(136 days)
The Straumann® screw-retained abutments are indicated to be placed implants 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 subject device is a modification of the NC Straight Ø4.6 mm GH 1.0 mm Screw Retained Abutment originally cleared to market per K133421. Dimensional changes have resulted in improved dynamic fatigue performance such that this device can now be used in the pre-molar region of the mouth in addition to the incisors.
The provided text is a 510(k) summary for a medical device (Straumann Screw-Retained Abutment) and outlines its equivalence to a predicate device. It does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human-in-the-loop performance evaluation. The "Performance Testing" section describes bench testing for fatigue load limits, which is a mechanical engineering test, not a clinical or AI performance study.
Therefore, most of the requested information cannot be extracted from this document, as it pertains to a different type of device evaluation.
However, I can provide the information that is available about the "Performance Testing" from the document:
1. A table of acceptance criteria and the reported device performance
The document states that "Dynamic fatigue tests were conducted in accordance with the FDA guidance document dated May 12, 2004: 'Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseious Dental Implants and Endosseous Dental Abutments' and ISO 14801."
While specific acceptance criteria values (e.g., minimum load cycles or maximum load) and reported performance values are not explicitly provided in this summary, the standard ISO 14801 and the FDA guidance document would define these. The general performance claim is "improved dynamic fatigue performance" and "greater wall thickness in the flexure zone of the abutment."
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 was bench testing, not a clinical study with patients or data.
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. This was bench testing, not an expert-driven ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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, an MRMC study was not done.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for mechanical testing is typically the physical measurement of material properties and performance under stress, as defined by engineering standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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.)