(83 days)
The SBI Radio-Capitellar implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis: 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The Avanta Radio-Capitellar implant is intended for cemented use only.
The SBI Radio-Capitellar Implant provides an alternative to hemi-arthroplasty of the proximal radial head. The implant is used for the treatment of degenerative joint disorders of the radio-capitellar joint allowing activities of daily living to be performed with no or significantly reduced pain. The radio-capitellar implant is designed to be used with the radial stem components of the rHead and rHead Recon stem implants cleared for market under 510(k) K011819 and K023604 respectively.
This document is a 510(k) summary for a medical device called the SBI Radio-Capitellar Implant. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study of its performance against specific acceptance criteria. Therefore, the information required for this request is largely not available in the provided text.
Here is what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The 510(k) summary focuses on demonstrating substantial equivalence, not on pre-defined performance acceptance criteria for a new study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document refers to "Documentation is provided which demonstrated the SBI Radio-Capitellar Implant to be substantially equivalent to other legally marketed devices," but does not describe a new study with a test set.
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)
This information is not available in the provided text. No new study requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. No new study is described.
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 available in the provided text. The device is an implant, not an AI-assisted diagnostic tool, so an MRMC study related to human readers is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available in the provided text. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided text. No new study requiring ground truth is described.
8. The sample size for the training set
This information is not available in the provided text. As this is a 510(k) for a physical implant, there is no "training set" in the context of device performance in the document.
9. How the ground truth for the training set was established
This information is not available in the provided text. As there is no training set mentioned, there is no information on its ground truth.
In summary, the provided 510(k) document is a regulatory submission for a physical medical implant (SBI Radio-Capitellar Implant) seeking clearance based on substantial equivalence to existing devices. It does not describe a clinical study with detailed acceptance criteria, test sets, or performance metrics in the way one would for a diagnostic or AI-powered device.
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K060038 p.1/2
MAR 3 0 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 Radio-Capitellar Implant |
| Classification name: | Class II, 888.3160 - Prosthesis, Elbow, Semi-Constrained,Cemented |
| Common/Usual Name: | Elbow joint metal/polymer semi-constrained cementedprosthesis |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBIRadio-Capitellar Implant to be substantially equivalent toother legally marketed devices. |
| Device Description: | The SBI Radio-Capitellar Implant provides an alternativeto hemi-arthroplasty of the proximal radial head. Theimplant is used for the treatment of degenerative jointdisorders of the radio-capitellar joint allowing activities ofdaily living to be performed with no or significantlyreduced pain. The radio-capitellar implant is designed tobe used with the radial stem components of the rHead andrHead Recon stem implants cleared for market under510(k) K011819 and K023604 respectively. |
| Intended Use: | The SBI Radio-Capitellar implant is indicated for use in theelbow for reduction or relief of pain and/or improved elbowfunction in skeletally mature patients with the followingconditions: 1) non-inflammatory degenerative joint diseaseincluding osteo-arthritis or traumatic arthritis: 2) |
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inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques.
Material:
The SBI Radio-Capitellar implant is designed from implantable grades of cobalt chrome alloy and ultra-high molecular weight polyethylene (UHMWPE).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 2006
Small Bone Innovations, Inc. c/o Mr. Robert Hoehn Regulatory Associate 505 Park Avenue - 14th Floor New York, New York 10022
Re: K060038
Trade/Device Name: SBI Radio-Capitellar Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow joint metal/polymer semi-constrained cemented prothesis Regulatory Class: II Product Code: JDB Dated: December 15, 2005 Received: January 6, 2006
Dear Mr. Hoehn:
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.
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 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); good manufacturing practice requirements as set
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Page 2 -Mr. Robert Hoehn
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premiated noticated device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours.
Hulut Lemus
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:
Device Name: SBI Radio-Capitellar
Indications For Use:
The SBI Radio-Capitellar implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease including osteo-arthritis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques.
The Avanta Radio-Capitellar implant is intended for cemented use only.
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)
Herbert Lemar us
Page 1 of 1
Division of General, Restorative. and Neurological Devices
510(k) Number K060038
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.