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510(k) Data Aggregation
(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.
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(44 days)
Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges and overdentures.
The Straumann NN CARES Titanium Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.
The Straumann NN CARES Ceramic Abutment is indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration can be cement-retained or directly veneered.
The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment:
Summary of Device Acceptance Criteria and Study Findings
The provided 510(k) summary for the Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. It does not present a study with specific acceptance criteria and reported device performance metrics in the typical sense of a clinical trial or performance study showing quantifiable outcomes like sensitivity, specificity, accuracy, etc.
Instead, the "acceptance criteria" are implicitly met by demonstrating that the new devices share the same fundamental characteristics as their predicates.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|
| Identical intended use as predicate devices. | "The intended use is identical to the predicate devices." |
| Same material composition as predicate devices. | "The proposed abutments have the same material composition..." |
| Basic design similar to predicate devices. | "...basic design..." (similar to predicates, implied) |
| Fundamental operating principles similar to predicate devices. | "...and fundamental operating principles to the currently cleared devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable. The submission is based on a comparison of characteristics to predicate devices, not a clinical test set with patient data.
- Data Provenance: Not applicable. There is no test set in the traditional sense of a study involving data from patients or a specific geographic region.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. There is no test set requiring expert ground truth establishment for performance metrics.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no test set for which adjudication would be required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This type of study is not mentioned or implied in the 510(k) summary. The submission focuses on substantial equivalence based on material, design, and intended use, not a comparison of human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Study: No. This device is a physical dental abutment, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not applicable.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable in the context of typical software or diagnostic device evaluations. The "ground truth" for this submission is the established legally marketed status and characteristics of the predicate devices. The new devices are deemed "substantially equivalent" if their characteristics match or do not raise new questions of safety or effectiveness compared to the predicates.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is a physical dental abutment, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
Conclusion:
This 510(k) submission for the Straumann NN CARES Titanium Abutment and NN CARES Ceramic Abutment falls under the category of substantial equivalence demonstration for a physical device. It does not involve a traditional performance study comparing a device against specific acceptance criteria using a test set with expert-established ground truth, as would be common for diagnostic software or AI-powered devices. The "study" here is the comparison of the new device's characteristics (intended use, material, design, operating principles) to those of legally marketed predicate devices. The FDA's acceptance (clearance) signifies that this comparison demonstrated substantial equivalence.
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