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The Tapered Screw-Vent® X 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 4.1mmD Tapered Screw Vent X Implants should be splinted to additional implants when used in the posterior region.

The Tapered Screw-Vent® X Implant is an endosseous dental implant. The implant is composed of titanium alloy and Trabecular metal. 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. In addition, the implant section is tapered with triple-lead threads. The Tapered Screw-Vent X implants will be offered in two different texturing configurations: full texture to the top of the implant and texture to 0.5mm from the top of the implant. In addition, both texturing configurations of the implant will have coronal grooves on the collar to within 0.64mm of the top of the implant similar to the predicate Tapered Screw-Vent P Dental implant. The implant/abutment interface platform diameter will be offered in sizes of 3.5mm, 4.5mm, or 5.7mm depending on the outside implant thread diameter. The new device will feature MTX surface equivalent to existing Zimmer Dental implants. The MTX surface is used on the titanium body and is exposed on surfaces apical and coronal to the Trabecular Metal.

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

This document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific, quantifiable acceptance criteria through performance metrics like sensitivity, specificity, etc. Therefore, the information typically requested in your prompt (such as a table of accuracy metrics, sample sizes for test/training sets for algorithm performance, expert qualifications for ground truth, MRMC studies, standalone performance, etc.) is not present because this type of regulatory submission does not require it.

Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating that the new device has the same intended use and similar technological characteristics as the predicate device(s), and that any differences do not raise new questions of safety or effectiveness. The "study" referenced is primarily non-clinical testing to ensure the device performs appropriately for its indicated use, and clinical studies for safety monitoring.

Here's a breakdown based on the information provided, explicitly stating where typical requested information is not available due to the nature of a 510(k) submission for a dental implant:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) pre-market notification for a dental implant, the "acceptance criteria" are related to demonstrating substantial equivalence rather than performance metrics of an AI/software device. The "performance" is demonstrated through non-clinical compliance and clinical safety without adverse events.

Details on Studies:

2. Sample size used for the test set and the data provenance

• Prospective Clinical Study: Mentioned for evaluation within a "controlled population" for 'posterior region only' implantation and 'two week final restoration immediate load protocol with a 6-month end point.'
  • Sample Size: Not specified.
  • Data Provenance: Prospective. Country of origin not specified, but typically conducted in the country where the sponsor is seeking approval (USA for Zimmer Dental Inc.).
• Longitudinal Data Collection Study: Initiated to gather data on "routine placement and functioning within normal clinical conditions." Included "normal patients and subjects with elevated risk factors" (alcoholics, substance abusers, mentally unstable, smokers, osteoporotics, uncontrolled diabetics, parafunctional habits, dental or oral infections, and bone graft patients).
  • Sample Size: Not specified.
  • Data Provenance: Prospective, ongoing. Country of origin not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable (N/A): This type of information is pertinent to studies validating diagnostic or predictive algorithms where a ground truth is established for comparison (e.g., expert consensus on image findings). For a dental implant 510(k), ground truth refers to clinical outcomes (safety, integration, absence of adverse events), which are assessed by treating clinicians and reported, not by a panel of independent experts establishing a "ground truth" for a test set in the same way an AI algorithm might be evaluated.

4. Adjudication method for the test set

• N/A: As explained above, an adjudication method in the context of expert consensus for a test set is not performed for this type of device submission. Clinical outcomes are reported from the studies.

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.

• N/A: This evaluation method is specific to diagnostic aids (often AI-powered) where human readers (e.g., radiologists) interpret cases with and without algorithmic assistance. This is not relevant to the substantial equivalence demonstration for a dental implant.

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

• N/A: The device is a physical medical implant, not an algorithm. Standalone performance as described is not applicable.

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

• For the clinical studies, the "ground truth" is implied to be outcomes data related to the safety and performance of the implant in a clinical setting. This would include:
  • Absence of device-related adverse events.
  • Successful implantation and loading (immediate or conventional).
  • Successful functioning over the study period.

8. The sample size for the training set.

• N/A: No "training set" in the context of machine learning or AI is mentioned or applicable to this device submission. The device is a physical implant.

9. How the ground truth for the training set was established.

• N/A: As there is no training set for an algorithm, this question is not applicable.

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