Search Results

The Kerator fixture is intended for use in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations. The Kerator abutments are intended use with overdentures or partial dentures. Kerator AO type is compatible with Kerator fixture and the following types are compatible with the fixtures made by other manufacturers as indicated below.

The Kerator is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. There are one fixture model and three abutment models in the Kerator. Among three abutment model is compatible with the Kerator fixture, and the other two abutment models are compatible with the fixtures made by other manufacturers. The implant may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the fixture has been treated with R.B.M (Resorbable Blast Media) and the head part of the abutment has TiN coating over it. The Kerator abutment is placed into the dental implant to provide support for a prosthetic restoration.

The Kerator system is a dental implant system. The provided text describes the device and its equivalence to predicate devices, but it does not contain any information about a study with acceptance criteria and reported device performance in relation to AI or any advanced analytical methods.

Therefore, I cannot provide the requested information in the format of the table or other points, as the document focuses on regulatory approval based on substantial equivalence to existing devices, primarily through material and design comparisons and standard non-clinical testing (sterilization, shelf life, chemical analysis). It does not involve AI or algorithms, nor does it present clinical performance data against specific acceptance criteria in the manner described in your prompt.

The document indicates "Non-Clinical Testing" for sterilization, shelf life, and chemical/SEM analysis, which are standard safety and manufacturing validations, not performance against clinical or analytical acceptance criteria.

If the prompt were referring to a different type of device or study that typically involves such criteria, the answer would differ. However, based solely on the provided text, there is no such study or acceptance criteria information to extract.

Ask a specific question about this device

The ACE Surgical Secure-Mini™ Locator® Implant System is is designed to provide immediate transitional splinting stability or intra-bony long term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients.

The ACE Secure-Mini™ Locator® Implant System is an additional set of machined surgical grade titanium alloy (Ti-6A1-4V ELI) screw implants to the Secure-Mini™ product family, intended to provide immediate transitional splinting stability or intra-bony long-term fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. The implants are supplied sterile in 2.3 mm diameter, and in lengths of the 10, 11.5, 13, and 15 mm, and with Zest Locator® Implant Anchor Abutments (cleared under K994257) and Denture Cap Males (cleared under K072878) in standard tray packaging and include placement instruments. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in materials and characteristics to that cleared under K073343. These screws are supplied sterile in standard Tvvek™ travs. The ACE Surgical Secure-Mini™ Locator® Implant System is a comprehensive system retaining prosthetic components, auxiliary components, and surgical tools as does the predicate ACE Surgical Secure-Mini™ Implant system.

The provided document is a 510(k) summary for a medical device (ACE Surgical Secure-Mini™ Locator® Implant System) seeking substantial equivalence to existing predicate devices. It focuses on demonstrating equivalence through device description, indications for use, materials, bench test results, and labeling, rather than presenting a detailed clinical study with acceptance criteria and performance metrics for a new AI-powered diagnostic device.

Therefore, most of the requested information regarding acceptance criteria, study design elements for AI performance (like sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details), and ground truth establishment is not available in the provided text.

The document states: "In particular, the bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the ACE Surgical Secure-Mini™ Locator® Implant System and the specified predicate devices." This implies that the 'acceptance criteria' were met by demonstrating non-inferiority or equivalence to the predicate devices through bench testing. However, the exact quantitative acceptance criteria and the detailed results of these bench tests are not provided.

Here's a breakdown of what can be extracted and what is not available:

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

2. Sample size used for the test set and the data provenance: Not applicable. This was a bench testing study, not a study involving patient data for an AI algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the diagnostic AI sense was established by experts; rather, the performance was assessed relative to predicate devices through engineering/bench testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: 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. This is not an AI-powered diagnostic device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic AI. The "ground truth" for the bench testing would be established engineering standards or the performance of the predicate devices.

8. The sample size for the training set: Not applicable. This is not an AI-powered device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.

Ask a specific question about this device