(115 days)
The Procera Implant Bridge Overdenture is indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially edentulous jaws for the purpose of restoring chewing function.
Nobel Biocare's Procera® Implant Bridge Overdenture is an overdenture bar that attaches to implants or abutments. The Procera® Implant Bridge Overdenture provides retention and support for a removable denture made of standard laboratory dental materials such as resin composite or porcelain veneer.
Procera® Implant Bridge Overdentures are made individually following instructions and models specific to each patient. The Procera® Implant Bridge is made entirely of titanium, titanium/vanadium alloy, or chromium/cobalt alloy.
The Procera® Implant Bridge Overdenture implant interfaces are the predicate Procera Implant Bridges.
This looks like a 510(k) summary for a medical device (Procera Implant Bridge Overdenture) which is typically about demonstrating substantial equivalence to a predicate device, not necessarily extensive clinical studies with acceptance criteria, ground truth, and reader studies in the way an AI/ML device would be evaluated. As such, most of the requested information regarding AI/ML device evaluation is not present in the provided document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain explicit acceptance criteria or detailed performance metrics in the way an AI/ML diagnostic device would. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily through descriptive device characteristics and intended use, rather than quantifiable performance data against predefined criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes a physical medical device (dental implant overdenture bar), not a software or AI/ML diagnostic tool that would typically use a test set of data.
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)
Not applicable. Ground truth establishment with experts is a concept for evaluating diagnostic accuracy, which is not the focus of this 510(k) for a physical implantable device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for resolving discrepancies in expert interpretations, which is not part of this device's submission.
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. An MRMC study with AI assistance is specifically for evaluating diagnostic AI systems, not a physical dental implant component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For a physical device like this, "ground truth" would relate to its structural integrity, biocompatibility, and mechanical properties, not diagnostic accuracy based on expert consensus or pathology in the context of an AI/ML device. The "ground truth" for demonstrating substantial equivalence would be that its materials and design are comparable to already marketed devices.
8. The sample size for the training set
Not applicable. This document does not describe an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of what is available from the provided text:
The document is a 510(k) Summary of Safety and Effectiveness for the "Procera Implant Bridge Overdenture."
- Device Description: It's an overdenture bar that attaches to implants or abutments to support a removable denture. It's made of titanium, titanium/vanadium alloy, or chromium/cobalt alloy.
- Indications for Use: Indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially edentulous jaws for restoring chewing function.
- Predicate Devices:
- Substantial Equivalence: The FDA's letter (K090069) confirms that the device is deemed "substantially equivalent" to legally marketed predicate devices. This means the FDA found that the device is as safe and effective as a legally marketed device that does not require premarket approval. The basis for this substantial equivalence would have been a comparison of technological characteristics, materials, and intended use to the predicate devices, likely supported by non-clinical bench testing for mechanical properties and biocompatibility, rather than clinical studies with human subjects or AI performance evaluations as requested.
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MAY .
510(k) Summary of Safety and Effectiveness 1.4
| Submitted by: | Herbert Crane, Director Global Regulatory Affairs |
|---|---|
| Address: | Nobel Biocare USA LLC22715 Savi Ranch ParkwayYorba Linda, CA 92887 |
| Telephone: | (714) 282-4800, ext. 5074 |
| Facsimile: | (714) 282-9023 |
| Date of Submission: | January 9, 2009 |
| Classification Name: | Endosseous Dental Implant Abutment (21 CFR 872.3630) |
| Trade or Proprietaryor Model Name: | Procera ® Implant Bridge Overdenture |
| Legally Marketed Devices: | Nobel Biocare - Procera Implant Bridge (K041236)Nobel Biocare - Procera Implant Bridge (K043042)BIOMET 3i - CAM StructurSURE Precision Milled Bars |
Device Description:
Nobel Biocare's Procera® Implant Bridge Overdenture is an overdenture bar that attaches to implants or abutments. The Procera® Implant Bridge Overdenture provides retention and support for a removable denture made of standard laboratory dental materials such as resin composite or porcelain veneer.
Procera® Implant Bridge Overdentures are made individually following instructions and models specific to each patient. The Procera® Implant Bridge is made entirely of titanium, titanium/vanadium alloy, or chromium/cobalt alloy.
The Procera® Implant Bridge Overdenture implant interfaces are the predicate Procera Implant Bridges.
Indications for Use:
The Procera® Implant Bridge Overdenture is indicated for use as an overdenture bar that attaches to implants or abutments in the treatment of partially edentulous jaws for the purpose of restoring chewing function.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Public Health Service
MAY - 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nobel Biocare AB C/O Mr. Herbert Crane Director, Global Regulatory Affairs Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887
Re: K090069
Trade/Device Name: Procera Implant Bridge Overdenture Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: May 1, 2009 Received: May 4, 2009
Dear Mr. Crane:
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 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. Crane
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 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 Renner
Susan Runner, D.D.S., MA Acting 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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510(k) Number (if known): K090069
Device Name: Procera Implant Bridge Overdenture
Indications For Use:
The Procera Implant Bridge Overdenture is indicated for use as an overdenture bar that attaches to implants or abulments in the treatment of partially edentulous jaws for the purpose of restoring chewing function.
Prescription Use × (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)
Kien M. Slig for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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51D(k) Number:
§ 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.)