(140 days)
EASY GRIP implants are designed for use in partially edentulous mandibles or maxillae for attachment of complete denture prostheses or as a terminal or intermediary abutment for fixed or removable bridgework or as a free-standing single tooth replacement. EASY GRIP implant system uses a two-stage implantation procedure or one-stage procedure.
EASY GRIP dental implants are root-form endosseous dental implant devices made out of biocompatible medical titanium, commercially pure or alloyed. There are three types of implants: cylindrical, anatomical, conical, available in different diameters from 3.3 to 5.5 mm and lenghts that vary from 8 to 16 mm. The anchorage surface of the implant is roughened by a sand-blasting and an acid-etching process, for better osseointegration. This submission also include compatible screws and prosthetic components.
The provided text is a 510(k) summary for the EASY GRIP dental implant system. It describes the device, its intended use, and its substantial equivalence to legally marketed predicate devices.
However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way you've outlined for AI/software-based devices.
Dental implants like the EASY GRIP are typically cleared based on substantial equivalence to existing devices, meaning they are demonstrated to be as safe and effective as a legally marketed predicate device. This often involves:
- Material composition: Ensuring the materials (e.g., biocompatible titanium) are identical or equivalent to those in predicate devices.
- Design features: Comparing dimensions, thread patterns, surface treatments (sand-blasting and acid-etching for better osseointegration), and component compatibility with predicate devices.
- Intended use: Confirming the intended applications (e.g., attachment of prostheses, abutment for bridgework, single tooth replacement) are consistent with predicate devices.
- Biocompatibility testing: (Implied, though not detailed in this summary) ensuring the materials are safe for use in the human body.
- Mechanical/Physical testing: (Implied, though not detailed here) demonstrating the implant's strength, fatigue resistance, and other physical properties meet standards comparable to predicate devices. This is where "acceptance criteria" for physical performance might be applied, but they are not reported in this specific 510(k) summary.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, experts, ground truth, or MRMC studies, as those types of studies and reporting are not part of this 510(k) summary for a physical medical device.
The 510(k) process for devices like dental implants relies on demonstrating that the new device is substantially equivalent to devices already on the market (predicates), rather than proving novel performance against acceptance criteria in a clinical study with human readers/AI, as would be the case for a diagnostic AI.
If you have a document describing a clinical study or performance testing with specific criteria for a device, I can help you extract that information. However, based solely on this 510(k) summary, the information you requested is not present.
§ 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.