(310 days)
Adin Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in fully or partially edentulous patients in order to restore a patient's chewing function. Adin Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading. Adin short implants are to be used only with straight abutments.
Adin Short Implants are self-tapping root-form two-piece screw type dental implants, indicated for use in Surgical and restorative applications for placement in the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Adin's Short Implants are provided in 6.25mm length and 4.2mm, 5.0 mm, and 6.0mm diameters. As two-piece devices, like the predicate devices, Adin Short Implants are to be used in combination with cover screws, healing caps and straight abutments. The Adin Short Implants are made of Titanium 6AL-4V-ELI Alloy, complying with ASTM F136-13 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.
The provided text describes a 510(k) premarket notification for a medical device, Adin Short Implants. However, this document does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device and its performance metrics.
The document details the substantial equivalence of the Adin Short Implants to predicate dental implants through a comparison of their technological characteristics and non-clinical performance data. This includes:
- Device Description: The physical characteristics of the Adin Short Implants (self-tapping, root-form, two-piece screw type, made of Titanium 6AL-4V-ELI Alloy, specific lengths and diameters, surface treatments).
- Intended Use: Surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients to restore chewing function, with immediate loading possible under certain conditions.
- Substantial Equivalence: A detailed comparison table (pages 8-9) of the subject device with several predicate devices, highlighting similarities in classification, indications for use, patient population, sterility, body contact, prescription status, single use, operation principle, placement method, self-tapping, implant material, biocompatibility, shape, connection (with some variations), surface treatment, implanted length, outer diameter, abutment angulation, packaging, and shelf-life.
- Non-Clinical Performance Data (Page 6-7):
- Pull-Out Testing: Measured axial pull-out strength compared to predicate devices, according to ASTM F543.
- Comparative Bone to Implant Contact Surface Area Analysis: Compared to predicate devices.
- Comparative Surface Analysis Before Surface Treatment: Compared to predicate devices.
- Biocompatibility: Tests conducted according to FDA Guidance for ISO 10993-1, ISO 10993-5, ISO 10993-11, and ISO 10993-18.
- Surface Analysis After Surface Treatment: Using SEM/EDS.
- Gamma Sterilization Validation: According to ISO 11137-2 and ISO/TS 13004.
- Shelf-life validation: According to ISO 11607-1.
- MR Environment Condition: Non-clinical worst-case MRI review based on scientific rationale and published literature.
The document concludes that the Adin Short Implants are substantially equivalent to the predicate devices and do not introduce new risks.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study that proves the device meets the acceptance criteria with respect to AI/ML device performance metrics because the provided text is for a mechanical dental implant and does not involve AI/ML.
If you have a document pertaining to an AI/ML medical device, please provide that, and I will be happy to extract the requested information.
§ 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.