Search Results
Found 1 results
510(k) Data Aggregation
(106 days)
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. Healing Caps should be used only with suitable implant connections. The healing components are intended to be used up to 6 months.
The Healing Caps are screws machined into 2 pieces and come in three gingival heights to accommodate individual gingival thickness. The material of the devices is yttria-stabilized tetragonal zirconia (Y-TZP) and titanium grade 4. 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 provided text describes a 510(k) premarket notification for the Straumann® CI RD Ceramic Healing Caps, asserting its substantial equivalence to previously marketed predicate devices. The document focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing efficacy against specific clinical outcomes. Therefore, the "acceptance criteria" and "device performance" in this context refer to engineering and biological performance characteristics compared against established standards for dental implant components.
Here's a breakdown of the requested information based on the provided text, noting where specific details are not available in a 510(k) summary:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission, the "acceptance criteria" are typically demonstrating compliance with relevant international standards and equivalence to predicate devices. The "reported device performance" refers to the results of engineering and biocompatibility testing.
| Acceptance Criteria Category | Specific Criteria / Standard Applied | Reported Device Performance |
|---|---|---|
| Sterilization | Sterility Assurance Level (SAL): Minimum SAL of 10-6 per ISO 11135 (Ethylene Oxide sterilization).Endotoxin Limits: < 20 EU/device (based on FDA Guidance for blood-contacting/implanted devices).Packaging Integrity: Maintained after sterilization, handling, distribution, transport, and storage (demonstrated by ISTA 2A transportation study and packaging stability study). | Sterility Assurance Level (SAL): Validation performed per ISO 11135 demonstrating reliable and consistent sterilization to a minimum SAL of 10-6.Endotoxin Limits: LAL Endotoxin Analysis performed on finished packages from a production lot after sterilization demonstrated compliance with the < 20 EU/device limit.Packaging Integrity: A transportation study per ISTA 2A demonstrated integrity of the sterile barrier system. A packaging stability study demonstrated integrity of the packaging system and sterile barrier after all relevant processes and for the defined shelf life. |
| Biocompatibility | Biological safety assessed according to ISO 10993-1 guidelines.Cytotoxicity: Evaluated per ISO 10993-5.Chemical Characterization: Evaluated per ISO 10993-18. | Biological Safety: Assessed according to ISO 10993-1.Cytotoxicity: Tests performed per ISO 10993-5.Chemical Characterization: Tests performed per ISO 10993-18.(The document states these tests were performed, implying they met the acceptance criteria, but does not explicitly state the specific results or numerical compliance for each test. In a 510(k) summary, positive results are generally implied for substantial equivalence.) |
| Material Equivalence | The device's material properties (Y-TZP and titanium grade 4) and dimensions should be comparable to predicate devices to establish substantial equivalence. | The materials (Y-TZP and titanium grade 4) are consistent with materials used in the predicate and reference devices, or are well-established for this type of device. The technological characteristics table (Table 1) compares dimensions and materials, indicating fundamental similarity. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify exact sample sizes for the sterilization, endotoxin, packaging, or biocompatibility tests. It indicates that testing was performed on "production lot" or "completed package," which typically implies a statistically relevant sample size for validation, but the exact number isn't provided.
- Data Provenance: Not specified. These are laboratory-based engineering and biological tests, not clinical studies involving human subjects or patient data. The manufacturer is Institut Straumann AG (based in Switzerland, submitted by Straumann USA, LLC), so the testing would likely have been conducted by them or a contract lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable for this type of submission. The "ground truth" for engineering and biocompatibility tests is based on established scientific principles and international standards (e.g., ISO, FDA guidance), not on expert consensus from clinical cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used in clinical studies when interpreting ambiguous patient data or images. The tests described are laboratory validations against objective criteria.
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 is a medical device for dental implants, not an AI/software device that involves human readers or image interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (healing caps), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance data (sterilization, endotoxin, biocompatibility, packaging) is based on pre-defined specifications and international standards. For example, a sterility assurance level of 10-6 is a defined standard, not an expert consensus or pathology result. Endotoxin limits are also defined by regulatory guidance.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this 510(k) for a physical medical device. This term is relevant for machine learning or AI models.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
Ask a specific question about this device
Page 1 of 1