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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 Implant Integration Systems Surgical Drills are intended to be used in the placement of the "Dual Integrator" Dental Implant (K944225).

This product is similar in design, composition (titanium nitrade coated stainless steel) and function to the Implant Innovations, Inc. Surgical Drills (K891615), the Impla-Med Corp. Titanium/Stainless Steel Dental Implant Drills (K902158) and the Steri-oss Drills and Taps (K915733).

The provided text describes a Surgical Drill system (Implant Integration Systems Surgical Drills) intended for use with a specific dental implant (Dual Integrator Dental Implant), and states that it is similar to other predicate devices.

However, this document is a 510(k) Summary of Safety and Effectiveness from 1996. It focuses on demonstrating substantial equivalence to pre-existing devices, which is the regulatory pathway for many medical devices in the US.

Therefore, the document does not contain any of the information requested regarding acceptance criteria, performance studies, sample sizes, expert involvement, or AI-related data. The concept of "acceptance criteria" and "device performance" in the context of advanced AI algorithms, multi-reader multi-case studies, and ground truth establishment as described in your request did not generally apply to the regulatory submission for a surgical drill system in 1996.

To directly answer your request based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document primarily identifies predicate devices for substantial equivalence.
2. Sample size used for the test set and the data provenance: This information is not present in the document. No test set or data studies are described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
4. Adjudication method for the test set: This information is not present in the document.
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 information is not present in the document. AI was not a factor in medical device regulation or development in this context in 1996.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not present in the document. This device is a surgical drill, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present in the document.
8. The sample size for the training set: This information is not present in the document.
9. How the ground truth for the training set was established: This information is not present in the document.

In summary, the provided document is a regulatory submission for a physical surgical tool from 1996, and the type of detailed performance criteria and study information you are asking for (which are common for AI-driven medical devices) are completely absent and not applicable to this kind of product or its regulatory pathway at that time.

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