Search Results

The Inclusive Zirconia Abutment Blank is intended to be used in conjunction with endosseous implants in the maxillary and/or mandibular arch to provide support for crowns, bridges or overdenture prostheses. The prosthesis can be cement retained to the abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

Inclusive Zirconia Abutment Blanks for Zimmer Implants are compatible with Zimmer Screw Vent and Tapered Screw Vent internal hex implants. Inclusive Zirconia Abutment Blanks for 3i Implant are compatible with 3i Certain internal hex implants. Inclusive Zirconia Abutment Blanks for Nobel Biocare Implant are compatible with Nobel Biocare Replace straight and tapered internal-connection implants.

Abutments with angulations greater than 20 degrees are contraindicated.

Not Found

The provided text is a 510(k) summary for a medical device (K083480) and a subsequent FDA letter acknowledging its clearance. It establishes substantial equivalence to predicate devices but does not contain information about specific acceptance criteria or a study proving device performance against those criteria.

The document explicitly states: "The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations." This indicates that the regulatory clearance was based on substantial equivalence rather than new performance studies with specific acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document, as it describes a device cleared based on equivalence, not on a new performance study with defined criteria.

Here's a breakdown of the requested information, indicating why it's not available in the provided text:

1. A table of acceptance criteria and the reported device performance

• Not available. The document does not define specific acceptance criteria for performance for this device, nor does it report detailed performance metrics from a study. Clearance was based on substantial equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not available. No new test set data is described as the basis for clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not available. No new test set requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not available. No new test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not available. This device is an abutment blank, not an AI diagnostic tool. No MRMC study was conducted or described.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable/Not available. This device is a physical dental component, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not available. No new ground truth for performance evaluation of this device is described. The basis for safety and efficacy is "wide, general use of similar other predicate devices."

8. The sample size for the training set

• Not applicable/Not available. No training set for an algorithm is described.

9. How the ground truth for the training set was established

• Not applicable/Not available. No training set for an algorithm is described.

In summary: The provided document is a 510(k) premarket notification and subsequent FDA clearance letter based on "substantial equivalence" to existing, legally marketed predicate devices. This regulatory pathway typically relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a predicate device, rather than requiring new, extensive performance studies with specific acceptance criteria like those outlined in the questions.

Ask a specific question about this device