The Skeletal Dynamics Inc's Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

Device Description

The Skeletal Dynamics Inc's Distal Humerus Plating System consists of five titanium bone plates in different shapes (medial direct, lateral direct, lateral capitellar, and supracondylar), in multiple lengths, and in left and right configurations to address distal humerus fractures. The plates are made of medical grade titanium allov. The system also includes 2.7mm, 3.5mm and 4.5mm locking and compression titanium alloy screws and 3.0mm polyaxial Cobalt Chrome locking screws which are provided in various lengths. The System is being modified to include additional lengths of existing screw options and new 3.5mm and 4.5mm locking and compression Titanium Alloy Screws. Additionally, minor modifications have been made to the plates to accept the new screws above mentioned. Also included in the system is specialized instrumentation. The System is provided nonsterile for sterilization in the user facility.

The Distal Humerus Plating System is comprised of:

· Titanium alloy plates, screws, and fasteners
· CoCr Cannulated Polyaxial Locking Screws (PLS)
· Stainless steel K-wires (for provisional fixation; not for implantation)
· System specific instrumentation

AI/ML Overview

This document describes a medical device, the "Distal Humerus Plating System," which is a metallic bone fixation appliance. The FDA clearance is based on substantial equivalence to a predicate device, not on extensive clinical outcome studies typically associated with AI/software devices.

Therefore, many of the requested points, particularly those related to AI algorithm performance (acceptance criteria, ground truth, expert consensus, MRMC studies, etc.), are not applicable to this type of device clearance. The clearance is based on engineering analysis and mechanical testing, ensuring the device's physical properties are safe and effective.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is absent:

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

Acceptance Criteria (for this type of device): The primary acceptance criterion for this type of medical device cleared through the 510(k) pathway is substantial equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. For metallic bone fixation, this typically involves material compatibility, mechanical strength, and design similarities.
Reported Device Performance: The document states:
- "Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamics Inc's Distal Humerus Plating System is equivalent to predicate devices currently marketed."
- "Static testing, which established equivalency included ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws."
- "The subject device is as safe and effective as the legally marketed predicate device."

Table of Acceptance Criteria and Performance (as applicable to this device type):

Acceptance Criteria Category	Specific Criteria (Implicitly Met for 510(k))	Reported Device Performance
Substantial Equivalence	Equivalence in Intended Use, Indications for Use, Materials, Design (Fundamental Scientific Technology), Performance, Sterility, and Packaging.	"demonstrated that the Skeletal Dynamics Inc's Distal Humerus Plating System is equivalent to predicate devices currently marketed."
Material Properties	Biocompatibility, appropriate material strength and longevity (Titanium alloy, CoCr).	Made of "medical grade titanium alloy" and "CoCr." Implies meeting standard material specifications.
Mechanical Performance	Mechanical strength and stability sufficient for intended use (bone fixation).	"Engineering analysis and mechanical testing demonstrated...Static testing, which established equivalency included ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws."
Safety & Effectiveness	No new issues of safety or effectiveness compared to predicate.	"does not present any new issues of safety or effectiveness." "The subject device is as safe and effective as the legally marketed predicate device."

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

Not Applicable. This is a hardware device cleared through a 510(k) pathway, not an AI/software device requiring a test set of medical images or patient data in the sense of an algorithm. The "testing" refers to mechanical and engineering tests, not data sets.

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

Not Applicable. See point 2. Ground truth in the context of AI relates to expert labels on data. For this device, "ground truth" relates to engineering standards and validated test methods.

4. Adjudication method for the test set

Not Applicable. See point 2.

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 a physical implantable device, not an AI-assisted diagnostic tool. MRMC studies are used for evaluating the impact of AI on human interpretation of medical images.

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

Not Applicable. This is not an algorithm.

7. The type of ground truth used

Ground Truth (for this device type): Engineering specifications, validated mechanical testing standards (e.g., ASTM-F543-17), and material properties are the "ground truth" against which the device's performance is measured for substantial equivalence. There isn't "expert consensus" or "pathology" in the sense of clinical image interpretation for this specific clearance.

8. The sample size for the training set

Not Applicable. This is a hardware device, not an AI algorithm requiring a training set.

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

Not Applicable. See point 8.

In summary: The provided FDA clearance document for the "Distal Humerus Plating System" pertains to a physical medical device. The regulatory pathway (510(k)) relies on demonstrating substantial equivalence to a predicate device, primarily through engineering analysis and mechanical testing. The questions you posed are highly relevant to AI/machine learning medical devices, but not to this specific hardware device clearance.

Summary

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January 13, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Skeletal Dynamics, Inc. Alexandra Rodriguez Regulatory Affairs Specialist 7300 N. Kendall Drive, Suite 400 Miami, Florida 33156

Re: K213895

Trade/Device Name: Distal Humerus 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 Dated: December 7, 2021 Received: December 14, 2021

Dear Alexandra Rodriguez:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-

combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K213895

Device Name

Distal Humerus Plating System

Indications for Use (Describe)

The Skeletal Dynamics Inc's Distal Humerus Plating System is intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY Skeletal Dynamics Inc.'s Distal Humerus Plating System

Submitter

Skeletal Dynamics, Inc. 7300 N. Kendall Drive Suite 400 Miami, FL 33156 Phone: 305-596-7585 ext.7121 Facsimile: 305-596-7591 Contact Person: Alexandra Rodriquez Date Prepared: January 13, 2022

Name and Classification

Trade Name: Distal Humerus Plating System Classification Name: Single/multiple component metallic bone fixation appliances and accessories Classification Number: 21 CFR §888.3030 Requlatory Class: Class II Product Code: HRS

Predicate Devices

Distal Humerus Plating System, K200367

Device Description

The Distal Humerus Plating System is comprised of:

· Titanium alloy plates, screws, and fasteners
· CoCr Cannulated Polyaxial Locking Screws (PLS)
· Stainless steel K-wires (for provisional fixation; not for implantation)
· System specific instrumentation

Indications for Use

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Summary of Technological Characteristics

The substantial equivalence of the Distal Humerus Plating 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

Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamics Inc's Distal Humerus Plating System is equivalent to predicate devices currently marketed. Static testing, which established equivalency included ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws. The subject device is as safe and effective as the legally marketed predicate device.

Conclusions

The Skeletal Dynamics Inc's Distal Humerus Plating System 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.