The Skeletal Dynamics Protean Fragment Plate System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, and pelvis, particularly in osteopenic bone.

Device Description

The Skeletal Dynamics Protean Fragment Plate System is a set of titanium bone plates designed for stabilization and repair of small bone fragments. Included in the set are titanium bone screws, fixation pegs, cobalt chrome cannulated polyaxial screws, and specialized instrumentation. The Fragment Plates are available in 3 configurations and are made of medical grade titanium alloy. The system is provided non-sterilized in the user facility. The Skeletal Dynamics Protean Fragment Plate System is comprised of: Titanium alloy plates and screws, Cobalt chrome polyaxial screws, Stainless steel K-wires (for provisional fixation not for implantation), System specific instrumentation.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Skeletal Dynamics Protean Fragment Plate System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies with detailed acceptance criteria as one might find for new drug applications or high-risk medical devices requiring PMA.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. The primary "study" is a preclinical mechanical testing study to show equivalence, not a clinical trial evaluating human performance or AI capabilities.

Here’s a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion Type	Acceptance Criterion (Not explicitly stated as numerical, but implied as "substantially equivalent")	Reported Device Performance
Mechanical Performance	Substantially equivalent to the predicate device (DePuy Small Bone Locking Plate System (K081546)) in static and dynamic testing.	"Preclinical analysis and testing demonstrated that the Skeletal Dynamics Protean Fragment Plate System is substantially equivalent to the predicate device currently marketed. Mechanical testing which established equivalency included static and dynamic testing." The exact numerical results are not provided.
Intended Use	Identical or highly similar to the predicate device.	"The Skeletal Dynamics Protean Fragment Plate System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, and pelvis, particularly in osteopenic bone." This is also considered substantially equivalent to the predicate.
Materials	Similar to predicate device; medical grade.	Titanium alloy plates and screws, Cobalt chrome polyaxial screws, Stainless steel K-wires. This is stated to be substantially equivalent to the predicate.
Design	Similar fundamental scientific technology to predicate device.	No specific design details against a criterion are given, but the overall design is stated to be substantially equivalent.
Sterility	Not explicitly detailed but implied to be manageable post-manufacturing by the user.	"The system is provided non-sterilized in the user facility." Stated as substantially equivalent to the predicate.
Packaging	Substantially equivalent to the predicate device.	Not detailed, but stated as substantially equivalent to the predicate.

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

Sample Size: Not specified. For mechanical testing of medical devices, "samples" typically refer to the number of devices or components subjected to a particular test. The document only states "Preclinical analysis and testing."
Data Provenance: Not applicable in the context of clinical data. This refers to in-vitro mechanical testing conducted by the manufacturer.

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

Not Applicable. This is a mechanical device evaluation, not a clinical study involving expert interpretation of data or images. "Ground truth" would relate to precisely measured mechanical properties or failure points, not expert consensus on diagnoses.

4. Adjudication method for the test set

Not Applicable. There is no adjudication method described because there's no clinical data or expert interpretation involved in determining a "ground truth" through consensus.

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

Not Applicable. This device is a bone plate system, not an AI or imaging diagnostic tool. No MRMC study was conducted.

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

Not Applicable. This is a hardware medical device, not an algorithm or AI.

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

For mechanical testing, the "ground truth" would be established by the physical testing parameters and measurements (e.g., force applied, displacement, cycles to failure, yield strength) as per recognized engineering standards (e.g., ASTM, ISO). The document does not specify which standards were followed, but these would define how performance is "measured."

8. The sample size for the training set

Not Applicable. This is a mechanical device, not an AI system that requires a "training set" of data.

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

Not Applicable. No training set exists for this type of device submission.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for Skeletal Dynamics. The logo consists of a stylized black symbol to the left of the words "skeletal dynamics" in black font. The symbol appears to be four squares arranged to form a larger square.

510(k) Summary of Safety and Effectiveness Skeletal Dynamics Protean Fragment Plate System

March 11, 2014

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. Vice President Email: aescagedo@skeletaldynamics.com

Establishment Registration Number: 3006742481

Name and Classification:

Name	Protean Fragment Plate System
Common Name	Plate, fixation, bone
Classification	21 CFR §888.3030
Product Code	HRS
Class	Class II

Predicate Devices:

DePuy Small Bone Locking Plate System (K081546)

Description of the Device:

The Fragment Plates are available in 3 configurations and are made of medical grade titanium alloy. The system is provided non-sterilized in the user facility.

The Skeletal Dynamics Protean Fragment Plate System is comprised of:

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

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K140372 page 2 of 2

Intended Use:

Summary of Technological Characteristics / Substantial Equivalence:

The substantial equivalence of the Skeletal Dynamics Protean Fragment Plate System 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 Protean Fragment Plate System 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 Protean Fragment Plate System is substantially equivalent to the predicate device identified in this premarket notification.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 7, 2014

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

Re: K140372

Trade/Device Name: Protean Fragment Plate 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 Dated: February 19, 2014 Received: February 21, 2014

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Ana M. Escagedo

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers. International and Consumer Assistance 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.

Ronald P. Jean -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): K140372

Device Name: Protean Fragment Plate System

Indications For Use: The Skeletal Dynamics Protean Fragment Plate System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, and pelvis, particularly in osteopenic bone.

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)

Elizabet阿莎rank -S

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Division of Orthopedic 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.