The AFT™ Proximal Humerus Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Device Description

The AFT™ Proximal Humerus Fracture Plate is a low-profile, anatomically shaped plate which matches the natural contour of the proximal humerus. The plate is available in 'long' and 'short' configurations with left and right options. The plate contains holes for 3.5mm locking and nonlocking screws and 4.5mm partially threaded screws. The screws are available in various lengths. Both the plates and the screws are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for single-use.

AI/ML Overview

K121672 is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions regarding AI/ML device performance, such as sample size for test sets, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, and training set information, are not applicable.

Here's a breakdown of the available information relevant to this device's acceptance criteria and studies:

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

Acceptance Criteria	Reported Device Performance
Mechanical Performance (demonstrate substantial equivalence to predicate devices in terms of mechanical strength and durability applicable for its intended use)	Static and Dynamic Bending Testing per ASTM F382-99: The device underwent static and dynamic bending testing according to ASTM F382-99. This standard typically defines the methods for mechanical testing of metallic bone plates. The purpose of this testing is to ensure the device can withstand the forces it will encounter in the body without failure, thereby demonstrating that its mechanical properties are comparable to or better than predicate devices. The submission states that this testing was performed "to demonstrate substantial equivalence," implying the results met the performance characteristics of the predicate devices.
Material Biocompatibility (use of biocompatible materials suitable for implantation)	Manufactured from Ti-6Al-4V (ASTM F136): The plates and screws are manufactured from Ti-6Al-4V, which is a widely accepted and biocompatible medical-grade titanium alloy with established use in orthopedic implants. ASTM F136 is the standard specification for wrought titanium-6aluminum-4vanadium alloy for surgical implant applications.
Design and Indications for Use (similar design and intended use as predicate devices)	Low-profile, anatomically shaped plate: The device is designed to match the natural contour of the proximal humerus, available in 'long' and 'short' configurations with left and right options. It accepts 3.5mm locking and non-locking screws and 4.5mm partially threaded screws. This design is consistent with similar humeral fracture plates on the market. Indications for Use: "The AFT™ Proximal Humerus Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone." This indication is explicitly stated to be the "same as" the predicate devices.

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

Not Applicable. This is a hardware device (bone plate), and the "test set" refers to mechanical testing of the device itself, not patient data in the context of an AI/ML study. The 510(k) summary does not specify the number of devices tested, but the standard ASTM F382-99 would dictate the number of samples required for static and dynamic testing. Data provenance for such mechanical testing typically pertains to the testing laboratory and its adherence to standards, not 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)

Not Applicable. Ground truth in the context of expert review for medical imaging or clinical outcome is not relevant for this type of mechanical device submission. The "ground truth" for mechanical testing is established by the ASTM F382-99 standard and the physical properties observed in controlled laboratory conditions.

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

Not Applicable. Adjudication methods are used to resolve discrepancies in expert opinions on ground truth, which is not relevant for mechanical testing of a hardware device.

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

Not Applicable. This device is a bone plate, so it does not involve human readers, AI, or MRMC studies.

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

Not Applicable. This device is a bone plate and does not involve any algorithms or AI.

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

Mechanical Performance Standards. For this device, the "ground truth" is defined by the established industry standards for mechanical testing of bone plates (ASTM F382-99). The device's performance is compared against the known safe and effective performance of the predicate devices according to these standards.

8. The sample size for the training set

Not Applicable. This device is a bone plate and does not involve AI or training sets.

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

Not Applicable. This device is a bone plate and does not involve AI or training sets.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" conducted for the AFT™ Proximal Humerus Fracture Plate to demonstrate it meets acceptance criteria and is substantially equivalent was primarily a mechanical performance study coupled with a comparison to predicate devices for materials and design.

