Search Results

The FRIALIT®-2 Dental Implant System is indicated for use in single tooth restoration, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used for immediate implant placement, delayed immediate or late implant placement.

The FRIALIT®-2 Dental Implant System consists of subgingival threaded dental implants in 3.4 - 6.5mm diameters with 8 - 15mm lengths. The implants are coated with the FRIADENT Surface M2.1. The FRIALIT®-2 Dental Implant System is comprised of dental implants, surgical and laboratory instruments and prosthetic components. The system is designed for single stage procedures for single tooth replacement, fixation of bridges and complete dentures.

The provided document is a 510(k) premarket notification for the FRIALIT®-2 Dental Implant System. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving device performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the way envisioned for a novel AI/software device. Instead, it demonstrates equivalence to previously cleared dental implants.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for a test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study, or effect size for human readers with/without AI assistance.
6. A standalone algorithm-only performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How ground truth for a training set was established.

Summary of what the document does provide regarding "performance evaluation":

The document states under "17.9 CONCLUSIONS": "Performance evaluations of the FRIALIT®-2 dental implant system show that the device performs as intended. Comparison the FRIALIT®-2 dental implant system to the predicate devices show that the device is substantially equivalent. The complete surface characterization of the new FRIADENT Surface M2.1 has been detailed in Device Master File MAF-1235."

This "performance evaluation" likely refers to non-clinical tests (e.g., mechanical strength, material characterization as mentioned for the FRIADENT Surface M2.1), and a comparison to the predicate devices to establish substantial equivalence. It is not a clinical study with a test set, ground truth, or an AI component as your questions imply.

Ask a specific question about this device