(574 days)
The BLUEDIAMOND IMPLANT System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.
The BLUEDIAMOND IMPLANT is a substructure of a dental implant system made of CP Ti Grade 4 with the surface treated by SLA method. It is intended to be surgically placed in the maxillary or mandibular molar areas. The fixture offers two types: Normal Thread Type and Deep Thread Type. As the name indicates the Deep Thread Type has slightly deeper threads than the Normal Thread Type.
The Abutment Screw is used for securing the abutment to the endosseous implant. It is made of Ti-6AL-4V ELI.
I am sorry, but the provided text is a 510(k) Premarket Notification from the FDA for a dental implant system. This document is a regulatory submission for a medical device and does not contain information about studies proving that a device meets specific acceptance criteria in the context of an AI/ML-enabled medical device.
The document describes:
- The device (BLUEDIAMOND IMPLANT and Abutment Screw)
- Its intended use (dental restorations)
- Comparison with predicate devices for substantial equivalence (materials, design, sterilization, etc.)
- Non-clinical testing performed (biocompatibility, surface treatment, pyrogen/endotoxin, sterilization, shelf life, performance tests based on ISO standards)
- A statement that no clinical studies were submitted.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance (in the context of an AI/ML device): The document reports performance testing to ISO standards for dental implants (e.g., fatigue testing for mechanical properties) but does not provide acceptance criteria and reported performance in the manner requested for an AI/ML device (e.g., sensitivity, specificity thresholds).
- Sample size used for the test set and data provenance: Not applicable as no AI/ML study is reported.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study information: Not applicable.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: Not applicable in the context of AI/ML. The device's "ground truth" for regulatory purposes relies on engineering and material standards.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document discusses non-clinical performance tests for mechanical properties (e.g., fatigue test according to "ISO 14801" and "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implant Abutment") to demonstrate substantial equivalence to predicate devices, but this is distinct from the type of performance data requested for an AI/ML-driven device.
§ 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.