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:
a. Joint destruction 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

Device Description

The SBi Lateral Assembly rHead prosthesis consists of a cobalt chromium stem and head. The stem of the implant is coated with CPTi coating and is designed to be inserted into the shaft of the proximal radius. The head of the implant articulates with the capitellum. The implant is available in several sizes, each of which can be used in right or left hands. A range of trial sizers for each type of implant is available to aid in bone preparation.

AI/ML Overview

This 510(k) premarket notification for the SBI Lateral rHead Implant for radial head replacement does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance.

Instead, this document is a regulatory submission outlining the device description, intended use, and a declaration of substantial equivalence to legally marketed predicate devices. It also includes the FDA's clearance letter for the device.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This document does not describe specific performance criteria or present results from a performance study.
Sample size used for the test set and the data provenance: No test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is discussed.
Adjudication method for the test set: No test set or adjudication is mentioned.
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 device is a physical implant, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical implant.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth for a study is described.
The sample size for the training set: No training set is mentioned as this is not an AI/software device.
How the ground truth for the training set was established: Not applicable.

The document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use, rather than presenting a performance study with defined acceptance criteria.

Summary

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K062898

NOV 1 3 2006

510(k) Summary

Manufacturer:	rms Company8600 Evergreen BoulevardMinneapolis, MN 55433763-786-1520 - Office763-783-5073
Submitted By:	Small Bone InnovationsJames O' Connor505 Park Avenue, 14th FloorNew York, NY 10022joconnor@totalsmallbone.com215-428-1791 - Office212-750-2112 - Fax
Proprietary Name:	SBI Lateral rHead Implant
Classification name:	Class II, 888.3170 - prosthesis, elbow, hemi-, radial,polymer
Common/Usual Name:	Elbow joint radial (hemi-elbow) polymer prosthesis
Substantial Equivalence:	Documentation is provided which demonstrated the SBILateral rHead Implant to be substantially equivalent toother legally marketed devices.
Device Description:	The SBi Lateral Assembly rHead prosthesis consists of acobalt chromium stem and head. The stem of the implant iscoated with CPTi coating and is designed to be insertedinto the shaft of the proximal radius. The head of theimplant articulates with the capitellum. The implant isavailable in several sizes, each of which can be used inright or left hands. A range of trial sizers for each type ofimplant is available to aid in bone preparation.
Intended Use:	The Radial Head Implant is intended for replacement of theproximal end of the radius:
	1. Replacement of the radial head for degenerative, post-traumatic disabilities presenting pain, crepitation anddecreased motion at the radio-humeral and or proximalradio-ulnar joint with:a. Joint destruction or subluxation visible on x-ray.b. Resistance to conservative treatment.

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1. Primary replacement after fracture of the radial head.
1. Symptomatic sequelae after radial head resection.

Material:

ASTM F-1537 wrought cobalt chromium molybdenum alloy for surgical implants ASTM F-1580 titanium powders for coating of surgical implants

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 3 2006

Small Bone Innovations % Mr. James O'Connor 505 Park Avenue, 14th Floor New York, New York 10022

Re: K062898

Trade/Device Name: SBI Lateral rHead Implant Regulation Number: 21 CFR 888.3170 Regulation Name: Elbow joint radial (hemi-elbow) polymer prosthesis. Regulatory Class: II Product Code: K WI Dated: September 15, 2006 Reccived: September 27, 2006

Dear Mr. O'Connor:

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 ideinetions for use stated in the enclosure) to legally marketed predicate devices marketed in intentive 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your revire can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FIA may publish further announcements concerning your device in the Federal I fir and

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the occur product radiation control provisions (Sections 531-542 of the Act), 21 CFR 100-1050.

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Page 2- Mr. James O'Connor

This letter will allow you to begin marketing your device as described in your Section 5 00(k) This letter will anow you to ocgin manketing your and equivalence of your device to a legally prematics notification. "The I DA Inturing of cassession on the spermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your don 2011-01-0120. Also, please note the regulation entitled, Colliact the Office of Compliance at (210) 216 - 216 - 21 807.97). You may obtain " Misorallung by relective to premarker notificansmission of Small of Small other general international and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Ocusanter Flowww.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buskup

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: KO6 2898

Device Name: SBI Lateral rHead

Indications For Use:

The SBi Lateral Assembly rHead is intended for replacement of the proximal end of the radius:

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:
- a. Joint destruction or subluxation visible on x-ray
- b. Resistance to conservative treatment
1. Primary replacement after fracture of the radial head
1. Symptomatic sequelae after radial head resection

Prescription Use V (Part 21 CFR 801 Subpart D)

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)

Page 1 of 1

Jarbare Buchum

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number

06,2898

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.