(154 days)
The 3i Patient-Specific CAM StructSURE® Precision Milled Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient.
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 machined using a CAD/CAM software system. The bars are milled from either titanium alloy or CP titanium.
The provided text describes a 510(k) premarket notification for BIOMET 3i Patient Specific CAM StructSURE Bars, focusing on the change from using Delcam and 3Shape scanning and milling systems to the Renishaw system.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in the form of numerical performance metrics. Instead, it describes "Validation performed on scanning equipment and software to ensure accuracy of scanning 3D models and performed Install Qualification." The reported "device performance" is an assertion of substantial equivalence based on this validation.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Accuracy of scanning 3D models using Renishaw system | "Validation performed on scanning equipment and software to ensure accuracy of scanning 3D models" |
| Proper installation and functioning of the Renishaw system | "performed Install Qualification" |
| Equivalence to previously cleared devices in terms of safety and effectiveness | "Validation data demonstrates that the modified process results in a finished device that is as safe and effective as BIOMET 31 's Patient-Specific CAM StructSURE Overdenture Bars that are currently cleared with previous scanner systems." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective). The validation appears to be a general process for the new Renishaw system rather than a study on a specific cohort of patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The study focuses on equipment and software validation, not on clinical outcomes assessed by human experts.
4. Adjudication Method for the Test Set
This information is not applicable and not provided, as the validation described does not involve expert adjudication of clinical cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The submission is for a material and process change (new scanning/milling system), not an AI-assisted diagnostic tool that would typically involve human reader performance evaluation.
6. Standalone (Algorithm Only) Performance Study
Yes, in a sense. The "validation performed on scanning equipment and software to ensure accuracy of scanning 3D models" can be considered a standalone performance assessment of the Renishaw system's ability to accurately capture 3D models, independent of human interaction beyond operating the equipment. No specific metrics are given, but the statement implies this standalone assessment was successful.
7. Type of Ground Truth Used
The ground truth for the validation appears to be based on physical measurements and technical specifications of the 3D models produced by the scanning and milling systems, as well as the functional verification of the installation. For example, comparing the scanned 3D model to the physical casting, or comparing the milled bar to the CAD design. It's not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. Sample Size for the Training Set
This information is not provided. The document describes a CAD/CAM system, which would involve training data for its algorithms, but details on the size and nature of this training data are not included in this summary.
9. How the Ground Truth for the Training Set Was Established
This information is not provided. For CAD/CAM systems, ground truth for training would typically involve precise 3D models, either physical or digitally generated, used to teach the system how to accurately interpret scans and generate designs.
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BIOMET 3i Special 510(k) Premarket Notification – BIOMET 3i Patient Specific CAM StructSURE Bars
510(k) SUMMARY
NOV - 8 2010
BIOMET 3i - CAM StructSURE Overdenture Bars
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92
| Submitter: | BIOMET 3i |
|---|---|
| Address: | 4555 Riverside DrivePalm Beach Gardens, FL 33410 |
| Establishment RegistrationNumber: | 1038806 |
| Contact Person: | Jose E. Cabrera |
| Telephone/Fax/Email: | Phone: 561-776-6840Fax: 561-514-6316Jose.cabrera@biomet.com |
| Date Prepared: | June 3, 2010 |
| Trade/Proprietary Name: | CAM StructSURE Precision Milled Bars |
| Common/Usual Name: | Overdenture Bars |
| Classification Name: | Endosseous Dental Abutments |
| Device Classification: | 872.3630 |
| Predicate Device(s) : | BIOMET 3i - PSR Overdenture BarBIOMET 3i - CAM StructSURE Overdenture Bar |
| Product Codes:CSDXXCSPXXCSHXXCSHYXXCSCMXX | |
| bars-are-designed-from-a-three-dimensional-optical-and/or digital scanner system that scans the castingof a patient's impression and then machined using aCAD/CAM software system. The bars are milledfrom either titanium alloy or CP titanium. | |
| Purpose of Special 510(k): | BIOMET 3i Patient-Specific CAM StructSURE®Precision Milled Bars are currently scanned anddesigned with CAD/CAM Delcam and 3Shapescanners and software - BIOMET 3i intends to useRenishaw's scanning, design and milling systemwhich is compatible with currently cleared BIOMET3i Patient-Specific CAM StructSURE® PrecisionMilled Bars. |
| Intended Use: | The 3i Patient-Specific CAM StructSURE®Precision Milled Bars are intended for use as anaccessory to endosseous dental implants to support aprosthetic device in a partially or edentulous patient. |
| Nonclinical Performance Data: | Validation performed on scanning equipment andsoftware to ensure accuracy of scanning 3D modelsand performed Install Qualification. |
| Clinical Data: | N/A |
| Substantial Equivalence: | The BIOMET 3i Patient-Specific CAM StructSUREOverdenture Bars have the same intended use andindications, principles of operation, andtechnological characteristics as BIOMET 3i Patient-Specific CAM StructSURE Overdenture Bars. Thedifference in scanning and milling do not raise anynew questions of safety or effectiveness. Validationdata demonstrates that the modified process resultsin a finished device that is as safe and effective asBIOMET 31 's Patient-Specific CAM StructSUREOverdenture Bars that are currently cleared withprevious scanner systems. Thus, the BIOMET 3iPatient-Specific CAM StructSURE OverdentureBars are substantially equivalent to its predicatedevices. |
Device Description:
All CAM StructSURE® Precision Milled Bars (Dolder, Primary, Hader, Hybrid and Copy Milled) are designed to match an individual patient. The
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BIOMET 3i Special 510(k) Premarket Notification – BIOMET 3i Patient Specific CAM StructSURE Bars
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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jose E. Cabrera Senior Manager, Regulatory Affairs BIOMET 3i, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
NOV - 8 2010
Re: K101582
Trade/Device Name: BIOMET 3i Patient Specific CAM StructSURE Bars Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: October 14, 2010 Received: October 15, 2010
Dear Mr. Cabrera:
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.
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Page 2- Mr. Cabrera
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 tollofmen number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/dofault.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. 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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BIOMET 3i Special 510(k) Premarket Notification - BIOMET 3i Patient Specific CAM StructSURE Bars
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
NOV - 8 2010
Device Name:
BIOMET 3i Patient Specific CAM StructSURE Bars
Indications for Use:
The 3i Patient-Specific CAM StructSURE Overdenture Bars are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or edentulous patient.
| Prescription Use(Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | Over-The-Counter Use(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Office of Device Evaluation Anesthesiology, General Hospital Infection Control, Dental Devices
| 16 | 510(k) Number: K101582 |
|---|---|
| ---- | ------------------------ |
§ 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.)