(118 days)
The TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems: · Zimmer SV/TSV 3.7, 4.1, 4.7, 6.0 mm All digitally designed abutments and/or coping for use with the TruAbutment are intended to be sent to a TruAbutment-validated milling center for manufacture.
The TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for cemented or "Screw- and Cement-Retained Prosthesis" (SCRP) restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-I 36). Each patient-specific 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 patient-specific 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 breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative table format for the device's main function (prosthetic rehabilitation). Instead, it focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests. The "performance" is implicitly deemed acceptable if these tests meet the standards and demonstrate equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance | Study (and relevant standard) |
|---|---|---|
| Mechanical Strength/Fatigue | "The results of the above tests have met the criteria of the standard, and demonstrated the substantial equivalence with the predicate device." Tested "worst-case scenario (smallest diameter with maximum angulation)." | Fatigue Test according to ISO 14801:2007 |
| Sterilization Efficacy | "The results of the above tests [for the predicate] have met the criteria of the standard, and demonstrated the substantial equivalence with the predicate device." | End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010 (leveraged from predicate K152559) |
| Biocompatibility | "The results of the above tests [for the predicate] have met the criteria of the standard, and demonstrated the substantial equivalence with the predicate device." | Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010 (leveraged from predicate K152559) |
| Implant-Abutment Compatibility & Dimensional Accuracy | "The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices." | Dimensional analysis and reverse engineering (assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests (e.g., how many abutments were fatigued). The document refers to testing "finished assembled implant/abutment systems of the worst-case scenario."
- Data Provenance: The studies are non-clinical (laboratory tests). There is no mention of country of origin for test data beyond the general context of the company (TruAbutment Inc., USA). The studies are inherently "retrospective" in the sense that they are laboratory evaluations, not studies on past patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable (N/A) as the study is non-clinical (mechanical, sterilization, biocompatibility testing) and does not involve human interpretation or subjective assessment that would require expert ground truth establishment in the traditional sense. The "ground truth" is defined by the technical standards (e.g., ISO 14801) themselves.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reasons as point 3. Testing against standards doesn't typically involve adjudication of ground truth by multiple experts.
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 (N/A). The TruAbutment DS is a physical medical device (patient-specific CAD/CAM abutment), not an AI/software device that involves human readers or image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable (N/A). As mentioned above, this is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the non-clinical tests is established by technical standards and specifications. For example:
- Mechanical performance: Defined by the requirements of ISO 14801:2007 for dental implants.
- Sterilization: Defined by ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
- Biocompatibility: Defined by ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
- Dimensional accuracy: Established by engineering specifications and comparison to OEM implant and abutment dimensions.
8. The Sample Size for the Training Set
This information is not applicable (N/A). This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable (N/A) for the same reasons as point 8.
§ 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.)