(161 days)
The Natural Line abutment is indicated for use in cases where the placement of the implant requires an angled reconstruction for an esthetic result. The abutment can be used to restore crowns for single tooth replacement and bridges for bound situations
Not Found
I am sorry, but the provided text from the FDA 510(k) clearance letter for the "NaturalLine Abutment" does not contain the information necessary to describe acceptance criteria and a study proving a device meets those criteria, as typically required for AI/ML medical devices.
This document is a standard FDA clearance letter for a dental implant abutment, which is a mechanical device. It outlines the regulatory classification, product code, and basic indications for use. It confirms that the device is "substantially equivalent" to predicate devices, which is the basis for 510(k) clearance.
Here's why the requested information cannot be extracted from this document:
- AI/ML Device Context: The NaturalLine Abutment is a physical medical device, not an AI/ML algorithm. Therefore, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" in the context of AI/ML performance (e.g., sensitivity, specificity, AUC) are not applicable here.
- Performance Data: The letter states the device is substantially equivalent to predicates but does not provide specific performance data (like sensitivity, specificity, accuracy, or any clinical trial results) that would be evaluated against acceptance criteria. The clearance is based on comparison to existing legally marketed devices, not on de novo performance metrics.
- Ground Truth, Experts, Sample Sizes, Adjudication: These terms are relevant to the validation of AI/ML models, where data is used to train and test the algorithm's diagnostic or predictive capabilities. For a mechanical dental abutment, the "ground truth" would be related to its mechanical properties, biocompatibility, and fit, which are assessed through engineering tests and material science, not through expert consensus on image interpretation or pathology.
- MRMC Study/Standalone Performance: These are specific types of studies for AI/ML performance evaluation, which are not relevant for a dental abutment.
In summary, the provided FDA document is for a traditional mechanical medical device and does not contain any of the information requested regarding acceptance criteria and performance studies for 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.)