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The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.

The Storm Mini screw is a self-tapping and self-drilling screw constructed of grade 5 titanium (Ti6Al4V) and anodized for the ease of identification through color. After bone insertion, the Storm Mini Screw is designed to be immediately used as an anchorage for orthodontic devices. The Storm mini-screw head is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures. The Storm Mini Screw is intended for single use only and used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is a threaded titanium dental implant screw intended to provide a fixed anchorage point for the attachment of orthodontic appliances and facilitate the orthodontic movement of teeth. It is used temporarily and must be removed after orthodontic treatment has been completed. The Storm Mini Screw is provided sterile and is intended for single use only.

This 510(k) premarket notification describes the Storm Mini Screw, an orthodontic mini screw. The submission primarily focuses on establishing substantial equivalence to predicate devices based on material, intended use, and mechanical characteristics rather than presenting performance metrics against specific acceptance criteria for a novel device. Therefore, many of the requested sections regarding detailed study design, sample sizes, and ground truth establishment are not applicable or not provided in the document.

Here's a breakdown of the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in the typical sense (e.g., a specific tensile strength value that must be met). Instead, the performance is demonstrated through comparison to predicate devices and general statements about meeting requirements for intended use.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "tests for sterilization validation" and "test certifications performed after sterilization and accelerated ageing," but specific sample sizes for these tests are not provided.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) for a physical device, these tests are typically conducted in a laboratory setting.

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

This section is not applicable as the device is a physical orthodontic screw, and its performance is evaluated through mechanical and sterilization testing, not through expert interpretation of data or images.

4. Adjudication Method for the Test Set

This section is not applicable as the device is a physical orthodontic screw and its performance is evaluated through objective physical and chemical tests, not through subjective assessment requiring adjudication.

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 section is not applicable. The Storm Mini Screw is a physical medical device, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.

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

This section is not applicable. The Storm Mini Screw is a physical medical device, not an algorithm, so standalone AI performance is not relevant.

7. The Type of Ground Truth Used

For the specific tests mentioned:

• Mechanical Strength: The "ground truth" would be established by the physical properties of the materials and the design, measured against engineering standards and comparison to predicate devices. It's a direct measurement of physical properties.
• Sterilization Validation: The "ground truth" is achieved when the sterilization process (VD Max25 dosage) effectively renders the device sterile, typically verified through biological indicator testing.
• Sterile Shelf Life: The "ground truth" is established by accelerated aging studies simulating the effects of time on sterility and packaging integrity.

8. The Sample Size for the Training Set

This section is not applicable. The Storm Mini Screw is a physical medical device, not an AI model, and therefore does not have a "training set."

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

This section is not applicable for the same reason as above.

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