(103 days)
Patient-specific abutment restorations, milled from Pre-milled Abutment Blanks (PMABs), are indicated for single tooth replacement and multiple tooth restorations. They are directly connected to various endosseous dental implant systems using a basal screw. Patient-specific abutment restorations milled from Pre-milled Abutment Blanks are to be digitally designed and milled using the Straumann InLab Validated Workflow. The Straumann InLab Validated Workflow 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, pre-milled abutment blanks, milling machines and associated tooling and accessories.
The Straumann InLab Validated Workflow is similar to the primary predicate K171649. It employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The 3Shape CAD software then allows the design of the desired restorations.
The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration. When choosing the Straumann Validated workflow, the user will only see the available and cleared components which were tested and demonstrated as part of the validated workflow. The milling command file is encrypted prior to transfer to the Roland DWX-42W Plus milling System; this encryption ensures that files generated using other CAD or CAM software cannot be used with the Straumann InLab Validated Workflow. The user will then load the milling command file into the Roland DWX-42W Plus milling System where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.
This premarket notification includes restorations (one-piece metal patient-specific abutment restorations) manufactured from various Pre-milled Abutment Blanks (PMABs) from the Straumann Group companies : Institut Straumann AG and Neodent PMABs. The digital workflow using the Straumann InLab Validated Workflow includes the use of the following products: Dental Scan of the patient's situation, CAD Software, CAM Module, Milling System, Abutment Milling Blanks.
The provided text is a 510(k) Summary for the Straumann InLab Validated Workflow, a device for designing and manufacturing patient-specific dental abutments from pre-milled abutment blanks (PMABs). The document describes the device, its intended use, technological characteristics, and performance testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria and reported device performance in a consolidated format as typically seen in a clinical study report. However, it mentions key performance areas and states that requirements were met.
Acceptance Criteria (Implicit from tests performed):
- Sterilization Validation: Meet ISO 17665-1 and FDA guidance for reprocessing medical devices.
- Biocompatibility: In line with ISO 10993-1 and FDA guidance for biological evaluation.
- Electromagnetic Compatibility (EMC): Considered MR Conditional.
- Milling Accuracy: Dimensions of milled restoration are the same as the intended CAD design, met within tool's expected lifetime.
- Simulated Use Validation: Correct implementation of PMABs, design constraints, and workflow restrictions in software and libraries.
- Implant-Abutment Connection Protection: No damage to the connection geometry during milling.
- Dynamic Fatigue: Performance consistent with FDA guidance for dental implants/abutments.
Reported Device Performance:
| Performance Area | Reported Device Performance |
|---|---|
| Sterilization Validation | The recommended sterilization method (moist heat/steam) was validated according to ISO 17665-1 and applicable FDA guidance on reprocessing medical devices. Sterilization parameters are equivalent. |
| Biocompatibility Testing | Biological assessment performed per ISO 10993-1 and FDA guidance. Device materials and manufacturing processes are equivalent to predicate, raising no new biocompatibility issues. |
| Electromagnetic Compatibility | No significant changes from currently marketed predicate devices; no new EMC issues raised. Device can be considered MR Conditional. |
| Milling Accuracy | Black-box validation confirmed that dimensions of the milled restoration are the same as the intended CAD design. The accuracy requirement was met considering the tool's expected lifetime. |
| Simulated Use Validation | Confirmed that relevant PMABs, design constraints, and workflow restrictions are correctly implemented (adequately written and locked into compatible design software and available libraries). |
| Implant-Abutment Connection Protection | A simulated implant-abutment connection protection test was conducted to mitigate potential risk of damaging the implant-abutment connection geometry during milling. |
| Dynamic Fatigue | The device design and performance testing submitted or referenced were conducted according to FDA guidance for root-form endosseous dental implants and abutments. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the test sets in the performance studies (e.g., dynamic fatigue, milling accuracy, simulated use validation). It refers to these as "Performance Testing - Bench."
Data Provenance: The studies are described as "nonclinical tests" and "bench" testing, suggesting they were conducted in a laboratory or simulated environment, rather than involving patient data. The document does not specify country of origin for the data (beyond the applicant being Institut Straumann AG in Switzerland and JJGC Indústria e Comércio de Materiais Dentários AS in Brazil, with contact in Andover, MA, USA). The studies appear to be prospective, designed specifically for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The validation methods described (e.g., milling accuracy, simulated use) imply technical verification against design specifications and functional requirements rather than expert consensus on diagnostic or clinical outcomes.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as there is no indication of multiple reviewers or subjective assessments requiring adjudication in the described bench tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The device is a workflow for manufacturing dental restorations, not an AI diagnostic or assistive tool for human readers in the traditional sense of comparing human performance with and without AI assistance for interpretation.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
The milling accuracy test ("black-box validation confirming that the dimensions of the milled restoration are the same as the intended CAD design") and the simulated use validation implicitly test the algorithm and workflow in a standalone manner, separate from a human operator's interpretative judgment. The "Straumann InLab Validated Workflow" itself is largely an automated process once the design is finalized. It is designed to ensure that the digital design translates accurately into a physical product.
7. Type of Ground Truth Used
The ground truth used for these performance tests appears to be:
- Design Intent/Specifications: For milling accuracy, the ground truth is the CAD design itself. For simulated use, the ground truth refers to the correct implementation of design constraints and workflow restrictions within the software and libraries.
- Industry Standards and Regulatory Guidance: For sterilization, biocompatibility, and dynamic fatigue, the ground truth is defined by recognized international standards (ISO) and FDA guidance documents.
- Functional Requirements: For implant-abutment connection protection, the ground truth is the prevention of damage to the connection geometry.
8. Sample Size for the Training Set
The document does not describe the use of machine learning or AI models in a way that would involve a distinct "training set" in the context of typical software or diagnostic AI submissions. The workflow involves CAD/CAM software where parameters and constraints are defined by engineering and design principles rather than learned from a large training dataset.
9. How the Ground Truth for the Training Set Was Established
As no specific training set for a machine learning model is described, there is no information on how its ground truth would have been established. The workflow relies on validated engineering designs, material properties, and manufacturing processes.
§ 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.)