(238 days)
THE SCREWS ARE INDICATED FOR USE AS A FIXED ANCHORAGE FOR ATTACHMENT OF ORTHODONTIC APPLIANCES TO FACILITATE THE ORTHODONTIC MOVEMENT OF TEETH. THEY ARE USED TEMPORARILY AND ARE REMOVED AFTER ORTHODONTIC TREATMENT HAS BEEN COMPLETED. THEY 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 from 1.4mm to 2.0 mm, and total thread lengths from 6.0mm to 12.0mm. The minor technological modification for Syntec Wetali Orthodontic Mini Screws is re-designed self-drilling angle for more easily 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 diameter hole can supply different orthodontic methods for orthodontists.
This document describes a 510(k) premarket notification for the "Syntec Wetali Orthodontic Mini Screws." The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device, the "Syntec Orthodontic Mini Screws (K090476)."
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (typically from standards) | Reported Device Performance (from the study) |
|---|---|
| Met the standard of ASTM-F543 for pull-out strength. | Performance of the Syntec Wetali Orthodontic Mini Screws was comparable to the predicate device, meeting ASTM-F543. |
| Met the standard of ASTM-F543 for insertion torque. | Performance of the Syntec Wetali Orthodontic Mini Screws was comparable to the predicate device, meeting ASTM-F543. |
| Implicit Acceptance Criterion: Substantial equivalence in intended use, technological characteristics, and principles of operation to the predicate device. | Reported Performance: The Syntec Wetali Orthodontic Mini Screws has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Minor technological differences raise no new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Both of comparative testing was done to our own predicate device," referring to the pull-out strength and insertion torque tests. However, it does not specify the sample size used for these tests.
Regarding data provenance:
- Country of Origin: The company is Syntec Scientific Corporation, located in Taiwan (R.O.C.). It can be inferred that the testing was conducted by or on behalf of Syntec Scientific, likely in Taiwan or a region accessible to them.
- Retrospective or Prospective: The text does not explicitly state whether the data was retrospective or prospective. Given that this is a premarket notification for a new version of a device, it is highly likely that the testing (e.g., mechanical tests like pull-out strength and insertion torque) was prospectively generated for the purpose of this submission. It's not clinical data, but rather mechanical testing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in this context. The "test set" for this submission consists of physical mechanical tests (pull-out strength and insertion torque) on the device, not clinical data requiring expert interpretation. The ground truth is established by the physical properties of the materials and the mechanical measurements, not by expert consensus in a medical diagnostic sense.
4. Adjudication Method for the Test Set
This information is not applicable. The "test set" involves objective mechanical measurements (pull-out strength and insertion torque) against a recognized standard (ASTM-F543), not subjective human assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic medical devices where expert readers evaluate images or data. The "Syntec Wetali Orthodontic Mini Screws" is a physical medical device (orthodontic mini screw) and its performance is evaluated through mechanical bench testing, not clinical imaging or diagnostic interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is not an algorithm or software requiring performance evaluation in a "standalone" or "human-in-the-loop" context. It is a physical medical device.
7. The Type of Ground Truth Used
The ground truth used here is based on objective mechanical measurements against a recognized industry standard. Specifically:
- ASTM-F543 standard: This standard defines the methodologies and acceptable parameters for evaluating the mechanical properties of bone screws, including pull-out strength and insertion torque. The "ground truth" is that the device's performance metrics (e.g., the measured pull-out strength and insertion torque values) must conform to or be comparable to acceptable values defined by this standard and/or to the predicate device.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device and the presented evaluation. Training sets are typically used for machine learning algorithms or AI models. This submission focuses on physical device characteristics demonstrated through mechanical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set."
§ 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.