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510(k) Data Aggregation
(290 days)
Straumann CARES P-Series CAD/CAM System
The Straumann CARES P-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, a restorative acrylic resin, 3D printers, post-curing unit and associated accessories. The system is used to design and fabricate CAD/CAM 3D printed coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments that are affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.
The Straumann P pro Crown & Bridge material in combination with the Straumann Variobase is indicated for temporary (up to 180 days) dental restoration of a Straumann dental implant.
The Straumann CARES P-Series CAD/CAM System is intended for the design and fabrication of dental restorations by dental laboratories by means of a digital workflow for 3D printing.
The Straumann CARES P-Series CAD/CAM System employs optical impression files that document the topoqraphical characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual CAD software then allows the desired restorations. The CAM software converts the digital restoration design into the sequential slice geometries needed to 3D print a restoration or multiple restorations in a print job. The printing file is transferred to the Straumann P-Series 3D printer; where it is decoded into the defined printing slices and the user initiates the printing operation. The Straumann P-Series 3D printer will then print the designed restoration using the Straumann P Pro Crown & Bridge resin.
The user of a Straumann CARES P-Series CAD/CAM System can design dental implant borne restorations using Straumann Variobases as the connecting interface to the implant. By this, the user will create two-piece abutments with the 3D printed part being the upper part of the implant borne restoration.
The provided text is a 510(k) summary for the Straumann CARES P-Series CAD/CAM System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study that proves the device meets specific acceptance criteria in the manner of a clinical trial or performance study comparing a new algorithm's efficacy.
Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details for an AI/algorithm-based device is not explicitly available in this document. The device in question is a CAD/CAM system for designing and fabricating dental restorations, not an AI diagnostic tool.
However, based on the provided text, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" for a specific performance metric in the context of an AI algorithm. Instead, it describes "Design Specifications" which serve as internal parameters for the CAD/CAM system and performance testing related to mechanical properties.
| Feature | Acceptance Criteria (Implicit from Predicate & Testing) | Reported Device Performance |
|---|---|---|
| Minimum wall thickness (Crown) | Sufficient for intended use (compared to predicate) | 1.0 mm |
| Maximum angulation (Crown) | Safe and effective (compared to predicate) | 30° |
| Minimum post-height of Variobase | Sufficient for intended use (compared to predicate) | 4.6 mm |
| Minimum diameter | Sufficient for intended use (compared to predicate) | 3.8 mm |
| Maximum number of units (Bridge) | Specified by material manufacturer (compared to predicate) | 6 units |
| Maximum number of pontics (Bridge) | Specified by material manufacturer (compared to predicate) | 2 pontics |
| Mechanical Properties | Equivalent to primary predicate and reference devices | Dynamic fatigue and static strength tests passed |
| Biocompatibility | Met for P pro Crown & Bridge material (K200039) | Biocompatibility tests passed (cytotoxicity, sensitization, irritation) |
| Sterilization Process | Validated according to FDA guidance | Validated for Straumann Variobase® |
| Software Restrictions | Prevent design outside allowable limitations | Demonstrated effective use; limitations locked |
| 3D Printer System Accuracy | Design input matches output; repeatable; independent of factors | Design input matched output; repeatable; independent of print orientation, build plate location, material reuse (up to 30 times) |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The testing described primarily involves mechanical material testing and software verification, not clinical or diagnostic data analysis. Therefore, concepts like "test set" in the context of an AI algorithm are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes a CAD/CAM system for fabricating dental prosthetics, not a diagnostic AI algorithm requiring expert ground truth for imaging or clinical decision support. The "ground truth" for the mechanical characteristics would be established by standardized testing protocols.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as in point 3.
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
This information is not applicable. The device is a CAD/CAM system for fabrication, not an AI for human reader assistance or diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The "standalone" performance described relates to the verification of the 3D printer system and the CAD software.
- Software Verification and Validation: This was performed to demonstrate that the software's restrictions prevent designing components outside allowable limitations and that the design library is locked. This implies a standalone verification of the software's adherence to design rules.
- 3D Printer System Verification: This confirmed that "the design input matched the output, that the process is repeatable and independent of print orientation, build plate location effects, and the effects of material reuse." This is a form of standalone performance assessment for the manufacturing component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing cited appears to be:
- Standardized Mechanical Testing: According to FDA guidance for dental implants and abutments. This involves objective measurements of strength and fatigue.
- Material Specifications: Biocompatibility data from a previously cleared 510(k) for the P pro Crown & Bridge material (K200039).
- Design Specifications: Defined parameters (e.g., minimum wall thickness, maximum angulation) that the CAD software must adhere to.
This is not "expert consensus, pathology, or outcomes data" in the typical sense of AI diagnostic systems.
8. The sample size for the training set
This information is not provided and is not applicable as the device is not an AI/machine learning algorithm requiring a "training set" in the conventional sense.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the same reasons as in point 8.
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