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510(k) Data Aggregation
(159 days)
Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.
Straumann® Closure Caps and Healing Abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months.
Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.
Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The connection is identified as conical fitting with Torx style engaging feature. The prosthetic platforms are identified as RB (Regular Base) and WB (Wide Base). The implants with a RB platform have a "small top/head", and implants with WB platform have a "large top/head", whereas the internal connection is identical for both platform and all the implant diameters and lengths.
The closure cap and healing abutments are manufactured from Titanium Grade 4, per ISO 5832-2 and ISO 5832-11, and are anodized signal violet for the parts compatible with the RB platform and brown for the parts compatible with the WB platform for identification purposes. Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submerged (submucosal) healing. Healing abutments are screwed into the implant to protect the inner configuration in cases of transmucosal healing and are placed out of occlusion.
The temporary abutments are manufactured from TAN and are anodized signal violet (RB platform) and brown (WB platform) for identification purposes. The temporary abutments are fixed in the implant with a basal screw which is also manufactured from TAN. The basal screw will be delivered with the temporary abutment.
BLX Variobase abutments is a two-piece abutment ultimately composed by three components: Variobase™ Abutment (Ti-base), Prosthetic restoration (coping and/or crown), and Basal Screw. The BLX Variobase Abutments are manufactured and are delivered with the corresponding basal screw. The prosthetic restoration (crowns) can be cemented onto the Variobase prosthetic components.
Basal screws are used to seat the temporary abutments and the BLX Variobase Abutments to the dental implant, and can be also be used during lab procedures to fix lab prosthetic parts on implant analogs. There is one basal screw for the RB platform and one for the WB platform. They have identical designs and differ only in color-coding (signal violet and brown) to ease the handling. They are provided along the abutments but they are also provided as standalone screws. The BLX basal screws are manufactured from TAN.
This document describes the Straumann® BLX Implant System, a dental implant system, and its various components. The information provided is for a 510(k) premarket notification to the FDA. The goal is to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific, quantitative acceptance criteria for novel performance. Instead, the "acceptance criteria" are implied by successful comparative testing and adherence to existing standards and guidance documents. The "reported device performance" is the outcome of these tests.
| Test Type | Implied Acceptance Criteria (Demonstrated by Equivalence/Compliance) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Achieves a Sterility Assurance Level (SAL) of 10⁻⁶ via gamma irradiation. Complies with ISO 11137-1:2006 and ISO 11137-2:2013. For end-user sterilized components, validation according to ISO 17665-1, ISO 17665-2, and FDA guidance "Reprocessing Medical Devices in Health Care Settings." | BLX implants, closure caps, and healing abutments are sterile via gamma irradiation (25 kGy minimum), validated to SAL 10⁻⁶ per ISO 11137-1:2006 and ISO 11137-2:2013 (overkill bioburden method). BLX Temporary Abutments and BLX Variobase Abutments are end-user sterilized by moist heat (steam), validated per ISO 17665-1, ISO 17665-2, and FDA reprocessing guidance. |
| Shelf Life | Packaging ensures maintaining sterility for a specified period and materials are not adversely affected. | Shelf life for sterile devices remains 5 years, as packaging is equivalent to predicate/reference devices and materials are not adversely affected by time. |
| Pyrogenicity | Meets pyrogen limit specifications based on LAL Endotoxin Analysis (e.g., < 20 EU/device). | Pyrogenicity determined by LAL Endotoxin Analysis, with a testing limit of 20 EU/device for blood contacting and implanted devices. |
| Biocompatibility | Complies with ISO 10993-1:2009 and FDA guidance "Use of International Standard ISO 10993-1." Equivalent nature of body contact, contact duration, material formulation, and sterilization methods compared to predicates. | Biological assessment performed per ISO 10993-1:2009 and FDA guidance. Subject devices have equivalent body contact, duration, material formulation, and sterilization methods compared to predicates. Differences in manufacturing assessed via Chemical Characterization and Cytotoxicity tests. |
| Dynamic Fatigue & Static Strength | Fatigue load limits are equivalent to reference devices, especially for worst-case configurations. | Tests performed according to FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." Both RB and WB platforms, for worst-case considerations, proved equivalent to reference devices. |
| Insertion Torque | Allows reaching suitable implant insertion torques. | Tests conducted on worst-case defined for each diameter (Ø4.5, Ø 5.5, Ø 6.5 mm) of the BLX portfolio (shortest, middle, longest implants). Demonstrated that BLX Implants and related cutting instruments allow reaching suitable implant insertion torques. |
| Pullout Strength, Surface Area, B-I Contact | Equivalent to reference devices. | Performed for 6mm long BLX implants with Ø 4.5, 5.5, and 6.5 mm. Equivalency to reference devices was demonstrated. |
| Software Verification & Validation | Complies with FDA guidance documents for CAD/CAM systems and general software validation. Software functions correctly within the digital workflow. | Conducted and documented according to FDA guidance documents "Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff." Software considered "moderate" level of concern. Implementation verification shows Variobase devices and modeling components work together within the digital workflow for copings/crowns. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state numerical sample sizes for most bench tests (e.g., fatigue, insertion torque, pullout strength). It refers to "worst case considerations" for selecting test configurations (e.g., shortest, middle, and longest implants for insertion torque; both RB and WB platforms for fatigue). This implies a representative selection but not a specific count.
The data provenance is not explicitly stated as "country of origin." However, as this is an FDA submission for a device from "Institut Straumann AG" and "Straumann USA, LLC" (Andover, Massachusetts), the testing would typically be conducted in facilities compliant with US/international standards relevant to medical device approval, likely either in the US or Europe where Straumann has its main operations. The tests are retrospective, as they are being submitted to demonstrate the device meets prior requirements for market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this document. The document describes a medical device (dental implants and components) and its engineering and biological testing, not an AI/diagnostic software. Therefore, there is no "ground truth" to be established by experts in the context of diagnostic interpretation, and no test set in that specific sense.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. There is no diagnostic "test set" requiring adjudication by multiple readers or experts.
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. This document describes a physical medical device (dental implants), not an AI-assisted diagnostic or clinical decision support tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document describes a physical medical device and some associated software for design/milling, not a standalone AI algorithm with performance metrics.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the engineering tests (fatigue, strength, torque, pullout), the "ground truth" is defined by established engineering and material science principles, industry standards (e.g., ISO, ASTM, FDA guidance), and the performance of legally marketed predicate devices. The "truth" is whether the device meets the performance requirements set forth by these standards and demonstrates equivalence to existing, safe, and effective devices. For biocompatibility, the ground truth is compliance with ISO 10993 standards and a lack of adverse biological reactions.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical dental implant system, not an AI model that requires a "training set." The software mentioned is for CAD/CAM and is validated, not "trained" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as point 8.
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