The ALPHALOK™ Plating System bone plates, screws, and washers are intended for use in bone fractures, osteotomies, and fixation of bones and bone fragments in the upper and lower extremities, primarily of the hand, wrist, foot, ankle, and digits. Specific examples include:

· Forefoot, Midfoot, and Hindfoot Osteotomies
· Metatarsals and Metacarpals Corrections and Osteotomies
· Stabilization and Fixation of Metatarsal and Metacarpal Fractures
Stabilization and Fixation of Ankle Fractures
Syndesmosis Joint Stabilization
· Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints
· Flatfoot and Cavus Foot Corrections
Charcot Fixation

The ALPHALOKTM Ankle Fx Plates are intended for fixation of fractures, and non-unions of the distal tibia and fibula such as:

· Lateral Malleolar Fractures
· Syndesmosis Injuries
· Medial Malleolar Fractures
Bi-Malleolar Fractures
Tri-Malleolar Fractures
· Posterior Malleolar Fractures
· Distal Anterior Tibia Fractures
· Vertical Shear Fractures of the Medial Malleolus
Pilon Fractures
· Distal Tibia Shaft Fractures
Distal Fibula Shaft Fractures
Distal Tibia Periarticular Fractures
· Medial Malleolar Avulsion Fractures
Lateral Malleolar Avulsion Fractures

Device Description

The ALPHALOK™ Plating System is a multi-indication solution providing polyaxial locking technology and low-profile plate designs. The ALPHALOK™ Ankle Fx plates and screws are intended to treat various fracture patterns of the ankle specifically tibia and fibula.

The intent of this submission is to expand indications to include ankle fractures, whereas the previous submissions for the ALPHALOK™ Plating Systems (K221558, K212348) were for forefoot and midfoot respectfully.

All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136).

Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ALPHALOK™ Plating System, which is a medical device for bone fixation. However, the document does not contain information about acceptance criteria, device performance in terms of clinical accuracy or statistical metrics, a study proving the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, or multi-reader multi-case studies, as typically requested for AI/algorithm-based diagnostic devices.

The document is a regulatory submission for a physical medical device (bone plates and screws) and primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and mechanical performance testing.

Therefore, I cannot provide the requested information from the given text alone.

Here's a breakdown of why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: Not available. The document mentions "Static four point bend testing per ASTM F382-17" but does not provide specific acceptance criteria values (e.g., minimum load to failure, maximum deflection) or the reported performance data from these tests. These are engineering performance metrics, not clinical performance metrics typically associated with AI devices.
Sample sized used for the test set and the data provenance: Not available. The performance data mentioned (static bend testing) would involve physical specimens, not a "test set" of data in the context of an AI study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/diagnostic device. Ground truth, in this context, would relate to an objective measurement of mechanical properties rather than expert interpretation of medical images or data.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating diagnostic accuracy with and without AI assistance, which is irrelevant for a physical bone fixation system.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic AI. For the mechanical testing, the "ground truth" would be the physically measured values from the tests.
The sample size for the training set: Not applicable. No AI model is described.
How the ground truth for the training set was established: Not applicable. No AI model is described.

In summary, the provided document is a 510(k) clearance for a physical medical device (bone fixation system) and does not contain the type of information requested regarding acceptance criteria and studies for an AI/algorithm-based device.

Summary

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April 25, 2023

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 acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the symbol is a blue square containing the acronym "FDA" in white letters, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.

Vilex LLC Brock Johnson President 111 Moffitt Street McMinnville, Tennessee 37110

Re: K230204

Trade/Device Name: ALPHALOK™ Plating System 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: January 24, 2023 Received: January 25, 2023

Dear Brock Johnson:

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

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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 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,

Shumaya Ali-S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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

510(k) Number (if known) K230204

Device Name ALPHALOK™ Plating System

Indications for Use (Describe)

· Forefoot, Midfoot, and Hindfoot Osteotomies
· Metatarsals and Metacarpals Corrections and Osteotomies
· Stabilization and Fixation of Metatarsal and Metacarpal Fractures
Stabilization and Fixation of Ankle Fractures
Syndesmosis Joint Stabilization
· Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints
· Flatfoot and Cavus Foot Corrections
Charcot Fixation

The ALPHALOKTM Ankle Fx Plates are intended for fixation of fractures, and non-unions of the distal tibia and fibula such as:

