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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.

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