The Arsenal Plating System is intended for use in trauma and reconstructive procedures of the small bones in the hand/ foot, ankle, and other bones appropriate for the device. The plates (implants), screws (implants), washers (implants), olive wires (instruments), and guide wires (instruments) are intended for single use only.

Device Description

The Arsenal Plating System consists of plates of various shapes and sizes composed of implant grade titanium alloy intended for use in trauma and reconstructive procedures of the small bones in the hand/foot, ankle, and other bones appropriate for the size of the device. The system will incorporate multiple locking and non-locking screws of various lengths and diameters, washers, and the necessary instruments to facilitate the placement of these implants.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Arsenal Plating System. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing, rather than reporting on a study to meet acceptance criteria for a new device performance.

Therefore, the requested information about acceptance criteria and a study proving device performance in the context of an AI/medical imaging device is not applicable to this submission. This is a traditional medical device submission for orthopedic hardware.

Here's a breakdown of why and what information is available (or not available) based on the provided text:

Rationale for Not Meeting Request:

Device Type: The Arsenal Plating System is an orthopedic hardware system (plates, screws, washers). It is not an AI/software device, imaging device, or diagnostic tool that would typically have acceptance criteria related to sensitivity, specificity, or reader performance.
Submission Type: This is a 510(k) Premarket Notification. The primary goal of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove absolute safety and effectiveness through extensive novel clinical trials against defined acceptance criteria (like an AI algorithm would).
Clinical Studies: The document explicitly states: "No clinical studies were performed." This immediately indicates that there will be no data on human reader performance, ground truth establishment, or multi-reader multi-case studies.
Non-Clinical Testing: The "studies" performed were mechanical bench tests (Single Cycle Bend Testing, Dynamic Bend Testing, Axial Pullout Strength Testing, Torsional Property Testing, Driving Torque Testing) designed to show equivalence in physical performance to the predicate devices, not diagnostic or AI performance.

Information based on the provided text (and why other requested sections are N/A):

Table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail criteria in the context of a new performance claim. The "acceptance" is implicitly that the device performs equivalently to the predicate devices in the listed mechanical tests.

Reported Device Performance:

Test Type	Referencing Standard	Performance
Single Cycle Bend Testing	ASTM F382	Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.)
Dynamic Bend Testing	ASTM F382	Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.)
Axial Pullout Strength Testing	ASTM F543	Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.)
Torsional Property Testing	ASTM F543	Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.)
Driving Torque Testing	ASTM F543	Results indicate the Arsenal Plating System is equivalent to predicate devices. (Specific quantitative results are not provided in this summary.)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the mechanical tests. Typically, these involve a small number of physical samples of the device components.
- Data Provenance: Not applicable. These are laboratory mechanical tests, not human data.
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)
- N/A. This device does not have "ground truth" established by experts in the context of diagnostic performance. Mechanical tests are assessed against engineering standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. Not relevant for mechanical testing.
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
- No. The document explicitly states: "No clinical studies were performed." This is not an AI or diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an algorithm or software device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A. The "ground truth" for mechanical testing is adherence to established ASTM standards for material properties and mechanical performance.
The sample size for the training set
- N/A. This device does not use a "training set" as it is not an AI/machine learning device.
How the ground truth for the training set was established
- N/A. As above, no training set.

Summary

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August 12, 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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

Trilliant Surgical Christopher Radzicki R&D Engineer 727 North Shepherd Drive, Suite 100 Houston, Texas 77007

Re: K191009

Trade/Device Name: Arsenal 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, NDG Dated: July 11, 2019 Received: July 11, 2019

Dear Christopher Radzicki:

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

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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 (OS) 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 mediation-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, MPH Assistant Director DHT6A: 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K191009

Device Name Arsenal Plating System

Indications for Use (Describe)

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)

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510(k) Summary Arsenal Plating System

In accordance with 21 CFR 807.92(c) of the Federal Code of Regulations, the following 510(k) summary is submitted for the Arsenal Plating System.

l. GENERAL INFORMATION

Date Prepared	April 15th, 2019
Submitted By	Trilliant Surgical727 North Shepherd DriveSuite 100Houston, TX 77007Telephone: 832-605-3167Contact: Christopher RadzickiEmail: cradzicki@trilliantsurgical.com
Trade Name	Arsenal Plating System
Common Name	Bone plate, bone screw, washer
Regulation Name	Single/multiple component metallic bone fixation appliances andaccessoriesSmooth or threaded metallic bone fixation fastener
Class	II
Product Code	HRS, HWC, NDG
CFR Section	21 CFR Section 888.303021 CFR Section 888.3040
Device Panel	Orthopedic
Predicate Devices	(Primary Predicate) Non-sterile Bone Plate and Screw Implants(Syntec-Taichung Medical Instruments, K983495, HRS & HWC)
	ExtremiLOCK Foot Plating System (Osteomed, K131445, HRS)
	Gridlock Ankle Plating System (Trilliant Surgical, K160177, HRS &HWC)
	Gridlock Plating System (Trilliant Surgical, K130964, HRS & HWC)

II. DEVICE DESCRIPTION

Materials

The implants of the Arsenal Plating System are made from Titanium Alloy (Titanium Ti-6AI-4V ELI, ASTM F-136). Surgical instrumentation is provided to facilitate modification,

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insertion, and removal of the implants. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymer.

Substantial Equivalence Claimed to Predicate Devices

The Arsenal Plating System is substantially equivalent to the predicate devices in terms of intended use, design, materials used, mechanical safety and performance. The plates of the Arsenal Plating System are manufactured from the same material as the predicate Non-sterile Bone Plate and Screw Implant System from Syntec-Taichung Medical Instruments. The screws of the Arsenal Plating System are manufactured from the same material as the predicate Non-sterile Bone Plate and Screw Implant System from Syntec-Taichung Medical Instruments, Gridlock Plating System from Trilliant Surgical, Gridlock Ankle Plating System from Trilliant Surgical, and ExtremiLOCK Foot Plating System from Osteomed. The Arsenal Plating System is sterilized using the same methods as the listed predicate devices. The technological characteristics and intended use of the proposed device and predicates are identical: all are titanium based plate and screw systems intended to fixate fractures and/or osteotomies of bones appropriate for their size in trauma and reconstructive procedures.

lll. Indications for Use

The Arsenal Plating System is intended for use in trauma and reconstructive procedures of the small bones in the handfoot, ankle, and other bones appropriate for the size of the device. The plates (implants), screws (implants), washers (implants), olive wires (instruments), and guide wires (instruments) are intended for single use only.

IV. Non-Clinical Test Summary

The following tests were performed:

Single Cycle Bend Testing referencing ASTM F382 .
. Dynamic Bend Testing referencing ASTM F382
Axial Pullout Strength Testing referencing ASTM F543
Torsional Property Testing referencing ASTM F543 .
. Driving Torque Testing referencing ASTM F543

The results of these evaluations indicate that the Arsenal Plating System is equivalent to the predicate devices.

V. Clinical Test Summary

No clinical studies were performed.

VI. Conclusions: Non-Clinical and Clinical

Trilliant Surgical considers the Arsenal Plating System to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials, and indications for use.

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.