(219 days)
Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandbular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and the mesostructured components make up a two-piece abutment.
All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Blanks are to be sent to a Preat validated milling center for manufacture.
Preat Abutments were previously cleared under K183518. The purpose of this submission is to obtain marketing clearance for additional compatible implant systems under the Preat Abutments device name. This submission for Preat Abutments is a dental implant abutment system that includes nine (9) abutment designs compatible with five (5) OEM implant systems. The Subject device abutment platform diameters range from 2.9 mm to 5.4 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 7.0 mm. The Subject device includes the following abutment designs: temporary engaging, multi-unit straight, multi-unit angled 17°, multi-unit angled 30°, engaging titanium base, titanium blank and healing abutments. The system also includes corresponding abutment screws.
All abutments and screws are manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136 and are provided non-sterile to the end user. All digitally designed custom abutments for use with Titanium Base (superstructures) or Titanium Blank are to be sent to a Preat validated milling center for manufacture. All superstructures are to be manufactured from zirconia conforming to ISO 13356. Digitally designed CAD/CAM abutments must have a 0.5 mm minimum gingival height dimension.
The Titanium Base abutment is composed of two-piece abutment that is a titanium base at the bottom and a zirconia superstructure (CAD/CAM patient specific superstructure) at the top. The zirconia superstructure is straight only and is not to be designed to provide an angle or divergence correction.
For the Titanium Base abutment, the design parameters for the CAD/CAM zirconia superstructure are: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations – 4.0 mm; Maximum gingival height – 5.0 mm; and All zirconia superstructures are for straight abutments only. The design parameters for the CAD/CAM Titanium Blank custom abutment are:
Minimum wall thickness – 0.5 mm to 0.9 mm (varies by implant line); Minimum post height for single-unit restoration – 4.0 mm; Maximum Angle - 30°*; and Minimum gingival height - 0.5 mm; Maximum gingival height – 2.0 mm to 4.5 mm (varies by implant line). * Astra Tech® OsseoSpeed™ Plus (OsseoSpeed™ EV) compatible are limited to 0° maximum correction angle.
The provided document describes the Preat Abutments and their substantial equivalence to predicate devices, based on non-clinical performance data. It does not contain information about studies involving human readers, ground truth establishment for a test or training set, or specific details on sample sizes for a test set in the context of AI/algorithm performance.
Here's the information that can be extracted relevant to acceptance criteria and device performance based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical performance data used to demonstrate substantial equivalence, focusing on mechanical testing and material properties. The acceptance criteria are implicitly met by comparing the subject device to predicate and reference devices, and by conforming to relevant ISO standards where applicable.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Mechanical Strength & Durability: | |
| - Static Compression (ISO 14801) | Worst-case constructs for each compatible OEM implant line (except Astra Tech OsseoSpeed EV) were subjected to static compression testing according to ISO 14801. (Performance data is implied to be acceptable as part of demonstrating substantial equivalence). |
| - Compression Fatigue (ISO 14801) | Worst-case constructs for each compatible OEM implant line (except Astra Tech OsseoSpeed EV) were subjected to compression fatigue testing according to ISO 14801. (Performance data is implied to be acceptable as part of demonstrating substantial equivalence). |
| Biocompatibility: | Demonstrated through predicate device testing according to ISO 10993-1 and ISO 10993-5. (Implies the Preat Abutments meet these biocompatibility standards). |
| Sterilization Efficacy: | Demonstrated through and leveraged from predicate device testing according to ISO 17665-1 and ISO 14937. (Implies the Preat Abutments, and the recommended end-user sterilization method, meet these standards). |
| Magnetic Resonance (MR) Safety: | Non-clinical worst-case MRI review performed based on scientific rationale and published literature (e.g., Woods et al., 2019) and FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment." Rationale addressed parameters including magnetically induced displacement force and torque. (Implies the device is deemed safe for the MR environment based on this review). |
| Material Conformance: | Abutments and screws manufactured from Ti-6Al-4V ELI alloy conforming to ASTM F136. Zirconia superstructures manufactured from Zirconia conforming to ISO 13356. (Implies materials meet specified standards). |
| Design Parameters for CAD/CAM Components (e.g., Superstructure, Blank): | For Titanium Base abutment zirconia superstructure: Minimum wall thickness - 0.5 mm; Minimum post height for single-unit restorations – 4.0 mm; Maximum gingival height – 5.0 mm; and All zirconia superstructures are for straight abutments only. |
| For CAD/CAM Titanium Blank custom abutment: Minimum wall thickness – 0.5 mm to 0.9 mm (varies); Minimum post height for single-unit restoration – 4.0 mm; Maximum Angle - 30°* (Astra Tech® OsseoSpeed™ Plus-compatible limited to 0° max. correction); Minimum gingival height - 0.5 mm; Maximum gingival height – 2.0 mm to 4.5 mm (varies). | |
| (Implies that these design parameters are met as part of manufactured components). | |
| Compatibility with Implant Systems: | Demonstrated through reverse engineering of OEM implant bodies, OEM abutments, and OEM abutment screws, confirmed with mechanical testing. (Implied that the device is compatible with the listed OEM implant systems and their interfaces). |
| "Substantially Equivalent" (Overall): | The subject device is substantially equivalent to the predicate device (K183518) in indications, intended use, design principles, materials (Ti-6Al-4V alloy), and mode of operation. Differences are related to compatible implant systems and additional abutment designs, supported by reference devices and mitigated by mechanical performance testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document does not detail specific sample sizes for the mechanical testing ("worst-case constructs"). The data provenance is not explicitly stated in terms of country of origin, nor is it described as retrospective or prospective in the context of test sets. The studies are non-clinical (laboratory testing).
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):
This information is not applicable. The studies described are non-clinical performance and material conformance tests, not diagnostic studies or those requiring expert interpretation of results to establish ground truth in the way medical imaging algorithms might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods typically apply to human interpretation of data, often in clinical studies or when establishing ground truth for AI algorithms, which is not the nature of the studies described.
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:
This information is not applicable. An MRMC comparative effectiveness study is used for diagnostic AI devices involving human readers. This document describes non-clinical performance testing for dental abutments, which is a physical device, not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical dental abutment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of "ground truth" as typically used in the context of evaluating diagnostic algorithms (e.g., expert consensus, pathology) is not applicable here. For the non-clinical tests, the "ground truth" or reference for performance is the compliance with specified ISO and ASTM standards and the performance of the predicate/reference devices through comparative testing. For example:
- Mechanical Testing: The "ground truth" would be the passing criteria defined by ISO 14801.
- Material Conformance: The "ground truth" would be the specifications in ASTM F136 and ISO 13356.
- Biocompatibility & Sterilization: The "ground truth" would be the specifications in ISO 10993-1, ISO 10993-5, ISO 17665-1, and ISO 14937.
8. The sample size for the training set:
This information is not applicable. There is no AI algorithm being described, and therefore no training set.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as above.
§ 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.)