(89 days)
The R&B Surgical Solutions SmartPlate™ Cervical Plate System is intended for anterior screw fixation of the cervical spine and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include failed previous fusion, pseudarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis or degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
The R&B Surgical Solutions SmartPlate™ Cervical Plate System consists of plates, screws and screw-retaining covers. The device, as a system, is designed to provide stabilization as an adjunct to cervical fusion.
The provided document is a 510(k) summary for the R&B Surgical Solutions SmartPlate™ Cervical Plate System. It describes the device, its intended use, materials, and substantial equivalence to previously cleared devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) summary explicitly states: "Documentation was provided which demonstrated the SmartPlate™ Cervical Plate System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in indications for use, anatomic sites, performance and material of manufacture."
This means that the device was cleared based on its similarity to existing, legally marketed devices, rather than through a new clinical performance study demonstrating specific acceptance criteria with metrics like sensitivity, specificity, or accuracy.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and the reported device performance: This information is not present in the document.
- Sample size used for the test set and the data provenance: Not applicable as no dedicated performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The clearance is based on substantial equivalence, which is a regulatory pathway that does not typically require new clinical performance studies demonstrating specific quantitative performance metrics when compared to a predicate device.
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DEC = 3 2003
Attachment VIII 510(k) Summary
| Sponsor: | R&B Surgical Solutions, LLC2530 Superior Ave., Suite 703Cleveland, OH 44114 |
|---|---|
| ContactPerson: | James M. Moran, Vice President of Engineering and Chief Technical Officer |
| ProprietaryTrade Name: | R&B Surgical Solutions SmartPlate™ Cervical Plate System |
| DeviceDescription: | The R&B Surgical Solutions SmartPlate™ Cervical Plate System consists ofplates, screws and screw-retaining covers. The device, as a system, is designed toprovide stabilization as an adjunct to cervical fusion. |
| Intended Use: | The R&B Surgical Solutions SmartPlate™ Cervical Plate System is intended foranterior screw fixation of the cervical spine and is designed to providestabilization as an adjunct to spinal fusion at these levels. Indications for theuse of this device include failed previous fusion, pseudarthrosis, tumor,deformity, spinal stenosis, trauma, spondylolisthesis or degenerative discdisease defined as neck pain of discogenic origin with the degeneration of thedisc confirmed by history and radiographic studies.WARNING: The R&B Surgical Solutions SmartPlate™ Cervical Plate System isnot intended for screw attachment or fixation to the posterior elements (pedicles)of the cervical, thoracic or lumbar spine. |
| Materials: | The SmartPlate™ Cervical Plate System components are manufactured fromtitanium alloy (ASTM F136). |
| SubstantialEquivalence: | Documentation was provided which demonstrated the SmartPlate™ CervicalPlate System to be substantially equivalent to previously cleared devices. Thesubstantial equivalence is based upon equivalence in indications for use,anatomic sites, performance and material of manufacture. |
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
R&B Surgical Solutions, LLC C/o Ms. Karen E. Warden, MEBE KWERC 8202 Sherman Road Chesterland, Ohio 44026
Re: K032752
K032732
Trade/Device Name: SmartPlate™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: September 5, 2003 Received: September 5, 2003
Dear Ms. Warden:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section > for(x) premainer is substantially equivalent (for the indications
referenced above and have determined the device is substanted in interstate referenced above and nave decemblicate devices marketed predicate devices marketed in interstate for use stated in the enclosury manoted provinces provide increating of the Rederal Food. Drug commerce prior to May 28, 1970, the chance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provision onlinestion (PM devices that have been reclassified in accenance whiles approval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . and Cosmetic Act (Act) that do not require approvate of the general controls of the Act. The You may, mercede, market the Act include requirements for annual registration. Insting of general controls provisions of the Fielding, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) moved in the major regulations affecting your device can
may be subject to such additional controls. Title of to 900 to 908 - In add may be subject to such additional controlior Links. John 800 to 898. In addition, FDA may be found in the Ood or I sates oncerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issumos of a backed in a problem with other requirements of the Act that FDA has made a determination an a Jecinistered by other Federal agencies. You must of any Federal Statutes and regulations and linited to: registration and listing (21) CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requiremts as see CFR Part 807), adomig (21 CFR Part 820), and if applicable, the electronic forth in the quality systems (QD) regalativ (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Karen Warden
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lower with and in yours of substantial equivalence of your device to a legally prematicated predicated wice 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 If you don't opportio arrivaliance at (301) 594-4659. Also, please note the regulation entitled, oonwood in Office of Court to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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 vours,
Mula M. Millerson
Celia M. Witten, Ph.D., M.D. 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 Attachment III
510(k) Number:
Device Name: SmartPlate™ Cervical Plate System
Indications for Use:
The R&B Surgical Solutions SmartPlate™ Cervical Plate System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma, spinal stenosis, deformity, tumor, pseudarthrosis or failed previous fusion.
WARNING: The R&B Surgical Solutions SmartPlate™ Cervical Plate System is not intended for WHITH OF Tixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
for Mark A. Milkers
Perforative
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prcscription Use $\surd$
(21 CFR 801.109)
ાર
()ver-the-Counter Use_
(Per 21 CFR 801.109)
N/A