(86 days)
The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.
This device is designed to serve as support for prosthetic devices to restore patient chewing function. This implant is 3.25 mm in diameter, 10 to 16 mm in length, and is fabricated from titanium alloy. They are threaded and have a superior external hex. The threaded portion of the implant body has a 50 micron thick plasma sprayed hydroxyapatite coating, and the surface of the external hex is anodized magenta in color.
The provided text is a 510(k) summary for a dental implant device and does not contain information about acceptance criteria, performance studies, or clinical trial results that would typically be found for a medical diagnostic device. It focuses on demonstrating substantial equivalence to a predicate device.
Therefore, the requested information cannot be extracted from the provided text.
Here is why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: The document does not define any acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or report performance metrics from a study.
- Sample size used for the test set and the data provenance: There is no mention of a "test set" or any data used for evaluating the device's performance.
- Number of experts used to establish the ground truth... and qualifications: Not applicable as no ground truth was established for a performance study.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states "Performance Data: Not applicable," which means no such study was conducted or provided.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable as this is a physical medical device, not a diagnostic algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
The document primarily focuses on:
- Device description (material, dimensions, coating).
- Intended use (support for prosthetic devices to restore patient chewing function).
- Comparison to predicate devices to establish substantial equivalence based on technological characteristics (material, surface characteristics, sterility).
- The FDA letter confirms substantial equivalence without requiring performance data for this specific type of submission.
§ 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.