Study Type: Mechanical Testing and Substantial Equivalence Comparison.
Methodology:
- Mechanical Testing: The device underwent static and dynamic bending testing according to the ASTM F382-99 standard. This standard prescribes methods for quantitatively determining the bending stiffness and strength of metallic bone plates. The 510(k) summary explicitly states this testing was performed "to demonstrate substantial equivalence." This implies that the device's performance in these tests was found to be comparable to or better than the predicate devices, thereby meeting the necessary mechanical acceptance criteria for safety and effectiveness.
- Predicate Device Comparison: The submission also relies heavily on direct comparison to legally marketed predicate devices (Synthes LCP Proximal Humerus Plate, Synthes 4.5mm Non-Locking Cannulated Screw, Zimmer NCB Proximal Humerus Non-Locking Screw). The manufacturer asserts that the AFT™ Proximal Humerus Fracture Plate has the "same 'Indications for Use'," uses similar materials (Ti-6Al-4V, a common and accepted material for such implants), and has a comparable design (low-profile, anatomically shaped, accepts standard screws).
Conclusion: Based on the mechanical testing (meeting ASTM F382-99 standards) and the comparison of indications, materials, and design to the predicate devices, the FDA concluded that the AFT™ Proximal Humerus Fracture Plate is "substantially equivalent" to the predicate devices. This determination signifies that the device meets the necessary safety and effectiveness criteria for market clearance.

Summary

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K121672

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OCT

8. 510(k) Summary

Shoulder Options, Inc. 100 E. South Main St. P.O. Box 1458 Waxhaw, NC 28173

June 5, 2012 Date Prepared: John Kapitan, CEO Contact Person: Tel: (704)512-0000

Fax: (704)831-5316 Email: kapitan@shoulderoptions.com

2. Device Name

Common/Usual Name:	Plate, Fixation, Bone
Classification Name:	Single/multiple component metallic bone fixation appliances and accessories
Regulation Number:	888.3030
Product Code:	HRS, HWC
Classification:	II
Panel:	Orthopedic

3. Predicate Devices

The Shoulder Options AFT™ Proximal Humerus Fracture Plate is substantially equivalent to the following devices:

510(k) Number	Device	Manufacturer
K041860	Synthes LCP Proximal Humerus Plate	Synthes
K011815	Synthes LCP Proximal Humerus Plate	Synthes
K963172	Synthes 4.5mm Non-Locking CannulatedScrew	Synthes
K042695	4.5mm NCB Proximal Humerus Non-Locking Screw	Zimmer

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K121672

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4. Description of the Device

5. Indications for Use

The AFT™ Proximal Humerus Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

6. Summary of Performance Data

Testing of the AFT™ Proximal Humerus Fracture Plate to demonstrate substantial equivalence included static and dynamic bending testing per ASTM F382-99.

7. Safety & Effectiveness

The AFT™ Proximal Humerus Fracture Plate is substantially equivalent to the Synthes LCP Proximal Humerus Fracture Plate (K041860, K011815), Synthes 4.5mm Non-Locking Cannulated Screw ( K963172), and Zimmer NCB Proximal Humerus Non-Locking Screw (K042695). The devices have the same "Indications for Use," are available by prescription only, and are provided non-sterile for single-use only. Based on this and the design similarities, it can be concluded that the AFT™ Proximal Humerus Fracture Plate is both a safe and effective device and is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.

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

OCT

קומא א

Shoulder Options, Incorporated
% Mr. John Kapitan
CEO
100 East South Main Street
P.O. Box 1458
Waxhaw, North Carolina 28173

Re: K121672

Trade/Device Name: AFT" Proximal Humerus Fracture Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: August 15, 2012 Received: August 20, 2012

Dear Mr. Kapitan,

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

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Page 2 - Mr. John Kapitan

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 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/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 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 yours,

Mark A. Milliken

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

Enclosure

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7. Indications for Use Statement

510(k) Number (if known): K121672

Device Name: AFT™ Proximal Humerus Fracture Plate

Indications for Use:

The AFT™ Proximal Humerus Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

Over-The-Counter Use Prescription Use × AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aht

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

K121672 510(k) Number

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.