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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:

1. 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.

2. 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.

3. 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.

4. 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.

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 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.

6. 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.

7. 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.

8. The sample size for the training set:

   • Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

9. 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.

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P.004 NC Temporary Abutment is indicated for use in Straumann P.004 NC Bone Level implants for temporary restorations of single crowns and bridges for up to six months.

P.004 NC Healing Abutment, customizable is indicated for use in Straumann P.004 NC Bone Level implants to protect the inner configuration of the umplant and maintains, stabilizes and forms the soft tissue during the healing process for up to six months and should be placed out of occlusion.

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, permanent and temporary abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are temporary abutments.

The basal portion of the abutment has 4 grooves diametrically opposed that engage in the 4 protrusions of the P.004 implant. The abutment is seated in the implant with a screw which is mounted in the basal portion of the abutment. The abutment is used for cemented and screw-retained and directly veneered restorations. Healing abutments protect the inner configuration of the abutment and contours the soft tissue during the healing phase.

The provided document is a 510(k) summary for a dental abutment, specifically the "P.004 NC Temporary Abutments" and "P.004 NC Healing Abutment". It is an FDA submission for market clearance based on substantial equivalence to predicate devices, not a study report detailing performance against acceptance criteria in the way a clinical trial or AI validation study would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not available in this document.

This document focuses on:

• Applicant and Device Identification: Contact information, device trade name, common name, classification, and regulation number.
• Predicate Device: Straumann P.004 Dental Implants (K062129) and P.004 RC Temporary Abutments (K070478) are named as legally marketed devices to which equivalence is claimed.
• Device Description: The P.004 Dental Implant System and the specific temporary and healing abutments are described.
• Intended Use: Detailed intended uses for the NC Temporary Abutment and Healing Abutments are provided.
• Technological Characteristics: A statement that the proposed abutments are substantially equivalent in material composition, basic design, and fundamental operating principles to currently marketed devices.
• FDA Communication: The letter from the FDA confirming substantial equivalence and market clearance.
• Indications for Use Statement: A formal statement of the device's indications for use.

In summary, this document does not contain the information required to fill out the requested table and answer the specific study-related questions. It is a regulatory filing, not a performance study report.

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Both the P.004 RC/NC Gold Abutment for Bars and RC/NC Titanium Abutment for Bars are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns, bridges and overdentures.

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.

The provided text is a 510(k) summary for a dental device, the "P.004 RC/NC Gold and Titanium Abutment for Bars." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through clinical or performance studies with detailed metrics.

Therefore, the information required in your request cannot be fully extracted from this document, as it describes a regulatory submission process based on equivalence rather than detailed performance study results.

Here's a breakdown of why and what little can be inferred:

• Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria or detailed performance data (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds) in the way a clinical or technical validation study would. The document states, "The proposed abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently marketed devices." This is the core "proof" presented for regulatory acceptance under the 510(k) pathway.

• Study That Proves the Device Meets Acceptance Criteria: There is no specific study described that "proves" the device meets acceptance criteria in the manner of defining and then testing against specific performance thresholds. The 510(k) process relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is typically achieved by comparing technological characteristics, materials, and intended use, often supported by non-clinical bench testing for mechanical properties (though not detailed here), rather than multi-reader studies or ground truth comparisons.

Given these limitations of the provided text, here's what can be answered, and what cannot:

1. A table of acceptance criteria and the reported device performance

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. This document does not describe a clinical or performance study with a "test set" in the context of AI/diagnostic device validation. It's a regulatory submission based on substantial equivalence to existing devices.

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. There is no "ground truth" establishment or expert review detailed in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) 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

• No. This document does not describe an MRMC study. The device is a physical dental abutment, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device (dental abutment), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable. The concept of "ground truth" for comparative performance evaluation is not relevant to this 510(k) submission, which relies on demonstrating equivalence in design, materials, and intended use to predicate devices.

8. The sample size for the training set

• Not Applicable. No training set is described.

9. How the ground truth for the training set was established

• Not Applicable. No training set or ground truth establishment is described.

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