(197 days)
TLX SRAs: Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous or partially edentulous patients with crowns, bridges, or full-arch prostheses.
TLX Gold Abutments: Straumann® abutments are indicated to be placed into Straumann® dental implants to provide a support structure for the functional and esthetic oral rehabilitation of edentulous or partially edentulous patients with crowns, bridges, or full-arch prostheses. Copings are indirectly connected to the endosseous dental implant and are indicated for use as an aid in prosthetic rehabilitations.
TLX SRAs: Straumann® TLX SRAs are intended to be placed on TLX Straumann dental implants to provide support for screw-retained single or multi-unit restorations. They are identical in design to the reference devices BLX SRAs cleared as per K181703, except for the laser marking and the anodization. The TLX SRAs have no anodization, but additional laser marking at the connection. The TLX SRAs are provided sterile by gamma radiation. The TLX SRAs are made of TAN (Ti-6Al-7Nb) and are available in angulations of 17° and 30°. The TLX SRAs are secured in the implant through a basal screw made of TAN. The SRAs are provided with a transfer piece (Pin).
TLX Gold Abutments: Straumann TLX Gold Abutments consist of a Ceramicor® alloy base, which is fixed to the implant by means of a basal screw made of Ti-6AI-7Nb, Titanium Aluminum Niobium (TAN). A modelling aid made of POM-C is attached onto the abutment by friction fit when delivered in the package. There are two versions of TLX Gold Abutments: one is for single crown restoration, and the other is for multiunit restoration such as bar or bridge. The TLX Gold Abutments for crown contain the TorcFit connection which provides the rotational indexation. On the other hand, the TLX Gold Abutments for bar/bridge do not have the TorcFit indexation feature since it is used in multiunit restorations. Both versions are available in three different platform diameters, NT (Narrow, TorcFit™), RT (Regular, TorcFit™) and WT (Wide, TorcFit™), allowing the abutments to sit on the shoulders of the corresponding TLX implants. The TLX Gold Abutments have a maximum angulation of 30°, a minimum post height of 4 mm, and a minimum wall thickness of 0.7 mm.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for dental implant abutments (TLX SRAs and TLX Gold Abutments).
Here's the breakdown of the information requested, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly met by demonstrating equivalence to predicate devices through performance testing. The reported device performance indicates successful completion of these tests without failure.
| Test Type | Acceptance Criteria (Implicit, based on equivalence) | Reported Device Performance |
|---|---|---|
| Dynamic Fatigue (Gold Abutments) | Conducted according to ISO 14801 and FDA guidance for endosseous dental implants and abutments. Acceptance of equivalence to primary predicate and reference devices, implying the ability to cover permanent restoration of the implant without failure. | The test for the Gold Abutments was conducted in saline (2 Hz and 37°C) at 2 million cycles, covering permanent restoration of the implant without failure. "demonstrated the subject TLX SRAs and Gold Abutments are equivalent to the primary predicate and reference devices." |
| Dynamic Fatigue (SRA Abutments) | Conducted according to ISO 14801 and FDA guidance for endosseous dental implants and abutments. Acceptance of equivalence to primary predicate and reference devices, implying the ability to cover permanent restoration of the implant without failure. | The test for the SRA Abutments was a pre-test conducted in ambient air (15 Hz and room temperature) at 5 million cycles, covering permanent restoration of the implant without failure. "demonstrated the subject TLX SRAs and Gold Abutments are equivalent to the primary predicate and reference devices." |
| Biocompatibility | Assessment according to ISO 10993-1 and FDA Guidance document "Use of International Standard ISO 10993-1...". Acceptance implies no new biocompatibility issues are raised compared to predicate devices. | A biological assessment was performed demonstrating "No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required." |
| Magnetic Resonance Compatibility | Equivalence to predicate devices (K181703), implying the applicability of previous MR Conditional wording. | "The reference devices K181703 and compatible prosthetics have obtained the status of MR Conditional. No new materials or worst-case constructs are introduced with the subject devices; thus, the previous MRI conditional wording is applicable." |
| Sterilization (TLX SRAs) | Sterility Assurance Level (SAL) of ≤ 10⁻⁶ in accordance with ISO 11137-1. Equivalent to reference devices K181703. | "The sterilization process for the subject TLX SRAs was validated to a sterility assurance level (SAL) of ≤ 10⁻⁶ in accordance with ISO 11137-1... The sterilization method and packaging of the subject TLX SRAs is identical to the reference devices K181703." |
| Shelf-life (TLX SRAs) | 5 years life. Equivalent to reference devices K181703. | "The shelf life for devices provided sterile is 5 years... The sterilization method and packaging of the subject TLX SRAs is identical to the reference devices K181703." |
| Pyrogenicity (TLX SRAs) | Meet pyrogen limit specifications of 20 EU/device, based on the LAL Endotoxin Analysis method (for blood contacting and implanted devices). | "The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device." |
| Sterilization (TLX Gold Abutments) | Sterility Assurance Level (SAL) of ≤10⁻³ using the biological indicator (BI) overkill method (for the product group, Implant Borne Prosthetics). Equivalent to reference devices K200597. | "These sterilization parameters have been validated to a sterility assurance level (SAL) of ≤10⁻³ using the biological indicator (BI) overkill method for the product group, Implant Borne Prosthetics. The subject TLX Gold Abutments do not introduce a new worst case compared to the reference devices K200597." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of clinical data or human subject studies. The testing described is primarily bench testing (dynamic fatigue) and assessments of material properties, biocompatibility, and sterilization validation. Therefore, there's no information about sample size for a test set of patient data, nor its provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. The described studies are not clinical trials involving expert interpretation of patient data to establish ground truth. They are bench tests and assessments against established engineering and biological standards.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a dental implant abutment, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical medical device (dental implant abutment), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the performance claims is based on:
- Established engineering standards: ISO 14801 for dynamic fatigue testing.
- Regulatory guidance documents: FDA guidance for endosseous dental implants and abutments.
- Biological safety standards: ISO 10993-1 and FDA guidance for biocompatibility.
- Sterilization validation standards: ISO 11137-1.
- Equivalence to legally marketed predicate and reference devices: The core of the 510(k) submission is to demonstrate substantial equivalence to previously cleared devices. The predicate and reference devices, having previously met regulatory requirements, serve as the benchmark for "ground truth" in terms of safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.)