(83 days)
PrimaConnex Ceramic Copings are intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae, in the construction of single-unit cement retained restorations.
The copings are designed to fit Lifecore's PrimaConnex Quick-Abutment.
Lifecore Biomedical PrimaConnex Ceramic Copings are pre-manufactured for use as a core structure in the construction of single-unit cement retained restorations. The Ceramic Copings will be offered in three sizes; Small Diameter (SD), Regular Diameter (RD), and Wide Diameter (WD) to fit with the corresponding PrimaConnex Quick-Abutments, previously cleared under K051614. The Ceramic Coping contains an internal flat for anti-rotation and is cemented onto the Quick-Abutment after completion of the prosthetic restoration.
The Ceramic Copings are manufactured from Yttria-Stabilized Tetragonal Zirconia (Y-TZP) in conformance with ISO Standard 13356, Implants for Surgery – Ceramic Abutments Based on Yttria-Stabilized Tetragonal Zirconia (Y-TZP).
The provided text is a 510(k) summary for a dental device, the Lifecore PrimaConnex™ Ceramic Coping. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with specific acceptance criteria, statistical analyses, or detailed performance metrics typically found in clinical trial reports for diagnostic or AI-driven devices.
Therefore, many of the requested elements (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, ground truth details, effect sizes) are not applicable or not present in this document.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
Since this is a submission for a device component (ceramic coping for dental restorations) and the 510(k) process focuses on substantial equivalence, there are no explicit "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or reader agreement) in this document. Instead, the "acceptance criteria" can be inferred as demonstration of substantial equivalence to existing, legally marketed predicate devices, primarily based on material conformity and intended use.
The device performance is described in terms of its characteristics and conformity to standards, rather than clinical efficacy data.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance |
|---|---|
| Material Conformity: Device material meets relevant ISO standards. | Manufactured from Yttria-Stabilized Tetragonal Zirconia (Y-TZP) in conformance with ISO Standard 13356. |
| Intended Use Equivalence: Device intended use is comparable to predicate. | Intended for use as a core structure for a prosthetic restoration in partially or fully edentulous mandibles and maxillae, in the construction of single-unit cement retained restorations. This is stated to be similar to predicate devices. |
| Design Equivalence: Device design is comparable to predicate for its stated purpose. | Incorporates equivalent coping designs to predicate devices. Offered in three sizes (SD, RD, WD) to fit corresponding PrimaConnex Quick-Abutments. Contains an internal flat for anti-rotation. |
| Safety and Effectiveness: No new questions of safety or effectiveness raised compared to predicates. | "When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaConnex Ceramic Copings." |
Study Information
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Sample size used for the test set and the data provenance:
- Not applicable/Not provided. This is a material and design equivalence submission, not a study evaluating performance on a patient test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided.
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Adjudication method for the test set:
- Not applicable/Not provided.
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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. This is not an AI-driven device or a diagnostic device subject to MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" equivalent for this type of submission is the established safety and effectiveness of the predicate devices and the conformity of the new device's material and design to relevant standards which ensures performance comparable to the predicates without raising new safety/effectiveness concerns.
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The sample size for the training set:
- Not applicable/Not provided.
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How the ground truth for the training set was established:
- Not applicable/Not provided.
§ 872.3920 Porcelain tooth.
(a)
Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.(b)
Classification. Class II.