(27 days)
The Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars.
The final processed devices have the purpose of restoring chewing function.
Straumann® Screw Retained Abutments are indicated for screw-retained restorations.
The proposed Straumann® NC Angled Screw Retained Abutments are a line extension of the NC Straight and RC Straight and Angled Screw Retained Abutments cleared to market per premarket notification submission K133421.
The Straumann® NC Angled Screw Retained Abutments include 17° and 30° abutments. This is consistent with the RC Angled Screw Retained Abutments cleared to market per premarket notification submission K133421.
This document is a 510(k) premarket notification for the Straumann® Screw Retained Abutments, a dental device. It focuses on demonstrating the substantial equivalence of the new device to existing predicate devices.
Here's a breakdown of the requested information based on the provided text:
1-7. Acceptance Criteria and Study Details
The document refers to bench studies and dynamic fatigue test data consistent with FDA guidance and ISO 14801 as the means to establish substantial equivalence. For medical devices like dental abutments, acceptance criteria often relate to mechanical properties, material compatibility, and structural integrity under simulated physiological conditions.
However, the specific numerical acceptance criteria (e.g., minimum fatigue life, maximum deformation) and the reported device performance against these criteria are not explicitly tabulated or detailed in the provided text. The document states: "Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices." This implies the performance met unstated acceptance criteria.
Let's address the specific points you requested based on the available information:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the provided text. They would likely be defined by ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants) and FDA guidance for endosseous dental implants and abutments. These typically involve demonstrating a certain number of load cycles at specific force levels without fracture or permanent deformation exceeding a threshold.
- Reported Device Performance: Not explicitly detailed with specific numerical results in the provided text. The document only concludes that the performance data "satisfactorily addressed" substantial equivalence.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. For mechanical bench testing, sample sizes are typically smaller than clinical trials, often statistical minimums (e.g., 5-10 samples per test group) to ensure statistical significance.
- Data Provenance: The studies were bench studies, presumably conducted by or for Straumann USA, LLC (or Institut Straumann AG). The country of origin of the data is not specified but would likely be where the manufacturing and testing facilities are located for Straumann (e.g., USA, Switzerland). The studies are by nature prospective as they are conducted specifically to demonstrate performance for regulatory submission.
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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):
- This question is largely not applicable in the context of this specific device and the provided document. The "ground truth" for mechanical testing is derived from objective physical measurements and engineering specifications, not expert consensus in the way a diagnostic imaging device would require. The experts involved would be engineers and material scientists conducting the tests and analyzing the data, but their "number" and "qualifications" for establishing ground truth are not relevant in the same manner as for clinical interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None (in the typical clinical sense): Adjudication methods like 2+1 or 3+1 are used for clinical studies where human interpretation of data (e.g., imaging scans) requires consensus among multiple experts. For bench testing of mechanical properties, "adjudication" is not performed in this manner. Results are usually objective measurements that are verified against established test protocols and specifications.
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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:
- No: An MRMC comparative effectiveness study is not applicable. This device is a physical dental abutment, not an AI or diagnostic imaging device that requires human readers for interpretation. Therefore, there's no "AI assistance" or "human readers" in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: This question is not applicable. The device is a physical dental abutment, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context refers to engineering specifications, material science standards (e.g., ISO 5832-11 for the alloy, ISO 14801 for fatigue testing), and mechanical performance metrics. The objective measurements from the bench studies (e.g., number of cycles to failure, measured deformation) are compared directly against these predefined engineering standards and specifications.
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The sample size for the training set:
- Not applicable: This device is not an AI algorithm, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable: As there is no training set, this question is not relevant.
In summary, for K141871 (Straumann® Screw Retained Abutments):
The acceptance criteria and device performance are established through adherence to recognized international standards (like ISO 14801) for mechanical fatigue testing, and material specifications (like ISO 5832-11 for titanium alloy). The document states that bench studies and dynamic fatigue test data were provided and deemed satisfactory to demonstrate substantial equivalence to predicate devices, but it does not provide the specific numerical results or detailed acceptance criteria. The context is mechanical engineering validation, not clinical diagnostic performance or AI evaluation.
§ 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.)