(90 days)
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures.
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Copings are intended to serve as a base for multi-unit bar or bridge restorations.
Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.
The Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
Abutments are placed into dental implants to provide support for prosthetic restorations, copings for bars and bridges are used as a base for bar and bridge constructions, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.
This 510(k) summary for the Straumann P.004 RC/NC Bar and Bridge Abutment Line does not contain the detailed information necessary to answer your questions about acceptance criteria and study design.
This document is a regulatory submission demonstrating substantial equivalence to previously cleared devices, not a detailed technical report of performance testing against specific acceptance criteria.
Here's why I cannot provide the requested information and what is available in the provided text:
What the document does state:
- Device Description: The Straumann P.004 Dental Implant System, including abutments, copings, and protective caps.
- Intended Use: For supporting prosthetic restorations (crowns, bridges, overdentures) in single or multiple tooth restorations, as bases for bar/bridge constructions, and for temporary restorations or soft tissue protection.
- Technological Characteristics: Claims substantial equivalence to predicate devices in material composition, basic design, and fundamental operating principles.
- Predicate Devices: A list of previously cleared Straumann devices to which equivalence is claimed.
Why the requested information is NOT in the document:
The provided text (a 510(k) summary) focuses on demonstrating "substantial equivalence" to existing, legally marketed devices. For this type of submission, the manufacturer typically highlights:
- Similarities in intended use.
- Similarities in technological characteristics (materials, design, operating principles).
- Performance data (if any significant differences exist or if new performance claims are made) is usually summarized or referenced, but the detailed study methodology, acceptance criteria, ground truth, and reader studies are rarely included in the brief summary itself. These details would be in a more comprehensive technical report or testing documentation (e.g., design control documents, test reports) that is part of the full 510(k) submission, but not typically released publicly in this summary format.
Therefore, I cannot populate the table or provide specific answers for most of your questions based solely on the provided text.
Here is a description of why each requested point cannot be answered from the provided text:
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A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not list any specific quantitative acceptance criteria (e.g., tensile strength, fatigue life, dimensional accuracy) or the results from performance studies against such criteria. It generally states that the device has "the same material composition, basic design and fundamental operating principles" as predicate devices, implying performance is equivalent, but without specific metrics.
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Sample size used for the test set and the data provenance:
- Cannot be provided. No specific performance studies with test sets are described. The submission relies on equivalence to predicate devices rather than novel performance data requiring a test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Cannot be provided. Since no specific test set or performance evaluation study (like a clinical study or even a detailed phantom study) is described in the summary, there's no mention of experts establishing ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Cannot be provided. No test set or expert evaluation process is described.
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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 a mechanical dental implant component, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Cannot be provided. No ground truth is mentioned because no specific performance study requiring it is described in the summary.
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The sample size for the training set:
- Not applicable. This device is a physical product, not an AI algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for an algorithm is involved.
In summary, the provided 510(k) summary is a regulatory declaration of equivalence, not a detailed scientific paper describing performance studies and acceptance criteria. To get the information you're asking for, you would typically need to review the full technical documentation supporting the original 510(k) submission, which is generally not publicly available in this level of detail.
§ 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.)