(333 days)
The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The NobelProcera Zirconia Implant Bridge (Dental Bridge) is a patient-specific, dental implant supported, screw-retained dental implant bridge which is connected to compatible Nobel Biocare root-form endosseous dental implants (Dental Implants) or Multi-unit Abutments and is intended to restore chewing function in partially and fully edentulous patients. The Dental Bridge is available as either a Framework requiring veneering in a dental lab or as a Full Contour design requiring minimum laboratory processing. The Dental Bridge is made from yttria-stabilized tetragonal zirconia. It is designed in a dental laboratory, hospital or dental practice by scanning, designing and ordering the restoration using dental CAD/CAM software and approved dental scanner. The finished design is sent to Nobel Biocare manufacturing facility for industrial production. After production, the Dental Bridge is sent to the laboratory for finishing. The Dental Bridge is available for use with Nobel Biocare's Dental Implants having Internal Conical Connection (CC), External Hex Connection, Internal Tri-Channel Connection and Nobel Biocare's Multi-unit Abutment connections. One Dental Bridge can feature connections to 2 up to 10 Dental Implants. All Dental Bridges are provided with the required Clinical and/or Prosthetic Screw: The Clinical Screw connects the Dental Bridge with the Dental Implant. The Prosthetic Screw connects the Dental Bridge with a Multi-unit Abutment. Dental Bridge connections on the Internal Conical Connection Dental Implant require use of Clinical Metal Adapters. Clinical Metal Adapters are provided with the Dental Bridge. No adapter is needed for the External Hex, Internal Tri-Channel, or Multi-unit Abutment connections. Clinical and Prosthetic Screws are placed from the occlusal side of the restoration. To facilitate access to the connection of the restoration to the implant/abutment a screw channel must be designed into the restoration. The Dental Bridge feature an Angulated Screw Channel (ASC) when connected to a Dental Implant with Internal Conical Connection and has an ASC feature to connect to Multi-unit Abutments. NobelProcera Zirconia Implant Bridges ASC's angulation can be defined by the customer in an angulation (to the implant's or Multi-unit Abutment's axis) between 0° and 25°. The ASC allows access through a screw channel which is not in line with the implant.
The provided text is a 510(k) summary for the NobelProcera Zirconia Implant Bridge. It describes the device, its indications for use, and a comparison to a predicate device.
However, the document states: "Clinical data is not required to establish substantial equivalence for the Subject Device. Non-clinical test data was conducted in accordance with FDA Guidance 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'. This testing involved examining finished assembled implant/abutment systems of the worst-case scenario through fatigue testing."
This indicates that a clinical study with acceptance criteria, sample sizes for test and training sets, expert ground truth, adjudication methods, or MRMC studies for AI performance was not part of the submission for this particular device. The evaluation relied on non-clinical (bench) testing, specifically fatigue testing, to demonstrate substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information from the provided text as it pertains to clinical studies or AI performance. The document only mentions "fatigue performance testing" as the evidence for the revised extension length.
To answer your request, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: While not explicitly listed as a "table of acceptance criteria" in the format usually requested for clinical studies, the document implies that the device's performance regarding "extension length" was evaluated through fatigue testing. The revised extension length of 16mm (for the subject device) versus 10mm (for the predicate device) suggests an acceptance criterion related to the ability to withstand fatigue at this increased length. The wording "fatigue performance testing was performed to demonstrate that the difference does not raise different questions of safety and effectiveness" implies that the device successfully met the fatigue requirements for the 16mm extension.
- Reported Device Performance: The document states that "The revised extension length is supported by the fatigue performance testing provided in the premarket notification." and "fatigue testing was performed to demonstrate that the difference does not raise different questions of safety and effectiveness." This indicates that the subject device, with its maximum extension length of 16mm, passed the non-clinical fatigue tests, demonstrating performance equivalent to or better than the predicate device.
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 for a non-clinical fatigue test. The testing involved "examining finished assembled implant/abutment systems of the worst-case scenario through fatigue testing." The number of units tested is not specified in this summary. Data provenance is not relevant for bench testing.
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. This was a non-clinical, benchtop fatigue test, not a study requiring expert ground truth for clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This was a non-clinical, benchtop fatigue test.
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:
- No. This device is a dental implant bridge, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable for non-clinical fatigue testing. The "ground truth" for fatigue testing would be the physical measurement of failure or deformation under specified loading conditions, and comparison against a defined standard or predicate performance.
8. The sample size for the training set:
- Not applicable. This document describes a physical medical device and non-clinical testing, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.)