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The Rescue® Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

Rescue® Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue® implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, which provide the clinician with screw and cement retained restoration for multi-mount, screw retained restoration for octa abutment, and cement retained restoration for solid abutment restorative options. The devices covered by this submission are Rescue® Implant Fixtures, Retained Restoration Abutment System.

The provided 510(k) summary for the Mega'Gen Co., Ltd. Rescue® Implant System does not contain acceptance criteria or a study that evaluates device performance against such criteria in the manner typically expected for AI/ML-based diagnostic devices.

This document describes a dental implant system, which is a physical medical device. The "performance" section refers to "Laboratory testing was conducted to determine device functionality and conformance to design input requirements," but it does not specify what those requirements were, what the test outcomes were, or any quantitative acceptance criteria.

The submission focuses on establishing substantial equivalence to predicate devices (BICON Implant Systems). This is a common pathway for physical medical devices where the manufacturer demonstrates that their new device is as safe and effective as a legally marketed predicate device. This typically involves comparing design, materials, indications for use, and manufacturing processes, rather than conducting a clinical study with detailed performance metrics against a defined ground truth.

Therefore, I cannot fulfill the request to provide the requested information for acceptance criteria and a study proving device performance as the provided document does not contain this type of data for this specific device.

Here's why the requested information isn't present in the context of this 510(k) for a dental implant system:

• Type of Device: Dental implants are physical devices, not AI/ML-based diagnostic tools. Their performance is typically assessed through mechanical testing, biocompatibility testing, and comparison of design features to established standards and predicate devices, rather than through metrics like sensitivity, specificity, or AUC based on AI model outputs.
• Submission Type: A 510(k) submission for this type of device aims to demonstrate "substantial equivalence" to a predicate device. This often means showing similar design, materials, and intended use, rather than conducting new clinical trials to prove efficacy against specific performance criteria as might be required for a novel diagnostic.
• "Performance" Section: The single line "Performance Laboratory testing was conducted to determine device functionality and conformance to design input requirements" is very generic and doesn't provide specific criteria or results.

If this were a submission for an AI/ML diagnostic device, the requested information would be crucial and would typically be found in detailed performance studies.

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