The BABY GORILLA®/GORILLA® Bone Plates and Bone Screws of the BABY GORILLA®/GORILLA® Plating System are indicated for use in stabilization of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus. The system can be used atric patients.

In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the device.

Device Description

The BABY GORILLA®/GORILLA® implants are lower extremity fixation systems. Gorilla Plates are offered in “mini” and “standard” set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in “mini” and “standard” sets and, in addition, in locking and non-locking versions. Size- matched washers are available for use with the non- locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw.

AI/ML Overview

This FDA 510(k) summary for the SILVERBACK Gorilla Plating System does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and study particulars for a device performance evaluation as it would typically be done for a diagnostic AI/ML device.

This document describes a bone plating system, which is a medical device, but not a diagnostic or AI/ML device. Therefore, the concepts of "acceptance criteria" and "device performance" in the context of sensitivity, specificity, or AUC, as well as aspects like "ground truth" established by experts or "MRMC comparative effectiveness studies," are not applicable in the way they would be for an AI-powered diagnostic tool.

Instead, the "performance data" for this type of device typically refers to engineering analyses and mechanical testing to ensure the device's structural integrity, biocompatibility, and functional equivalence to predicate devices. The document explicitly states:

"Engineering analysis is presented to provide evidence that the original testing and subsequence performance is not adversely affected by the geometry of the modified plates, screws, and washers. The results of the analysis demonstrated the modified designs are substantially equivalent to the predicate devices."

Given this, I can provide the information available in the document, but many sections will indicate "Not Applicable" or explain why the requested information isn't present for this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

This table is generally used for diagnostic devices with quantifiable performance metrics. For a bone plating system, acceptance criteria relate to mechanical properties and equivalence to predicate devices, not diagnostic accuracy.

Acceptance Criterion	Reported Device Performance
Material Properties:	Materials used are medical-grade titanium (ASTM F67), stainless steel (ASTM F138), and titanium alloy (ASTM F136).
Mechanical Integrity (Implied by Engineering Analysis):	"Original testing and subsequence performance is not adversely affected by the geometry of the modified plates, screws, and washers."
Substantial Equivalence:	"The results of the analysis demonstrated the modified designs are substantially equivalent to the predicate devices."
Performance (Functional):	"The modified Gorilla plates, screws, and washers possess the same technological characteristics as the predicate devices. These include performance, basic design, material, manufacturing and sizes (dimensions are comparable to those offered by the predicate systems)."

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

Not Applicable in the context of a diagnostic test set with human data. The performance was evaluated through engineering analysis. This would involve testing of physical samples (plates, screws, washers) and/or computational modeling, not a "test set" of patient data.

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

Not Applicable. As this device is not a diagnostic tool, there is no "ground truth" to be established by clinical experts in the context of diagnostic accuracy. The evaluation relies on engineering principles and comparisons to predicate devices.

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

Not Applicable. Clinical adjudication of a test set is not relevant for the engineering analysis performed for this 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 is a hardware device (bone plating system), not an AI-powered diagnostic tool. MRMC studies and AI assistance are not relevant.

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

Not Applicable. This is a hardware device, not an algorithm.

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

Not Applicable in the diagnostic sense. For an orthopedic implant, the "ground truth" for performance is effectively defined by its mechanical properties, biocompatibility, and functional equivalence to established, safe, and effective predicate devices, as demonstrated through engineering analysis and adherence to standards.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set of data.

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

Not Applicable. As per point 8, there is no training set for this type of device.

Summary

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September 9, 2018

Paragon 28, Inc. Eric Lintula Director of Regulatory Affairs 4B Inverness Ct. E. STE 280 Englewood, Colorado 80112

Re: K182148

Trade/Device Name: SILVERBACK Gorilla 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, HTN Dated: August 2, 2018 Received: August 8, 2018

Dear Eric Lintula:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known)

K182148

Device Name SILVERBACK Gorilla Plating System

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date:	August 2nd, 2018
Sponsor:	Paragon 28, Inc.4B Inverness Ct. E., STE 280Englewood, Colorado 80112Phone: (888) 728-1888Fax: (888) 728-1220
Sponsor contact:	Eric LintulaSenior Director of Quality and Regulatory Affairs
Trade Names:	SILVERBACK Gorilla Plating System
Regulatory Class:	Class II
Regulation, ProductCode, Classification, andCommon Name:	888.3030, HRS, Single/multiple component metallicbone fixation appliances and accessories, bone platesystem
	888.3040, HWC, Smooth or threaded metallic bonefixation fastener, bone screw
	888.3030, HTN, Single/multiple component metallicbone fixation accessories, washer
Device Description:	The BABY GORILLA®/GORILLA® implants are lowerextremity fixation systems. Gorilla Plates are offered in“mini” and “standard” set sizes in a variety of shapesbased upon the anatomical fixation required. Screws arealso offered in “mini” and “standard” sets and, inaddition, in locking and non-locking versions. Size-matched washers are available for use with the non-locking screws when the latter are used for fixationwithout the plates. Size-matched plate washers are alsoavailable for use with plate holes when there is no desireto use a screw.
Materials:	The BABY GORILLA®/GORILLA® implants aremanufactured from medical grade titanium (per ASTMF67), stainless steel (per ASTM F138), and titaniumalloy (per ASTM F136).
Indications for Use:	The BABY GORILLA®/GORILLA® Bone Plates andBone Screws of the BABY GORILLA®/GORILLA®Plating System are indicated for use in stabilization andfixation of fractures or osteotomies; intra and extraarticular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusionand reconstruction of small bones of the toes, feet andankles including the distal tibia, talus, and calcaneus. Thesystem can be used in both adult and pediatric patients.
	In addition, the non-locking, titanium screws andwashers are indicated for use in bone reconstruction,osteotomy, arthrodesis, joint fusion, fracture repair andfracture fixation, appropriate for the size of the device.
Primary Predicate:	K140397, BABY GORILLA®/GORILLA® PlatingSystem (formerly ParaLock Plating System), Paragon28, Inc.
Additional Predicates:	K172886, BABY GORILLA®/GORILLA® BreakawayScrew System, Paragon 28, Inc.K121425, ORTHOLOCTM 3Di Ankle Fusion System,Wright Medical Technology, Inc.K141735, Ankle Fusion Plating System, Arthrex, Inc.
Performance Data:	Engineering analysis is presented to provide evidencethat the original testing and subsequence performance isnot adversely affected by the geometry of the modifiedplates, screws, and washers.The results of the analysis demonstrated the modifieddesigns are substantially equivalent to the predicatedevices.
TechnologicalCharacteristics:	The modified Gorilla plates, screws, and washers possessthe same technological characteristics as the predicatedevices. These include:performance, basic design, material, manufacturing and sizes (dimensions are comparable to those offeredby the predicate systems). Therefore, the fundamental scientific technology of themodified Gorilla Plates, Screws, and Washers is similarto previously cleared devices.
Conclusion:	The modified Gorilla Plates, Screws, and Washerspossess indications for use and technologicalcharacteristics that are the same as the predicate devices.Therefore, the modified Gorilla Plates, Screws, and

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Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.