(138 days)
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.
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.
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.
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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."
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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.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for mechanical testing.
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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.
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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.
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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.
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The sample size for the training set: Not applicable. This is not an AI/ML device.
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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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.