The MBD Plate System is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

Device Description

The MBD Plate System is a titanium plating system comprised of various length plates and screws. The plates are low profile straight plates ranging in length from 72mm to 136mm. The plate thickness and width are 3mm and 11mm, respectively. Plate sizes are from 6 to 11 holes and each plate hole and/or slot accepts 4.0mm non-locking bone screws. Bone screws range from 12 to 24mm in length. Additionally, the system comprises low-profile 2.5mm diameter fragment screws in lengths from 10 to 24mm.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the MBD Plate System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Requirements)	Reported Device Performance
Meet fatigue performance requirements	Met fatigue requirements
Meet static performance requirements	Met static requirements
Meet four-point bend testing requirements	Met four-point bend testing requirements

The document states: "The testing demonstrated that the MBD Plate system components met four-point bend testing. performance requirements and are as safe and effective as their predicate devices." This implies that meeting these performance requirements is the acceptance criteria for safety and effectiveness in comparison to predicates.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated within the provided text. The document refers to "non-clinical performance testing for fatigue and static" but does not give a specific number of samples tested.
Data Provenance: The document implies the data was generated through laboratory "non-clinical performance testing." There is no indication of human or animal data, retrospective or prospective studies, or country of origin for the data generation. It's a bench test, so provenance is generally less complex than clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable. The ground truth for this device is based on objective engineering measurements from mechanical testing (fatigue, static, four-point bend), not expert interpretation of medical data.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. As the "ground truth" is defined by objective mechanical testing results against predetermined performance requirements, there is no need for expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No. This is a mechanical orthopedic implant (bone plate system), not an imaging device or AI-driven diagnostic tool that would typically involve a multi-reader multi-case study.
Effect size of human readers with vs. without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was it done? Yes, in a sense. The "Performance Data" section describes non-clinical performance testing of the device itself, without human interaction influencing the results of the mechanical tests. This is essentially a standalone performance evaluation of the physical product.

7. Type of Ground Truth Used

Type of Ground Truth: Objective engineering measurements and predetermined performance requirements (e.g., fatigue life, static strength, four-point bend deflection/load at failure) derived from industry standards or benchmarks against predicate devices.

8. Sample Size for the Training Set

Sample Size: Not applicable. This is a physical medical device, not a software algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set was Established: Not applicable.

Summary

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Section 5: 510(k) Summary

The following information is provided as required by 21 CFR § 807.87 for MBD Medical's 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

The safety and effectiveness of the MBD Plate System is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate device(s).

Sponsor:	MBD Medical, LLC84 Honeck StreetEnglewood, NJ 07631
Contact:	Jennifer A. DaudelinM Squared Associates, Inc.575 Eighth Avenue, Suite 1212New York, NY 10018Ph: 703-562-9800 x251Fax: 703-562-9797Email: jdaudelin@msquaredassociates.com
Date Prepared:	April 8, 2014
Proposed Class:	II
Proprietary Name:	MBD Plate System
Common Name:	Plate, Fixation, Bone
Classification Name:	Plate, Fixation, Bone
Regulation Number:	21 CFR 888.3030
Product Codes:	HRS, HWC
Predicate Device(s):

Manufacturer	Device Name	Procode	510(k) Number	Common Name	Class
Synthes(USA)	Synthes One-ThirdTubular DCL Plate	HRS	K011335	Plate, Fixation Bone	II
HowmedicaOsteonicsCorp.	Variax ClavicleSystem	HRS,HWC	K113760	Plate, Fixation Bone	II

Indication for Use

The MBD Plate System is intended for fixation of fractures, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

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Device Description

Performance Data

The MBD Plate System has been evaluated through non-clinical performance testing for fatigue and static The testing demonstrated that the MBD Plate system components met four-point bend testing. performance requirements and are as safe and effective as their predicate devices.

Technological Characteristics and Substantial Equivalence

The MBD Plate System has the same indications for use, materials, and similar design features as compared with the predicate systems. The bench testing demonstrates that the performance characteristics of the MBD Plate System are equivalent to those of other legally marketed plate/screw systems, and therefore supports a determination of Substantial Equivalence for the proposed indications for use. Any differences between the subject and predicate devices would not render the device NSE, affect the safety or effectiveness, or raise different questions of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

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

June 30, 2014

MBD Medical, LLC % Jennifer A. Daudelin Regulatory Consultant III M Squared Associates, Inc. 575 Eighth Avenue, Suite 1212 New York, New York 10018

Re: K141045

Trade/Device Name: MBD Plate 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: May 9, 2014 Received: May 13, 2014

Dear Ms. Daudelin:

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 (reporting of medical

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Page 2 - Ms. Jennifer A. Daudelin

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,

Lori A. Wiggins

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

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Section 4: Indications for Use Statement

K141045 510(k) Number: Device Name: MBD Plate System Indications for Use:

The MBD Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 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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Elizabet标秘厨Frank -S

Division of Orthopedic 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.