The Acumed Anatomic Radial Head System, the Acumed Anatomic Radial Head Long Stems, the Acumed ARH Slide-Loc™ 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 radiohumeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation, 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 device is intended to be press fit or cemented.

Device Description

The Acumed Anatomic Radial Head Long Stems and the Acumed ARH Slide-Loc "" System include modular heads and stems with accessories to anatomically replace the proximal portion of the radius and restore the natural articulation of the radial head with the radial notch of the ulna and capitulum of the distal humerus.

AI/ML Overview

The provided document (K131845) is a 510(k) summary for the Acumed Anatomic Radial Head Long Stems and ARH Slide-Loc™ System, which are elbow hemi-prostheses. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the way one might see for a diagnostic AI device.

Therefore, many of the requested elements regarding acceptance criteria, study design, ground truth, and expert involvement are not applicable or cannot be extracted from this type of regulatory submission. This document describes non-clinical (bench) testing to characterize the strength of the device.

Here's an attempt to answer the questions based on the provided text, indicating where information is not applicable (N/A) or not provided (NP):

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

The document does not specify quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or specific numerical performance results from the non-clinical tests. It broadly states that the devices "underwent static and cyclic load testing to characterize their strength." The comparison table focuses on material, dimensions, and design features, not performance metrics related to acceptance criteria.

Acceptance Criteria	Reported Device Performance
Not explicitly stated as numerical criteria. The implicit acceptance criterion for a 510(k) is that the device is "substantially equivalent" to a legally marketed predicate device, ensuring similar safety and effectiveness. This is assessed through design, material, and in this case, non-clinical (mechanical) testing.	The devices "underwent static and cyclic load testing to characterize their strength." The results were presumably sufficient to demonstrate substantial equivalence to the predicate device, but no specific performance data (e.g., load sustained, cycles to failure) is provided.

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 for Test Set: Not specified. This refers to the number of devices or components tested in the static and cyclic load assessments.
Data Provenance: Not applicable in the context of device mechanical testing. These tests are typically performed in a laboratory setting by the manufacturer or a contract testing facility. It's not clinical data from patients.

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)

Number of Experts: Not applicable. For mechanical testing of an elbow prosthesis, "ground truth" is not established by medical experts interpreting images or patient outcomes. It's determined by engineering standards and measurements.
Qualifications of Experts: Not applicable.

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

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant interpretations in clinical studies or for establishing ground truth from multiple human readers. This is mechanical bench testing.

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

MRMC Study: No. This document describes a medical device (prosthesis), not an AI diagnostic tool.
Effect size of AI improvement: Not applicable.

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

Standalone Performance: No. This device is an implant, not an algorithm.

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

Type of Ground Truth: For mechanical testing, the "ground truth" would be established by the physical properties of the materials and the mechanical performance of the device as measured against engineering standards (e.g., ASTM standards for implants). The document refers to "static and cyclic load testing to characterize their strength," implying that the measured mechanical properties are the "ground truth" for evaluating the physical integrity of the device.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI/machine learning study requiring a training set.

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

Ground Truth Establishment for Training Set: Not applicable.

Summary

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Acumed Anatomic Radial Head Long Stems and ARH Slide-Loc™System 510(k) Notification

K131845

510(k) Summary

Contact Details

Applicant Name:	Acumed LLC5885 NW Cornelius Pass Road, Hillsboro, OR 97124-9432
	Kara Budor, Regulatory Specialist503-207-1412
Date Prepared:	June 19, 2013

Device Name

SEP 30 2013

Trade Name: Acumed Anatomic Radial Head System Acumed Anatomic Radial Head Long Stems Acumed ARH Slide-Loc TM System

Common Name: Elbow Hemi -. Prosthesis

Classification: 21 CFR 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis

Class: II

Product Code: K WI

Legally Marketed Predicate Device(s)

The Anatomic Radial Head System cleared in 2004 (K041858) serves as the predicate device.

Device Description

Intended Use/Indications for use

The Acumed Anatomic Radial Head System, the Anatomic Radial Head Long Stems, the ARH Slide-Loc' System. and accessories are designed specifically for:

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KI31845

Acumed Anatomic Radial Head Long Stems and ARH Slide-Loc™ System 510(k) Notification

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, resistance to conservative treatment.

1. Primary replacement after fracture of the radial head.
1. Symptomatic sequelae after radial head resection.
1. Revision following failed radial head arthroplasty.

The device is intended to be press fit or cemented.

Substantial Equivalence Comparison

The basic comparison between the Anatomic Radial Head Long Stems and the ARH Slide-Loc'ld System to the Acumed Anatomic Radial Head System is given in the table below.

	Anatomic Radial Head Long Stemsand the ARH Slide-Loc™ System	Predicate
Material	Titanium alloy per ASTM F136Cobalt Chromium per ASTM 1537	Titanium alloy per ASTM F136Cobalt Chromium per ASTM 1537
Head Diameter	18mm to 30mm	20mm to 28mm
Stem Diameter	5mm to 12mm	6mm to 10mm
Stem Length	25mm to 65mm	22mm
Stem Finish	Grit Blast	Grit Blast
Head-to-StemConnection	Slide-Loc™ groove and rail connection withneck component and/or Morse Taper	Morse Taper
Head Configuration	Neutral or Left/Right Specific	Neutral
Stem Configuration	Neutral or Left/Right Specific	Neutral
Provided Sterile /Non-sterile	Sterile	Sterile

The Anatomic Radial Head Long Stems, the ARH Slide-Loc™ System, and the Anatomic Radial Head System all include implants and instruments used to replace the radial head. There are some differences, but none of them raise new issues of safety or effectiveness. The Anatomic Radial Head Long Stems and the ARH Slide-Loc™ System are substantially equivalent to the Acumed Anatomic Radial Head System.

Non-clinical Testing

The Anatomic Radial Head Long Stems and the ARH Slide-Loc™ System underwent static and cyclic load testing to characterize their strength.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Acumed. LLC Ms. Kara Budor Regulatory Specialist 5885 North West Cornelius Pass Road Hillsboro, Oregon 97124

September 30, 2013

Re: K131845

Trade/Device Name: Acumed Anatomic Radial Head System Acumed Anatomic Radial Head Long Stems Acumed ARH Slide-Loc'" System Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis Regulatory Class: Class II Product Code: KWI Dated: August 30, 2013 Received: September 3, 2013

Dear Ms. Budor:

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

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Page 2 -- Ms. Kara Budor

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 (OS) 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Elizabeth L. Frank -S

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

Enclosure

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Acumed Anatomic Radial Head Long Stems and ARH Slide-Loc™ System 510(k) Notification

Page 1/1

Indications for Use

510(k) Number (if known): K131845

Device Name: Acumed Anatomic Radial Head System Acumed Anatomic Radial Head Long Stems Acumed ARH Slide-Loc TM System

Indications for Use:

The Acumed Anatomic Radial Head System, the Acumed Anatomic Radial Head Long Stems, the Acumed ARH Slide-Loc™ System, and accessories are designed specifically for: 1. 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, 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 device is intended to be press fit or cemented.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey C. Hanley, Ph.D.
Division of Orthopedic Devices

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.