(217 days)
ET SmartFit Abutment is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.
The ET SmartFit Abutment is device made of titanium alloy intended for use as an aid in prosthetic restoration. That is customized abutment considering shape of the finial prosthesis based on the patient's mouth model using CAD/CAM system during the manufacturing. All manufacturing processes of ET SmartFit abutment such as CAD/CAM manufacturing and milling are conducted in the Hiossen factory. The ET SmartFit Abutment is used for cement-retained crowns and bridges using customized abutment considering based on the patient's mouth using CAD/CAM system. Use only the basal screws provided for the Customized Abutment. The surgical procedure for Customized abutment is the same as the surgical procedure for the cement-retained abutments.
Acceptance Criteria and Device Performance Study for ET SmartFit Abutment
The ET SmartFit Abutment is a dental device made of titanium alloy intended for use as an aid in prosthetic restoration, specifically for cement-retained crowns, bridges, or overdentures with dental implants.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Predicate Equivalence & Testing) | Reported Device Performance (ET SmartFit Abutment) |
|---|---|
| Material Composition | Titanium Alloy (Ti-6Al-4V) - Matches predicate device (K110308). |
| Intended Use | "Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures." - Matches predicate device. |
| Design Characteristics | Customized abutment considering shape of the final prosthesis based on the patient's mouth model using CAD/CAM system. - Substantially equivalent to predicate. |
| Performance - Fatigue Resistance (Worst Case Scenario) | Compliant with ISO 14801 Dentistry - Fatigue test for endosseous dental implants. Results similar to previously cleared predicate devices. |
| Biocompatibility | Performed and ensures compliance with applicable international and US regulations. |
| Dimensions (Range of Diameters) | Ø4 mm ~ Ø15mm (Stated as characteristic, not explicit criterion in summary, but assumed to meet functional needs). |
| Dimensions (Possible Range of Angulations) | 0° ~ 30° (Stated as characteristic and confirmed not to be under 30° when angulated, indicating compliance with design limitations). |
| Implant-Abutment Connection Types | Hex (2.1mm, 2.5mm), Non Hex (Stated as characteristic). |
| Manufacturing Process | Same as predicate, utilizing CAD/CAM and milling in-house. |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not mention a specific "test set" for the ET SmartFit Abutment's performance. The primary approach for demonstrating safety and effectiveness was via substantial equivalence to a predicate device (K110308).
- For Fatigue Testing: While not explicitly stated as a "test set" with a specific sample size, the fatigue testing was conducted according to ISO 14801 using a "worst-case scenario." This implies that a sufficient number of samples were tested to meet the requirements of the standard, but the exact number is not provided.
- Data Provenance: The document does not specify the country of origin for the data if the testing took place outside of the US. The studies were likely prospective in nature as they describe mechanical tests performed on the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that this is a 510(k) submission primarily relying on substantial equivalence and non-clinical bench testing, there is no mention of experts establishing a ground truth for a clinical test set. The "ground truth" for the non-clinical tests would be the established international standards (e.g., ISO 14801) and the performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. As noted above, there was no clinical test set for which an adjudication method would be required. The evaluation was based on compliance with international standards and comparison to a predicate device's characteristics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor would it be relevant for this type of device (dental abutment) and submission. MRMC studies are typically used for diagnostic or imaging devices to assess human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The ET SmartFit Abutment is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm performance study was not conducted.
7. The Type of Ground Truth Used
- For Non-Clinical Testing (Fatigue, Biocompatibility): The "ground truth" was established by recognized industry standards (e.g., ISO 14801) and regulatory compliance requirements for biocompatibility. The performance was also benchmarked against the predicate device.
- For Substantial Equivalence: The ground truth for comparative purposes was the characteristics and performance of the legally marketed predicate device (K110308).
8. The Sample Size for the Training Set
Not applicable. The ET SmartFit Abutment is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth for a training set to be established.
Summary of the Study Proving Device Meets Acceptance Criteria:
The Hiossen Inc. ET SmartFit Abutment demonstrated its safety and effectiveness through a 510(k) Pre-market Notification pathway by establishing substantial equivalence to a legally marketed predicate device, The Prosthetic System (K110308) from Osstem Implant Co., Ltd.
The key study performed was non-clinical bench testing, specifically fatigue testing, conducted according to ISO 14801. This testing focused on the "worst-case scenario" to ensure the device's mechanical integrity under simulated oral conditions. The results of this fatigue testing were reported to be in compliance with the standard and similar to previously cleared predicate devices.
Additionally, biocompatibility testing was performed to confirm that the device materials (Titanium Alloy - Ti-6Al-4V) comply with applicable international and US regulations.
The manufacturer explicitly states that no clinical studies were submitted because the ET SmartFit Abutment shares the same materials, manufacturing process, chemical composition, indication for use, and body contact characteristics as the predicate device (K110308). This strong similarity, supported by the non-clinical testing, formed the basis for the FDA's determination of substantial equivalence.
§ 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.)