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510(k) Data Aggregation
(332 days)
ET Hybrid Abutment
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 and bonded into the ET Link Abutment by Hiossen only with design input using CAD 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.
This document is a 510(k) summary for the ET Hybrid Abutment by HIOSSEN Inc., intended for use with HIOSSEN ET dental implants to support prosthetic restorations. The submission relies on the substantial equivalence to a primary predicate device, ET Hybrid Abutment (K162390), and two reference predicates: Straumann Variobase Abutments (K132219) and ET SmartFit Abutment (K123627). No clinical studies were submitted. Therefore, the information provided below will be based on the non-clinical testing and comparison to predicate devices, rather than a clinical study establishing the device's meeting of acceptance criteria from human data.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative format for the entire device. Instead, it relies on demonstrating substantial equivalence to predicate devices through material similarity, manufacturing processes, intended use, and non-clinical testing (biocompatibility and fatigue). The performance is demonstrated by conformance to relevant ISO standards for dental implants.
| Acceptance Criteria (Implied / Indirect) | Reported Device Performance (Demonstrated vs. Predicate) |
|---|---|
| Biocompatibility: Meet requirements for implantable devices. | Demonstrated by relying on the predicate K162390. The subject device is manufactured using identical materials (Titanium Alloy Ti-6AL 4V, Zirconia Oxide) and manufacturing processes. Chemical composition, body contact (BONE / TISSUE, permanent > 30 days), and sterilization methods are the same as predicate devices. No additional biocompatibility testing was deemed necessary. |
| Fatigue Strength: Withstand static and dynamic forces in oral environment. | Successfully demonstrated through additional non-clinical testing: static and dynamic fatigue tests according to ISO 14801 in saline at 2Hz on the final finished sterilized abutment. The details of the performance (e.g., specific load cycles endured) are not provided in this summary but are implicit in the conclusion of substantial equivalence. |
| Sterilization Efficacy: Ensure sterility after processing. | Demonstrated by relying on the predicate device's sterilization validation. The subject device uses the same materials (Titanium & Zirconia, Cement) and the predicate's validation for steam sterilization was conducted according to ISO 17665-1, ISO/TS 17665-2 for gravity displacement on wrapped conditions. The worst-case sample (longest height, largest diameter) was used. |
| Dimensional Specifications: Adhere to design limitations. | The device specifications (Angulation, Gingival Diameter, Total Height, Contact Diameter, Wall Thickness, Gingival Height, Post Diameter, Post Height) are explicitly listed (e.g., Angulation 0 |
| Material Composition: Use specified materials. | Uses Titanium Alloy Ti-6AL 4V and Zirconia Oxide, identical to the primary predicate device. |
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: Specific sample sizes for the fatigue tests (ISO 14801) are not explicitly stated in this 510(k) summary. ISO standards typically specify minimum sample sizes for such tests.
- Data Provenance: The origin of the testing data is not explicitly stated in terms of country, but it would have been conducted by or for HIOSSEN Inc., which is based in Fairless Hills, Pennsylvania, USA. The testing is prospective as it was conducted to support the
510(k) submission.
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)
Not applicable. This is a medical device (dental abutment) undergoing non-clinical mechanical and biological testing for substantial equivalence, not an AI or diagnostic device requiring expert consensus for a ground truth in image interpretation or patient diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not a diagnostic device or a study involving human interpretation of data, there is no adjudication method used. The testing relies on objective, standardized physical and material property measurements.
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 not an AI-assisted diagnostic device, and therefore, no MRMC study or AI-related effectiveness study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (dental abutment), not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established standards and specifications for material properties, mechanical performance, and biocompatibility of dental implant abutments. These are based on:
- International Standards: Primarily ISO 14801 for fatigue testing, and ISO 17665-1, ISO/TS 17665-2 for sterilization validation.
- Predicate Device Data: The performance and safety profile of the legally marketed predicate devices (K162390, K132219, K123627) serve as the benchmark for demonstrating substantial equivalence.
- Material Specifications: Established specifications for Titanium Alloy Ti-6AL 4V and Zirconia Oxide.
8. The sample size for the training set
Not applicable. There is no training set as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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(157 days)
ET Hybrid Abutment
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.
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