(157 days)
ET Hybrid Abutment is a customized abutment intended for use with HIOSSEN ET dental implant in the edentulous or partially edentulous maxilla or mandible to provide support for prosthetic restorations such as crowns and bridges. All digitally designed copings for use with the ET Hybrid Abutment for CAD/CAM are intended to be sent to a HIOSSEN Inc. manufacturing facility for manufacture.
ET Hybrid Abutment is intended to be placed onto Hiossen dental implants to provide support for customized prosthetic restorations such as crowns and bridges. The proposed devices are composed of ET Link Abutment and Coping. The ET Link Abutment is premanufactured abutment by Hiossen Inc. only and the coping would be manufactured by Hiossen only with design input using CAD/CAM software from both by dental laboratories and by Hiossen Inc. The final device of ET Hybrid Abutment is under controlled by Hiossen's Quality System and provided to the customer. ET Hybrid Abutment is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. Titanium alloy is the raw material for the Link Abutment and Zirconia material is for the Coping. The ET Hybrid Abutment gives the flexibility to design customized prosthetics. The coping is straight only and the ET Link abutment is not intended to provide an angle and/or divergence correction.
The provided text is a 510(k) summary for the "ET Hybrid Abutment" by HIOSSEN Inc. This document focuses on demonstrating substantial equivalence to predicate devices, rather than providing detailed acceptance criteria and a study proving that the device meets those criteria.
Therefore, most of the requested information regarding acceptance criteria, specific device performance, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth establishment is not available in the provided text, as this type of information is typically part of performance studies, which are not included here.
However, based on the non-clinical testing summary, we can glean some information regarding the sterilization validation.
Here's what can be extracted and what is explicitly not available:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Relied upon predicate devices (K123627, K100245) for biocompatibility. Subject device manufactured using identical materials and manufacturing processes to previously cleared predicates. |
| Sterilization Validation (Steam sterilization) | All tests conducted in accordance with ISO 17665-1 and ISO/TS 17665-2 for gravity displacement on unwarped condition; no discrepancies. |
2. Sample size used for the test set and the data provenance:
- Not available. The document states "No additional biocompatibility testing was necessary for this device" as it relies on predicate devices. For sterilization validation, the specific sample size for the test set is not provided. Data provenance is also not specified beyond adherence to ISO standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not available. No specific ground truth establishment by experts for performance testing is detailed, as most of the evaluation relies on substantial equivalence to predicates and adherence to international standards for sterilization.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not available. No adjudication method is mentioned as there were no clinical studies or reported performance evaluations that would typically require such a method.
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 a dental abutment, not an AI-powered diagnostic device. Therefore, MRMC studies and AI-related effectiveness are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a dental abutment, not a software algorithm.
7. The type of ground truth used:
- For biocompatibility: Implicitly, the "ground truth" relies on the established biocompatibility of the materials (Titanium Alloy Ti-6AL 4V and Zirconia) in the predicate devices and their manufacturing processes, which were deemed safe and effective.
- For sterilization validation: The "ground truth" is adherence to the validated sterilization parameters and protocols defined by ISO 17665-1 and ISO/TS 17665-2.
8. The sample size for the training set:
- Not applicable. As this is a medical device (dental abutment) and not an AI/machine learning system, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. No training set exists for this type of 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.)