(294 days)
J2I Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or interminal or intermediate abuments upport for fixed bridgework. J21 Implant System is for single and two stage surgical procedures. It in intended for delating.
The J2I Implant System is a dental implant system made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implant may be used to replace one or more missing teeth. 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. The surface of the system has been treated with R.B.M (Resorbable Blast Media).
This document describes the J2I Implant System, a dental implant device, but it lacks the specific information requested about acceptance criteria and a study proving those criteria are met, especially in the context of AI/ML performance.
The provided text is a 510(k) summary for a dental implant system. It focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medical devices that are similar to devices already legally marketed. This process primarily involves comparing design, materials, indications for use, and performance characteristics to a previously cleared device.
Here's a breakdown of why the requested information is not present and what is included instead:
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Acceptance Criteria and Reported Device Performance (Table): This document does not specify quantitative acceptance criteria (e.g., specific thresholds for success, failure rates, or clinical outcomes) for the J2I Implant System itself. Its performance is implicitly deemed acceptable by virtue of its substantial equivalence to the predicate device, which would have had its own performance data reviewed for its original clearance. The document lists the material (Ti 6Al 4V ELI, ASTM F136) and various sizes (Platform Dia, Diameter, Length) of the implant.
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Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): The document describes non-clinical testing for sterilization, shelf-life, and surface analysis (chemical and SEM image analysis). It does not describe a clinical study in the way one would for evaluating the performance of an AI/ML diagnostic or prognostic device.
- Sample size for test set and data provenance: Not applicable in the context of an AI/ML study; the non-clinical tests likely used specific batches of implants for verification.
- Number of experts and qualifications, Adjudication method: Not applicable as there's no diagnostic or interpretative task involving human experts.
- MRMC comparative effectiveness study: Not applicable. This device is a physical implant, not an AI/ML system assisting human readers.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth: For the non-clinical testing, the "ground truth" would be the specifications and standards (e.g., ISO 11137 for sterilization, ASTM F136 for material). This is not the type of ground truth (e.g., pathology, expert consensus) typically associated with AI/ML performance studies.
- Sample size for training set, how ground truth for training set was established: Not applicable, as this is not an AI/ML device relying on a trained model.
What is provided in the document:
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Non-Clinical Testing:
- Sterilization validation testing per ISO 11137, ISO 11737-1 & ISO 11737-2 (gamma) and ISO 17665-1 and ISO 17665-2 (steam).
- Three years of shelf life validated through accelerated testing.
- Chemical and SEM image analyses performed to verify no residual after RBM treatment.
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Basis for Substantial Equivalence: The document asserts that the J2I Implant System is substantially equivalent to the SS SYSTEM by OSSTEM IMPLANT CO., LTD (K062051) and Hero II Dental Implant System, IS Dental Implant System by KJ Meditech Co., Ltd. (K121047). The similarities highlighted are:
- Same intended use.
- Similar fundamental scientific technology (threaded, root form implants of titanium with RBM roughened surfaces).
- Same internal octagon abutment connection system.
- Similar body shape design (straight walled neck and tapered body).
- Same operating principle.
- Same basic design.
- Same material and surface treatment.
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Differences noted: Body shape, cutting edge design, and taper angle, which are deemed minor and not raising new questions of safety or effectiveness.
In summary, this document is a regulatory submission for a physical medical device (dental implant) and demonstrates substantial equivalence based on engineering and material characteristics, and non-clinical laboratory testing. It does not contain the kind of AI/ML device performance study details you've requested.
§ 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.