(142 days)
Straumann® Bone Level Tapered Implants Ø2.9 mm are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and aesthetic oral rehabilitation of patients with missing teeth. Straumann® Bone Level Tapered Implants 02,9 mm can also be used for immediate or early implantation following extraction or loss of natural teeth. 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 components (abutments).
The Straumann® Bone Level Tapered Implants 02.9 mm are indicated for reconstruction of missing incisors in the lower jaw and lateral incisors in the upper jaw.
Straumann® Closure Caps and Healing Abutments are indicated to be placed in the dental implant after placement in the patient's jaw to protect the inner configuration of the implant and stabilize the soft tissue during the healing process. Closure Caps and Healing Abutments should be used only with the corresponding implant comection.
Straumann® SC Temporary Abutments are indicated 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. Strauman® SC Temporary Abutments have a maximum duration of usage of 180 days.
Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when 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.
Straumann® SC CARES® abutments are indicated for single-tooth replacements and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.
The Straumann Ø2.9mm Bone Level Tapered (BLT) Implants are apically tapered implants with an external diameter of Ø2.9 mm and lengths of 10 mm, 12 mm, and 14 mm. The implants are manufactured utilizing the Roxolid material and are finished with either the SLA® or SLActive® surface. The prosthetic platform is identified as SC (Small CrossFit®) which corresponds to a shoulder diameter of Ø2.9 mm.
The closure cap and healing abutments are manufactured from Titanium Grade 4 and are anodized blue for identification purposes. The closure cap is conical and has a height of 0.5 mm. The healing abutments are seated in the implant with a basal screw which is manufactured from TAN. The healing abutments are oval in shape and are available in four different heights ranging between 2.0 mm and 6.5 mm.
The temporary abutments are manufactured from TAN and are anodized blue for identification purposes. The temporary abutments are oval in shape in order to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The temporary abutments are seated in the implant with a basal screw which is also manufactured from TAN.
There are three components to the Straumann® SC Variobase™ Abutments:
- Straumann® SC Variobase™ Abutments (Ti-base)
- Prosthetic restoration (coping and/or crown)
- Basal Screw
The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw.
The following is an overview of the possible prosthetic restoration (coping and/or crown) materials:
- Cast materials:
- Type 4 metals (ISO 22674)
- Base metal alloys (e.g., cobalt-chromium (CoCr))
- Noble metal alloys (e.g., gold alloy)
- Press materials:
- IPS e.max® Press Ceramic (K120053)
- Digital materials:
- coron®
- zerion® LT
- polycon® ae
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® SC CARES® Abutments are customized abutments manufactured from TAN. The abutments are designed by the customer by scanning the intraoral situation and designing of the shape with the CAD module of the integrated software. The design data is then sent to Straumann where the fabrication of the customized abutment is performed. The TAN alloy is capable of being directly veneered once the abutment is subject to a heat treatment step by the dental laboratory technician. A finished crown may also be cemented to the subject abutments rather than by direct veneer. The abutments will be delivered with the corresponding basal screw.
The provided document (K162890) describes the regulatory submission for Straumann dental implants and associated components. However, it does not contain information about studies proving the device meets acceptance criteria for performance metrics related to diagnostic accuracy, such as sensitivity, specificity, or AUC, as these types of metrics are typically associated with diagnostic or AI-powered devices.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through various non-clinical tests. The "acceptance criteria" here relate to the successful completion of these engineering and safety tests, rather than clinical performance metrics for diagnostic capability.
Therefore, the requested information cannot be fully provided in the format desired for diagnostic devices because this submission deals with dental implants, not a diagnostic AI.
However, I can extract the information related to the performance testing that was conducted to support the substantial equivalence claim.
Acceptance Criteria and Device Performance (Not applicable in the typical sense for diagnostic AI):
The document does not present acceptance criteria or reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) because the devices (dental implants and abutments) are not diagnostic AI devices. Instead, the "performance testing" focuses on engineering, biocompatibility, and sterilization validations to demonstrate substantial equivalence to predicate devices.
Summary of Performance Testing Conducted (which can be seen as meeting "acceptance criteria" for safety and efficacy in this context):
-
Sterilization Validation (Section 5.8.1):
- Acceptance Criteria: Validation according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".
- Reported Device Performance: The sterilization process for SC Temporary Abutments, SC Variobase Abutments, and SC CARES Abutments was validated.
-
Biocompatibility Testing (Section 5.8.2):
- Acceptance Criteria: Compliance with ISO 10993-1:2009 and the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016". The subject devices should have identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to predicate devices, raising no new biocompatibility issues.
- Reported Device Performance: The subject devices have identical biocompatibility characteristics to the primary and reference predicate devices. Therefore, no additional biocompatibility testing was required or performed.
-
Software Verification and Validation Testing (Section 5.8.3): (Applicable to CARES Visual software for abutment design, which is part of the manufacturing process, not a diagnostic AI)
- Acceptance Criteria: Compliance with 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".
- Reported Device Performance: Software verification and validation testing were conducted; the software for the device (CARES Visual) was considered a "moderate" level of concern.
-
Bench Testing (Section 5.8.4):
- Acceptance Criteria: Compliance with the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" for dynamic fatigue, static strength, and insertion torque tests.
- Reported Device Performance: Dynamic fatigue, static strength, and insertion torque tests demonstrated the Straumann® Ø2.9 mm Bone Level Tapered implants, SC Temporary Abutments, SC Variobase Abutments, and SC CARES abutments are equivalent to the predicate and reference devices.
Regarding the specific questions about diagnostic AI studies:
- A table of acceptance criteria and the reported device performance: As explained above, not applicable for diagnostic metrics. The performance relates to engineering and safety tests.
- Sample size used for the test set and the data provenance: Not applicable. The "tests" mentioned are non-clinical engineering and bench tests, not studies on patient data for diagnostic evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no diagnostic test set or ground truth in this context.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a diagnostic AI scenario. The "ground truth" for the bench tests would be the established engineering standards and physical properties of the materials.
- The sample size for the training set: Not applicable, as there is no AI training set.
- How the ground truth for the training set was established: Not applicable.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.