· Lateral Malleolar Fractures
· Syndesmosis Injuries
· Medial Malleolar Fractures
Bi-Malleolar Fractures
Tri-Malleolar Fractures
· Posterior Malleolar Fractures
· Distal Anterior Tibia Fractures
· Vertical Shear Fractures of the Medial Malleolus
Pilon Fractures
· Distal Tibia Shaft Fractures
Distal Fibula Shaft Fractures
Distal Tibia Periarticular Fractures
· Medial Malleolar Avulsion Fractures
Lateral Malleolar Avulsion Fractures

Type of Use (Select one or both, as applicable)

X 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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510(k) Summary

I. Submitter

Vilex LLC

111 Moffitt Street

McMinnville, TN 37110

Contact Person: Brock Johnson, President of Vilex

Phone: (801) 916-4157 brock.johnson@vilex.com

Date Prepared: May 27, 2022

Device Proprietary Name:	ALPHALOKTM Plating System
Common or Usual Name:	Bone Fixation Plates and Screws
Classification Name:	Plate, Fixation, Bone - (Primary)Screw, Fixation, Bone
Regulation Number:	21 CFR 888.303021 CFR 888.3040
Product Code:	HRS, HWC
Device Classification	II

II. Device

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Predicate Device III.

Substantial equivalence is claimed to the following devices:

. Stryker (Wright Medical) Ortholoc 3Di Ankle Fracture Plating System (K163044) -(Primary Predicate)
. Vilex ALPHALOK™ Plating System (K221558, K212348) -(Additional Predicate)

IV. Device Description

All implant components are manufactured from titanium (Ti-6AI-4V, ASTM F136).

Specific instrumentation including wires, drills, torx drivers, and drill guides are required for use with the system. The ALPHALOK™ instruments are manufactured from stainless steel.

V. Indications for Use

Forefoot, Midfoot, and Hindfoot Osteotomies
Metatarsals and Metacarpals Corrections and Osteotomies ●
Stabilization and Fixation of Metatarsal and Metacarpal Fractures .
. Stabilization and Fixation of Ankle Fractures
Syndesmosis Joint Stabilization
. Arthrodesis of Metatarsophalangeal (MTP) and Metacarpophalangeal (MCP) joints
Flatfoot and Cavus Foot Corrections
Charcot Fixation .

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The ALPHALOK™ Ankle Fx Plates are intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula such as:

Lateral Malleolar Fractures ●
Medial Malleolar Fractures .
Bi-Malleolar Fractures
Tri-Malleolar Fractures
. Posterior Malleolar Fractures
Distal Anterior Tibia Fractures
Vertical Shear Fractures of the Medial Malleolus ●
Pilon Fractures .
Distal Tibia Shaft Fractures
Distal Fibula Shaft Fractures ●
Distal Tibia Periarticular Fractures
Medial Malleolar Avulsion Fractures
. Lateral Malleolar Avulsion Fractures
Syndesmosis Injuries

VI. Comparison of Technological Characteristics

The subject and predicate devices have similar intended uses and share identical core characteristics.

The systems are intended to be used in the hand, foot, and ankle along with other bones of the upper and lower extremities. The subject and predicate systems include bone plates along with locking and nonlocking screws with similar implant designs made from titanium alloy material. Similar instrumentation is included in all the system.

The inclusion of additional Ankle Fracture plates in this submission expands the original system; however, it is still comparable in scope to marketed systems such as Stryker (Wright Medical) Ortholoc 3Di Ankle Fracture Plating System (K163044).

The technological differences between the subject device and predicate devices do not raise different questions of safety or effectiveness and substantial equivalence is demonstrated through the testing described below.

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Performance Data VII.

The following performance data were provided in support of the substantial equivalence determination:

· Static four point bend testing per ASTM F382-17
In addition, cleaning and sterilizations, performed in accordance with ANSVAAMI/ISO 17665-1, from the applicant's own predicate device were leveraged. Biocompatibility, cleaning and sterilization are identical to K212348 and K221558. No changes have

been made with respect to material, manufacturing, cleaning, or sterilization.

VIII. Conclusion

The information provided above supports the claim that the ALPHALOK™ Plating System is substantially equivalent to the predicate device. Although minor differences in design exist between the subject and predicate devices, the testing supports that these differences do not raise any new questions with respect to substantial equivalence. Therefore, it is concluded that the ALPHALOK™ Plating System is substantially equivalent to the predicate device.

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.