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The TSI and ERI Dental Implants are artificial root structures intended for permanent surgical implantation in the bone for the purpose of single or multiple tooth replacements (splinted or free standing), or for stabilization of a prosthetic system, such as artificial teeth in order to restore the patient's chewing function. The TSI and ERI can be placed in the anterior or posterior mandible/maxilla for immediate or delayed loading purposes. Immediate loading is only intended when good primary stability is achieved and appropriate occlusal loading.

The TS1 & ERI implants are self-tapping, commercially pure. CP Titanium or Titanium Alloy threaded screws. with light grit blasting or roughened surface treatment. The TSI includes a 2mm collar and is available in 3.25, 4.0. 5.0mm diameters and each are available in 8. 10. 12. 14. and 16mm len gths. The ERI includes a 1 mm collar and is available in 3.25. 4.0. 5.0mm diameters and each are available in 8. 10. 12. 14. and 16mm lengths.

The provided text (K090174) is a 510(k) summary for a dental implant called TSI & ERI. It outlines the device description, indications for use, and claims substantial equivalence to previously cleared predicate devices.

However, the provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically seen for AI/ML-based devices or complex diagnostic tools.

Dental implants like TSI & ERI are cleared through the 510(k) pathway by demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness. Clinical studies or performance data with acceptance criteria are generally not required if substantial equivalence can be demonstrated through non-clinical means (e.g., comparison of materials, design, manufacturing processes, and published literature on the predicate devices).

Therefore, I cannot provide the requested information because it is not present in the provided text.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of 510(k) clearance. Performance is inferred through substantial equivalence to predicates.
2. Sample size used for the test set and the data provenance: No test set or associated data for performance evaluation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
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, as this is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The 510(k) summary for TSI & ERI focuses on demonstrating that its materials, design, intended use, packaging, and sterilization processes are similar enough to existing cleared devices (Immediate Stabilizing Implant (ISI) K033392, OCO 5.0mm Taper Implant K023336, and MegaGen ExFeel K052369) such that it does not require new efficacy or safety studies.

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