(189 days)
S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for singleunit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
All digitally-designed custom abutments for use with Interface CAD-CAM abutments are to be sent to a S.I.N. - validated milling center for manufacture.
The purpose of this submission is to add to the S.I.N. Dental Implant System components cleared in K170392 and K170398. The K170392 submission included dental implants with a Morse taper abutment interface, mating abutments, abutment screws, and other associated components. Components cleared in K 170392 included the Unitite line of dental implants that have a threaded endosseous surface produced by acid-etching followed by application of a hydroxyapatite coating (HA""). All other dental implants cleared in K170392 had a threaded endosseous surface that was acid-etched only (no HA100).
This submission adds the following components to the S.I.N. Dental Implant System: the identical HA1000 coating to the Strong SW CM (Morse taper) implant line cleared in K170392; the identical HA™® coating to the Strong SW HE (external hexagon) implant line cleared in K170398; the identical HA-"00 coating to the Strong SW HI (internal hexagon) implant line cleared in K170398: a new implant line, Tryon Conic HE, with an external hexagon abutment interface; a series of conventional (not CAD-CAM) prosthetic components that are compatible with implants from the S.I.N. Dental Implant System; and a series of CAD-CAM prosthetic components for fabrication of patient-specific restorations that are compatible with implants from the S.I.N. Dental Implant System.
This document is a 510(k) Premarket Notification from the FDA regarding the S.I.N. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study proving a device meets specific acceptance criteria based on performance data.
Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies is not available and cannot be extracted from the provided text.
Specifically:
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A table of acceptance criteria and the reported device performance: This information is not provided. The document outlines design and material specifications for various components and compares them to predicate devices, but it does not list specific numerical acceptance criteria or performance metrics for the device itself. The "PERFORMANCE DATA" section states "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: sterilization validation... bacterial endotoxin testing and shelf life testing... biocompatibility data... and biocompatibility testing for the ISO 13356 zirconia material... No clinical data were included in this submission." This indicates that performance data generally refers to compliance with standards (e.g., ISO, ASTM) and physical/biological characteristics, not clinical performance metrics against acceptance criteria.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No clinical or performance study with a "test set" and corresponding sample size is described. The non-clinical data mentioned are related to validation and biocompatibility, not a clinical performance study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. There is no mention of a test set requiring expert ground truth.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set requiring adjudication is described.
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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 document is for a dental implant system, not an AI software or system that involves human readers and AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is for a dental implant system, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No clinical ground truth is established for performance evaluations in this submission, as it relies on substantial equivalence to predicate devices based on design and material similarities, and compliance with recognized standards.
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The sample size for the training set: Not applicable. This is not an AI/algorithm submission requiring a training set.
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How the ground truth for the training set was established: Not applicable. This is not an AI/algorithm submission requiring a training set.
In summary, the provided text describes a 510(k) submission for a dental implant system, which focuses on demonstrating substantial equivalence through comparisons of design, materials, and intended use with already cleared devices and adherence to relevant non-clinical standards (sterilization, biocompatibility, etc.). It explicitly states that "No clinical data were included in this submission." Therefore, the detailed information requested about acceptance criteria, study design, and performance metrics in the context of clinical or comparative effectiveness studies is not present.
§ 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.