(90 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 add components to the DESS Dental Smart Solutions system, which includes abutments cleared previously in K170588, K173908, K191986, K203464, K212577, and K212628. This submission adds various abutments to eight (8) OEM implant lines from Keystone Dental, Inc., having three (3) implant-abutment connections (Internal TiLobe, Internal Conical). The subject device abutment designs include Multi Unit Abutments (straight and angled 17° and 30°), Ti Base abutments, and Premilled Blank Abutments. Abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant, and the appropriate prosthetic screw (if applicable) for attachment of a screw-retained prosthesis. All abutments and screws are provided non-sterile.
The provided text is a 510(k) Summary for a dental device (DESS Dental Smart Solutions abutments). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through engineering specifications, material composition, and non-clinical performance data for mechanical integrity and biocompatibility.
Crucially, this document does not describe an AI/ML-driven device or study parameters related to AI/ML performance. Therefore, most of the requested information (related to AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI) cannot be extracted from this text.
The document details the physical characteristics, intended use, and mechanical testing of dental abutments, which are physical components used in dental implants. There is no mention of algorithms, artificial intelligence, machine learning, or any form of image analysis or diagnostic support that would involve such technologies.
Therefore, I can only provide information related to the device itself and its non-clinical testing, not an AI/ML study.
Here's what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance (for non-AI device):
The document discusses "performance data" in the context of non-clinical analyses, referencing compliance with various ISO standards and published literature. The acceptance criteria are implied by adherence to these standards and the demonstration of substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization validated according to ISO 17665-1 and 17665-2 | Referenced from predicate K212628 (meets standard) |
| Biocompatibility according to ISO 10993-5 and 10993-12 | Referenced from predicate K212628 (meets standard) |
| Metallic devices evaluated for MR environment safety | Analysis performed using scientific rationale and published literature (TO Woods, JG Delfino, "Assessment of Magnetically Induced Displacement Force and Torque on Metal Alloys Used in Medical Devices," 2021); addressed displacement force and torque per FDA guidance. |
| Static compression and compression fatigue testing of worst-case constructs in conformance with ISO 14801 | Testing performed on worst-case constructs comprising subject device Multi Unit Angled Abutments and compatible OEM implants (meets standard). |
Regarding the AI-specific questions (2-9), the document provides no relevant information.
- 2. Sample sized used for the test set and the data provenance: Not an AI device.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not an AI device.
- 4. Adjudication method for the test set: Not an AI device.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not an AI device.
- 6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not an AI device.
- 7. The type of ground truth used: Not an AI device (ground truth concepts apply to AI/diagnostic performance, not mechanical devices). For this device, "ground truth" would be the measured physical properties and clinical use case defined by dental/medical standards.
- 8. The sample size for the training set: Not an AI device.
- 9. How the ground truth for the training set was established: Not an AI device.
Summary of Device and its "Study":
The device is a set of dental implant abutments. The "study" described is a non-clinical bench testing and engineering analysis to demonstrate the physical and material characteristics of the abutments and their substantial equivalence to previously cleared devices. It involves:
- Material composition analysis: Ensuring materials meet ASTM standards (Ti-6Al-4V ELI).
- Biocompatibility testing: Referenced from previous 510(k) submissions.
- Sterilization validation: Referenced from previous 510(k) submissions.
- MR environment compatibility analysis: Based on scientific rationale and published literature.
- Mechanical testing: Static compression and compression fatigue testing performed in conformance with ISO 14801 on worst-case configurations of the Multi Unit Angled Abutments and compatible implants.
This document clearly states: "No clinical data were included in this submission." This reinforces that the review process for this particular device is based on technical specifications and non-clinical performance, not clinical trials or AI/ML performance evaluations.
§ 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.)