Search Results

SS System is intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. SS System is for one stage surgical procedures. It is not for immediate load.

The SS system is a dental implant system made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches.

The provided text describes a 510(k) summary for the "SS System" dental implant. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for reporting on new clinical studies that establish acceptance criteria and device performance in the way an AI/software device would.

Therefore, many of the requested sections related to acceptance criteria, ground truth, sample sizes for testing sets, and human reader performance with AI assistance are not applicable to this document as it pertains to a physical medical device (a dental implant) that underwent safety and performance validations rather than an AI/software device.

Here's an analysis based on the information provided:

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

The document does not specify quantitative acceptance criteria or a direct performance table in the context of a new functional study. Instead, it relies on demonstrating substantial equivalence to a predicate device. The "performance" is implicitly tied to meeting the safety and effectiveness profile of the predicate device.

2. Sample size used for the test set and the data provenance

Not applicable for this type of submission. The safety and performance validations mentioned likely refer to bench testing, material characterization, and biocompatibility tests rather than clinical studies with a "test set" in the context of an AI/software device. No specific sample sizes for such tests or data provenance are detailed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the context of expert consensus, is typically associated with AI/software performance evaluation. For a physical dental implant, safety and performance are evaluated through engineering tests, material science, and biocompatibility assessments, not by experts establishing a "ground truth" on images or data.

4. Adjudication method for the test set

Not applicable. This concept is relevant for clinical or observational studies where expert review is needed to establish ground truth or assess outcomes, often with multiple readers and an adjudication process for discrepancies. This is not described for a dental implant.

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 specifically for AI-assisted diagnostic or decision-support systems. The SS System is a physical dental implant, not an AI product.

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

Not applicable. This also pertains to AI/software performance.

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

As noted, the concept of "ground truth" in the context of expert consensus or pathology isn't precisely defined for a physical implant in this submission. The "ground truth" for the implant's safety and performance is established through compliance with recognized standards, material specifications, biocompatibility testing, and comparison to the predicate device's known history of safe and effective use.

8. The sample size for the training set

Not applicable. There is no "training set" for a physical dental implant device in the context of this 510(k) submission.

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

Not applicable.

Ask a specific question about this device