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The Tapered Screw-Vent® M Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

The Tapered Screw-Vent® M Implant is an endosseous dental implant. The implant is composed of titanium alloy. The implant section is designed for ease of implantation and with greater surface area for osseointegration. The implant section surface is treated to facilitate osseointegration. The implant contains a 1mm machined collar and small grooves to the top of the implant. In addition, the implant section is tapered with triple-lead threads.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Tapered Screw-Vent® M Implant:

This document describes a 510(k) premarket notification for a medical device (dental implant). For such submissions, the primary "acceptance criterion" is Substantial Equivalence to a predicate device, rather than specific performance metrics like sensitivity, specificity, or accuracy which are common for diagnostic or AI-driven devices. Therefore, the information requested in the prompt (e.g., performance metrics, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance) is largely not applicable in this context.

The study described is a non-clinical study focused on demonstrating mechanical equivalence, not a clinical study assessing patient outcomes or an AI performance study.

Acceptance Criteria and Reported Device Performance (Non-Applicable for this 510k)

For this 510(k) submission, the "acceptance criteria" and "reported device performance" are framed around demonstrating Substantial Equivalence to legally marketed predicate devices. The core of the "study" is a comparison of technological characteristics and non-clinical mechanical similarity.

Since this is a 510(k) submission primarily relying on substantial equivalence through design and material comparison, many of the typical questions for AI/diagnostic devices are not applicable.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • N/A. No formal 'test set' in the sense of patient data for performance evaluation was used. The evaluation was based on design specifications, material properties, and comparison to predicate devices. This is a non-clinical submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • N/A. No ground truth was established by external experts for a test set in this context. The "truth" is established by the manufacturer demonstrating equivalence to legally marketed predicates.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • N/A. No adjudication of a test set occurred.

4. 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:

   • N/A. This is not an AI device, and no MRMC study was conducted. No human readers or AI assistance are involved in the function or evaluation of this dental implant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is not an algorithm or AI device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" here is the established safety and effectiveness of the legally marketed predicate devices. The new device is demonstrated to be substantially equivalent to these predicates based on design, materials, and intended use, eliminating the need for new complex ground truth determination.

7. The sample size for the training set:

   • N/A. No training set was used as this is not an AI/machine learning device.

8. How the ground truth for the training set was established:

   • N/A. No training set or associated ground truth was established.

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