(795 days)
The Orthodontic Screw is indicated for use as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. Screws are intended for single use only.
The screws are manufactured from commercially SUS316L (stainless steel) and Ti6AL-4V (Titanium alloy). The screws are available with thread diameter are 1.5mm and 2.0 mm, and total thread lengths is 7.0mm. The minor technological modification for Mico One Orthodontic Screw is designed for easy insertion and removal. The design of smooth curve surface of screw head is comfortable to patient and the screws with or without a 0.7mm/0.8mm diameter hole can supply different orthodontic methods for orthodontists.
This document is a 510(k) summary for a medical device called "Mico One Orthodontic Screw". It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.
Here's an analysis based on your requested information:
This document does NOT describe the acceptance criteria and a study proving a digital device meets acceptance criteria. Instead, it describes acceptance criteria and testing for a physical medical device (an orthodontic screw).
Therefore, many of your requested points, especially those related to AI/algorithm performance, ground truth establishment, expert adjudication, and training/test set sizes for digital devices, are not applicable to this submission.
However, I can extract the relevant information for the physical device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with specific numerical targets and corresponding reported performance values for each criterion. Instead, it refers to industry standards and general performance categories.
| Acceptance Criteria Category | Reported Device Performance (as described) |
|---|---|
| Mechanical Performance | - ASTM F543 Standard: The device's mechanical function (Shear Bond Strength, Torque Strength test, and structure integrity) was tested and demonstrated to fulfill design specifications. |
| - Reliability: Mechanical performance tests confirmed the device's reliability for its intended function during use. | |
| Biocompatibility | - Adherence to Standards: Evaluation and testing conducted in accordance with FDA-recognized ISO 10993 series standards (10993-1, 10993-3, 10993-5, 10993-6, 10993-10, 10993-11, 10993-12). |
| Sterilization Validation | - Adherence to Standard: Moist Heat sterilization validation conducted in accordance with ISO 17665-1. |
| Dimensional Conformance | - Predicate Range: Diameter (1.5mm, 2.0mm) and length (7mm) are included within the range of the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the mechanical performance or biocompatibility testing. It also does not explicitly state the provenance of the data (e.g., country of origin). Since these are bench tests, "retrospective" or "prospective" as typically applied to clinical data don't fully apply, but they would be controlled laboratory studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as this is testing for a physical device, not a digital device requiring human expert ground truth for interpretation. Mechanical and biocompatibility tests rely on standardized measurement methods and laboratory analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in interpreting medical images or clinical data, which is not relevant to the physical device testing described.
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 as this document pertains to a physical orthodontic screw, not an AI or digital device designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable as this document pertains to a physical orthodontic screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the mechanical performance, the "ground truth" is established by the specifications defined in the ASTM F543 standard. For biocompatibility, the "ground truth" is determined by the Pass/Fail criteria outlined in the ISO 10993 series of standards.
8. The sample size for the training set
This section is not applicable as this document describes testing for a physical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
§ 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.