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The Promimic AB, Promimic Dental Implant is intended for surgical placement into the bone of upper/ lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function. The Promimic Dental Implant can be immediately loaded only with good primary stability and appropriate occlusal loading. The Promimic Dental Implants are only to be used with straight abutments.

The Promimic Dental Implant consists of 4 implants, diameter 3.75 mm, and length from 8.5 to 15.0 mm.

Here's a breakdown of the acceptance criteria and study information for the Promimic Dental Implant, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative "acceptance criteria" for the Promimic Dental Implant's performance. Instead, it uses a substantial equivalence (SE) approach, comparing its characteristics to previously cleared predicate devices. The "acceptance" is based on demonstrating that the new device's technological characteristics are similar to the predicates and that any differences do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• The document does not report specific sample sizes for a "test set" in the context of clinical or performance data for the Promimic Dental Implant itself. The performance testing mentioned refers to mechanical testing, not clinical trials on human subjects.
• The data provenance pertains to mechanical testing performed by Promimic AB to demonstrate the physical properties of the device. There's no mention of country of origin for clinical data or whether it's retrospective or prospective, as clinical data for this specific device is not presented.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not applicable or not provided in the context of this 510(k) summary. The "ground truth" for showing substantial equivalence relies on comparing the device's technical specifications and mechanical testing results to established predicate devices and recognized standards, not on expert adjudication of clinical outcomes for a test set.

4. Adjudication Method for the Test Set

• This information is not applicable or not provided. There is no mention of a clinical "test set" requiring adjudication by experts.

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 is not applicable. The Promimic Dental Implant is a physical medical device (dental implant), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

• This is not applicable. As stated, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for the substantial equivalence determination is the technical specifications and established performance characteristics of legally marketed predicate devices and compliance with recognized mechanical testing guidelines (specifically, "Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, dated May 12, 2004").

8. The Sample Size for the Training Set

• This information is not applicable or not provided. There is no "training set" in the context of developing this physical medical device. The manufacturing processes and design are based on established engineering principles and materials science.

9. How the Ground Truth for the Training Set was Established

• This information is not applicable or not provided. There is no "training set" or corresponding ground truth for this type of device submission.

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