(269 days)
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.
| Acceptance Criteria (Implied/General) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Strength (Static Load Resistance) | "Test results concluded that the Storm Micro Screw provides adequate mechanical strength for its intended use in an orthodontic application and has equivalent performance to the predicate devices." |
| Sterilization Validation | "Test for sterilization validation indicated that treatment method reached the established VD Max25 dosage." |
| Sterile Shelf Life | "Test certifications performed after sterilization and accelerated ageing confirmed a 5 year sterile shelf life." |
| Biocompatibility | "Made of biocompatible, medical grade anodized titanium, ISO 10993 compliant." |
| Material Composition | "Grade 5 Titanium ASTM F136-95 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications." (Matches predicate devices) |
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.