The MDS Plating System is internal fixation of fractures of various bones such as the clavicle, olecranon. humerus, radius, ulna, distal tibia, and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage of material compatible with system implants including titanium alloy and cobalt chromium.

The Low Profile Head Screw is used independently and is internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.

Device Description

The MDS Plating System is an internal fixation system intenal fixation of fractures of various bones. The system consists of the following single-use implants:

Straight (broad and narrow) and pre-contoured plates available in a variety of sizes -
-Screws of various lengths and diameters, some of which are identified in previously cleared premarket notifications (K141493, K161292/K162635, and K162898).
Locking Caps of various diameters identified in previously cleared premarket notifications -(K141493, K161292/K162635, and K162898).
Low Profile Head Screws -
-Threaded cerclage buttons of various diameters used in conjunction with MDS plates to augment fracture stabilization.

Additionally, the system includes single use and reusable instruments.

Materials: Titanium alloy and Stainless Steel.

AI/ML Overview

This document describes a 510(k) premarket notification for the "MDS Plating System," a medical device for internal fixation of bone fractures. As such, the FDA's review for substantial equivalence primarily relies on non-clinical performance data and comparison to predicate devices, rather than clinical studies with acceptance criteria in the typical sense of AI/Dx devices.

Therefore, the requested information elements related to clinical studies, ground truth establishment, expert adjudication, and specialized sample sizes (training/test sets for algorithms) are not applicable in this context. The data provided focuses on mechanical and material performance testing.

Here's an interpretation of the available information in the context of the device and regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

For devices like the MDS Plating System, acceptance criteria are generally established based on recognized industry standards for mechanical performance and material properties. The "reported device performance" refers to the results of tests demonstrating compliance with these standards and comparability to predicate devices.

Acceptance Criteria Category	Specific Criteria (Derived from Standards)	Reported Device Performance
Material Properties	Biocompatibility, mechanical properties (e.g., tensile strength, fatigue resistance) of Titanium alloy and Stainless Steel.	Not explicitly detailed in the summary, but implied through "material, design, indications for use, and performance characteristics" equivalence to predicates. Compliance with standards for these materials is expected.
Plate Mechanical Strength	ASTM F382-99: Standard Test Method for Metallic Medical Bone Plates (e.g., bending strength, stiffness for various plate designs and sizes).	"Testing according to ASTMF382-99" demonstrates performance comparable to predicate devices. The system "performs as well as the predicate devices."
Screw Mechanical Strength	ASTM F543-07: Standard Specification and Test Method for Metallic Bone Screws (e.g., torsional strength, pull-out strength, bending strength).	"Testing according to ASTM F543-07" demonstrates performance comparable to predicate devices. The system "performs as well as the predicate devices."
Design Equivalence	Comparison to predicate devices for overall design, dimensions, and intended use.	"Documentation is provided which demonstrates that the MDS Plating System is equivalent to its predicate devices in terms of material, design, indications for use, and performance characteristics."
Sterilization & Packaging	Sterility assurance level (SAL), packaging integrity.	Not explicitly detailed in the summary, but implied through general good manufacturing practices and regulatory requirements for medical devices.

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

This is not applicable as there isn't a "test set" in the sense of an AI algorithm or diagnostic device. The performance testing involves mechanical and material tests performed in a laboratory setting. There are no "patients" or "data provenance" (country of origin, retrospective/prospective) in this context. The "samples" would be the manufactured device components (plates, screws, etc.) subjected to mechanical testing. The sample size for such tests is typically determined by relevant ASTM standards to achieve statistical significance for the mechanical properties measured.

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

This is not applicable. For mechanical performance testing of orthopedic implants, "ground truth" is defined by established engineering principles and measurements against recognized standards (e.g., ASTM). No human "experts" are establishing diagnostic ground truth for a test set.

4. Adjudication Method for the Test Set

This is not applicable. There is no human adjudication process involved in assessing the mechanical performance against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The MDS Plating System is a surgical implant, not a diagnostic tool or an AI-assisted diagnostic system.

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

No, a standalone performance test in the context of an algorithm was not done. Again, this device is a surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering standards and physical measurements. This includes:

Mechanical Test Results: Direct measurements of tensile strength, torsional strength, bending strength, fatigue life, etc., obtained through laboratory testing.
Material Specifications: Compliance with established properties for titanium alloy and stainless steel as per international standards.
Design Specifications: Conformance to detailed engineering drawings and specifications.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" for an AI algorithm in this context.

