(76 days)
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:
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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.
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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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified as quantitative criteria in this document. The overarching "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device. | The device (P.004 RC/NC Gold and Titanium Abutment for Bars) is described as having "the same material composition, basic design and fundamental operating principles" as the predicate devices (Straumann P.004 Dental Implants, synOcta® Gold Coping, synOcta® Titanium Coping, Abutment for Bars). Its intended use is also identical. |
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.
§ 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.)