The Geminus Volar Distal Radius Plate System contains bone plates for the repair of distal volar radial fractures. Included in the set are titanium bone screws, fixation pegs, fragment plates, and specialized instrumentation. Also included are a Hook Plate Extension to buttress a volar marginal fragment, and cannulated cobalt chrome polyaxial locking screws for trajectories different than those of the fixed angled bone plates.

The 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, fixed angle pegs are used for distal bone fragments. The titanium Hook Plate Extension locks to the plate by a means of titanium screw. The system is provided non-sterile and is sterilized in the user facility.

The Geminus Volar Distal Radius Plate System is comprised of:

· Titanium alloy plates, washers and screws
· Cannulated cobalt chrome polyaxial locking screws
· Titanium alloy hook plate extension
· Stainless steel k-wires (for provisional fixation not for implantation)
· System specific instrumentation.

AI/ML Overview

The provided text describes a medical device, the Skeletal Dynamics GEMINUS Volar Distal Radius Plate System, and its clearance through the 510(k) pathway. This pathway relies on demonstrating substantial equivalence to predicate devices, rather than performing clinical studies to establish specific acceptance criteria and performance metrics for the device itself in terms of diagnostic accuracy or clinical outcomes.

Therefore, many of the requested elements for describing acceptance criteria and a study that proves the device meets them are not applicable in this context. The 510(k) summary focuses on preclinical performance testing to demonstrate equivalence, not clinical performance.

Here's an analysis based on the provided text, addressing elements that are applicable and explaining why others are not:

Acceptance Criteria and Reported Device Performance

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

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	Similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility, and packaging to predicate devices. No new issues of safety or effectiveness.	The device demonstrates substantial equivalence to the predicate devices (Skeletal Dynamics GEMINUS Volar Distal Radius Plate K111620, K122737; Synthes Distal Radius Plate K963798; Medpac SFC K951303) based on these characteristics. The minor difference in the hook plate extension does not raise new questions of safety or effectiveness. Performance data demonstrates it is as safe and effective as the predicate devices.
Preclinical Mechanical Performance	Meets static and dynamic mechanical testing standards sufficient to demonstrate equivalence to predicate devices.	Mechanical testing, including static and dynamic testing, was conducted and established equivalency to the predicate devices. This implies the device performed within acceptable bounds comparable to the predicate devices, though specific numerical criteria or results are not detailed in this summary.

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

Not Applicable / Not Provided: The text describes preclinical mechanical testing rather than testing on a clinical "test set" of patients or data. Mechanical tests typically involve a specific number of manufactured units or samples for laboratory testing. The sample size for these mechanical tests is not specified, nor is data provenance in the clinical sense (country, retrospective/prospective).

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)

Not Applicable: This device is a bone fixation plate, not a diagnostic imaging device or AI algorithm that requires expert ground truth for interpretation. Mechanical testing typically involves engineers and quality assurance personnel, but "ground truth" in the clinical imaging sense is not relevant here.

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

Not Applicable: Adjudication methods are used for resolving disagreements in expert interpretations, primarily in clinical studies or evaluations of diagnostic performance. This is irrelevant for mechanical testing of a medical implant.

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: An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic tasks. This device is a surgical implant and does not involve AI or human reading tasks.

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

Not Applicable: This device is a metallic bone fixation system, not an algorithm.

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

Not Applicable: For mechanical testing, the "ground truth" would be established engineering principles, material specifications, and regulatory standards for device performance, against which the device's mechanical behavior is measured. No clinical "ground truth" type (like pathology or outcomes data) is identified as this is not a clinical study.

8. The sample size for the training set

Not Applicable: This device is not an AI/ML algorithm that requires a "training set."

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

Not Applicable: As stated above, there is no training set for this device.

Summary of the 510(k) for the GEMINUS Volar Distal Radius Plate System:

The 510(k) clearance for the Skeletal Dynamics GEMINUS Volar Distal Radius Plate System relies on demonstrating substantial equivalence to existing predicate devices already on the market. This means the device met acceptance criteria related to having the same intended use, indications for use, materials, fundamental scientific design, performance characteristics (including preclinical mechanical testing), sterility, and packaging as its predicates. The key finding is that the device does not present any new issues of safety or effectiveness compared to the predicate devices. The performance testing conducted was preclinical mechanical testing (static and dynamic), which was deemed sufficient to establish this equivalency. No clinical studies involving human subjects, diagnostic performance evaluation, or AI algorithms were part of this 510(k) submission.

Summary

{0}------------------------------------------------

510(k) SUMMARY

SKELETAL DYNAMICS, LLC's GEMINUS VOLAR DISTAL RADIUS PLATE SYSTEM

JAN 1 8 2013

January 11, 2013

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

Trade name, common name, classification:

Trade names	Geminus Volar Distal Radius Plate System
Common name:	Plate, fixation, bone
Classification:	21 CFR §888.3030, Single/Multiple Component Metallic Bone FixationAppliances and Accessories
Product code:	HRS
Class:	Class II

Predicate devices:

Skeletal Dynamics GEMINUS Volar Distal Radius Plate (K111620, K122737), Synthes Distal Radius Plate (K963798), and Medpac SFC (K951303)

Description of the device:

The Geminus Volar Distal Radius Plate System is comprised of:

· Titanium alloy plates, washers and screws
· Cannulated cobalt chrome polyaxial locking screws
· Titanium alloy hook plate extension
· Stainless steel k-wires (for provisional fixation not for implantation)
· System specific instrumentation.

Intended use:

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

{1}------------------------------------------------

Summary of technological characteristics / substantial equivale nce:

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

Conclusion

The Skeletal Dynamics Geminus Volar Distal Radius Plate System has the same intended use and indications, principles of operation and technological characteristics as the minor difference in the hook plate extension does not raise any new questions of safety or effectiveness. Performance data demonstrates that the Geminus Volar Distal Radius Plate System is as safe and effective as the Geminus Volar Distal Radius Plate System (K111620, K122737) and therefore is substantially equivalent to its predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES.USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a stylized human figure, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter dated: January 18, 2013

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

Re: K122310

Trade/Device Name: 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: Class II Product Code: HRS Dated: November 30, 2012 Received: December 3, 2012

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

{3}------------------------------------------------

Page 2 – Ms. Ana M. Escagedo

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 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,

Mark N. Melkerson

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications for Use Statement

510(k) Number (if known): K122310

Device Name: 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 × (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Michael C. Owens 2013.01.18 14:23:35 -05'00'

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.