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510(k) Data Aggregation
(242 days)
Neodent Implant System - Mini Abutment 60°
The Mini Conical Abutments are indicated for use with Zygomatic Implants, in cases of severe jaw resorption, in order to restore patient aesthetics and chewing function. It may be used with single-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.
Mini Abutments 60°
- Intended for single use;
- Provided sterile via ethylene oxide gas;
- Manufactured of titanium alloy (Ti6Al4V-ELI) per ASTM F136;
- Available in different gingival heights;
- Screw-retained to the implant;
- Provided with an anti-rotational implant-to-abutment interface compatible with GM Zygomatic Implants;
- Provided with coronal geometries in rotational (non-indexed) versions to support multi-unit restorations
- . The subject devices are compatible with Impression copings, Provisional cylinders, Protective cylinders and Copings of the Neodent GM Line previously cleared per market.
The provided document is a 510(k) Summary for the Neodent Implant System - Mini Abutment 60°. It describes the device, its indications for use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence through non-clinical performance data.
Based on the provided text, there is no information about a clinical study involving human subjects or AI performance. The summary explicitly states "SUMMARY OF NON-CLINICAL PERFORMANCE DATA". Therefore, most of the requested information regarding acceptance criteria, study type, sample sizes, experts, ground truth, and MRMC studies for AI devices is not available in this document.
Here's what can be extracted:
Acceptance Criteria and Reported Device Performance
The document describes non-clinical acceptance criteria related to mechanical properties, sterilization, and biocompatibility.
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria | Reported Device Performance/Conclusion |
|---|---|---|---|
| Mechanical Properties | Dynamic fatigue test (per ISO 14801 and FDA guidance) | Performance suitable for intended use | Demonstrated performance suitable for intended use |
| Mechanical Properties | Torsion testing (for screws) | Results met the acceptance criteria | Results met the acceptance criteria |
| Sterilization | Ethylene Oxide sterilization (per ISO 11135) | Minimum Sterility Assurance Level (SAL) of 1 x 10^-6 | Validated to a minimum SAL of 1 x 10^-6 |
| Sterilization | Ethylene oxide residuals (per ISO 10993-7) | Within accepted limits | Residuals are within accepted limits |
| Biocompatibility | Cytotoxicity testing (per ISO 10993-5) | (Not explicitly stated, but implied positive) | Performed; reference to previous biocompatibility testing |
| Biocompatibility | Chemical characterization (per ISO 10993-18) | (Not explicitly stated, but implied positive) | Performed; reference to previous biocompatibility testing |
| Shelf-life | Product and package stability (per ASTM F1980) | (Not explicitly stated, but implied positive) | Determined to be 5 years |
| MRI Safety | MR Compatibility | No new worst-case constructs, safe scanning | Subject devices do not result in new worst-case constructs for MR compatibility; can be safely scanned observing established parameters |
Information not available in the document:
- Sample size used for the test set and the data provenance: Not applicable. The document describes non-clinical (laboratory) testing, not a test set of data from clinical subjects.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant to these non-clinical tests.
- 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: No MRMC study was done, as this is not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance was done, as this is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as this is not an AI device and no clinical ground truth was established for the non-clinical tests. The "ground truth" for these tests are objective measurements against established standards (e.g., ISO 14801, ISO 11135).
- The sample size for the training set: Not applicable, as this is not an AI device.
- How the ground truth for the training set was established: Not applicable, as this is not an AI device.
In summary, this document pertains to a traditional medical device (dental abutment) and relies on non-clinical engineering and materials testing to demonstrate substantial equivalence, not AI algorithm performance or clinical trial data.
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