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This product is designed for use in the placement of the "Dual Integrator" Dental Implant (K944225).

The Parallel Pin is used to insure correct vertical placement of the implant. The Depth Gauge is used to measure the depth of surgical site, while the Surgical Ratchet is used to screw the "Dual Integrator" Dental Implant into the surgical site.

These products along with the "Dual Integrator" Dental Implant make up the total system of tooth replacement by Implant Integration Systems.

The "Dual Integrator" Parallel Pin, Depth Gage, and Surgical Ratchet are all intended to be used with the Implant Integration Systems "Dual Integrator" Dental Implant (K944225).

This document describes the "Dual Integrator" Parallel Pin, Depth Gage, and Surgical Ratchet, which are dental implant accessories, and their intended use with the "Dual Integrator" Dental Implant (K944225).

However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting performance metrics from a specific study.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
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: This document is about mechanical dental instruments and predates common AI applications in medical devices. No such study is mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a mechanical device, not an algorithm.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not applicable, as this is a mechanical device, not a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Device Description: The "Dual Integrator" Parallel Pin, Depth Gage, and Surgical Ratchet are described as being made of stainless steel and similar in design, composition, and function to other predicate devices.
• Intended Use: Used for the placement of the "Dual Integrator" Dental Implant. Specific functions are outlined: Parallel Pin for vertical placement, Depth Gauge for depth measurement, and Surgical Ratchet for screwing in the implant.
• Substantial Equivalence: The FDA clearance confirms that the device is substantially equivalent to legally marketed predicate devices (e.g., Minimatic Implant Tech. BC 1208, Impla-Med, Inc. Stainless Steel Instruments). This demonstrates that the device meets safety and effectiveness requirements by virtue of being comparable to devices already on the market, but it does not detail specific performance studies with acceptance criteria for the new device itself.

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The "Dual Integrator" Healing Cap, Implant Carrier Assembly, and Activator Pin Driver are all intended to be used with the Implant Integration Systems "Dual Integrator" Dental Implant (K944225).

Not Found

The provided document is a "Summary of Safety and Effectiveness Information" for a dental implant accessory ("Dual Integrator" Healing Cap, Implant Carrier Assembly, and Activator Pin Driver) from Implant Integration Systems, Inc., dated October 18, 1996.

This document does not contain any information regarding acceptance criteria, device performance, clinical study design, sample sizes, expert involvement, or any of the other specific details requested in your prompt.

It is a regulatory submission describing the product and its similarity to other existing devices, rather than a report on clinical trial results or performance studies.

Therefore,Based on the provided document, I cannot fulfill your request as it does not contain the necessary information to describe the acceptance criteria and the study that proves the device meets them.

Ask a specific question about this device