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Intra-Lock International Angled Prosthetic Abutments are intended to prosthetically restore Endosseous Implants. These abutments are designed to be used on single tooth applications and or multiple tooth bridge applications. They are intended to be used when minor correction or alignment will improve the aesthetics of the final restoration.

The Intra-Lock International Angled Prosthetic Abutments are an accessory to the Intra-Lock Endosseous Dental Implants. They perform the function of connecting the laboratory fabricated prostheric bridge or crown to the implanted dental implant. They are manufactured from Titanium Alloy (6 Al-4V ELI, ASTM F136) and are provided in a number of sizes to accommodate tissue depth. These prositietic abutments are provided in non-sterile packaging.

This document is a 510(k) summary for the Intra-Lock International Angled Prosthetic Abutments. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, it does not contain information about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

The document is a "Special 510(k): Abbreviated 510(k)" relying on conformity with FDA's guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA." This type of submission generally means that the manufacturer is demonstrating that their device meets recognized standards or guidance documents, rather than conducting a de novo performance study with specific quantitative acceptance criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text. To answer your questions, I would need a different type of document, such as a full performance study report or design verification and validation report, which would detail specific acceptance criteria and the results of tests performed to meet them.

Based on the provided text, I can only state the following:

• 1. A table of acceptance criteria and the reported device performance: Not provided. The document states "Intra-Lock International has provided information to demonstrate conformity with FDA's guidance document entitled: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Abutments Draft Guidance for Industry and FDA." This implies conformity to general requirements and standards, not specific quantitative acceptance criteria for device performance in the context of a clinical study.
• 2. Sample sized used for the test set and the data provenance: Not applicable, as no specific performance study with a test set is described.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• 4. Adjudication method for the test set: Not applicable.
• 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 device is a physical medical device (dental abutment), not an AI-powered diagnostic or assistive technology.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used: Not applicable.
• 8. The sample size for the training set: Not applicable.
• 9. How the ground truth for the training set was established: Not applicable.

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