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 at ic 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 size of 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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "Breakaway Screw System". This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a new device meets specific acceptance criteria through a clinical study. As such, the information typically requested in your prompt (e.g., acceptance criteria, detailed study design, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth establishment) is generally not included in a 510(k) summary of this nature.

The document states:

"Engineering analysis is presented to provide evidence that the original testing and subsequence performance is not adversely affected by the modified screw geometry. The results of the analysis demonstrated the modified design is substantially equivalent to the predicate device."

This indicates that the "study" conducted was an engineering analysis comparing the new device (modified screw geometry) to a predicate device (K140397, Gorilla Plating System). The goal was to show that the modifications did not adversely affect the performance, implying that the existing performance of the predicate device was considered acceptable and the new device maintains that level.

Therefore, most of your requested information is not applicable or not provided in this specific document. However, I can extract what is available:

1. Table of acceptance criteria and the reported device performance:

Since this is an engineering analysis for substantial equivalence, formal acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, etc.) are not established for the new device. The acceptance criterion is essentially "not adversely affected" compared to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Performance not adversely affected by modified screw geometry.	"The results of the analysis demonstrated the modified design is substantially equivalent to the predicate device."
Same technological characteristics as predicate in terms of:	The modified Gorilla screw possesses the same technological characteristics as the predicate devices:
- Performance	- Performance
- Basic design	- Basic design
- Material, manufacturing	- Material, manufacturing
- Sizes (dimensions comparable to predicate)	- Sizes (dimensions are comparable to those offered by the predicate systems)

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

Sample Size: Not applicable. The "study" was an engineering analysis, not a clinical study involving a test set of data. It would likely involve mechanical testing and comparisons to existing predicate device data.
Data Provenance: Not applicable in the context of clinical data. The analysis compares the modified screw geometry to the predicate device's original testing and performance.

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

Not applicable. No "ground truth" in the clinical sense was established by experts for a test set in this engineering analysis.

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

Not applicable. There was no test set requiring expert adjudication.

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 not an AI/software device and no MRMC study was conducted.

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

Not applicable. This is not an algorithm/software device.

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

For an engineering analysis, the "ground truth" would be the established performance characteristics of the predicate device (e.g., mechanical strength, durability, material properties), against which the modified design was compared. This is not clinical ground truth.

8. The sample size for the training set:

Not applicable. There is no training set mentioned, as this is an engineering analysis, not a machine learning model.

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

Not applicable. No training set was used.

Summary

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December 20, 2017 Paragon 28 Eric Lintula Director of Regulatory Affairs 4B Inverness Ct. E Ste 280 Englewood, Colorado 80112

Re: K172886

Trade/Device Name: Breakaway Screw 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: November 3, 2017 Received: November 14, 2017

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

Vincent J. Devlin -S

for

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)

K172886

Device Name Breakaway Screw System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 8: 510(k) Summary

Date:	9/18/17
Sponsor:	Paragon 28, Inc.4B Inverness Ct. E., STE 280Englewood, Colorado 80112Phone: (888) 728-1888Fax: (888) 728-1220
Sponsor contact:	Eric Lintula, Director of Regulatory Affairs
Trade Names:	Breakaway Screw System
Regulatory Class:	Class II
Regulation, ProductCode, Classification, andCommon Name:	888.3030, HRS, Single/multiple component metallicbone fixation appliances and accessories, bone platesystem888.3040, HWC, Smooth or threaded metallic bonefixation fastener, bone screw888.3030, HTN, Single/multiple component metallicbone fixation accessories, washer
Device Description:	The BABY GORILLA®/GORILLA® implants arelower extremity fixation systems. Gorilla Plates areoffered in "mini" and "standard" set sizes in a variety ofshapes based upon the anatomical fixation required.Screws are also offered in "mini" and "standard" setsand, 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 fixationwithout the plates.
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 and fracture fixation, appropriate for the size of the device
Primary Predicate:	K140397, Gorilla Plating System (formerly Paralock Plating System)
Performance Data:	Engineering analysis is presented to provide evidence that the original testing and subsequence performance is not adversely affected by the modified screw geometry.The results of the analysis demonstrated the modified design is substantially equivalent to the predicate device.
Technological Characteristics:	The modified Gorilla screw possesses 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).Therefore, the fundamental scientific technology of the modified Gorilla Screw is similar to previously cleared devices.
Conclusion:	The modified Gorilla Screw possesses indications for use and technological characteristics the same as the predicate device. Therefore, the modified Gorilla Screw is substantially equivalent to the predicate.

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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.