Humeral Plates
Diaphyseal Plates
Screws (Locking and Standard)
Trials
Instruments
All implants and trials in the PRCT2 system are manufactured from medical grade titanium alloy (TA6V ELI) according to ISO 5832-3.

AI/ML Overview

The device in question is a medical device for bone fixation (PRCT2, a system of plates and screws for fractures of the humerus). The provided text describes the 510(k) submission for this device. For medical devices seeking 510(k) clearance, the primary "study" is usually a demonstration of substantial equivalence to a legally marketed predicate device, often through mechanical testing, rather than clinical trials with human subjects as might be seen for AI algorithms.

Here's an analysis based on the provided text, using the requested categories. Please note that several categories related to AI performance, human readers, and ground truth in a clinical context are not applicable to this type of medical device clearance document, which focuses on mechanical performance.

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

Acceptance Criteria (Bench Test Standards)	Reported Device Performance
Mechanical properties in accordance with ASTM F382-99 (Metallic Bone Plates)	Device tested in accordance with standard.
Mechanical properties in accordance with ASTM F543-13 (Metallic Bone Screws)	Device tested in accordance with standard.
Equivalence in terms of mechanical strength when tested side-by-side against a predicate device.	Test results show equivalence in terms of mechanical strength, therefore substantially equivalent.

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

Sample Size: Not explicitly stated for each test, but implied to be sufficient for mechanical testing according to ASTM standards. Mechanical testing typically involves multiple samples for statistical validity, but the exact number is not provided in this summary.
Data Provenance: The testing was mechanical bench testing, not clinical data from patients. The location of the testing is not specified, but the applicant (Fx Solutions) is based in France, and the US contact is in Virginia Beach, USA.

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. This document describes mechanical bench testing of a bone fixation device, not an AI algorithm that would require expert-established ground truth from clinical data.

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

Not Applicable. Mechanical testing results are typically quantifiable and do not require expert adjudication in the same way clinical image interpretation or AI output evaluation would. The "ground truth" here is the physical measurement against an established standard.

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 medical device (bone plate and screw system) clearance, not an AI algorithm. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this study was defined by established engineering standards and specifications (ASTM F382-99 and ASTM F543-13) for mechanical properties of bone plates and screws. The performance of the device was compared against these standards and against a predicate device.

8. The sample size for the training set

Not Applicable. There is no "training set" in the context of mechanical bench testing for medical device clearance. This is not an AI algorithm or a statistical model that requires training data.

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

Not Applicable. As there is no training set for this type of study, this question is not relevant.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo are three stylized human profiles facing to the right, stacked on top of each other.

August 27, 2015

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

Fx Solutions % Mr. Frank Ferguson CEO Ferguson Medical International Device Consultants LLC 332 Laskin Road, Suite 437 Virginia Beach, Virginia 23451

Re: K143721 Trade/Device Name: PRCT2 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: July 29, 2015 Received: July 31, 2015

Dear Mr. Ferguson:

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

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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); 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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K143721

INDICATIONS FOR USE

510(k) Number: K143721

Device Name: PRCT2

Indications For Use:

PRCT2 is indicated for use in fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

Prescription Use _______XX (21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92 for the Ex Solutions PRCT2 device.

DATE PREPARED: 17 August 2015

APPLICANTS NAME AND ADDRESS:

Fx Solutions Attn: Jean-Jacques Martin 1663 rue de Majornas 01440 Viriat France Phone: +33 474 55 35 55; FAX: +33 474 52 44 01 jjmartin@fxsolutions.fr

APPLICANTS CONTACT PERSON IN THE USA:

Ferquson Medical International Device Consultants LLC Attn: Frank Ferguson, CEO 332 Laskin Road Suite 437 Virginia Beach, VA 23451 Phone: 757.286.4383; FAX: 801.749.0451 frankf@ferqusonmedical-idc.com

DEVICE NAME:

Trade Name: PRCT2 Common Name: Bone plates and screws Classification Name: 21CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories

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21CFR 888.3040 Smooth or threaded metallic bone fixation fastener Product Code: HRS: Plate, Fixation, Bone HWC: Screw, Fixation, Bone

LEGALLY MARKETED DEVICES TO WHICH FX SOLUTIONS IS CLAIMING SUBSTANTIAL EQUIVALENCE:

Device Names: Synthes (USA) 3.5mm LCP Periarticular Proximal Humerus Plates (K082625), Internal Fixation Systems, Inc. IFS Bone Plates, Screws, and Washers (K110086)

DEVICE DESCRIPTION:

The PRCT2 is a system of plates and screws intended to be used in the fixation of fractures of the humerus. PRCT2 consists of 5 components:

1. Humeral Plates
1. Diaphyseal Plates
1. Screws (Locking and Standard)
1. Trials
1. Instruments

All implants and trials in the PRCT2 system are manufactured from medical grade titanium alloy (TA6V ELI) according to ISO 5832-3.

INTENDED USE:

PRCT2 is indicated for use in fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus.

SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES:

The components of the Fx Solutions PRCT2 device are offered in the same general range of sizes and shapes of the predicate devices. The materials used for the Fx Solutions device are the same as that used to manufacture the predicates.

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PERFORMANCE DATA:

The mechanical properties of the Fx Solutions PRCT2 device were tested in accordance with ASTM F382-99, Standard Specification and Test Method for Metallic Bone Plates, and ASTM F543-13, Standard Specification and Test Method for Metallic Bone Screws.

The Fx Solutions device was mechanically tested side-by-side against the predicate device. The test results show equivalence in terms of mechanical strength, therefore substantially equivalent.

CONCLUSION:

Based upon the testing and comparison to the predicate device, the Fx Solutions PRCT2 device has the same intended use and similar technological characteristics. The device performs as intended and does not raise any new safety or effectiveness issues, and is therefore substantially equivalent to the predicate devices.

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.