(21 days)
PrimaConnex SD Esthetic Contour Zi Abutment is intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.
PrimaConnex SD Esthetic Contour 7: Abutment is intended for use in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.
The provided 510(k) summary for the PrimaConnex® SD Esthetic Contour Zi Abutment (K073032) focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a study with specific acceptance criteria and device performance metrics.
Therefore, the document does not contain information to fill in most of the requested sections regarding acceptance criteria, device performance, study details, sample sizes, expert involvement, or ground truth establishment.
Specifically, there is no mention of a study conducted to prove the device meets any particular acceptance criteria for performance, clinical effectiveness, or standalone algorithm performance. The basis for clearance is substantial equivalence to previously cleared devices.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific acceptance criteria or report on device performance metrics through a study. The substantial equivalence argument rests on similar intended use, materials, design, and packaging.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. No test set or study data is described.
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)
- Cannot be provided. No test set or related ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication process 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
- Cannot be provided. This device is a ceramic abutment, not an AI or imaging device. Therefore, an MRMC study is not relevant, and no such study was performed or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a ceramic abutment, not an algorithm. Therefore, no standalone algorithm performance study was performed or reported.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. No study involving ground truth for performance evaluation is described.
8. The sample size for the training set
- Cannot be provided. As there is no AI component, and no performance study mentioned, there is no training set.
9. How the ground truth for the training set was established
- Cannot be provided. As there is no AI component, and no performance study mentioned, there is no training set or ground truth for it.
Summary of Device Equivalence Argument (from the document):
The submission for the PrimaConnex® SD Esthetic Contour Zi Abutment demonstrates substantial equivalence to predicate devices (PrimaConnex RD and WD Esthetic Contour Zi Abutment (K072572), PrimaConnex Esthetic Contour Abutment (K051614), and PrimaConnex Ceramic Abutment (K062876)) based on the following:
- Intended Use: All devices share the same intended use: in conjunction with the PrimaConnex Internal Connection Implant System in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit cement retained restorations.
- Material: The new device and predicates are manufactured from the same material.
- Design: The new device incorporates the same design as the predicates.
- Packaging: The new device is packaged using the same materials and processes as the predicates.
Therefore, the "proof" that this device meets acceptance criteria is the argument of substantial equivalence to existing legally marketed devices, rather than a de novo performance study against defined acceptance criteria.
§ 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.)