Search Results

Abutments are intended to be placed into dental implants as support for prosthetic reconstructions such as crowns and bridges. The abutments are indicated for cemented restoration in areas of the mouth and used to restore crowns for single tooth replacements and bridges for multiple tooth restorations.

The Titan Dental Implant Attachments and accessories are an integrated system of endosseous implant abutments, which are designed to support prosthetic devices for partially, or fully edentulous patients. The system consists of a variety of dental implant abutments and accessories. The devices covered in this submission include abutments, combination transfer coping/permanent abutments and miscellaneous accessories.

I'm sorry, but based on the provided document, I cannot fulfill your request for information about acceptance criteria and a study proving device performance.

Here's why:

• The document is a 510(k) clearance letter. This type of document from the FDA indicates that a device has been found substantially equivalent to a predicate device already on the market. It does not typically contain detailed information about performance studies, acceptance criteria, or specific clinical trial results.
• The content focuses on regulatory classification and substantial equivalence. The provided text discusses the device name, classification, intended use, and the FDA's determination that it is substantially equivalent to existing devices. There's no mention of performance metrics, study designs, sample sizes, or ground truth establishment.
• The device is an "Endosseous Dental Implant Abutment." For devices like this, the 510(k) clearance often relies heavily on material equivalence, design equivalence, and established safety and effectiveness of the predicate device, rather than new, extensive clinical performance studies with specific statistical acceptance criteria for "device performance" in the way one might see for an AI diagnostic tool, for example.

Therefore, the specific information requested in your numbered points (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) is not present in the provided 510(k) summary.

Ask a specific question about this device

The TITAN Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch and to provide support for crowns, bridges or overdentures.

The TITAN Dental Implant System is comprised of 26 root-form solid screw-type implant designs and a broad range of abutment designs, all of which are based on existing dental implant systems that are cleared for marketing in the United States. Implant design features include external shapes that are cylindrical (15 designs), tapered (10 designs) and stepped (1 design). Both transgingival and submerged designs are included. External implant thread forms include V, square and buttress designs. Anti-rotational features include external and internal design elements. All implants are made from titanium or titanium alloys conforming to ASTM and ISO standards. Surfaces include as-machined surfaces, grit blasted and acid etched surfaces, surfaces treated with resorbable blast media (RBM) and surfaces coated with plasma-sprayed titanium (TPS) or hydroxyapatite (HA). Diameters range from 3.25 mm to 6.5 mm, and lengths from 5.0 mm to 20.0 mm..

Abutment designs include long and short conical abutments, stepped abutments, gold cylinder abutments, gold/plastic castable abutments and ball head abutments. Antirotational features include external and internal design elements. All abutments are made from titanium or titanium alloys conforming to ASTM and ISO standards or from gold alloy. Surfaces include as-machined surfaces and surfaces treated with titanium nittide. Platform diameters range from 3.25 mm to 6.5 mm.

Abutment screws appropriate to each implant/abutment combination, healing abutments, temporary abutments and laboratory components are included in the TITAN Dental Implant System.

The provided document is a 510(k) premarket notification for the TITAN Dental Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving clinical efficacy or meeting specific performance acceptance criteria through clinical studies. Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

Instead, the submission focuses on comparing the TITAN Dental Implant System to previously cleared predicate devices based on:

• Intended Use: The same intended use (surgically placed in maxillary/mandibular arch for crowns, bridges, or overdentures).
• Operating Principle: Uses the same operating principle.
• Basic Design: Incorporates the same basic design.
• Materials: Incorporates the same materials (titanium or titanium alloys, gold alloy for abutments).
• Packaging and Sterilization: Uses the same or equivalent materials and processes.

The FDA's review letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which allows it to proceed to market. This substantial equivalence determination does not involve setting or testing against specific performance acceptance criteria in the way a clinical trial for a novel device would.

Missing Information Summary:

1. Table of Acceptance Criteria and Reported Device Performance: Not present. The submission focuses on substantial equivalence to predicate devices, not on proving performance against specific quantitative or qualitative criteria.
2. Sample Size and Data Provenance: Not applicable/not present. There is no study described that would require a test set.
3. Number of Experts and Qualifications for Ground Truth: Not applicable/not present. No ground truth was established for a performance study.
4. Adjudication Method for Test Set: Not applicable/not present.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not conducted or described.
6. Standalone Performance: Not conducted or described.
7. Type of Ground Truth Used: Not applicable/not present.
8. Sample Size for Training Set: Not applicable/not present. This is not an AI/algorithm-based device requiring a training set in the conventional sense.
9. How Ground Truth for Training Set Was Established: Not applicable/not present.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device