The Skeletal Dynamics Geminus Volar Distal Radius Plate System contains bone plates for the repair of either distal or volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. The Skeletal Dynamics Geminus Volar Distal Radius Plate is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis and fixed angle pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility. The Skeletal Dynamics Geminus Volar Distal Radius Plate System is comprised of: titanium alloy plates, washers and screws; stainless steel K-wires (for provisional fixation not for implantation); system specific instrumentation.

AI/ML Overview

This is a 510(k) premarket notification for a medical device (Skeletal Dynamics Geminus Volar Distal Radius Plate System), not an AI/ML device. Therefore, the questions related to AI/ML device performance (acceptance criteria, training/test set details, expert ground truth, MRMC studies, standalone performance) are not applicable.

The provided document describes the safety and effectiveness of a bone plate system by demonstrating its substantial equivalence to a predicate device already on the market.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in the way one would for an AI/ML model (e.g., specific thresholds for accuracy, sensitivity, specificity). Instead, the "acceptance criteria" for this conventional medical device revolve around demonstrating substantial equivalence to a legally marketed predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Substantial Equivalence to predicate device (Synthes Titanium Alloy Volar Distal Radius Plate System K963798) in:	The Skeletal Dynamics Geminus Volar Distal Radius Plate System demonstrated substantial equivalence by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility, and packaging.
- Intended Use	Similarities demonstrated
- Indications for Use	Similarities demonstrated
- Materials	Similarities demonstrated
- Design (fundamental scientific technology)	Similarities demonstrated
- Performance	Preclinical analysis and cadaveric testing, including static, fatigue, and dynamic mechanical testing, established equivalency.
- Sterility	Similarities demonstrated
- Packaging	Similarities demonstrated
Safe and Effective	Concluded to be as safe and effective as legally marketed predicate devices based on equivalence.

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

Test Set Sample Size: Not specified in terms of numerical count. The testing involved "preclinical analysis and cadaveric testing."
Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted by Skeletal Dynamics, LLC. It's prospective in the sense that the testing was performed for this 510(k) submission to demonstrate equivalence.

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

This concept is not applicable to a conventional medical device like a bone plate system. The "truth" is established through mechanical and cadaveric testing against established engineering principles and medical device standards, not through expert consensus on interpretations of data.

4. Adjudication method for the test set:

Not applicable. There's no "ground truth" to adjudicate in the context of expert review for this type of device. Performance is determined by objective mechanical testing and cadaveric studies.

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 is not an AI/ML device, and no human reader studies are mentioned or relevant for demonstrating equivalence of a bone plate system.

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

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

For the performance testing (mechanical and cadaveric testing), the "ground truth" is based on:
- Mechanical properties and performance standards: The device's ability to withstand static, fatigue, and dynamic loads as expected for bone fixation, likely compared against established benchmarks or the predicate device's performance.
- Cadaveric testing: Demonstrating the surgical implantation characteristics and initial biomechanical stability in a simulated human environment.
- Comparison to predicate device: The ultimate "ground truth" for substantial equivalence is demonstrating that its performance is comparable to an already approved device.

8. The sample size for the training set:

Not applicable. There is no AI/ML model to train for this device.

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

Not applicable. There is no AI/ML model to train for this device.

Summary

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K111620

AUG 2 3 2011

Image /page/0/Picture/2 description: The image shows a logo for a company called "Skeletal Dynamics". The logo consists of a stylized graphic to the left of the company name. The graphic is composed of four squares arranged in a 2x2 grid, with the top-right and bottom-left squares filled in black, and the other two squares are white.

510(k) Summary of Safety and Effectiveness Skeletal Dynamics Geminus Volar Distal Radius Plate System

August 3, 2011

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

Trade Name, Common Name, Classification:

Trade Names Skeletal Dynamics Geminus Volar Distal Radius Plate System Common Name Plate, fixation, bone Classification 21 CFR §888.3030 Product Code HRS Class Class II

Predicate Devices:

Synthes Titanium Alloy Volar Distal Radius Plate System (K963798)

Description of the Device:

The Skeletal Dynamics Geminus Volar Distal Radius Plate is available in 6 sizes and is made of medical grade titanium alloy. Cortical locking screws affix the plate to the diaphysis and fixed angle pegs are used for distal bone fragments. The system is provided non-sterile and is sterilized in the user facility.

The Skeletal Dynamics Geminus Volar Distal Radius Plate System is comprised of:

· titanium alloy plates, washers and screws
· stainless steel K-wires (for provisional fixation not for implantation)
· system specific instrumentation.

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Intended Use:

The Skeletal Dynamics Geminus Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.

Summary of Technological Characteristics / Substantial Equivalence:

The substantial equivalence of the Skeletal Dynamics Geminus Volar Distal Radius 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 cadaveric testing demonstrated that the Skeletal Dynamics Geminus Volar Distal Radius Plate System is substantially equivalent to the predicate device which is currently marketed. Mechanical testing which established equivalency included static, fatigue and dynamic testing. Therefore, the subject device is as safe and effective as legally marketed predicate devices.

Conclusion:

The Skeletal Dynamics Geminus Volar Distal Radius Plate System is substantially equivalent to the predicate device identified in this premarket notification.

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KIII620

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping figures representing people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

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

Skeletal Dynamics, LLC % Ms. Ana Escagedo 8905 SW 87" Avenue Suite 201 Miami, Florida 33176

AUG 23 2011

Re: K111620

Trade/Device Name: Skeletal Dynamics Geminus Volar Distal Radius Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS, HWC Dated: August 2, 2011 Received: August 4, 2011

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

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Page 2 - Ms. Ana Escagedo

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 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erin I. Keith

-S- Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KHI620

Device Name: Skeletal Dynamics Geminus Volar Distal Radius Plate System

Indications For Use: The Skeletal Dynamics Geminus Volar Distal Radius Plate System is intended for fixation of fractures and osteotomies of the distal radius.

Prescription Use X (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)

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(Division Sign Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111620

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.