(83 days)
This device is intended to provide 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. For use in adults over the age of 12.
This device is designed for orthodontic use. The screws are made of alloy (ASTM F 136-98). The head of the screw is dual head type. The upper head is a hex type. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Also, Dual head design of screw mandible and mannia in the screw with the orthodontic appliances (bracket, wire, and elastic band etc.) The tip of the screw is designed available to self-drilling and self-tapping. (Surgeon's option) This device is comprised of screws ranging in diameter of 1.4mm to 2.0mm and in length ranging from 6.0mm to 12mm. These screws are provided non-sterile. Therefore, this device must be sterilized prior to use. Steam sterilization is recommended. Therefore, and device mast Polyethylene package. The top of packaging bag is sealed with sealing strip.
This looks like information from a 510(k) premarket notification for a medical device, specifically the "Dual Top Anchor System Screws". These documents are generally used to demonstrate substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies with defined acceptance criteria in the same way one might for a novel device requiring a PMA.
Therefore, the typical "study that proves the device meets the acceptance criteria" in the context of a 510(k) usually involves comparing the new device's characteristics (material, design, intended use) to those of the predicate device and showing they are substantially equivalent, rather than conducting a full-blown clinical trial with performance metrics.
Based on the provided text, here's a breakdown of the requested information, noting that much of it is not directly applicable or explicitly stated as would be in a clinical study report:
1. Table of acceptance criteria and the reported device performance
In a 510(k) submission, "acceptance criteria" for performance are not typically presented as quantitative metrics with corresponding "reported device performance" values in the same way a clinical trial might. Instead, the acceptance criterion is substantial equivalence to a predicate device. The "performance" is the demonstration that all key attributes (material, intended use, design, potential adverse effects) are either identical or do not raise new questions of safety and effectiveness compared to the predicate.
| Characteristic | Acceptance Criteria (based on predicate device) | Reported Device Performance (as demonstrated by comparison) |
|---|---|---|
| Material | Composed of Titanium Alloy used generally in this kind of bone screw (specifically ASTM F 136-98, as seen in predicate OsteoMed). | Made of Titanium Alloy (ASTM F 136-98). Stated to be "manufactured from material of titanium alloy (ASTM 136-98) that is used generally in this kind of bone screw." |
| Intended Use | To provide fixed anchorage point for attachment of orthodontic appliances to facilitate orthodontic movement of teeth, used temporarily and removed post-treatment. Single use. | Identical: "This device is intended to provide 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. For use in adults over the age of 12." |
| Design/Function | Self-drilling/self-tapping, dual head type (hex upper, lower for appliances), available in various diameters and lengths. | Dual head type (hex upper head, hole for wire, lower for appliances). Tip designed for self-drilling and self-tapping. Ranging in diameter of 1.4mm to 2.0mm and length of 6.0mm to 12mm. |
| Sterility | Non-sterile, recommended steam sterilization before use (consistent with OsteoMed predicate). | Non-sterile. "Therefore, this device must be sterilized prior to use. Steam sterilization is recommended." |
| Adverse Effects | Potential adverse effects and complications common to all devices of this type (poor bone formation, loosening, migration, metal sensitivity, pain, necrosis, infection, etc.). | "Potential Adverse Affects and Complications: (Common to all devices of this type)" are listed and are identical to those of already marketed devices. |
| Overall | Substantially equivalent to OsteoMed Orthodontic Screw System (K031936) and Nobel Biocare Implant Orthodontic Anchor System (K000643). | Concluded to be "substantially equivalent in design, material, intended use and function to the certified by notified body for CE." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This 510(k) submission does not describe a "test set" in the context of a clinical study with patients. The "test set" here would refer to the technical and performance characteristics of the "Dual Top Anchor System Screws" being compared to the predicate devices. The data provenance would be internal company data (Jeil Medical Corporation, Korea) on their device's specifications and comparison to publicly available information on the predicate devices. No human subject data (prospective or retrospective) is mentioned for demonstrating equivalence in this document.
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. The "ground truth" for a 510(k) is typically the established safety and effectiveness of the legally marketed predicate devices. No expert panel is described for evaluating a specific "test set" of performance data for the new device. The evaluation is done by the FDA, based on manufacturers' submitted data and comparisons.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a human-adjudicated "test set" for performance evaluation in this 510(k) summary.
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 document pertains to a mechanical medical device (bone screws) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly used in a 510(k) is the established safety and effectiveness of the predicate devices as determined by their prior clearance by regulatory bodies (like the FDA). The current device demonstrates equivalence to this established "ground truth" by showing similar characteristics and lack of new safety/effectiveness concerns.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an artificial intelligence or machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" for this device.
§ 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.