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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.
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.
Temporary Copings are intended to serve as a base for temporary restorations for less than 30 days.

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, temporary copings support a temporary restoration out of occlusion and protective caps protect the abutment during the healing phase.

The provided text is a 510(k) summary for dental abutments, temporary copings, and protective caps. It describes a medical device seeking clearance based on substantial equivalence to a predicate device, rather than a study validating its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the given text.

Here is an analysis based on the available information:

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

The document does not provide a table of acceptance criteria or reported device performance in the context of a study. The clearance is based on substantial equivalence to a predicate device, meaning the new device is deemed as safe and effective as a legally marketed device without requiring clinical performance data against specific 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. No study involving a test set and associated data is described. The clearance is based on the "Technological Characteristics" being substantially equivalent to the predicate device, implying that design, materials, and fundamental operating principles are the same, not on performance data from a specific test set.

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. No test set requiring expert-established ground truth is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring expert adjudication is mentioned.

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 document describes mechanical dental components, not an AI-assisted diagnostic device. Therefore, no MRMC study or AI-related effectiveness is discussed.

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

Not applicable. This is not an algorithm or software device.

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

Not applicable. No performance study with a defined ground truth is described. The basis for clearance is "Technological Characteristics" and "intended use" being identical to a predicate device.

8. The sample size for the training set

Not applicable. No dataset (training or otherwise) is mentioned, as this is not a data-driven device clearance.

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

Not applicable. No training set or ground truth establishment is described.

Summary of Device and Clearance Information Provided:

• Device Name: P.004 NC Cementable Abutments, P.004 NC Temporary Copings, P.004 NC Protective Caps
• Common Name: Abutment, Dental, Endosseous implants
• Regulation Number: 21 CFR 872.3630
• Regulatory Class: II
• Product Code: NHA
• Predicate Device: P.004 RC Cementable Abutments, K072071; RC Temporary Copings, K072071; RC Protective Caps, K072071
• Basis for Clearance: Substantial equivalence to the predicate device based on identical intended use, material composition, basic design, and fundamental operating principles.
• Intended Use:
  • Abutments: To provide support for prosthetic restorations (crowns, bridges, overdentures) in dental implants.
  • Temporary Copings: To serve as a base for temporary restorations for less than 30 days.
  • Protective Caps: To protect the outer configuration of the abutment and maintain/condition soft tissue during healing for up to 6 months.

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