The 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
a. Joint destruction and/or subluxation visible on x-ray
b. Resistance to conservative treatment
Primary replacement after fracture of the radial head.
Symptomatic sequelae after radial head resection
Revision following failed radial head arthroplasty.

Device Description

The Synthes Radial Head Prosthesis is a two-piece modular system comprised of titanium alloy stem and cobalt chrome head components with an integral screw and side-loading application to allow for in situ assembly. The system consists of a range of lengths and diameters for the stem in both straight and curved configurations as well as heads in a range of diameters and heights to accommodate the surgical need.

AI/ML Overview

This document is a 510(k) Summary for the Synthes Radial Head Prosthesis System. It is focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way one might for a novel diagnostic or AI device.

Therefore, many of the specific questions regarding acceptance criteria, device performance metrics (e.g., sensitivity, specificity), sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not directly applicable or explicitly detailed in this type of submission for a medical implant device.

However, I can extract the relevant information regarding the performance testing and the approach to demonstrating substantial equivalence.

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

Context: The Synthes Radial Head Prosthesis System is a medical implant (a modular radial head prosthesis) intended for the replacement of the radial head in specific orthopaedic conditions. The 510(k) submission aims to demonstrate that this new device is "substantially equivalent" to existing, legally marketed predicate devices. This means it has the same intended use, fundamental technological characteristics, and similar materials, and that performance testing shows it is as safe and effective as the predicates.

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

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics typical of, for example, diagnostic accuracy (like sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices through various tests and analyses.

Acceptance Criteria (Implied)	Reported (Demonstrated) Device Performance
Withstand clinical loads of the radiocapitellar joint (similar to predicates)	In vitro performance testing demonstrates the ability of the proposed device to withstand the same clinical loads of the radiocapitellar joint. (Specific numerical thresholds or comparative data against predicates are not provided in this summary but would have been part of the full 510(k) submission).
Similar surface characteristics to predicate devices (for stems)	Macro Surface Analysis (roughness, pore size, pore depth, etc.), Scanning Electron Microscopy (SEM), and X-Ray Photoelectron Spectroscopy (XPS) have been conducted to demonstrate similar macro- and micro-surface characteristics in comparison to existing devices (Titan Endoskeleton Interbody Fusion Devices, Rhausler Plage Anterior Cervical Fusion System, Straumann Dental Implant System, Synthes Epoca Titanium Humeral Stem, Synthes Epoca Titanium Humeral Stem w/ (HA) Coating). The literature review also relates these device surface characteristics to physiological responses. Specific quantitative comparisons are not provided in this summary.
Same indications for use as predicates	The proposed Synthes Radial Head Prosthesis has the same indications for use as the predicate Biomet ExploR™ (K051385) and Ascension® (K032686) Modular Radial Head Devices.
Same fundamental technological characteristics as predicates	The proposed Synthes Radial Head Prosthesis has the same fundamental technological characteristics as the predicate Biomet ExploR™ (K051385) and Ascension® (K032686) Modular Radial Head Devices. This refers to the two-piece modular system with a titanium alloy stem and cobalt chrome head components with integral screw and side-loading application.
Similar materials as predicates	The proposed Synthes Radial Head Prosthesis has similar materials as the predicate Biomet ExploR™ (K051385) and Ascension® (K032686) Modular Radial Head Devices (titanium alloy and cobalt chrome).
No new issues of safety and effectiveness	Based on the discussed similarities in conjunction with performance testing, physical macro and micro surface analysis, surface chemistry analysis, and literature review the proposed Synthes Radial Head Prosthesis System does not raise any new issues of safety and effectiveness in comparison to the predicate devices.

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

Sample Size: The document does not specify a "sample size" in terms of patients or anatomical specimens as one would for a clinical trial or diagnostic study. The "test set" here refers to the actual physical devices (or components thereof) that underwent in vitro performance testing and surface analysis. The number of such devices or samples tested is not disclosed in this summary.
Data Provenance: The tests are described as "in vitro performance testing," "Macro Surface Analysis," "Scanning Electron Microscopy (SEM)," and "X-Ray Photoelectron Spectroscopy (XPS)." These are laboratory-based studies, not clinical studies involving patient data from specific countries or populations. The data provenance is controlled laboratory conditions.

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

This question is not applicable to this type of device submission. The "ground truth" for a mechanical implant is its physical and mechanical properties, not expert-derived diagnostic labels. The performance is assessed through engineering and materials science testing, not clinical diagnosis by experts.

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

This question is not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations of clinical data or images. This submission focuses on the objective physical and mechanical properties of an 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

This question is not applicable. The device is a physical implant, not a diagnostic imaging or AI algorithm that would involve human readers or AI assistance.

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

This question is not applicable. The device is a physical implant, not an algorithm.

