The Align Radial Head System and accessories are designed specifically for
· Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

o Joint destruction and/or subluxation,
o Resistance to conservative treatment.
· Primary replacement after fracture of the radial head.
· Symptomatic sequelae after radial head resection.
· Revision following failed radial head arthroplasty.

The system is intended for press fit use.

Device Description

The Align Radial Head System is a radial head prosthesis and instrumentation platform that is designed orient the radial head perpendicular to the axis of forearm rotation. The fluted plasma coated radial Stem may assist in biological fixation, and is press fit. Combined with its unique instrumentation, the Align Radial Head System offer the flexibility to adjust the orientation during implantation and restore motion at the radial head, then locks to form a monoblock prosthesis after the optimal implant positioning has been achieved.

The Align Radial Head System is comprised of:

· Multiple sized CoCr Radial Heads with Locking Screw
Multiple sized titanium alloy Stems, titanium plasma spray coated
· System specific instrumentation.

AI/ML Overview

This document is a 510(k) premarket notification for the "Align Radial Head System," a medical device. The information provided focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study where a device meets specific acceptance criteria with quantifiable metrics. Therefore, many of the requested categories for device performance studies cannot be directly extracted or are not applicable.

Here's an attempt to answer based on the provided text, highlighting where information is unavailable or not directly relevant to the request as phrased for AI/software-centric device studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device	Demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility, and packaging.
Mechanical Performance	Passed static, shear, and abrasion testing.
Material Characterization	Performed as part of equivalence testing.
Biocompatibility	Implied through substantial equivalence to predicate device materials.
Sterility and Packaging	Found to be similar to the predicate device.

Note: The document states "Preclinical analysis and testing demonstrated that the Align Radial Head System is substantially equivalent to the predicate device currently marketed. Mechanical and characterization testing which established equivalency included static, shear and abrasion testing." However, specific quantitative acceptance criteria (e.g., "shear strength must be > X MPa") and the exact numerical results are not provided.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The testing mentioned (mechanical and characterization) would involve physical samples of the device, not a "test set" of data in the context of an AI/software study. Data provenance (country of origin, retrospective/prospective) is not applicable for this type of device testing described.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/provided. The ground truth for this device (an implantable prosthesis) would be established through engineering specifications, material science, and pre-clinical mechanical testing, not by expert consensus on a test set in the way AI/software studies use "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for human review of data or images to establish ground truth, which is not the type of testing described for this physical medical device.

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

This information is not applicable. This document describes an orthopedic implant, not an AI or software device that assists human readers.

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

This information is not applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established through engineering specifications, material properties, and physical mechanical testing results (static, shear, and abrasion tests) designed to confirm the device's functional integrity and safety. It's not expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or AI devices.

8. The Sample Size for the Training Set

This information is not applicable/provided. This device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/provided. As above, this device does not use a "training set" in the computational sense.

Summary

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December 22, 2017 Skeletal Dynamics, LLC Ana Escagedo President 8905 SW 87 Avenue, Suite 201 Miami, Florida 33176

Re: K172688

Trade/Device Name: Align Radial Head System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow Joint Radial (Hemi-Elbow) Polymer Prosthesis Regulatory Class: Class II Product Code: KWI Dated: November 17, 2017 Received: November 22, 2017

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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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K172688

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Vincent J. Devlin -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) K172688

Device Name ALIGN Radial Head System

Indications for Use (Describe)

The Align Radial Head System and accessories are designed specifically for

· Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:

o Joint destruction and/or subluxation,
o Resistance to conservative treatment.
· Primary replacement after fracture of the radial head.
· Symptomatic sequelae after radial head resection.
· Revision following failed radial head arthroplasty.

The system is intended for press fit use.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary of Safety and Effectiveness Skeletal Dynamics Align Radial Head System

September 5, 2017

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	Align Radial Head System
Common Name	Elbow Hemi Prosthesis, Radial Head
Classification	21 CFR §888.3170
Product Code	KWI
Class	Class II

Predicate Devices:

Align Radial Head System (K092721)

Description of the Device:

The Align Radial Head System is comprised of:

· Multiple sized CoCr Radial Heads with Locking Screw
Multiple sized titanium alloy Stems, titanium plasma spray coated
· System specific instrumentation.

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Intended Use:

The Align Radial Head System and accessories are designed specifically for

Replacement of the radial head for degenerative or post-traumatic disabilities . presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- o Joint destruction and/or subluxation.
- o Resistance to conservative treatment.
Primary replacement after fracture of the radial head.
Symptomatic sequelae after radial head resection. ●
Revision following failed radial head arthroplasty. 0

The system is intended for press fit use.

Technoloqical Characteristics:

The substantial equivalence of the Align Radial Head 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 Align Radial Head System is substantially equivalent to the predicate device currently marketed. Mechanical and characterization testing which established equivalency included static, shear and abrasion testing. Therefore, the subject device is as safe and effective as legally marketed predicate devices.

Conclusion:

The Skeletal Dynamics Align Radial Head System is substantially equivalent to the predicate device identified in this premarket notification.

Regulation Number and Section

§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.

(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.