(90 days)
Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular 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 mesostructured components make up a two-piece abutment.
All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Blank are to be sent to a Preat validated milling center for manufacture.
Preat Abutments is a dental implant abutment system that includes ten (10) abutment designs compatible with twelve (12) OEM implant systems. The subject device abutment platform diameters range from 3.0 mm to 6.5 mm, and the corresponding compatible implant body diameters also range from 3.0 mm to 6.5 mm. The subject device includes the following abutment designs: temporary, esthetic angled 15°, multi unit straight, multi-unit angled 17°, ball (Clix Ball and O-Ring), titanium base, and titanium blank. The system also includes corresponding abutment screws.
All abutments and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and are provided non-sterile to the end user. All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Base 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.
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; Minimum post height for single-unit restoration - 4.0 mm; Maximum Angle - 30°; and Maximum gingival height - 1.5 mm to 2.65 mm (varies by implant line).
The provided document is a 510(k) Premarket Notification for dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance data from a clinical or standalone study. Therefore, most of the requested information regarding acceptance criteria for an AI/device performance study, sample sizes for test/training sets, expert qualifications, and ground truth establishment is not available in this document.
The document details the technical and material characteristics of the Preat Abutments and compares them to predicate devices to argue for their equivalence. It includes non-clinical performance data related to mechanical testing, sterilization, and biocompatibility, but not data related to an AI's diagnostic performance or human reader improvement with AI assistance.
Here's an attempt to answer the questions based on the provided text, indicating when the information is not present:
Analysis of Device Performance and Acceptance Criteria (Based on Substantial Equivalence)
This 510(k) submission for Preat Abutments relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The "acceptance criteria" here are implicitly related to meeting the performance characteristics and safety profiles of these predicates, rather than specific statistical thresholds for a new diagnostic algorithm's accuracy or efficacy. The "study" proving acceptance is primarily the non-clinical testing performed and the comparison to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Method/Finding) |
|---|---|
| Sterilization Efficacy | |
| (Device can be effectively sterilized by end-user) | Demonstrated: Sterilization validation performed according to ISO 17665-1 and ISO 14937. (Same method as predicate K170588) |
| Biocompatibility | |
| (Device materials are safe for human contact) | Demonstrated: Confirmatory biocompatibility testing performed according to ISO 10993-12 (and ANSI / AAMI / ISO 10993-5, though 10993-12 refers to sample preparation and reference materials, and 10993-5 refers to in vitro cytotoxicity, suggesting this was the specific test performed). |
| Mechanical Strength/Fatigue Resistance | |
| (Device can withstand forces in intended use) | Demonstrated: Mechanical performance testing performed according to ISO 14801 (static compression and compression fatigue testing). Worst-case constructs for each compatible OEM implant line were tested. For Astra Tech OsseoSpeed™ and BioHorizons Tapered Internal (3.0 mm implant body/platform), a fatigue limit of 133 N was established, supported by reference device K100993. Other implant lines demonstrated sufficient strength for intended use. |
| Compatible Implant System Fit/Function | |
| (Device interfaces correctly with implants) | Demonstrated: Reverse engineering of OEM implant bodies and abutment screws was performed to confirm compatibility. |
| Equivalence in Intended Use | Demonstrated: "Subject device abutments are substantially equivalent in intended use to the primary predicate K170588, and the reference devices K120414, K161416, K151621, and K100993. All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible." Minor language differences were deemed not to affect intended use. |
| Equivalence in Technological Characteristics | Demonstrated: The device is made of the same materials (Ti-6Al-4V alloy), has similar abutment designs (with some additions justified by reference devices), similar restoration types (single/multi-unit), and platform diameters, and is sterilized similarly. (Details provided in comparison tables on pages 10-11) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of an AI/diagnostic performance study. For the mechanical testing, the document states "worst-case constructs were subjected to static compression fatigue testing," but does not specify the number of samples or "test set" size.
- Data Provenance: Not applicable for location (country of origin), as this is a physical device testing submission. The data is from laboratory testing (mechanical, biocompatibility, sterilization validation). The testing is prospective in nature, as it was conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. There is no "ground truth" established by experts in the context of a diagnostic performance study. The ground truth for mechanical and material properties is based on established engineering standards and test methods (e.g., ISO 14801, ISO 10993, ISO 17665).
4. Adjudication Method for the Test Set
- Not applicable. No human-based adjudication was performed for a diagnostic test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. This is not a submission for a diagnostic AI device, so an MRMC comparative effectiveness study was not performed.
- Effect Size: Not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI algorithm submission. The "standalone" performance here relates to the physical device's mechanical and material properties, which were tested in a laboratory setting as described under "Performance Data."
7. The Type of Ground Truth Used
- For physical device performance: The "ground truth" is defined by international standards (e.g., ISO 14801 for mechanical testing, ISO 10993 for biocompatibility, ISO 17665 for sterilization) and engineering specifications derived from predicate device performance and design. It's not clinical outcomes data or expert consensus in the diagnostic sense.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. There is no "training set." The understanding of predicate device performance and design parameters, which inform the design and testing of the subject device, is derived from existing regulatory clearances and documented technical specifications of those predicate devices.
§ 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.)