(93 days)
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.
§ 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.