The Skeletal Dynamics 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 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 alloy. Locking and compression screws in 2.7mm, 3.5mm and 4.5mm and 3.0mm polyaxial locking screws are provided in various lengths. Also included in the system is specialized instrumentation. The System is provided non-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

The provided text is a 510(k) summary for a medical device called the "Distal Humerus Plating System," which is a metallic bone fixation appliance. It describes the device, its indications for use, and how its substantial equivalence to predicate devices was demonstrated through mechanical testing.

However, the request asks for information related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD). The provided document does not describe an AI/SaMD device; instead, it describes a hardware device (bone plates and screws) and the performance testing (mechanical testing, specifically ASTM standards) done to demonstrate its equivalence to predicate devices.

Therefore, I cannot fulfill all aspects of your request because the document does not contain information about:

A table of acceptance criteria and reported device performance related to AI metrics (e.g., sensitivity, specificity, AUC).
Sample sizes for test sets in the context of AI (e.g., number of images).
Data provenance for AI test sets.
Number of experts and their qualifications for establishing ground truth for AI.
Adjudication methods for AI test sets.
MRMC studies for AI and human-in-the-loop performance.
Standalone performance for an AI algorithm.
Types of ground truth for AI (e.g., pathology, outcomes data).
Sample size for AI training sets.
How ground truth for AI training sets was established.

The document focuses on the mechanical and material equivalence of a physical implantable device.

Here's what can be extracted and inferred from the provided text, reinterpreted as much as possible for your request, but with the explicit understanding that it's not an AI/SaMD context:

Device Description:
The Skeletal Dynamics Distal Humerus Plating System is a physical medical device consisting of titanium bone plates, locking and compression screws, and specialized instrumentation, designed for fixing fractures of the distal humerus.

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

Since this is a physical device, the "acceptance criteria" and "performance" are based on mechanical equivalency to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical properties equivalent to predicate devices	Demonstrated equivalency through ASTM F382 and ASTM F543 testing.
Safe and effective as legally marketed predicate devices	Subject device is concluded to be as safe and effective as predicate devices.
Compliance with ASTM F382 (Metallic Bone Plates) standards	Met (stated a study included this standard)
Compliance with ASTM F543 (Metallic Bone Screws) standards	Met (stated a study included this standard)

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

Test Set Sample Size: Not explicitly stated as "sample size" in the context of a discrete number of tests on identical units, but indicated to be sufficient to demonstrate equivalency according to ASTM standards. ASTM standards define the number of samples typically required for such tests.
Data Provenance: The "study" is an engineering analysis and mechanical testing performed to demonstrate equivalency. The data provenance would be laboratory testing conducted by the manufacturer or a third-party lab. No information on country of origin of "data" in a clinical/retrospective sense, as this is pre-market mechanical testing.

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

Not applicable in the context of mechanical testing. The "ground truth" for mechanical testing is established by the specified parameters and methodologies within the ASTM standards themselves, interpreted and executed by qualified engineers and technicians. This is not about human labelers/readers.

4. Adjudication method for the test set:

Not applicable. This is mechanical testing against defined engineering standards, not human expert adjudication.

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 physical implant, not an AI or imaging device that would involve human readers.

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

Not applicable. No algorithm is involved.

7. The type of ground truth used:

The "ground truth" for the performance testing of this physical device is the mechanical and material specifications and performance parameters outlined in the referenced ASTM standards (ASTM F382 for plates and ASTM F543 for screws) and the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a "training set."

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

Not applicable.

In summary, the provided document details the regulatory clearance of a physical orthopedic implant based on demonstrating mechanical equivalence to existing products, not an AI/SaMD product. Therefore, most of your specific questions related to AI/SaMD testing and ground truth cannot be answered from this text.

Summary

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May 14, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".

Skeletal Dynamics, Inc. Ana M. Escagedo President 7300 N. Kendall Drive, Suite 400 Miami, Florida 33156

Re: K200367

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, HWC Dated: February 13, 2020 Received: February 14, 2020

Dear Ana 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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 mediation-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, MPH 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)

K200367

Device Name

Distal Humerus Plating System

Indications for Use (Describe)

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 Dvnamics Inc.'s Distal Humerus Plating System

Submitter

Skeletal Dynamics, Inc. 7300 N. Kendall Drive Suite 400 Miami, FL 33156 Phone: 305-596-7585 Facsimile: 305-596-7591 Contact Person: Ana M. Escagedo Date Prepared: March 29, 2020

Name and Classification

Name:	Distal Humerus Plating System
Common Name:	Plate, Fixation, Bone
Classification:	21 CFR §888.3030
Regulatory Class:	Class II
Product Code:	HRS

Predicate Device

Synthes Variable Angle LCP Elbow System (Medial and Posterolateral Distal Humerus Plates), K120717

Additional Predicate: Synthes 3.5mm LCP Distal Humerus System, K033995

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

The 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.

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.

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Performance Testing

Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamics Distal Humerus Plating System is equivalent to predicate devices currently marketed. Mechanical testing which established equivalency included ASTM F382, Standard Specification and Test Methods for Metallic Bone Plates, and ASTM F543, Standard Specification and Test Methods for Metallic Bone Screws. Therefore, the subject device is as safe and effective as the legally marketed predicate device.

Conclusions

The Skeletal Dynamics 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.