(115 days)
The CAM StructSURE® Precision Milled Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
All CAM StructSURE® Precision Milled Bars (Dolder, Primary, Hader, Hybrid and Copy Milled) are designed to match an individual patient. The bars are designed from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression and then is machined using a CADCAM software system. The bars are milled from titanium alloy or CP titanium.
CAM StructSURE® Precision Milled Bars:
CSHxx CAM StructSURE Hader Bar: 2-10 implants
CSPxx CAM StructSURE Primary Bar: 2-10 implants
CSDxx CAM StructSURE Dolder Bar: 2-10 implants
CSCMxx CAM StructSURE Copy Milled Bar: 4-10 implants
CSIYxx CAM StructSURE Hybrid Bar: 4-10 implants
The provided document is a 510(k) summary for a dental device (CAM StructSURE® Precision Milled Bars). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as typically found for complex AI/diagnostic devices.
Therefore, much of the requested information regarding acceptance criteria, study design elements (sample size, ground truth, experts, adjudication, MRMC, standalone), and training set details are not applicable or available within this specific document. This document is a regulatory submission for a medical device approval that is not based on a statistical study with specific performance outcomes.
Here's an analysis based on the provided text, highlighting where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in this context. This 510(k) submission for the CAM StructSURE® Precision Milled Bars focuses on demonstrating "substantial equivalence" to a legally marketed predicate device (K034035 3i Patient Specific Overdenture Bars) rather than meeting specific quantifiable performance metrics through a clinical trial or performance study with acceptance criteria.
The "conclusion" states: "Appropriate verification and validation activities were performed to provide assurance that CAM StructSURE® Precision Milled Bars remain substantially equivalent to the predicate and the modifications have not changed the intended use, altered the fundamental scientific technology or the safety and effectiveness of the device." This indicates general design control and validation rather than a study against a specific performance benchmark.
2. Sample size used for the test set and the data provenance
Not applicable. The document does not describe a "test set" in the context of a statistical study for device performance. It refers to "verification and validation activities" but provides no details on sample size, data origin, or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No "ground truth" or expert review process is described for performance evaluation of this device as it is not a diagnostic or AI-driven device.
4. Adjudication method for the test set
Not applicable. No "test set" or adjudication method 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
Not applicable. This device is not an AI-assisted diagnostic tool, and therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental overdenture bar, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The concept of "ground truth" as it applies to performance studies for AI/diagnostic devices is not relevant here. The substantial equivalence is based on comparison to a predicate device and adherence to design controls.
8. The sample size for the training set
Not applicable. This device is not an algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. Since there is no training set mentioned, the establishment of ground truth for it is also not applicable.
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Image /page/0/Figure/2 description: The image shows the logo for BIOMET 3i. The logo is in black and white and features a bold, sans-serif font. The letters are blocky and geometric, with a modern and clean design.
JUL 2 1 2008
Summary of Safety & Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter: | BIOMET 3i4555 Riverside DrivePalm Beach Gardens, FL 33410 |
|---|---|
| Establishment RegistrationNumber: | 1038806 |
| Contact: | Tamara J. WestInternational Regulatory Affairs ManagerBIOMET 3i4555 Riverside DrivePalm Beach Gardens, FL 33410Tel. 561-776-6923Fax. 561-514 6316Email twest@3implant.com |
| Date Prepared: | March 27, 2008 |
| Trade/Proprietary Name: | CAM StructSURE® Precision Milled Bars |
| Common/Usual Name: | Overdenture Bar |
| Classification Name: | Endosseous dental implant abutment21 CFR § 872.3630 |
| Device Classification: | Class IIDental Devices Panel |
| Legally Marketed PredicateDevices: | K034035 3i Patient Specific Overdenture Bars |
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| Device Description: | All CAM StructSURE® Precision Milled Bars (Dolder,Primary, Hader, Hybrid and Copy Milled) are designedto match an individual patient. The bars are designedfrom a three-dimensional optical and/or digital scannersystem that scans the casting of a patient's impressionand then is machined using a CADCAM softwaresystem. The bars are milled from titanium alloy or CPtitanium.CAM StructSURE® Precision Milled Bars:CSHxx CAM StructSURE Hader Bar:2-10 implants CSPxx CAM StructSURE Primary Bar:2-10 implants CSDxx CAM StructSURE Dolder Bar:2-10 implants CSCMxx CAM StructSURE Copy Milled Bar:4-10 implants CSIYxx CAM StructSURE Hybrid Bar:4-10 implants |
|---|---|
| Indications for Use: | The CAM StructSURE® Precision Milled Bars areintended for use as an accessory to an endosseous dentalimplant to support a prosthetic device in a partially oredentulous patient. It is intended for use to supportmultiple tooth prostheses in the mandible or maxilla.The prostheses can be screw retained. |
| Conclusion: | The proposed design modifications for the CAMStructSURE® Precision Milled Bars were completedunder Quality System Design Controls in accordancewith 21 CFR 820.30.Appropriate verification and validation activities wereperformed to provide assurance that CAMStructSURE® Precision Milled Bars remainsubstantially equivalent to the predicate and themodifications have not changed the intended use,altered the fundamental scientific technology or thesafety and effectiveness of the device. |
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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 stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2008
Ms. Tamara West International Regulatory Affairs Manager BIOMET, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K080864
Trade/Device Name: CAM StructSURE® Precision Milled Bars Regulation Number: 872.3636 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 6, 2008 Received: May 19, 2008
Dear Ms. West:
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.
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Page 2 - Ms. West
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 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 marketed predicate 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Rimmer
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Figure/1 description: The image shows the logo for BIOMET 3i. The logo is in black and white and features a stylized font. The words "BIOMET" and "3i" are clearly visible in the logo. The logo appears to be for a medical or dental company.
Indications for Use
510(k) Number (if known): K089 864
Device Name: CAM StructSURE® Precision Milled Bars
Indications for Use:
The CAM StructSURE® Precision Milled Bars are intended for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susel Rumm
Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080864
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)