(123 days)
The device is intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended for single use only.
The Ortho Easy Pin is designed for use in orthodontic treatments as element of anchorage. The screws are made of titanium alloy. The slots in the screw head are cross-shaped. Rectangular wires are inserted to accommodate orthodontic elements, such as arches, elastic bands and brackets. Preferably, the wire should be fixed to the screw head using an elastic band or steel ligature. A retention groove below the slots serves as the anchor for fixing elements in the slot. The thread of the Pin is self-trapping and self-drilling. The Pin is inserted and screwed into the bone either manually or mechanically. To insert the screw, the hexagon head of the screw is picked up using an instrument. The sleeve between the thread and the functional head serves to protect the soft tissue. These screws are supplied non-sterile. Therefore, the device must be sterilized prior to use. Steam sterilization is recommended. The device is available in different lengths (6, 8, 10, 12 mm), diameter 1,7 mm, and supplied in sealed polyethylene bags.
The Ortho Easy Pin is a temporary anchorage device used in orthodontics. The device's performance was evaluated through a series of tests to demonstrate substantial equivalence to predicate devices, rather than establishing new acceptance criteria against a specific clinical outcome.
Here's a breakdown of the information provided in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission relying on comparison to predicate devices, there aren't explicit numeric "acceptance criteria" defined in the same way one might find for a diagnostic device's sensitivity or specificity. Instead, the acceptance is based on demonstrating comparable performance and characteristics to existing, legally marketed devices.
| Characteristic | Acceptance Criteria (Implied by Predicate Devices) | Reported Device Performance (Ortho Easy Pin) |
|---|---|---|
| Material | Titanium alloy (ASTM F 136 or Grade 5 TITAN 3.7165) | Titanium alloy ASTM F 136 |
| Dimensions | Diameter: 1.2 - 2 mm, Length: 6 - 12 mm (across predicates) | Diameter: 1.7 mm, Length: 6 - 12 mm |
| Performance (Mechanism) | Self-trapping/self-drilling screw mechanism | Self-trapping/self-drilling screw mechanism |
| Torque Levels (Insertion) | Comparable to predicate devices (tomas®-pin, Dual-Top Anchor Screw) | The level of torque is comparable to predicate devices. Low insertion level at the beginning, torque increases at the end of insertion, providing feedback. Torque amount is "clearly far from the load limit of 30 Ncm." No fracture occurred during measurements. |
| Resistance to Active Forces | Withstands active forces during orthodontic treatment (implied by predicate use) | Measurement results indicate the OrthoEasy® pin withstands active forces during orthodontic treatment. |
| Root Damage Risk | Minimal/acceptable risk of root damage (implied by predicate use) | Testing found the risk of root damage while inserting an OrthoEasy® pin into a root is not justified as the thread peak is not able to cut the tooth. The thread peak has a "protective function." |
| Sterility | Non-sterile (requiring sterilization prior to use) | Supplied non-sterile. Steam sterilization recommended prior to use. |
| Biocompatibility | Accepted for endosseous implant (Titanium alloy ASTM F 136) | Titanium alloy in medical grade according to ASTM- F 136 is accepted for endosseous implant. |
| Intended Use | Fixed anchorage point for orthodontic appliances, temporary, single-use, removable after treatment | Intended to provide a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The screws are intended for single use only. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size for the mechanical performance testing (torque, impact on tooth roots, resistance to active forces). It only mentions "our measurements" and "All reports."
The data provenance is from Bernhard Forster GmbH (Germany), the manufacturer. The studies appear to be prospective bench testing conducted specifically for this submission, comparing the Ortho Easy Pin to the two predicate devices under the same parameters. There is no mention of human subject data or clinical trials in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission pertains to a medical device's mechanical and material properties, not a diagnostic algorithm. Therefore, there is no "ground truth" in the clinical imaging sense, nor were experts used to establish it for a test set. The validation relies on engineering and material standards (ISO 7405, ASTM F-136) and comparative mechanical testing.
4. Adjudication Method for the Test Set
Not applicable, as this is not a diagnostic study requiring human adjudication of findings. Mechanical test results are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission is for a mechanical medical device, not an AI-assisted diagnostic tool for imaging interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithmic or AI-based device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth or validation for this device is based on:
- Material standards: ASTM F-136 for titanium alloy.
- Performance standards: ISO 7405.
- Comparative mechanical testing: Measuring torque, force resistance, and impact characteristics against predicate devices.
- Biocompatibility: Accepted status of ASTM F-136 titanium alloy for endosseous implants.
8. The Sample Size for the Training Set
Not applicable. There is no training set for this type of mechanical device submission, as it does not involve machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is primarily a comparative mechanical and material testing study. The goal of the study was to demonstrate substantial equivalence to two predicate devices: Tomas PIN (K062733) from Dentaurum and Dual Top Anchor System Screws (K033767) from Jeil Medical Corporation.
The study involved:
- Material Analysis: Confirming the Ortho Easy Pin is made of titanium alloy ASTM F 136, a material already accepted and widely used in similar bone screws and equivalent to the predicate devices.
- Mechanical Performance Testing:
- Torque Measurements: The Ortho Easy Pin was tested to determine its insertion torque levels, and these were compared to the predicate devices. The study found the torque levels to be comparable and "clearly far from the load limit of 30 Ncm," with no fractures occurring.
- Force Resistance: Measurements were performed to ensure the pin withstands active forces during orthodontic treatment.
- Impact on Tooth Roots: Testing was conducted to assess the risk of root damage. This test concluded that the thread peak of the Ortho Easy Pin has a protective function and is not able to cut the tooth, thus not causing unjustified root damage.
- Design and Intended Use Comparison: A detailed table compared the design parameters (dimensions, self-drilling/self-tapping nature), intended use, indications for use, target population, and other characteristics of the Ortho Easy Pin to the predicate devices, showing strong similarities.
- Biocompatibility: The use of ASTM F-136 titanium alloy, an accepted material for endosseous implants, ensured biocompatibility.
Conclusion of the Study:
The overall conclusion from the testing and comparison was that the Ortho Easy Pin is "substantially equivalent in design, material, intended use and function to the products listed as predicate devices." The comparable torque levels led to the estimation that "OrthoEasy® pin will show the same clinical results like the other screws."
§ 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.