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

The "ground truth" for this device's performance is established by engineering and materials science standards and measurements. This includes:
- Mechanical properties: The ability to withstand clinical loads.
- Material properties: Chemical composition and physical and macro/micro surface characteristics.
- Peer-reviewed literature: Used to demonstrate how these material and surface characteristics relate to physiological responses.

8. The sample size for the training set

This question is not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a physical implant. The design and manufacturing processes are based on engineering principles and prior knowledge from predicate devices, rather than machine learning training.

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

This question is not applicable, as there is no training set. The "ground truth" for the device's design and material selection would be established through established engineering principles, materials science, and conformity to relevant ASTM/ISO standards (though specific standards are not named in this summary).

Summary

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JUN 1 9 2012

510(k) Summary

K112030 ( V2)

Date Prepared: June 13, 2011

Sponsor: Synthes Angela F. Lassandro 1301 Goshen Parkway West Chester, PA 19380 (610) 719-6854 Synthes Radial Head Prosthesis System Device Name: Classification: CLASS II, §888.3170 - Elbow joint radial (hemi-elbow) polymer prosthesis Product Code: K WI · Biomet ExploR™ Radial Head Prosthesis System (K051385) Predicate Device: Ascension® Modular Radial Head (K032686) Titan Endoskeleton Interbody Fusion Devices (K 11626, K 102067, K 100889, K083714, and K080615) Rhausler Plage Anterior Cervical Fusion System (K111272) Straumann Dental Implant System (K053088 and K033984) Synthes Epoca Titanium Humeral Stem (K072578) Synthes Epoca Titanium Humeral Stem w/ (HA) Coating (K083439) The Synthes Radial Head Prosthesis is a two-piece modular system comprised Device of titanium alloy stem and cobalt chrome head components with an integral Description: screw and side-loading application to allow for in situ assembly. The system consists of a range of lengths and diameters for the stem in both straight and curved configurations as well as heads in a range of diameters and heights to accommodate the surgical need. The Synthes Radial Head Prosthesis System is indicated for the: Intended Use: Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radiohumeral and/or proximal radio-ulnar joint with: Joint destruction and/or subluxation visible on x-ray a. Resistance to conservative treatment b. Primary replacement after fracture of the radial head 2. Symptomatic sequelae after radial head resection 3. Revision following failed radial head arthroplasty

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KII 2030 (2/2)

Substantial Equivalence:

The proposed Synthes Radial Head Prosthesis has the same indications for use, the same fundamental technological characteristics, and similar materials as the predicate Biomet ExploR™ (K051385) and Ascension® (K032686) Modular Radial Head Devices. In vitro performance testing demonstrates the ability of the proposed device to withstand the same clinical loads of the radiocapitellar joint.

Additionally, the Synthes Radial Head Prosthesis Stems have been shown to have similar surface characteristics to the Titan Endoskeleton Interbody Fusion Devices (K111626, K102067, K100889, K083714, and K080615), Rhausler Plage Anterior Cervical Fusion System (K111272), Straumann Dental Implant System (K053088 and K033984), Synthes Epoca Titanium Humeral Stem (K072578), Synthes Epoca Titanium Humeral Stem w/ (HA) Coating (K083439). Macro Surface Analysis (roughness, pore size, pore depth, etc.), Scanning Electron Microscopy (SEM), and X-Ray Photoelectron Spectroscopy (XPS) have been conducted to demonstrate similar macroand micro- surface characteristics in comparison to existing devices. Additionally, a literature review has been conducted demonstrating relating the device surface characteristics to physiological responses.

Based on the discussed similarities in conjunction with performance testing, physical macro and micro surface analysis, surface chemistry analysis, and literature review the proposed Synthes Radial Head Prosthesis System does not raise any new issues of safety and effectiveness in comparison to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white, giving it a formal and official appearance.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUN 1 9 2012

Synthes USA, LLC % Ms. Angela F. Lassandro 1301 Goshen Parkway West Chester, Pennsylvania 19380

Re: K112030

Trade/Device Name: Synthes Radial Head Prosthesis System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: II Product Code: KWI Dated: May 17, 2012 Received: May 21, 2012

Dear Ms. Lassandro:

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. Angela F. Lassandro

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 (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 vours.

Euin Keith

6-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 Statement

510(k) Number (if known):

Device Name: Synthes Radial Head Prosthesis System

Indications for Use:

The Synthes Radial Head Prosthesis System is intended for:

1. The 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
  a. Joint destruction and/or subluxation visible on x-ray
b. Resistance to conservative treatment
1. Primary replacement after fracture of the radial head.
1. Symptomatic sequelae after radia! head resection
1. Revision following failed radial head arthroplasty.

Prescription Use X (Per 21 CFR 801.109)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Of Division of Surgic i. Orthopedic, and Restorative De vices

510(k) Number K112030

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.