The Olecranon Plating System is an internal fixation system to be used for the treatment of Olecranon fractures. The system consists of plates, screws, and locking caps, as well as single use and reusable instruments. The Olecranon plates are pre-contoured and side-specific, available in two different sizes; 2 hole and 4 hole. The Olecranon Plating System Screws are 2.7mm in diameter and available in various lengths.

The MDS implants are single-use ONLY.

Materials: Titanium alloy and stainless steel

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Olecranon Plating System:

It's important to note that the provided document is a 510(k) summary for a medical device, specifically an Olecranon Plating System. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This is not a study of an AI-powered device or a comparative effectiveness study in the typical sense of measuring algorithm performance. Instead, it focuses on the engineering and material characteristics of a physical implant.

Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and MRMC studies will not be applicable to this document.

1. Table of acceptance criteria and reported device performance:

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Mechanical Strength	Demonstrated to be as safe and effective as the predicate devices.	Engineering analysis and testing according to ASTM F382-99 (Standard Test Method for Metallic Medical Bone Plates) and ASTM F543-07 (Standard Specification and Test Method for Metallic Bone Screws) showed the device performs as well as predicate devices.
Material Compatibility	Materials (Titanium alloy and stainless steel) must be acceptable for medical implants.	Uses Titanium alloy and stainless steel, which are standard materials for bone fixation.
Design and Functionality	Similar design and functionality to predicate devices for internal fixation of olecranon fractures.	"The Olecranon Plating System has the same intended use, similar performance characteristics, and is similar in design and material to the predicate devices." Plates are pre-contoured and side-specific; screws are 2.7mm in diameter.
Intended Use	Intended for internal fixation of fractures of the Olecranon.	The MDS Olecranon Plating System is intended for internal fixation of fractures of the Olecranon.
Sterility/Reprocessing	Implants are single-use ONLY. Instruments may be reusable and require reprocessing instructions.	"The MDS implants are single-use ONLY." Reference to Paragon 28, Inc.; The Monster Screw System: Instrument Reprocessing Instructions for Reusable Instruments (K151418) for guidance on reusable instruments.

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

Sample Size: Not applicable in the context of a clinical test set. The performance data is based on non-clinical (laboratory/performance) testing and engineering analysis of the device itself (plates, screws). The sample size would relate to the number of physical components tested in the lab. The document does not specify the exact number of plates or screws physically tested.
Data Provenance: Not applicable in terms of country of origin for a data set. The testing was non-clinical (laboratory) rather than using patient data. It involved materials and mechanical testing.
Retrospective/Prospective: Not applicable.

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

Not Applicable. This document describes the mechanical and material equivalence of a physical implant, not an AI or diagnostic device that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the established mechanical performance standards (ASTM standards) and the characteristics of the predicate devices.

4. Adjudication method for the test set:

Not Applicable. There was no human adjudication of results in the context of a diagnostic test set. The "adjudication" was through engineering analysis and comparison against established industry standards (ASTM) and predicate device specifications.

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:

No. This was not an MRMC study. This device is a physical bone implant, not an AI software or diagnostic tool that assists human readers.

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

No. This is not an algorithm. It's a physical medical device.

7. The type of ground truth used:

For mechanical properties: Established industry standards (ASTM F382-99 for bone plates, ASTM F543-07 for bone screws) and the specifications/performance of the predicate devices.
For material composition: Accepted medical-grade titanium alloy and stainless steel (as verified against predicate devices).

8. The sample size for the training set:

Not Applicable. There is no "training set" in the context of a physical medical device like this, which relies on engineering design, material science, and mechanical testing, not machine learning.

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

Not Applicable. See point 8.

Summary

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

March 17, 2017

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

Re: K162898

Trade/Device Name: Olecranon 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: March 7, 2017 Received: March 9, 2017

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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements

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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.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), 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,

Lori A. Wiggins -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) K162898

Device Name Olecranon Plating System

Indications for Use (Describe)

The MDS Olecranon Plating System is intended for internal fixation of fractures of the Olecranon.

Type of Use (Select one or both, as applicable)

X 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 25 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:	3/7/2017
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:	Olecranon 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 threadedmetallic bone fixation fastener
Predicate Device:	Primary: Acumed Small Fragment Base Set, K143394Additional: Miami Device Solutions Distal Radius PlatingSystem, K161292Additional: Synthes Variable Angle LCP Elbow System,K120070

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Reference Devices:

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

Device Description:

The MDS implants are single-use ONLY.

Materials: Titanium alloy and stainless steel

Intended Use:

The MDS Olecranon Plating System is intended for internal fixation of fractures of the Olecranon.

Summary of Technologies:

The Olecranon Plating System has the same intended use, similar performance characteristics, and is similar in design and material to the predicate devices listed above with the exception of the Miami Device Solutions Distal Radius Plating System (K161292) which is also used for fixation of bone fragments but it is indicated for the distal radius. The Miami Device Solutions Distal Radius Plating System (K161292) is considered a predicate because it utilizes the same screws and locking technology as the subject device.

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 predicate. 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 Olecranon Plating System performs as well as the predicate devices and should thereby be considered substantially equivalent.

Clinical Performance and Conclusions:

Clinical testing was not performed for this device.

Conclusion

The Miami Device Solutions Olecranon 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.