Search Results

THE IMPLANT(S) IS DESIGNED FOR USE IN THE EDENTULOUS SITES IN THE MANDIBLE OR MAXILLA FOR SUPPORT OF A COMPLETE DENTURE PROSTHESIS, A TERMINAL OR INTERMEDIATE ABUTMENT FOR FIXED OR PARTIAL DENTURES, OR A SINGLE TOOTH REPLACEMENT. THE 8,25MM LONG IMPLANT CAN NOT BE USED AS A SINGLE TOOTH REPLACEMENT.

Not Found

The provided document is an FDA 510(k) clearance letter for a dental implant. It states that the device is substantially equivalent to legally marketed predicate devices and therefore does not require a premarket approval application (PMA).

However, this document *does not contain any information regarding:

• Acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy)
• Details of any specific study (clinical or analytical) that would prove the device meets acceptance criteria.
• Sample sizes used for test sets or training sets.
• Data provenance, number or qualifications of experts, adjudication methods, multi-reader multi-case studies, standalone performance, or types of ground truth.

This document is a regulatory clearance and not a study report. It confirms that the device can be legally marketed based on its equivalence to existing products, but it does not provide the technical performance data that would typically be found in a study proving acceptance criteria.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor the other requested details about a study, because this information is not present in the provided text.

Ask a specific question about this device

The implant(s) is designed for use in the edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed or partial dentures, or a single tooth replacement.

Various Dental Implants with Various abutments

I am sorry, but the document provided does not contain information about acceptance criteria or a study proving device performance. The document is an FDA 510(k) substantial equivalence letter for "Various Dental Implants with Various Abutments." It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory requirements. It does not include details on specific device performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment.

Ask a specific question about this device

The implant(s) is designed for use in the edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed or partial dentures, or a single tooth replacement.

Various Dental Implants

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study proving the device meets them. The document is a 510(k) clearance letter from the FDA for "Various Dental Implants," confirming their substantial equivalence to previously marketed devices.

This type of document typically focuses on regulatory clearance based on substantial equivalence, rather than detailing the specific performance studies and acceptance criteria that would have been submitted by the manufacturer as part of their 510(k) application.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Information about an MRMC comparative effectiveness study or effect size.
6. Whether a standalone performance study was done.
7. The type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The letter only states that the FDA "reviewed your Section 510(k) notification of intent to market the device... and we have determined the device is substantially equivalent... to legally marketed predicate devices." It also lists the "Indications For Use."

Ask a specific question about this device

Ask a specific question about this device