(114 days)
The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.
The screws are manufactured from commercially SUS316L ( stainless steel ) and Ti-6AL-4V ( titanium alloy ) . The screws are available with thread diameter are from 1.3mm to 2.0 mm, and total lengths from 5mm to 17mm. There is a pair of self-tapping flutes and self-drilling flutes for easy insertion and removal. The design of smooth curve surface of screw head is comfortable to patients, and the screws with or without a 0.65mm diameter hole can supply different orthodontic methods for orthodontists.
This document is a 510(k) premarket notification for the "Syntec orthodontic mini screws." It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study reporting on the device's performance against specific acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and performance metrics is generally not present in this type of regulatory document.
However, I can extract the information that is available and explain why other details are missing:
1. A table of acceptance criteria and the reported device performance
- Not Applicable. This document does not describe acceptance criteria and reported device performance through a study. Instead, it asserts "substantial equivalence" to a predicate device. Substantial equivalence means the device has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or data provenance is detailed because this is not a clinical study report. The submission relies on demonstrating equivalence through comparison of materials, intended use, and general characteristics to a predicate device, rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No ground truth establishment by experts is mentioned as this is not a study assessing diagnostic accuracy or clinical outcomes requiring such a process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is mentioned.
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
- Not Applicable. This device is a physical orthodontic mini screw, not an AI software or diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm, so standalone performance in that context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Since no performance study against a ground truth is presented, this information is not included.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device, so there is no concept of a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, there is no training set mentioned.
Summary of what is available in the document regarding the device and its regulatory clearance:
- Device Name: Syntec orthodontic mini screws
- Intended Use: To provide fixed anchorage for attachment of orthodontic appliances to facilitate orthodontic movement of teeth. They are temporary and removed after treatment. Single use only.
- Material: Surgical stainless steel (ISO 5832-1) and Surgical titanium alloy (ISO 5832-3).
- Sterility: Non-sterile. Steam sterilize before use.
- Predicate Device: Leone Orthodontic Mini Implant (cleared 510(k) no. K071490).
- Substantial Equivalence: The submission asserts that the Syntec orthodontic mini screws have the "same intended use" as the predicate and "equivalent performance characteristics," raising "no new issues of safety or effectiveness." The FDA concurred with this determination, clearing the device for market.
§ 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.