(316 days)
The Straumann PURE Ceramic Implant is indicated for the restoration of single-tooth gaps and in edentulous or partially edentulous jaws. The prosthetic restorations used are single crowns, fixed partial or full dentures, which are connected to the implants through the corresponding components.
Closure and Healing caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Closure and Healing caps should be used only with suitable implant connections. Do not use healing components for longer than 6 months.
The provisional components are intended to serve as a base for temporary crown or bridge restoration out of occlusion for the Straumann® PURE Ceramic Implant System. The Straumann® Temporary Abutment VITA CAD-Temp® for the Straumann® PURE Ceramic Implant is indicated for temporary usage of up to 180 days.
CI RD Straumann PUREbase abutment is a titanium base placed onto Straumann ceramic dental implants to provide support for customized prosthetic restorations and is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. 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 PURE Ceramic Implant is a dental implant made out of yttrium-stabilized zirconium dioxide (Y-TZP). The Straumann PURE Ceramic Implant is based on features of the Straumann PURE Ceramic implant Monotype. Straumann PURE Ceramic Implants can be placed using the existing instruments using the same osteotomy preparation protocol as for Bone Level implants. The subject implant is a two -piece implant and is available in Ø4.1 mm with lengths of 8, 10, 12, and 14 mm.
The Closure and Healing caps are screws machined as one piece and come in three gingival heights to accommodate individual gingival thickness. The material of the devices is titanium grade 4. The 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 protocols and do not support a prosthetic restoration. Healing caps are screwed into the implant to protect the inner configuration in cases of transmucosal healing protocols and are placed out of occlusion and do not support a prosthetic restoration.
The Temporary Abutments are used to serve as a temporary crown or bridge restoration for the Straumann PURE Ceramic Implant System.
The CI RD Straumann PUREbase Abutment for Ceramic implant is a premanufactured (stock) abutment (the first piece of the two-piece abutment), sometimes referred to as "Tibase", and is used as a base when fabricating a CAD/CAM customized restoration (the second piece of the two-piece abutment). The assembly of the two-pieces becomes a finished medical device after cementation of the CAD/CAM customized restoration on the PURE base abutment.
The Straumann PURE Ceramic Implant System did not present specific, quantified acceptance criteria with corresponding performance data in the provided text. Instead, the document focuses on demonstrating substantial equivalence to predicate and reference devices through various tests.
However, based on the provided "Performance Data 5.7" section and the comparison tables, we can infer the types of acceptance criteria and the nature of the study that proves the device meets those criteria. The acceptance criteria generally revolve around demonstrating equivalence to legally marketed predicate and reference devices in terms of safety and effectiveness, as per FDA guidelines for 510(k) submissions.
Here's an attempt to structure the information based on the request, interpreting "acceptance criteria" as the performance standards expected for demonstrating substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria were not stated, this table describes the type of performance evaluated and the outcome in relation to the predicate/reference devices.
| Acceptance Criterion (Inferred from regulatory requirements and comparative studies) | Reported Device Performance |
|---|---|
| Biocompatibility: Device materials are safe for biological contact and do not cause adverse reactions. (In accordance with ISO 10993-1:2009). | The subject device materials are identical to the predicate and reference device materials. Therefore, no new issues regarding biocompatibility were raised. |
| Sterilization Efficacy (for sterile components): Sterilization process reliably achieves a Sterility Assurance Level (SAL) of 10-6. (Per ISO 11135). | Sterilization validation was performed using the Half Cycle Overkill Approach, demonstrating the process can reliably and consistently sterilize to a minimum SAL of 10-6. |
| Pyrogenicity: Device does not contain pyrogens above acceptable limits. (Based on FDA Guidance, testing limit of 20 EU/device for blood contacting/implanted devices). | The device meets pyrogen limit specifications as determined by LAL Endotoxin Analysis, with a testing limit of 20 EU/device. |
| Reprocessing Validation (for non-sterile components to be reprocessed by end-user): Reprocessing methods (e.g., autoclaving) are effective. (Per ISO 17665-1:2006 and FDA guidance). | The sterilization process for the Straumann PURE temporary abutment and CI RD Straumann PUREbase abutments (as recommended in labeling) was validated according to applicable recommendations in FDA guidance and ISO 17665-1:2006. |
| Mechanical Strength/Fatigue: Device can withstand dynamic loading forces typical of oral function without failure. (Per ISO 14801:2016 and FDA guidance). | Dynamic fatigue tests demonstrated the Straumann PURE Ceramic Implant, Straumann PURE temporary abutments, and CI RD Straumann PUREbase abutments are equivalent to the predicate and reference devices. |
| Wear on Implant-to-Abutment Connection: Connection surfaces exhibit comparable wear behavior to predicate/reference devices. | Post-fatigue bench tests concluded comparable behavior of the subject device to the reference devices in terms of wear on the implant-to-abutment connection. |
| Screw Loosening: Risk of screw loosening is comparable to predicate/reference devices. | Post-fatigue bench tests concluded comparable behavior of the subject device to the reference devices in terms of screw loosening. A literature review was also provided to evaluate the risk of screw loosening with ceramic abutments. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench testing for mechanical performance, biocompatibility, and sterilization. It does not refer to a "test set" in the context of clinical data or data from human subjects.
- Sample Size: Not explicitly stated for each test, but typically, mechanical and sterilization validations involve a statistically representative number of units or replicates to demonstrate consistency and meet statistical confidence levels defined in the relevant ISO standards (e.g., ISO 11135, ISO 14801). Biocompatibility is based on material composition equivalency, not a specific sample size.
- Data Provenance: The studies are described as bench tests (laboratory studies), biocompatibility assessments based on material equivalency, and sterilization/reprocessing validations. There is no mention of country of origin of data in the context of test subjects, as these are not human studies for this specific assessment. The data is generated from laboratory testing and analytical comparisons.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is typically relevant for studies involving human interpretation (e.g., image analysis by radiologists). For this device, which involves material properties and mechanical performance, the "ground truth" is established by adherence to international standards (ISO) and FDA guidance documents, and the expertise lies in the validation engineers and materials scientists performing and interpreting these tests. There is no mention of "experts" in the sense of clinical adjudicators for a "test set" in the provided text.
4. Adjudication Method for the Test Set
Not applicable as this is not a study involving human interpretation of medical data (e.g., images) requiring adjudication of findings. Performance is evaluated against objective engineering and scientific standards.
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
Not applicable. This device is an endosseous dental implant system, not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software. It is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluations (mechanical, sterilization, biocompatibility) is defined by the International Organization for Standardization (ISO) standards and FDA guidance documents to which these tests were conducted.
- Biocompatibility: ISO 10993-1:2009.
- Sterilization: ISO 11135 and FDA Guidance on "Submission and Review of Sterility Information...".
- Reprocessing: ISO 17665-1:2006 and FDA guidance "Reprocessing Medical Devices in Health Care Settings...".
- Mechanical Testing (Dynamic Fatigue): ISO 14801:2016 and FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments".
- Wear and Screw Loosening: Bench tests demonstrating comparable behavior to reference devices, supported by a literature review for screw loosening risk.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is not an AI/machine learning model.
§ 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.