The Distal Radius Plating System is an internal fixation system to be used for the treatment of distal radius fractures. The system consists of plates, screws, and locking caps. The Distal Radius Plates are bilateral and available in two different models; standard or with a multi-directional oblong hole (MDOH) feature. Each model comes in two sizes, 5 hole and 6 hole. The Distal Radius Plating System Screws are 2.7mm in diameter and available in various lengths.

The MDS device is single-use ONLY.

Materials: Ti-6A1-4V ELI alloy conforming to ASTM F136.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Distal Radius Plating System." As such, it focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel safety and effectiveness through clinical trials with acceptance criteria for device performance.

Therefore, the typical metrics and study designs used to demonstrate performance of an AI/ML device (like sensitivity, specificity, MRMC studies, standalone performance with ground truth based on pathology or outcomes) are not applicable here. This document describes a traditional hardware medical device.

Here's an analysis based on the provided document, addressing the closest applicable sections:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied): The device must perform as well as the predicate devices in terms of mechanical properties and material composition. This is assessed by demonstrating compliance with recognized ASTM standards for metallic bone plates and screws.
- Reported Device Performance:
  - Mechanical Testing (via ASTM standards):
    - ASTM F382-99: Standard Test Metallic Medical Bone Plates
    - ASTM F543-07: Standard Specification and Test Method for Metallic Bone Screws
  - Material Composition: Ti-6Al-4V ELI alloy conforming to ASTM F136.
  - Conclusion: The results of non-clinical testing demonstrate that the subject device (Distal Radius Plating System) and predicate devices have similar performance properties and perform "as well as" the predicate devices. This implies the device met the performance expectations defined by these standards when compared to the predicates.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This being a hardware device submission, the "test set" would refer to mechanical testing samples. The document does not specify the exact number of plates or screws tested.
- Data provenance is not applicable in the context of device performance of this type, as it relates to internal lab testing for mechanical properties and material verification.
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. "Ground truth" in this context would be physical measurements and material analyses. The "experts" would be engineers and laboratory technicians responsible for conducting the ASTM standard tests and material verification.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Mechanical and material testing of hardware devices typically involves direct measurement and comparison to standard specifications, not expert adjudication in the clinical sense.
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/ML device, nor is it a device that is 'read' by humans in a diagnostic capacity.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance assessment involves established engineering standards and material specifications. This includes:
  - ASTM F382-99: Standard Test for Metallic Medical Bone Plates (e.g., fatigue life, bending strength)
  - ASTM F543-07: Standard Specification and Test Method for Metallic Bone Screws (e.g., torsional strength, pull-out strength)
  - ASTM F136: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (material composition and properties).
The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set.
How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model, hence no ground truth establishment for it.

Summary specific to this device and its 510(k) submission:

The "Distal Radius Plating System" is a Class II medical device. Its acceptance criteria for regulatory clearance are based on demonstrating "substantial equivalence" to legally marketed predicate devices. This is achieved primarily through non-clinical performance testing that shows comparable mechanical properties and material composition. The study involves laboratory testing according to recognized ASTM standards (F382-99 for plates, F543-07 for screws, and F136 for material). No clinical performance data or studies involving human subjects were deemed necessary for this 510(k) submission.

Summary

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

August 15, 2016

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

Re: K161292

Trade/Device Name: Distal Radius 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: July 7, 2016 Received: July 8, 2016

Dear Ms. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (21CFR 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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161292

Device Name Distal Radius Plating System

Indications for Use (Describe)

The MDS Distal Radius Plating System is internal fixation of fractures of the distal radius.

Type of Use (Select one or both, as applicable) > 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 NWth 25 Street, Unit 3; Miami, FL33122
Contact Person:	Michelle MontesinoPhone: (786) 422-1400 Ext. 106Fax: (786) 422-1401
Date of Submission:	August 5, 2016
Manufacturer Name:	Miami Device Solutions, LLC
Manufacturer Address:	7620 NWth 25 Street, Unit 3; Miami, FL 33122
Registration Number:	3009222247
Contact Name:	Markku Biedermann
Title:	President
Device Trade Name:	Distal Radius Plating System
Device Common Name:	Distal Radius Plating System
Classification Names:	Plate, fixation, bone; and screw, fixation, bone
Classification Code:	HRS; and HWC - Class II
Classification Panel:	Orthopedic
Regulation Number:	21 CFR section 888.3030; and 888.3040
Predicate Devices:	Synthes Locking Distal Radius Plate System – K012114Variax Distal Radius Plating System - K141430Proximal Humerus Plating System – K141493
Reference Devices:	Paragon 28, Inc.; The Monster Screw System: InstrumentReprocessing Instructions for Reusable Instruments - K151418

Device Description:

The MDS device is single-use ONLY.

Materials: Ti-6A1-4V ELI alloy conforming to ASTM F136.

Intended Use:

The MDS Distal Radius Plating System is internal fixation of fractures of the distal radius.

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Summary of Technologies:

The Distal Radius Plating System has the same intended use, similar performance characteristics, and is similar in design and materials to the Synthes (K012114) and Stryker (K141430) predicate devices listed above; with the exception of the Miami Device Solutions predicate (K141493) which is indicated for the proximal humerus. The Miami Device Solutions Proximal Humerus Plating System (K141493) is considered a predicate because it utilizes the same locking technology as the subject device. Additionally, the subject device provides the option of a multi-directional oblong hole (MDOH) that the listed predicates do not.

Performance Data:

Non-Clinical Performance and Conclusions:

The results of non-clinical (laboratory/performance) testing demonstrate that the subject and predicate devices have similar performance properties. Substantial equivalence was demonstrated in the performance testing section of the submission by comparing the design and testing according to ASTM F382-99, Standard Test Metallic Medical Bone Plates and ASTM F543-07, Standard Specification and Test Method for Metallic Bone Screws, which show that the Distal Radius Plating System performs as well as the predicate devices. Comparison of the design, intended use, and testing demonstrate that the Distal Radius Plating System performs as well as the predicate devices and should thereby be considered substantially equivalent.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

Conclusion

The Miami Device Solutions Distal Radius 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.