The Skeletal Dynamics Dorsal Spanning Plate consists of a bone plate designed for fracture fixation of the distal radius and wrist arthrodesis. Included in the system are titanium bone screws, k-wires, and specialized instrumentation. The system is provided non-sterile and is sterilized in the user facility. The Skeletal Dynamics Dorsal Spanning Plate is comprised of: Titanium alloy plate and screws; Stainless steel K-wires (for provisional fixation not for implantation); System specific instrumentation.

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets those criteria. The document is a 510(k) premarket notification for a medical device (Dorsal Spanning Plate) and primarily focuses on demonstrating substantial equivalence to a predicate device.

Specifically, the text mentions:

Performance Testing: "Mechanical testing which established equivalency included static and dynamic testing." This indicates testing was performed but does not provide specific acceptance criteria or detailed results.
Conclusion: "The Skeletal Dynamics Dorsal Spanning Plate is substantially equivalent to the predicate device identified in this premarket notification." This is the overall conclusion of the 510(k) submission, based on the comparison to the predicate.

The document does not include:

A table of acceptance criteria and reported device performance.
Sample sizes or data provenance for a test set.
Information on experts, ground truth establishment, or adjudication methods.
Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
Details on training set sample size or ground truth establishment for a training set.

Therefore, I cannot extract the requested information from the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

May 12, 2015

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

Skeletal Dynamics, LLC Ms. Ann Escagedo President 8905 SW 87 Avenue. Suite 201 Miami, Florida 33176

Re: K150675 Trade/Device Name: Dorsal Spanning Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: April 23, 2015 Received: April 24, 2015

Dear Ms. Escagedo:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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,

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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Indications for Use

510(k) Number (if known): K150675

Device Name: Dorsal Spanning Plate

Indications For Use: The Skeletal Dynamics Dorsal Spanning Plate is intended for fixation of fractures involving the distal radius and for wrist arthrodesis.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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510(k) Summary of Safety and Effectiveness Skeletal Dynamics Dorsal Spanning Plate

April 22, 2015

Submitter:

Skeletal Dynamics, LLC 8905 SW 87 Avenue Suite 201 Miami, FL 33176 Tel: (305) 596-7585 Fax: (305) 596-7591 Contact: Ana M. Escagedo, President Email: aescagedo@skeletaldynamics.com

Establishment Registration Number: 3006742481

Name and Classification:

Name Dorsal Spanning Plate Common Name Single/multiple component metallic bone fixation appliances and accessories Classification 21 CFR §888.3030 Product Code HRS Class Class II

Predicate Devices:

OptiLock VL Distal Radius Plating System (K093761)

Description of the Device:

The Skeletal Dynamics Dorsal Spanning Plate is comprised of:

· Titanium alloy plate and screws
· Stainless steel K-wires (for provisional fixation not for implantation)
· System specific instrumentation.

Intended Use:

The Skeletal Dynamics Dorsal Spanning Plate is intended for fixation of fractures involving the distal radius and for wrist arthrodesis.

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Summary of Technological Characteristics / Substantial Equivalence:

The substantial equivalence of the Skeletal Dynamics Dorsal Spanning Plate to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness.

Performance Testing:

Preclinical analysis and testing demonstrated that the Skeletal Dynamics Dorsal Spanning Plate is substantially equivalent to the predicate device currently marketed. Mechanical testing which established equivalency included static and dynamic testing. Therefore, the subject device is as safe and effective as legally marketed predicate devices.

Conclusion:

The Skeletal Dynamics Dorsal Spanning Plate is substantially equivalent to the predicate device identified in this premarket notification.

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.