(161 days)
DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.
All digitally designed custom abutments for use with TiBase or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.
DESS Dental Smart Solutions is a dental implant abutment system that includes seven abutment design types (Healing, Temporary, Straight, TiBase, Pre-milled Blank, DESS LOC, Multi-Unit), and ten abutment connections compatible with eleven implant systems. Platform diameters range from 3.3 mm to 5.7 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. Abutments are offered in a variety of connection types to enable compatibility with a large number of currently marketed implants. Straight, Temporary and TiBase abutments have a SelectGrip® surface. DESS LOC Abutments have a ZrN coating. Selected DESS screws include DLC coating. DESS Dental Smart Solutions abutments are straight abutments. All abutments are provided non-sterile.
This document describes the premarket notification for the DESS Dental Smart Solutions, an endosseous dental implant abutment. The information provided is for regulatory clearance based on substantial equivalence, not a standalone performance study of the device. Consequently, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based medical device are not applicable or find direct answers within this document.
However, I can extract the relevant information from this regulatory document concerning the device's performance evaluation to demonstrate its substantial equivalence to predicate devices, which serves as its "acceptance criteria" for market clearance.
Here's an analysis of the provided text in relation to your questions, focusing on the available "performance data":
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" for this device are based on demonstrating substantial equivalence to legally marketed predicate devices, rather than meeting specific performance metrics of an AI algorithm like sensitivity, specificity, or accuracy. The "performance" is shown through engineering and dimensional analysis, and material compatibility, to ensure it functions similarly to the predicate devices.
| Acceptance Criteria (based on Substantial Equivalence) | Reported Device Performance (as demonstrated by non-clinical testing) |
|---|---|
| Sterilization: Ensure sterilization of the final finished device. | Sterilization validation to an SAL of 10^-6 according to ISO 17665-2. |
| Biocompatibility: Demonstrate devices are non-cytotoxic. | Biological evaluation according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5 for all surfaces. |
| Surface Suitability: Demonstrate suitability of specialized surfaces (ZrN and SelectGrip). | SEM evaluation and measurement of the ZrN and SelectGrip surfaces. |
| Compatibility with OEM Implant Systems: Confirm compatibility with various OEM implant bodies, abutments, and abutment fixation screws. | Engineering and dimensional analysis of OEM implant bodies, OEM abutments, and OEM abutment fixation screws. |
| Design, Function, Material, Size, and Indications for Use: Be substantially equivalent to predicate devices. | Detailed comparison tables demonstrating similarity in Indications for Use and Technological Characteristics (Prosthesis Attachment, Restoration, Abutment Platform Diameter, Abutment Angle, Abutment/Implant Interface, Material for Abutment and Screw). |
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: Not explicitly stated in terms of a "test set" as one would define it for an AI/algorithm study. The "test set" here refers to the actual physical devices (parts, materials) subjected to engineering, dimensional, and biological evaluations. The document does not specify the number of individual abutments or components tested for each non-clinical evaluation.
- Data Provenance: The document states that Terrats Medical SL is located in Montcada i Reixac, Spain. The testing was non-clinical. No information is provided regarding the country of origin of testing data beyond the manufacturer's location.
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 type of expertise for establishing ground truth is relevant for AI/algorithm studies involving image interpretation or clinical diagnosis. For a dental implant abutment, "ground truth" is based on established engineering and material science standards (e.g., ISO standards, dimensional specifications, material composition), which do not typically involve human expert consensus in the same way as an AI diagnostic study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods like 2+1 or 3+1 are used in studies where multiple human readers interpret data (e.g., medical images) and their discrepancies need to be resolved. This document pertains to the physical and material properties of a medical device, which are evaluated against defined engineering and biological standards, not subjective interpretations requiring adjudication.
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: No MRMC study was performed. This document concerns the regulatory clearance of a physical medical device (dental abutment), not an AI-assisted diagnostic tool. The document explicitly states: "No clinical data were included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI algorithm. The device "DESS Dental Smart Solutions" refers to a system of dental implant abutments, which are physical components. The document indicates that "All digitally designed custom abutments... are to be sent to a Terrats Medical validated milling center for manufacture," implying a digital design process, but the device itself is a physical product, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance relies on established engineering standards, material specifications, and biological safety standards (e.g., ISO 17665-2 for sterilization, ISO 10993-1/5 for biocompatibility), and dimensional compatibility with OEM implant systems. It is a physical and material "ground truth" rather than a clinical or diagnostic "ground truth."
8. The sample size for the training set
- Not Applicable: This device is a physical product, not an AI model that requires a "training set."
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set for an AI model, this question is not relevant.
§ 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.)