submission. No country of origin for clinical data is mentioned as this is not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Experts and qualifications: Not applicable. For a device like a fracture plate, "ground truth" isn't established by human expert consensus as it would be for an image-based diagnostic AI. Instead, the "truth" or performance is determined by objective physical and mechanical testing against predefined standards and comparative performance with predicate devices.

4. Adjudication method for the test set:

Adjudication method: Not applicable. This is not a study assessing human reader performance or diagnostic accuracy. Performance is determined by experimental measurements against engineering specifications and comparison with predicate device performance.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

MRMC study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation tasks, not for the mechanical performance of a surgical implant.

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

Standalone performance: Not applicable. This device is a physical implant; there is no algorithm involved to perform "standalone" analysis.

7. The type of ground truth used:

Type of ground truth: The "ground truth" for this device's performance is based on engineering specifications, material science standards (e.g., ASTM F138-08), and the established biomechanical performance of legally marketed predicate devices. The device's components must meet material standards and then demonstrate similar or superior mechanical strength and fatigue resistance compared to the predicate devices under simulated physiological conditions.

8. The sample size for the training set:

Sample size for training set: Not applicable. There is no "training set" in the context of an AI/ML algorithm. For the physical device, design and development would involve iterative testing, but this isn't reported as a "training set."

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

Ground truth for training set: Not applicable as there is no training set mentioned in the context of AI/ML. For the design and development of the physical device, ongoing R&D would rely on engineering principles, material science, and testing results against historical data and design requirements to refine the product.

Summary

{0}------------------------------------------------

MAY 1 1 2010

Exactech® Equinoxe® Proximal Humerus Fracture Plate System Traditional 510(k)

510(k) Summary

Company:	Exactech®, Inc
Date:	December 22, 2009
Contact Person:	Shing Jen Tai, PhDRegulatory Affairs Specialist
Proprietary Name:	Exactech® Equinoxe® Proximal Humerus Fracture PlateSystem
Common Name:	Proximal Humerus Fracture Plate
Classification Name:	Single/Multiple Component Metallic Bone FixationAppliances and Accessories (21 CFR 888.3030, Class II,Product Code KTW)

Legally Marketed Devices to Which Substantial Equivalence Is Claimed

Synthes LCP® Proximal Humerus Plate (#K011815) �
. Synthes (USA) LCP® Proximal Humerus Plates, Long (#K041860)
Hand Innovations Modified Shoulder Fixation Systems (#K042059, #K051728, . #K060290)

Device Description

. Proximal Humerus Fracture Plates
Locking Screws, Cancellous and Cortical ●
. Humeral Blades
Blade Locking Screws .
� Compression Screws, Cortical

Made of 316L Stainless Steel (per ASTM F138-08), all components are supplied nonsterile and must be sterilized in a provided re-usable sterilization container, prior to

{1}------------------------------------------------

K093978 Exactech® Equinoxe® Proximal Humerus Fracture Plate System Traditional 510(k)

implantation. Cleaning and Sterilization instructions are provided in the package insert for the Equinoxe® Proximal Humerus Fracture Plate System.

Indications for Use

The Equinoxe® Shoulder Proximal Humerus Fracture Plate System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Clinical indications are as follows:

Fractures, fracture dislocations, osteotomies, and non-unions of the proximal . humerus.

Summary of Technological Characteristics

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

Intended Use. Similar to the intended uses for its predicate devices. the Equinoxe® . Proximal Humerus Fracture Plate System is intended to be used for internal fixation of fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus. Equinoxe® Proximal Humerus Fracture Plate System and predicate devices also have similar indications for use statements.
Materials. Equinoxe® Proximal Humerus Fracture Plate System and predicate . devices are composed of equivalent materials conforming to recognized industry standards for orthopedic and trauma implants.
. Dimensions. Equinoxe® Proximal Humerus Fracture Plate System and predicate device components are available in equivalent size ranges.
Sterilization processes. Equinoxe® Proximal Humerus Fracture Plate System and . predicate devices are provided non-sterilized prior to implantation, using equivalent sterilization processes conforming to recognized industry standards.
. Performance specifications. Equinoxe® Proximal Humerus Fracture Plate System and predicate devices withstand clinically relevant biomechanical loads that are exerted on the humerus during post-operative rehabilitation and fracture healing.

Substantial Equivalence Conclusion

Results from mechanical tests and simulated-use studies provided within this 510(k) premarket notification demonstrate that Exactech® Equinoxe® Proximal Humerus Fracture Plate System is substantially equivalent to the identified predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. 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 Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 1 2010

2320 N.W. 66th Court Gainesville, Florida 32653

% Ms. Shing Jen Tai

Re: K093978

Exactech, Inc.

Trade/Device Name: Exactech Equinoxe Proximal Humerus Fracture Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: April 16, 2010 Received: April 22, 2010

Dear Ms. 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. 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

{3}------------------------------------------------

Page 2 - Ms. Shing Jen Tai

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/McdicalDcvices/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 Small Manufacturers, International and Consumer Assistance 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 vours.

Cboulare BrehmD

Mark N. Me Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Exactech® Equinoxe® Proximal Humerus Fracture Plate System Traditional 510(k)

Indications for Use Statement

K093978 510(k) Number:

Device Name: Exactech® Equinoxe® Proximal Humerus Fracture Plate System

INDICATIONS FOR USE:

The Equinoxe® Shoulder Proximal Humerus Fracture Plate System is indicated for Open Reduction Internal Fixation (ORIF) procedures of the proximal humerus. Clinical indications are as follows:

. Fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus.

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)

Onette for Mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K093978

Page 1 of 1

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.