(300 days)
The IBS System is intended to replace missing teeth to restore chewing function. The IBS System can be placed in support of single or multiple-unit restorations including; cement retained, screw 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.
The fixtures and abutments in this system are below:
- Fixture
- Magicore (RBM)
- Magicore (RBM Cutting Edge)
- Magicore II (SLA) .
- Magicore II (SLA Cutting Edge)
- Abutment
- Magic Angled Abutment (Screw type _Hex, Non-Hex) ●
- Magic Motion
- Magic Motion Housing ●
- Magic Abutment (Screw type Hex, Non-Hex & Cement type Hex, Non-Hex) ●
- Magic Multiunit Abutment (Cement type Hex, Non-Hex)
- Magic Multiunit Cap .
An endosseous dental implant is a device made of a material such as Ti-6AL-4V Eli (Conforming to ASTM Standard F-136). The implant-abutment connection is tight and precise fitting with internal hex, non-hex and Morse taper bevel. The surface of the Magicore implant is treated with RBM (Resorbable Blasted media) and Magicore II implants are treated with SLA(sand-blasted, large-grit, acid-etched).
The provided text is a 510(k) summary for the IBS System, an endosseous dental implant. It focuses on demonstrating substantial equivalence to predicate devices rather than providing specific performance data against acceptance criteria from a study on the IBS System itself. Therefore, I cannot extract the full details you requested regarding acceptance criteria and the study that proves the device meets them.
The document primarily shows a comparison of technological characteristics between the subject device (IBS System) and various predicate and reference devices. The "SE Discussion" (Substantial Equivalence Discussion) sections explain why the differences are not considered to affect safety and effectiveness, thus supporting the claim of substantial equivalence.
However, I can extract the following information based on the provided text, particularly from the "Non-Clinical Data" section, which outlines the types of tests performed and the standards met:
Inferred Acceptance Criteria and Reported Device Performance (Summary based on tests performed for substantial equivalence):
| Acceptance Criteria Category | Reported Device Performance (Based on testing standards met) |
|---|---|
| Sterilization (Abutments) | Met standards: ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1. Sterility Assurance Level (SAL) of 10-6 achieved via overkill method (Moist heat). |
| Biocompatibility (Abutments) | Met standards: ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, and ISO 10993-10:2010. Demonstrated that subject abutments are biocompatible. |
| Surface Modification | Surface roughness, surface composition analysis, and SEM imaging provided to demonstrate substantial equivalence to predicate devices K152520 and K162099 for RBM and SLA treatments. (The document states "this surface change is intended to only improve scanning surface area and does not affect the actual equivalence of the product.") |
| Packaging (Aseptic Presentation) | Human Factors testing (usability evaluation in line with ISO 11607-1:2019 and FDA guidance), evaluation of broken tip at various degrees of rotation, and Quality System (QS) plan to ensure conformance with product specifications. |
| Materials | Verified to be Ti-6AL-4V ELI (conforming to ASTM Standard F-136) for fixtures and most abutments, and Co-Cr-Mo Alloy for the body of the Magic Motion abutment. |
Further Breakdown of Requested Information (where available):
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A table of acceptance criteria and the reported device performance: See table above. It's important to note that these are inferred from the standards cited as being met for establishing substantial equivalence, not explicit performance metrics from a comparative study of the new device against specific performance criteria.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text for any of the non-clinical tests (e.g., number of abutments for sterilization, number of implants for fatigue testing, number of participants for human factors).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The manufacturer is InnoBioSurg Co., Ltd. from the Republic of Korea.
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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. This document describes non-clinical engineering and biological tests, not studies involving human expert assessment for ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. As above, this is for non-clinical 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 endosseous dental implant, not an AI-powered diagnostic or assistive technology.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Sterilization: Ground truth is defined by the demonstrated sterility assurance level (SAL) of 10^-6, verified by biological indicators and physical parameters outlined in the referenced ISO and AAMI standards.
- For Biocompatibility: Ground truth is established by the cellular responses and tissue reactions observed in tests, interpreted against the criteria of the ISO 10993 series.
- For Fatigue Testing: Ground truth is the material's resistance to fracture under cyclic loading, compared to the ISO 14801:2016 standard.
- For Surface Modification: Ground truth involves microscopic and chemical analysis (e.g., surface roughness, composition analysis, SEM imaging) against established benchmarks or predicate device characteristics.
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The sample size for the training set: Not applicable. This is not a machine learning or AI device.
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How the ground truth for the training set was established: Not applicable.
§ 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.