(106 days)
The HDC Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. The device is used temporarily and shall be removed after orthodontic treatment.
The HDC Spider Screws are titanium fixation devices to be inserted into the upper or lower jaws, designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. Spider Screws are provided in two configuration "Self Tapping" and "Self Drilling and Self Tapping." Self Tapping Spider Screws are manufactured from ASTM F67. Self Drilling and Self Tapping Spider Screws are manufactured from ASTM F136. The HDC Spider Screws are provided in two tip size diameters, 1.5 mm and 2.0 mm. These devices are provided non-sterile and must be sterilized prior to use.
The provided text is a 510(k) summary for the HDC Spider Screw, a dental implant device. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria and detailed statistical analysis.
Therefore, I cannot provide the requested information about acceptance criteria and a study that proves the device meets them because the document does not contain this type of data.
Specifically, the document discusses:
- Device Description: Materials, configurations ("Self Tapping" and "Self Drilling and Self Tapping"), and tip sizes.
- Intended Use: As a temporary fixed anchorage point for orthodontic appliances.
- Basis of Substantial Equivalence: Similarities to predicate devices in intended use, material, design, and function.
- Regulatory Information: Device classification, product code, and predicate devices.
- FDA Clearance Letter: Confirming substantial equivalence based on the submitted information.
There is no mention of:
- Acceptance criteria defined for performance metrics.
- A study designed to test the device against specific performance criteria.
- Sample sizes for test sets or training sets.
- Data provenance or details about a study cohort.
- Number or qualifications of experts for ground truth.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used in a study.
- How ground truth for a training set was established.
The 510(k) pathway for medical device clearance in the US often relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive de novo clinical trials or performance studies with predefined acceptance criteria for novel safety and effectiveness endpoints that are typically found in PMA applications or for devices with entirely new technologies.
§ 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.