This special 510(k) submission is intended to add the following device instruments and caddy as accessories to the Miami Device Solutions Distal Radius Plating System which was cleared in K161292:

Polyaxial Drill Guide
Polyaxial Drill Guide Sleeve for K-Wire
Polyaxial Drill Guide Caddy

The polyaxial drill guide caddy holds polyaxial drill guides and polyaxial drill guide sleeves for Kwires. The polyaxial drill guide and the polyaxial drill guide sleeve for K-wire helps the user during drill and K-wire insertion. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information:

Based on the provided document, the device in question (Distal Radius Plating System with added polyaxial drill guides and associated accessories) did not undergo a clinical study to establish acceptance criteria or performance relevant to clinical outcomes such as diagnostic accuracy or treatment effectiveness.

Instead, this submission (K162635) is a Special 510(k) application to add accessories to an already cleared device (K161292). The focus of this specific submission is on non-clinical performance and substantial equivalence to the predicate device.

Here's a breakdown of your requested information based only on the provided text:

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

Acceptance Criteria	Reported Device Performance
Compatibility with applicable implants and instruments	The additional instruments and caddy were shown to be compatible with applicable implants and instruments.
Biocompatibility	Verification testing showed that the system is biocompatible.
Cleanliness and Sterilizability	Verification testing showed that the system can be cleaned and sterilized.
Substantial Equivalence (overall)	The device is substantially equivalent in intended use, materials, and performance characteristics to the predicate device. The addition of accessories does not alter the technology.

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

Sample Size: Not specified. The document only mentions "Verification testing," which typically involves bench testing of samples but does not provide specific numbers for components tested.
Data Provenance: Not specified, but given it's non-clinical testing, it would be laboratory-based rather than patient-derived.

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)

N/A. Since no clinical study or diagnostic/treatment outcome assessment was performed, there was no need for experts to establish ground truth in this context. The "ground truth" for non-clinical tests is typically defined by engineering standards or material science principles.

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

N/A. No clinical study involving expert interpretation or adjudication was conducted.

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

N/A. No MRMC study was conducted. This device is not an AI-assisted diagnostic tool.

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

N/A. This device is a mechanical surgical system, not an algorithm or software. "Standalone" performance testing would refer to the mechanical properties and function of the components, which falls under "Non-Clinical Performance."

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

For the non-clinical performance (compatibility, biocompatibility, cleaning/sterilization), the "ground truth" would be established by engineering specifications, recognized standards (e.g., ASTM F136 for materials, sterilization validation standards), and laboratory test results demonstrating compliance with these standards.

8. The sample size for the training set

N/A. No training set was used as this device is not a learning algorithm or AI system.

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

N/A. No training set was used.

Summary of Clinical Data (from the document):

"Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

This explicitly states that no clinical studies were performed, and thus no clinical acceptance criteria or human-performance metrics (like those for AI/diagnostic devices) were established or reported for this specific submission. The approval is based on substantial equivalence and non-clinical performance testing of the added accessories.

Summary

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

October 21, 2016

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

Re: K162635

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: September 20, 2016 Received: September 21, 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,

Image /page/1/Picture/8 description: The image shows the name "Mark N. Melkerson -S" in a simple, sans-serif font. The text is horizontally aligned and appears to be part of a document or label. The letters are clear and legible, with consistent spacing between them.

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) K162635 (Page 1 of 1)

Device Name Distal Radius Plating System

Indications for Use (Describe) The MDS Distal Radius Plating System is intended for internal fixation of fractures of the distal radius.

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

Special 510(k) Application

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
Date of Submission:	September 20, 2016
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:	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:	Miami Device Solutions Distal Radius Plating System –K161292

Device Description:

This special 510(k) submission is intended to add the following device instruments and caddy as accessories to the Miami Device Solutions Distal Radius Plating System which was cleared in K161292:

1. Polyaxial Drill Guide
1. Polyaxial Drill Guide Sleeve for K-Wire
1. Polyaxial Drill Guide Caddy

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

Intended Use:

The addition of the polyaxial drill guide caddy, polyaxial drill guides, and polyaxial drill guide sleeves for K-wire does not alter the intended use of the predicate system as cleared in K161292 Distal Radius Plating System. The indications for use for the subject device are provided below.

Indications for Use

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

Summary of Technologies:

The proposed device is substantially equivalent in intended use, materials, and performance characteristics to the predicate device. The addition of the following instruments as accessories to the plating system does not alter the technology.

Performance Data:

Non-Clinical Performance and Conclusions:

The additional instruments and caddy were shown to be compatible with applicable implants and instruments. Verification testing showed that the system is biocompatible and can be cleaned and sterilized.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for this device.

Conclusion

The Miami Device Solutions Distal Radius Plating System and the addition polyaxial drill guides, polyaxial drill guide sleeves for K-wire, and the polyaxial drill guide caddy is substantially equivalent to the predicate device.

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.