(254 days)
The TruAbutment DS is a patient-specific CAD/CAM custom abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with all diameters of the Osstem TS Fixture System which consists of Mini (2.08mm) and Regular (2.48mm) interface sizes.
All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.
The TruAbutment DS system includes custom abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for screwretained restorations. The custom abutment and abutment screw are made of Titamium grade Ti-6A1-4V ELI (meets ASTM Standard F-I 36) for Osstem TS Fixture System (K121995) which consists of both Mini and Regular interface sizes. Each custom abutment is supplied with two identical screws which are used for:
- (1) For fixing into the endosseous implant
- (2) For dental laboratory use during construction of related restoration.
The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the custom abutments take into consideration the shape of final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.
Here's a summary of the acceptance criteria and study information for the TruAbutment DS, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity, etc.) for the device itself. Instead, the "acceptance criteria" are implied by meeting various regulatory and engineering standards. The reported device performance is therefore described in terms of compliance with these standards and demonstrated substantial equivalence to a predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 17665-1:2006, 17665-2:2009, ANSI/AAMI ST79:2010 (End User Steam Sterilization) | Met the standard. Device is packaged non-sterile and intended for end-user sterilization. |
| Compliance with ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010 (Biocompatibility) | Met the standard. |
| Compliance with ISO 14801:2007 (Fatigue Test) | Met the standard. Testing included finished assembled implant/abutment systems of the worst-case scenario (smallest diameter with maximum angulation). Demonstrated implant to abutment compatibility. |
| Substantial Equivalence to Predicate Device | Demonstrated with predicate device (ET SmartFit Abutment K123627) in terms of material (Ti-6A1-4V ELI), similar indications for use, dimension, design, abutment seat, screw seat, anatomical site, connection (internal hex), and type of retention (screw-retained). Differences in manufacturing process and maximum abutment angulation (25° vs 30° for predicate) were deemed not to raise new questions of safety or effectiveness. |
| Compliance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments" | Non-clinical testing was conducted in accordance with this guidance. |
| Dimensional Compatibility | Dimensional analysis and reverse engineering of the implant-to-abutment connection platform, including assessment of maximum/minimum dimensions, tolerances, and cross-sectional images, demonstrated compatibility. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document describes non-clinical testing for mechanical and material properties. For the Fatigue Test (ISO 14801:2007), it states "testing finished assembled implant/abutment systems of the worst case scenario, (smallest diameter with maximum angulation)." While the exact number of samples tested isn't specified, this indicates a specific test configuration rather than a large statistical sample of diverse cases. The other tests (sterilization, biocompatibility) typically involve multiple samples to demonstrate compliance, but specific numbers are not provided.
- Data Provenance: Not applicable in the context of clinical data for a medical device. This is a technical performance study, not a study involving patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device (an implant abutment) is based on engineering standards, material specifications, and physical measurements, rather than expert consensus on medical imaging or clinical diagnoses.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring human adjudication of results in the way a diagnostic imaging study would. The "adjudication" is essentially the determination of whether the device met the specified engineering and material performance standards.
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. This is not an AI-based device or a diagnostic tool that would involve human readers. It is a custom dental implant abutment.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical device (an abutment), not an algorithm or software. It is designed using CAD/CAM, but the "performance" discussed is related to its physical properties and mechanical compatibility.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is primarily:
- Engineering Standards: Compliance with international standards such as ISO 14801 (Fatigue), ISO 10993 series (Biocompatibility), and ISO 17665 series/ANSI/AAMI ST79 (Sterilization).
- Material Specifications: Adherence to ASTM Standard F-I 36 for Ti-6A1-4V ELI titanium.
- Dimensional Specifications: Measured dimensions and tolerances to ensure compatibility with the Osstem TS Fixture System.
- Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (ET SmartFit Abutment K123627) serves as a benchmark for demonstrating substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. The device is not an AI algorithm that requires a training set of data. Its design and manufacturing process utilize CAD/CAM, but the "training set" concept doesn't apply to the device's physical evaluation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set." The CAD/CAM system used for design would operate based on established anatomical parameters, prosthetic requirements, and material properties, rather than being "trained" on a dataset in the AI sense.
§ 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.)