Search Results

TLX Novaloc Abutments: The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants (NT, RT, and WT).
TLX Cementable Abutments: Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Final abutments may be placed into occlusion for implants with sufficient primary stability and with appropriate occlusal loading to restore chewing function or for implants that are fully osseointegrated.

Straumann TLX Novaloc Abutments: The subject TLX Novaloc Abutments are intended to be placed onto Straumann TLX implants to provide support for full arch detachable restorations (over-denture). The coronal portion of the subject abutments is similar to the primary predicate devices, whereas the apical portion of the abutments has the appropriate implant-to-abutment interface geometry for each of the platforms of the Straumann TLX Implant System (NT, RT and WT). The Novaloc Abutments are manufactured from TAV (Ti-6Al-4V, Titanium-Aluminum-Vanadium). The restoration is connected to the Novaloc Abutment through a snap-on fixture provided by a negative shape of Novaloc snapon fixture embedded into the final restoration. The snap-on feature is TiN coated. The subject TLX Novaloc Abutments are provided in straight and angulated versions, in different heights. The TLX Novaloc Abutments are provided non-sterile with instructions for end user sterilization.
Straumann TLX Cementable Abutments: The subject TLX Cementable Abutments are intended to provide support for prosthetic reconstructions such as crowns and bridges and are used with cemented restorations. They are made of titanium alloy (Ti-6Al-7Nb or TAN) and are attached to the implant with a basal screw. To allow for more flexibility they are offered in a straight and in an angulated version for each of the three platforms (NT, RT and WT). The TLX Cementable Abutments are provided non-sterile with instructions for end user sterilization.

The provided text describes the regulatory clearance of a medical device (Straumann TLX Novaloc and Cementable Abutments) and includes a summary of performance testing. However, it does not contain the specific information required to complete numbers 2, 3, 4, 5, 6, 7, 8, and 9 of your request. These details are typically associated with clinical studies and AI performance evaluations, which are not the focus of this 510(k) summary.

Here's the information that can be extracted and a note on the missing information:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for this device are based on demonstrating equivalence to predicate devices through various performance tests. The specific numerical acceptance criteria (e.g., minimum breaking strength or fatigue cycles) are not explicitly stated as numerical values in this summary but are referenced against established standards and guidance documents.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The testing described is bench testing, not a clinical study with human subjects, so concepts like "test set" in the context of clinical data are not applicable here.

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 provided as the submission focuses on bench testing for mechanical and biological equivalence, not expert-adjudicated clinical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this was bench testing.

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

Not applicable. This device is a dental abutment, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a dental abutment, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical and biocompatibility testing, the "ground truth" refers to established scientific principles, standards (ISO 14801, ISO 10993-1, ISO 17665-1, ISO 17665-2), and FDA guidance documents. There is no biological "ground truth" derived from patient outcomes or expert consensus in the context of this 510(k) summary.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device