(204 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 DESS Bases or Blanks are to be sent to a Terrats Medical validated milling center for manufacture.
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588, K173908 and K191986 to add additional components for previously cleared OEM platform compatibilities and to additional OEM platform compatibilities for previously cleared DESS designs. This submission includes three (3) abutments (Healing Abutments, straight Multi Unit Abutments and DESSLoc Abutments), three (3) bases, two (2) blanks, and seven (7) screws.
Among the subject devices for this submission are abutments and screws compatible with three (3) implant systems for which Terrats Medical has no prior clearance and one (1) implant system for which new platform compatibilities are included, for a total of nine (9) new platforms.
The direct correlation between each subject device design and the corresponding compatible implant platforms is shown in the table Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems. The subject device DESS Dental Smart Solutions provides a range of prosthetic solutions for dental implant restoration. DESS abutments, bases and blanks are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.
The provided document is a 510(k) premarket notification for dental implant abutments. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove device performance against specific acceptance criteria in the manner one might see for an AI/ML medical device.
Therefore, many of the requested items related to AI/ML device studies (such as test set details, expert ground truthing, MRMC studies, or training set information) are not applicable to this submission.
However, based on the information available in the document, here's a breakdown of the relevant points:
Acceptance Criteria and Device Performance for DESS Dental Smart Solutions Abutments
The acceptance criteria for this device are largely implicit in the demonstration of substantial equivalence to predicate devices, particularly regarding material composition, design principles, intended use, and performance data (non-clinical).
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission for dental implant abutments and not an AI/ML device, the acceptance criteria are not typically expressed as performance metrics (e.g., sensitivity, specificity) against a ground truth dataset. Instead, the acceptance criteria are met by demonstrating that the device is as safe and effective as a legally marketed predicate device, primarily through non-clinical testing and comparison of technological characteristics.
| Acceptance Criterion (Implicit) | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Intended Use Equivalence: Device intended for use with endosseous dental implants to support prosthetic restorations. | Met: "Subject device abutments are substantially equivalent in intended use to the primary predicate device... All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation..." (page 9) |
| Material Composition Equivalence: Materials conform to specific ASTM/ISO standards. | Met: All abutments and screws are made of Ti-6Al-4V ELI (ASTM F136) or Co-Cr-Mo Alloy (ASTM F1537). Zirconia superstructures made of Y-TZP (ISO 13356). Cement is Multi-Link (cleared under K130436). These are "identical to those of the primary predicate device K170588 and the reference devices K173908 and K191986." (page 9) |
| Biocompatibility: Device materials are biocompatible. | Met: "biocompatibility according to ISO 10993-5 and ISO 10993-12, leveraged from K170588, K173908 and K191986;" (page 9) |
| Sterilization Efficacy: Sterilization method validated. | Met: "sterilization validation according to ISO 17665-1 and ISO 14937, leveraged from K170588;" (page 9) The device is to be sterilized by the end-user (page 10). |
| Design and Technological Characteristics Equivalence: Similar designs (e.g., healing abutments, Ti Bases, screws) and features (e.g., coatings, connection types, prosthetic dimensions). | Met: "All subject device abutments are identical in design, materials and technological characteristics to those of the primary predicate K170588 and the reference devices K173908 and K191986, except for variations in gingival height and the elliptical shape of the ELLIPTIBase post." (page 9) Minor differences in dimensions/implant lines do not affect substantial equivalence (page 10). |
| Mechanical Compatibility: Compatibility with specified OEM implant systems and platforms. | Met: "reverse engineering analysis of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility." (page 9) The list of compatible implant systems is provided (pages 2, 4-5, 7, 11-13). "Substantial equivalence of new compatibilities is supported by compatibility analysis." (page 10) |
| Manufacturing Process: Device manufactured using validated processes. | Met: "All of the subject device components are manufactured from the same materials and in the same facilities using the same manufacturing processes as used for the Terrats Medical components previously cleared in K170588, K173908 and K191986." (page 10) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on substantial equivalence to predicate devices and non-clinical testing (material properties, sterilization, biocompatibility, reverse engineering). There isn't a "test set" in the context of clinical performance data or AI/ML model evaluation. The "data provenance" for non-clinical testing would relate to the test reports from specific labs and the standards applied.
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. No "ground truth" establishment by experts in a clinical context is described for this device type. The ground truth for engineering specifications and material properties would be established by relevant industry standards and validated test methods.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No "adjudication method" as described for clinical interpretation or AI/ML ground truth is mentioned or relevant.
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 or AI assistance is mentioned. This is a traditional medical device (dental implant abutment).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance data, the "ground truth" is derived from:
- Established standards: e.g., ISO 17665-1, ISO 14937 for sterilization; ISO 10993-5, ISO 10993-12 for biocompatibility; ASTM F136, ASTM F1537, ISO 13356 for material composition.
- Reverse engineering analysis: Comparison to OEM implant bodies, OEM abutments, and OEM abutment screws to confirm mechanical compatibility (page 9).
8. The sample size for the training set
Not applicable. This device is not an AI/ML system and does not involve a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML system and does not involve a training set.
§ 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.)