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

This is not applicable for the same reasons as point 8.

Summary

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December 8, 2017

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Miami Device Solutions, LLC Michelle Montesino Regulatory Affairs Associate 7620 NW 25th Street. Unit 3 Miami, Florida 33122

Re: K172786

Trade/Device Name: MDS 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 Dated: September 14, 2017 Received: September 15, 2017

Dear Michelle Montesino:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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,

Katherine D. Kavlock -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)

K172786

Device Name MDS Plating System

Indications for Use (Describe)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

See PRA Statement below.

The Low Profile Head Screw is used independently and is internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.

and in the mail one of the collegend desires the minimal come the many of the may be any and the may be any and
Type of Use (Select one or both, as applicable)read analysis and research and any and security of the creative and security and on

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Submitter Name:	Miami Device Solutions, LLC
Submitter Address:	7620 NW 25th Street, Unit 3;Miami, FL 33122
Contact Person:	Michelle MontesinoPhone: (786) 422-1400 Ext. 106Fax: (786) 422-1401
	Anderson GiraldoPhone: (786) 422-1400 Ext 115Fax: (786) 422-1401
Date of Submission:	9/14/2017
Manufacturer Name:	Miami Device Solutions, LLC
Manufacturer Address:	7620 NW 25th Street, Unit 3;Miami, FL 33122
Registration Number:	3009222247
Contact Name:	Markku Biedermann
Title:	President
Device Trade Name:	MDS Plating System
Device Common Name:	Primary: Plate, Fixation, BoneSecondary: Screw, Fixation, Bone
Classification Names:	Primary: Plate, fixation, boneSecondary: Screw, fixation, bone
Classification Code:	Primary: HRS – Class IISecondary: HWC – Class II
Classification Panel:	Orthopedic
Regulation Number:	Primary: 21 CFR section 888.3030 – Single/multiple componentmetallic bone fixation appliances and accessories
	Secondary: 21 CFR section 888.3040 – Smooth or threaded metallicbone fixation fastener
Predicate Device:	Primary	K143394	Acumed Small Fragment Base Set
	Secondary	K161292/K162635	Miami Device Solutions DistalRadius Plating System
		Plating System
Secondary	K141493	Miami Device Solutions ProximalHumerus Plating System
Secondary	K992891	Synthes Cerclage Positioning Pin
Secondary	K132502,K140769	Variax 2 System Bone Screws

Secondary

K162898

Miami Device Solutions Olecranon

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K172786

Reference Devices:

Paragon 28, Inc .; The Monster Screw System: Instrument Reprocessing Instructions for Reusable Instruments – K151418

Device Description:

The MDS Plating System is an internal fixation system intenal fixation of fractures of various bones. The system consists of the following single-use implants:

Straight (broad and narrow) and pre-contoured plates available in a variety of sizes -
-Screws of various lengths and diameters, some of which are identified in previously cleared premarket notifications (K141493, K161292/K162635, and K162898).
Locking Caps of various diameters identified in previously cleared premarket notifications -(K141493, K161292/K162635, and K162898).
Low Profile Head Screws -
-Threaded cerclage buttons of various diameters used in conjunction with MDS plates to augment fracture stabilization.

Additionally, the system includes single use and reusable instruments.

Materials: Titanium alloy and Stainless Steel.

Intended Use:

The MDS Plating System is intended for internal fixation of fractures of various bones such as the clavicle, olecranon, humerus, radius, ulna, distal tibia, and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage cable of material compatible with system implants including titanium alloy and cobalt chromium.

The Low Profile Head Screw is used independently and is internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.

Substantial Equivalence Statement:

Documentation is provided which demonstrates that the MDS Plating System is equivalent to its predicate devices in terms of material, design, indications for use, and performance characteristics.

Performance Data:

Non-Clinical Performance and Conclusions:

The results of non-clinical (laboratory/performance) testing as well as engineering analysis for subject devices demonstrate that the device is as safe and as effective as the predicates. Substantial equivalence is demonstrated in the performance testing section of the submission by comparing subject and predicated designs, as well as testing according to ASTMF382-99, Standard Test Method for Metallic Medical Bone Plates and ASTM F543-07, Standard Specification and Test Method for Metallic Bone Screws. Comparison of the design, intended use, and testing demonstrate that the MDS Plating System performs as well as the predicate devices and should thereby be considered substantially equivalent.

Clinical Performance and Conclusions:

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Clinical data and conclusions were not needed for this device.

Conclusion

The MDS Plating System is 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.