(113 days)
Inclusive® Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive® Titanium Abutments are compatible with:
- Straumann: Bone Level NC and RC implant sizes
- Nobel Biocare: Branemark RP size implant
- Nobel Biocare NobelActive NP and RP internal connection implants
Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is fastened into the implant with a screw. Abutments are made of titanium grade 23 (Ti-6AL-4V ELI) and meet ASTM F-136 Standard.
This document is a 510(k) Summary for Inclusive® Titanium Abutments. It describes the device, its intended use, and demonstrates substantial equivalence to a predicate device through non-clinical testing. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical trials or performance studies involving human subjects or AI-driven systems.
Therefore, the requested information elements (1-9) cannot be extracted from this document, as they pertain to aspects that are not present in a 510(k) summary for a dental abutment, which relies on non-clinical testing for substantial equivalence.
However, based on the provided document, I can infer the "acceptance criteria" and "study" as they relate to a 510(k) clearance for this type of medical device.
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission of a dental abutment, "acceptance criteria" are typically related to mechanical and material performance outlined in recognized standards. "Reported device performance" would be the results of tests demonstrating compliance with these standards.
| Acceptance Criteria (Inferred from FDA Guidance & Substantial Equivalence) | Reported Device Performance (Inferred from "Non-clinical testing was performed...") |
|---|---|
| Mechanical Performance: |
- Reliability Calculation (meeting specified statistical confidence levels for dental abutments)
- Fatigue Testing (withstanding specified number of cycles at given load without failure, as per ISO 14801 or similar)
- Static Load Failure Testing (withstanding specified static load without catastrophic failure, as per ISO 14801 or similar)
Material Performance: - Material composition (conforming to ASTM F-136 Standard for Ti-6AL-4V ELI)
Sterilization: - Sterility Assurance Level (SAL) per ANSI/AAMI ST79 and ISO 17665-1 (e.g., SAL of 10^-6)
Interface Compatibility: - Compatibility with specified implant systems (Straumann Bone Level, Nobel Biocare Branemark, Nobel Biocare NobelActive) without compromise to fit or function. | Mechanical Performance:
- "The testing performed demonstrated implant to abutment compatibility and established that the predicate device is as safe, as effective, and performs as well or better than the predicate device(s)." (This implies that all mechanical tests were passed and results were comparable or superior to the predicate). Actual numerical results are not provided in this summary but would have been in the full submission.
Material Performance: - "Abutments are made of titanium grade 23 (Ti-6AL-4V ELI) and meet ASTM F-136 Standard."
Sterilization: - "Sterilization validation information and a recommended sterilization method based on ANSI/AAMI ST79 and ISO 17665-1 is provided in the Information for Use." (This implies successful validation to achieve the required SAL).
Interface Compatibility: - Demonstrated for "Straumann Bone Level NC and RC implant sizes," "Nobel Biocare: Branemark RP size implant," and "Nobel Biocare NobelActive NP and RP internal connection implants" via mechanical testing. |
Study that proves the device meets the acceptance criteria:
The study that proves the device meets the acceptance criteria is the Non-Clinical Testing described in section F of the 510(k) summary.
2. Sample sized 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 (N-numbers) for the non-clinical tests (Reliability Calculation, Fatigue Testing, Static Load Failure Testing). This level of detail is typically included in the full testing reports submitted to the FDA, not in the summary. For mechanical tests like fatigue, sample sizes are usually quite small (e.g., n=6-12 per group) as mandated by relevant ISO standards.
- Data Provenance: The data is generated from prospective non-clinical laboratory testing conducted by Prismatik Dentalcraft, Inc. in Irvine, CA, USA, with some testing possibly outsourced to certified labs. The country of origin for the data generation would be the USA (where the company is based and likely conducted or commissioned testing).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the non-clinical testing for a dental abutment does not involve human expert consensus for "ground truth" in the way a clinical study or an AI diagnostic device would. The "ground truth" in this context is established by objective engineering measurements against defined performance standards (e.g., maximum load before fracture, number of cycles to failure), and material specifications. Engineers and technicians with expertise in dental device testing would perform and interpret these tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to clinical studies or expert review processes, which are not described here for non-clinical mechanical testing. The evaluation of test results is based on direct measurement and comparison to predefined acceptance thresholds in recognized 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 type of study (MRMC for AI assistance) is for diagnostic devices that involve human interpretation of medical images or data. The Inclusive Titanium Abutments are mechanical prosthetic components and do not involve AI or human "readers" in their intended use or evaluation for 510(k) clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical dental abutment, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device, in the context of its 510(k) clearance, is primarily defined by:
- Engineering Standards and Specifications: Adherence to established ASTM (material) and ISO (mechanical testing, sterilization) standards.
- Predicate Device Performance: Comparison of mechanical performance to the legally marketed predicate device, demonstrating "as safe, as effective, and performs as well or better than the predicate device(s)."
8. The sample size for the training set
Not applicable. This device is a mechanical component and does not utilize a "training set" in the context of machine learning or AI algorithms.
9. How the ground truth for the training set was established
Not applicable as there is no training set for this mechanical device.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)