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The SQ IT System is indicated 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. IT System is dedicated for two stage surgical procedures and for immediate loading.

Device Description

The SQ IT 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 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. IT System is made from pure titanium and the surface treatment is done with R,B.M.

AI/ML Overview

The provided text describes the Neobiotech Co., Ltd. SQ IT System, an endosseous dental implant system, and its FDA 510(k) clearance (K090527). The clearance relies on substantial equivalence to predicate devices, supported by performance data. However, the document does not detail specific acceptance criteria and a study proving those criteria are met in the way requested for AI/ML device evaluations.

Here's an analysis based on the provided text:

Summary of Acceptance Criteria and Reported Device Performance

The FDA clearance for the SQ IT System is based on established substantial equivalence, not on specific performance criteria typically associated with AI/ML device evaluations like sensitivity, specificity, or AUC. Instead, the focus is on mechanical strength and equivalence to predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Mechanical Strength	Possesses mechanical strength at least equivalent to the predicate devices.
Design Equivalence	Substantially equivalent in design to predicate devices.
Material Equivalence	Substantially equivalent in materials to predicate devices.
Indications for Use Equivalence	Substantially equivalent in indications for use to predicate devices.
Intended Use Equivalence	Substantially equivalent in intended use to predicate devices.
Packaging Equivalence	Substantially equivalent in packaging to predicate devices.
Labeling Equivalence	Substantially equivalent in labeling to predicate devices.

Study Details:

The document refers to "Performance Data" through "mechanical testing of the implants" but does not provide specific details about a study with acceptance criteria in the context of an AI/ML device.

Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML device testing as described. The testing was mechanical. The document does not specify sample sizes for mechanical testing or data provenance beyond stating "All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004."
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 AI/ML, refers to expert-validated labels for data. For a mechanical dental implant, "ground truth" would be the measured physical properties.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.
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 an implant, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" would be the physical properties measured according to established standards.
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided 510(k) summary (K090527) is for an endosseous dental implant system. The approval is based on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing in accordance with FDA guidance for such medical devices. The document does not contain the type of AI/ML specific acceptance criteria, study methodologies, or ground truth establishment details that your prompt is designed to elicit for AI/ML-based medical devices. The request for AI/ML specific information is not applicable to this particular 510(k) submission.

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