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The Leone orthodontic mini implant is an implant device providing a fixed anchorage for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily in the maxillary and mandibular bone and must be removed after orthodontic treatment has been completed.

The Leone orthodontic mini implant is a medical device made of stainless steel for surgical use (ISO 5832-1). The orthodontic mini implant is a one-piece endosseous mini implant where the endosseous portion is a right-hand thread screw, while the head section is made of a smooth tapered neck. It is available in different diameters, lengths and head shapes.

Here's an analysis of the provided text regarding the Leone orthodontic mini implant.

Acceptance Criteria and Study for the Leone Orthodontic Mini Implant

The provided 510(k) summary for the Leone orthodontic mini implant (K071490) focuses on demonstrating substantial equivalence to a predicate device, rather than presenting specific performance acceptance criteria and a detailed study proving the device meets those criteria. In the context of a 510(k) submission, "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as a legally marketed predicate device.

The "study" described herein is the comparison and testing performed to establish this substantial equivalence.

1. Table of Acceptance Criteria and the Reported Device Performance

As mentioned, explicit, quantitative acceptance criteria are not stated in this summary. Instead, the "acceptance" is based on the new device being comparable to the predicate device across several key characteristics. The reported device performance is presented through a direct comparison with the predicate.

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

The summary does not explicitly state the sample size used for any testing. It mentions "results of the testing performed" but does not detail the nature of these tests (e.g., mechanical, biocompatibility, in-vivo, etc.), their design, or the sample size of any materials or subjects involved.

Regarding data provenance, the summary does not provide this information. Given the nature of a 510(k) for a device like an orthodontic mini implant, the "testing performed" would typically involve laboratory (bench) tests to evaluate mechanical properties and biocompatibility.

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

This information is not applicable to this 510(k) summary. The submission is a regulatory filing demonstrating substantial equivalence to a predicate device, not a clinical study requiring expert consensus on a test set to establish ground truth for a diagnostic or AI device.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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 applicable. The device is an orthodontic mini implant, not an AI-powered diagnostic or decision support system that would involve human readers or AI assistance.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to diagnostic or AI studies is not directly relevant here. For this type of medical device 510(k), the "truth" is established through:

• Compliance with recognized standards: Such as ISO 5832-1 for surgical stainless steel, which inherently assumes material suitability.
• Bench testing: To verify mechanical properties (strength, fatigue, etc.) of the implant. The "ground truth" for these would be the specified engineering requirements or comparison to the predicate.
• Biocompatibility testing: To ensure the material is non-toxic and suitable for implantation. These tests have defined endpoints that serve as their "ground truth."

The summary states equivalence is "supported by the results of the testing performed," implying these types of tests were conducted, but the specific "ground truth" for each is not detailed.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of an orthodontic mini implant's regulatory submission, as it is not an AI/machine learning device.

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

This information is not applicable as there is no training set.

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