(216 days)
Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they are to be placed out of occlusion. Final abutments may be placed into occlusion for implants with sufficient primary stability or for implants that are fully osseointegrated.
Temporary Abutments have a maximum duration of usage of 180 days.
The subject devices described in the submission are prosthetic components that are intended for use in prosthetic rehabilitations, directly or indirectly connected to the endosseous dental implant. These devices are intended for use as an aid in prosthetic rehabilitations. The subject devices described in this submission are to be added Straumann's existing prosthetic portfolio.
The provided text is a 510(k) summary for Straumann® Screw-Retained Abutments. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and performance data, mainly bench testing and biocompatibility assessments. It explicitly states that no device-specific clinical data has been submitted.
Therefore, the information required to describe acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human reader study or performance metrics typical for AI devices (like sensitivity, specificity, AUC), is not present in this document.
This document describes a traditional medical device (dental implants and abutments) cleared via the 510(k) pathway, which fundamentally relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel clinical studies or AI algorithm validation.
To address the user's request, I must state that the information is not available in the provided document, as it pertains to a different type of device and regulatory submission pathway.
Specifically, the document states:
- "No device specific clinical data has been submitted to demonstrate substantial equivalence." (Page 12, Section 5.7.4)
Here's an explanation with respect to the user's request:
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A table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence through comparison with predicates, not on meeting predefined performance metrics from a study in the way an AI/software device would. The "performance data" refers to bench testing (dynamic fatigue, static strength, torque) and biocompatibility, which are compared to predicate devices rather than against specific numerical acceptance criteria.
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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): Not applicable, as no clinical study (with test sets of patient data) was conducted or submitted. The 'samples' referred to in bench testing are physical abutment components.
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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. Ground truth for clinical data involving human perception (like AI for image analysis) is not relevant here as no such clinical study was performed.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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 is not an AI-powered device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
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The sample size for the training set: Not applicable. This is not an AI-powered device with a training set.
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How the ground truth for the training set was established: Not applicable.
In summary: The provided 510(k) summary for Straumann® Screw-Retained Abutments does not contain the type of AI/clinical performance study information requested. The device is a traditional medical device (dental implant components) and its clearance is based on substantial equivalence to predicate devices, verified through bench testing and biocompatibility assessments, not through human reader studies or AI algorithm performance evaluations on clinical datasets.
§ 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.)