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Implantium II is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient is chewing function. Implantium II is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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I am sorry but this document is a 510(k) clearance letter from the FDA for a dental implant (Implantium II). It does not contain information about acceptance criteria, device performance, validation studies, sample sizes, expert qualifications, or ground truth establishment. This document is primarily an administrative letter confirming that the device is substantially equivalent to legally marketed predicate devices.

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Implantium II is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetics devices, such as artificial teeth, and to restore the patient's chewing function. Implantium II are for single stage or two stage surgery.

The Implantium II is a dental fixture made of pure titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The Implantium II 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 differences between them are shape and surface. The Implantium II has one-stage and two-stage surgery. The Implantium II has S.L.A. or Anodizing surface while Implantium has S.L.A (Sand-blasted Large grit Acid-etched).

The provided text is a 510(k) summary for a dental implant device called "Implantium II." This type of document is for medical device approval and focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study or standalone algorithm evaluation.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The "Review" and "Conclusions" sections state that "Implantium II has the same device characteristics as the predicate device. Material, design and use concept is similar" and "Implantium II is safe and effective and substantially equivalent to predicate devices." This substantial equivalence is the primary "acceptance criterion" for this type of submission.

Here's a breakdown of why the requested information is absent:

• Acceptance Criteria & Device Performance Table: Not applicable. The document focuses on demonstrating equivalence to a previously approved device (Implantium, K041368), not on meeting specific, quantitative performance metrics with a new study.
• Sample Size (test set) & Data Provenance: Not applicable. There is no specific "test set" in the context of an AI/algorithm performance study. The evaluation is based on a comparison of device characteristics, materials, and intended use to a predicate device.
• Number of Experts & Qualifications: Not applicable. There is no expert review of specific cases or data for ground truth establishment.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study would be relevant for evaluating human reader performance with and without an AI assist, which is not the subject of this 510(k).
• Standalone (algorithm-only) Performance Study: Not applicable. This document is not for an AI/algorithm device; it's for a physical dental implant.
• Type of Ground Truth Used: Not applicable. Ground truth typically refers to a definitive diagnosis or outcome for evaluating an AI's accuracy, which is not relevant here.
• Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided 510(k) summary is designed to establish substantial equivalence for a physical medical device (dental implant) by comparing it to a predicate device, not by presenting data from a study that evaluates performance against specific acceptance criteria in the manner described in the prompt for an AI or diagnostic algorithm.

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