(42 days)
The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.
This submission is to add new implants and abutments to the previously cleared device, Magicore System (K152520). The newly added implants and abutments are below: Fixture - Magicore (4mm of Neck length Implants) . - . Magicore (Cutting Edge) Abutment - Magicore Solid Abutment - Healing Cap For Magicore Solid Abutment Cap, no other changes are being made to the previous clearance except for product name change. An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The Magicore System consists of dental implants, and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the system has been treated with RBM (Resorbable Blasted media).
This document describes the Magicore System, an endosseous dental implant system, and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria based on performance metrics. The information provided is for regulatory clearance (510(k)) and focuses on comparing the new components of the Magicore System to previously cleared devices.
Therefore, many of the requested categories related to clinical study design, performance metrics, and ground truth establishment are not applicable.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for the Magicore System or clinical performance results. Instead, it relies on demonstrating "substantial equivalence" to predicate devices based on design, materials, indications for use, and non-clinical testing.
The acceptance criteria for this 510(k) submission are based on meeting the requirements for substantial equivalence to legally marketed predicate devices. This means showing that the new components of the Magicore System are as safe and effective as the predicate devices and do not raise new questions of safety or effectiveness.
The document states: "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." However, it does not specify what those "criteria" were in terms of quantifiable device performance. It refers to compliance with ISO and ASTM standards for non-clinical aspects.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document is a 510(k) submission for new dental implant components, not a clinical study assessing performance with a test set of data. The testing mentioned is non-clinical (material properties, sterilization, biocompatibility, etc.).
3. 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. Ground truth establishment by experts for a test set is not relevant to this type of regulatory submission, which relies on engineering and biological testing against established standards and comparison to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication for ground truth was used in this submission.
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 a study assessing AI performance or human reader improvement.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This product is a physical dental implant system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as it applies to diagnostic or treatment efficacy studies is not relevant here. The "truth" in this context is adherence to recognized standards and demonstrated equivalence to already approved devices through non-clinical testing.
8. The sample size for the training set
Not applicable. This product is a physical dental implant system, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.