(175 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 Aurum™ Abutment or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture.
DESS Dental Smart Solutions subject devices include four abutment design types (Aurum Base, Pre-milled Blank, CoCr Pre-milled Blank, CoCr Abutment) and one screw type (Aurum Base Screw). Abutments are provided in ten abutment connections compatible with eleven implant platform diameters range from 3.3 mm to 6.5 mm. Corresponding implant body diameters range from 3.25 mm to 6.0 mm. All abutments are provided non-sterile.
The document describes the DESS Dental Smart Solutions, which are dental implant abutments. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a typical tabular format with specific numerical targets. Instead, it relies on demonstrating equivalence to predicate devices through various performance tests and comparisons. The "acceptance criteria" are implied by the successful completion of these tests and the determination that the device is "substantially equivalent" to already marketed devices.
However, some design parameters are mentioned as remaining the same or being comparable to the predicate devices, which can be seen as implicit performance criteria:
| Feature / Performance Metric | Acceptance Criteria (Implied by Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Sterilization | SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2 | "Sterilization to an SAL of 10^-6 according to ISO 17665-1 and ISO 17665-2 to ensure sterilization of the final finished device" (Successful) |
| Biocompatibility | Non-cytotoxic according to ISO 10993-1 and ISO 10993-5 | "Biological evaluation according to ISO 10993-1 and cytotoxicity testing to ISO 10993-5 to demonstrate that all devices are non-cytotoxic" (Successful) |
| Minimum Wall Thickness | Aurum Abutment: 0.4 mm | |
| Pre-milled Blank: 0.45 mm | ||
| CoCr Abutment: 0.4 mm (Same as primary predicate K170588) | Aurum Abutment: 0.4 mm | |
| Pre-milled Blank: 0.45 mm | ||
| CoCr Abutment: 0.4 mm (Stated to remain the same as primary predicate K170588, implying conformity to existing successful designs) | ||
| Minimum Post Height (single-unit) | Aurum Abutment: 4.0 mm | |
| Pre-milled Blank: 4.0 mm | ||
| CoCr Abutment: 4.0 mm (Increased from previous version, but deemed substantially equivalent to K092341 at 4mm) | Aurum Abutment: 4.0 mm (Stated as the new minimum for single-unit restorations, deemed substantially equivalent to K092341's titanium post height which also requires additional castable component to create 4mm) | |
| Pre-milled Blank: 4.0 mm | ||
| CoCr Abutment: 4.0 mm (Stated to remain the same as primary predicate K170588) | ||
| Maximum Gingival Height | Aurum Abutment: 6.0 mm | |
| Pre-milled Blank: 6.0 mm | ||
| CoCr Abutment: 6.0 mm (Same as primary predicate K170588) | Aurum Abutment: 6.0 mm | |
| Pre-milled Blank: 6.0 mm | ||
| CoCr Abutment: 6.0 mm (Stated to remain the same as primary predicate K170588) | ||
| Maximum Total Abutment Height | Pre-milled Blank: 19 mm | Pre-milled Blank: 19 mm |
| Angulation Correction | No angulation correction (Same as primary predicate K170588) | All abutments are for straight abutments only (implies no angulation correction, same as primary predicate K170588) |
| Chemical Composition | Materials used are comparable to predicate devices (Titanium Alloy, CoCr, Zirconia) | Aurum Base (Titanium Alloy ASTM F136), CoCr Pre-milled Blank (CoCr ASTM 1537), Ti Pre-milled Blank (Titanium Alloy ASTM E136), CoCr Abutment (CoCr ASTM 1537). Screws are Titanium Alloy. (Found to be substantially equivalent to predicates) |
| Physical Dimensions | Encompasses the same range of physical dimensions including diameter and design of abutments as predicate devices. | "The subject device and predicate devices encompass the same range of physical dimensions, including diameter and design of the abutments." (Stated as a conclusion of equivalence) |
| Packaging/Sterilization Methods | Similar to predicate devices. | "The subject and predicate devices are packaged in similar materials and are to be sterilized using similar methods." (Stated as a conclusion of equivalence) |
2. Sample Size Used for the Test Set and the Data Provenance
The document states: "Non-clinical testing data submitted to demonstrate substantial equivalence included: sterilization... biological evaluation... and compatibility analysis by reference to K170588."
- The report does not specify sample sizes for the sterilization or biocompatibility tests.
- The data provenance is implied to be from the manufacturer's (Terrats Medical SL) internal testing as part of their submission for regulatory clearance. It's not explicitly stated whether the data is retrospective or prospective, or the country of origin of the raw data, beyond the manufacturer being from Spain. The "compatibility analysis by reference" means using existing data/information from the predicate device (K170588).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information – number and qualifications of experts for ground truth – is typically relevant for studies involving subjective assessments, like image interpretation in AI/ML medical devices. This document is for a physical dental implant abutment, and the tests performed are objective, non-clinical tests (sterilization, biocompatibility, mechanical properties based on design parameters). Therefore, this information is not applicable and not provided in the submission.
4. Adjudication Method for the Test Set
As the tests are objective non-clinical tests, an adjudication method for a "test set" (in the context of expert review) is not applicable and not mentioned. The results of the non-clinical tests would either meet or not meet the specified standards (e.g., SAL, non-cytotoxicity).
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
No MRMC comparative effectiveness study was done. This type of study is specifically relevant for AI/ML-driven diagnostic or interpretative devices involving human readers. The device described here is a physical dental implant abutment, not an AI/ML diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This is not an AI/ML device. The "CAD/CAM process" mentioned refers to computer-aided design and manufacturing for custom abutments, which is a manufacturing process, not an analytical algorithm for diagnosis or interpretation.
7. The Type of Ground Truth Used
For the non-clinical tests conducted:
- Sterilization: The ground truth is the scientific standard for sterility, defined as a Sterility Assurance Level (SAL) of $10^{-6}$ based on ISO 17665-1 and ISO 17665-2.
- Biocompatibility: The ground truth is the absence of cytotoxicity, determined by adherence to ISO 10993-1 and ISO 10993-5.
- Design Parameters/Mechanical Equivalence: The "ground truth" for design parameters (e.g., wall thickness, post height) is derived from engineering specifications and comparison to the proven safety and effectiveness of the legally marketed predicate devices (K170588 and other reference devices). The ultimate ground truth effectively is that the device performs equivalently to previously approved devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth establishment process in that context.
§ 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.)