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The Insight Dental Implant System is intended for use in the mandible or maxilla as an artificial root structure for single tooth replacement or fixed bridgework and dental retention. The Insight Dental Implant System is intended for delayed loading.

The Insight Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially or fully endetulous patients. The Insight Dental Implant System consists of one-stage and two-stage root form dental implants and abutments, which provide the dentist with screw retained restoration options. The devices covered by this submission are implants, abutments, and healing caps. Implants are manufactured from titanium and feature a blasted finish on the threaded screw surface. The implants are provided in bone level and tissue level. The diameters of the implant fixtures are 3.5mm, 3.8mm, 4.6mm and 5.4mm; the lengths are 8.0mm, 10.0mm, and 12.0mm and is defined as the threaded implanted portion of the implant. Abutments are available in both standard and angled configurations. Abutments are manufactured from titanium. Standard abutments are straight, 4.6mm in diameter and sized for every implant diameter including 3.5mm, 4.6mm and 5.4mm. Angled abutments are 17°, 4.9mm in diameter and sized for every implant diameter including 3.5mm, 3.8mm, 4.6mm and 5.4mm. Healing caps are manufactured from titanium. The diameter of each healing cap matches an implant at 3.5mm, 3.8mm, 4.6mm and 5.4mm. Healing caps are straight. The dental implants provided consist of a straight wall or tapered body type with a basic screw-type design in various platform options and feature an internal connection and antirotation feature. Insight Dental Implant System is available with either prevail platform switching feature or standard collar. The Insight Dental System is packaged in a two section sterile tray with all of the implants and instruments needed for a single procedure included. All components of the system are intended for single use only.

The provided text is a 510(k) Premarket Notification for the Insight Dental Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical testing. The document does not contain information about a study proving the device meets acceptance criteria related to a machine learning or AI-driven system.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets acceptance criteria using AI performance metrics, as the document does not describe such a study.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• Nature of the Device: The Insight Dental Implant System is described as an artificial root structure, consisting of physical implants, abutments, and healing caps made of titanium. It is a mechanical device, not an AI or software-based medical device.
• Study Type: The "Summary of Testing" section (page 7) details tests related to:
  • Mechanical Properties: Comparative Dynamic Fatigue testing (ISO-14801-2007).
  • Material Analysis: Surface treatment (SEM, X-ray spectroscopy, auger electron spectroscopy).
  • Biocompatibility: Cytotoxicity testing (ISO 10993-5).
  • Shelf Life: Accelerated aging (ASTM F1980-07).
  • Sterility: Gamma irradiation (ISO 1137-1).
• Absence of AI/ML Information: There is no mention of algorithms, machine learning, AI, image analysis software, diagnostic performance in terms of sensitivity/specificity, or human reader studies. The "device performance" described is mechanical and material-specific.
• Ground Truth: The "ground truth" for these tests would be established by physical measurements, chemical analysis, and standardized mechanical test results, not expert consensus on interpretations of data (which would be relevant for an AI system).
• Clinical Data: The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence." This further indicates the absence of human-in-the-loop or standalone AI performance studies which typically involve clinical data.

In summary, the provided document does not describe the type of product or study that would generate the information you've requested regarding AI acceptance criteria and performance.

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