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The Zimmer Dental Tapered Screw-Vent®T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional or delayed 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 Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated are a self-tapping, screw type endosseous dental implant designed for bone level placement and can be used in a single or two stage protocol. The implant is composed of titanium alloy with hydroxylapatite (HA) coating, and has a tapered body with an external triple lead thread design. Identical to predicate #1, the new device has the same implant to abutment internal hex friction-fit connection. The new device will have coronal microgrooves that extend to the collar within 0.64mm of the top of the implant identical to predicate #2.

The new implant will be offered in two surface finish configurations at the coronal end: full MTX texturing to the top of the implant and partial MTX texturing to 0.5mm from the top of the implant leaving a machined collar. Both coronal configurations are identical to the currently marketed predicate #2 device (K101977, K111889).

The Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated family is composed of tapered implants with a choice of diameters and lengths. Both implant configurations, machined and fully textured collar, will be available in diameters of 3.7mm, 4.1mm, 4.7mm, and 6.0mm and in five lengths: 8, 10, 11.5, 13, and 16mm. 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 drilling sequences and drills that will be utilized to place the new device are pre-existing sequences and drills that are listed in the previous 510(k) K011028.

The provided document describes a pre-market notification (510(k)) for dental implants. It does not contain information about acceptance criteria or a study that proves a device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity, as would be typical for AI/Software as a Medical Device (SaMD).

Instead, this K133339 submission focuses on demonstrating substantial equivalence of a new dental implant (Zimmer Dental Tapered Screw-Vent® T Implant, HA Coated and Zimmer Dental Tapered Screw-Vent® M Implant, HA Coated) to existing predicate devices already on the market.

Therefore, many of the requested criteria in your prompt are not applicable to this type of medical device submission.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not specify performance-based acceptance criteria (e.g., accuracy, sensitivity, etc.) because it is for a physical dental implant, not AI/SaMD. The "acceptance criteria" here are related to demonstrating substantial equivalence in terms of design, materials, indications for use, and mechanical performance compared to predicate devices.

The non-clinical testing sections hint at the performance criteria:

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

For the non-clinical mechanical testing (fatigue and compression), the document does not specify the sample size used. It only states that "Non-clinical test data was used to support the decision of substantial equivalence." Details like the number of implants tested or the specific test conditions (e.g., cycles for fatigue) are not provided in this summary.

Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided for this type of mechanical device testing.

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

This is not applicable. The "ground truth" for mechanical testing of implants involves engineering specifications and performance standards, not expert clinical interpretation.

4. Adjudication method for the test set

Not applicable for mechanical testing.

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 is a physical dental implant, not an AI/SaMD. No MRMC study was conducted.

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

Not applicable. This is a physical dental implant, not an algorithm.

7. The type of ground truth used

For the mechanical tests (fatigue and compression), the "ground truth" would be established by specified engineering standards and regulatory guidance documents (e.g., FDA guidance Class II Special Controls Guidance Document: Root-form Dental Implants and Endosseous Dental Implant Abutments). For MRI safety, it relates to the FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment.

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/SaMD.

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

Not applicable. There is no training set as this is not an AI/SaMD.

In summary:

This 510(k) submission primarily relies on demonstrating substantial equivalence to already legally marketed devices through:

• Design comparison: Showing the new device has the same fundamental technology, materials, and intended use as predicate devices. The key differences (coronal microgrooves, surface finish configurations) were shown to be identical to different aspects of existing predicate devices.
• Non-clinical testing: Mechanical tests (fatigue and compression) and MRI compatibility were performed to ensure the new device meets established performance standards and is safe. The document states these tests "demonstrated improvements over the predicate device" in mechanical strength, suggesting the new design's modifications did not negatively impact performance and might have enhanced it.
• No clinical testing: The submission explicitly states, "No clinical testing was performed. Non-clinical testing was used to support the decision of substantial equivalence." This is common for devices demonstrating substantial equivalence where the risks are well understood and adequately addressed by non-clinical means.

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