(9 days)
The Ceramic Abutment is intended for customized prosthetic treatment. The Ceramic Abutment is used with dental implant supported restorations in the anterior, canine, and premolar regions where high esthetic demands are expressed.
This 510k describes an additional component for the Astra Tech Implants -Dental System, the Ceramic Abutment. Ceramic Abutment 4.5/5.0 ST ø 5.5 mm. The Ceramic Abutment is a transmucosal element that can be customized to meet high anatomical and esthetic demands. The Ceramic Abutment is designed to allow for individual solutions regarding function and esthetics. It is intended for cement-retained constructions and follows the same preparation principles as for reqular crown and bridgework. The cement-retained superstructure excludes the need for non-esthetic screw entries through the crown. The design provides flexibility to mimic the anatomy of a natural tooth and to compensate for non-parallel fixtures. The esthetic properties of the Ceramic Abutment create a natural appearance of the soft tissue marqin as well as a better result for the all-ceramic crown restoration. The Ceramic Abutment is ground and customized to its ideal shape using diamond wheels/burrs or silicone carbide stones. The Ceramic Abutment has a conical relation to the fixture which enables a tight and stable connection between the components. There is a hexagonal interlock in relation to the fixture for antirotation and indexing. The Ceramic Abutment is connected to the fixture and tightened with the Abutment Screw ST/Long using a Hex screwdriver or Hex CA Driver.
The provided document is a 510(k) summary for the Astra Tech Ceramic Abutment and an FDA clearance letter. It describes the device, its intended use, and the basis for substantial equivalence to predicate devices, including performance testing. However, it does not explicitly define specific acceptance criteria (numerical thresholds for performance metrics) or detail a study design that directly proves the device meets such criteria.
The document states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." but does not provide the specifics of these tests, their results, or the acceptance thresholds used.
Therefore, many of the requested details cannot be extracted from the given text. Below is an attempt to answer the questions based on the available information, noting where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (If available) | Acceptance Threshold (If available) | Reported Device Performance (If available) |
|---|---|---|---|
| Functionality | (Not specified beyond "functionality") | (Not specified) | "Device functionality and conformance to design input requirements" confirmed through laboratory testing. Details not provided. |
| Material Properties | (Implied by comparison to predicate) | (Implied by comparison to predicate) | "Very similar in terms of size, materials of construction, performance characteristics, and basic design" to predicate devices. |
| Mechanical Performance | (Implied by comparison to predicate) | (Implied by comparison to predicate) | "Performance testing" conducted. "Differences have no effects on the performance or safety of the Ceramic Abutments." |
| Safety | (Implied by comparison to predicate) | (Implied by comparison to predicate) | "Same types of safety and effectiveness characteristics are raised with each of the devices" (compared to predicates). |
Missing Information: Specific quantitative acceptance criteria or numerical results from performance testing are not provided in this 510(k) summary. The document focuses on declaring substantial equivalence based on similarity and confirmation of functionality, rather than detailed performance metrics against predefined thresholds.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided. This document describes laboratory performance testing, not a clinical study involving a "test set" of patient data. The testing mentioned in the summary is "Laboratory testing."
- Sample Size for Test Set: Not specified.
- Data Provenance: Laboratory testing (not patient data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. This refers to laboratory performance testing and comparison to predicate devices, not studies requiring expert-established ground truth on patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. This refers to laboratory performance testing and comparison to predicate devices, not studies requiring adjudication of disagreements among experts on patient data.
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
No. This device is a dental implant component. The provided document details its physical characteristics, intended use, and substantial equivalence, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is a dental implant component. Not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable/Not provided in the context of patient data. The "ground truth" for this device's performance testing would be engineering specifications, material standards, and benchmark performance of the predicate devices. The document implies that the device confirmed "conformance to design input requirements."
8. The sample size for the training set
Not applicable/Not provided. This refers to laboratory performance testing and comparison to predicate devices, not machine learning model training.
9. How the ground truth for the training set was established
Not applicable/Not provided. This refers to laboratory performance testing and comparison to predicate devices, not machine learning model training. The "ground truth" for the physical and material properties would have been established through engineering design, material specifications, and regulatory standards.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)