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To serve as artificial root structures for single teeth or bridge abutments for bridgework in edentulous sites with adequate bone of sufficient quality to support the implant and function.

Saber Tech Implants System (GIS) endosseous implant

The provided text is a 510(k) premarket notification letter from the FDA to IMTEC Corporation regarding their Saber Tech Implants System (GIS) Endosseous Implant. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was approved based on substantial equivalence to a predicate device, not on a new study demonstrating its performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The text does not include:

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

This document is a regulatory approval letter based on substantial equivalence, not a clinical trial report or a performance study.

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