(363 days)
The newly improved AIDI Dental Implant System (AIDI Fixtures and AIDI Abutments with Screws) is made up of endosseous implants intended to be surgically placed in the bone of the upper or lower jaws to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted applications. The device is intended for immediate loading when good primary stability has been achieved with the appropriate occlusal loading.
The improved AIDI Dental Implant System is a threaded root-form dental implant intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments (which provide cemented and screw retained restorative options), cover screws, abutment screws, and healing abutments.
The provided text is a 510(k) summary for the AIDI Dental Implant System. It describes the device, its indications for use, technical characteristics, and a nonclinical test summary, concluding with a statement of substantial equivalence. However, it does not contain information about acceptance criteria, specific device performance metrics (beyond generalized statements of "high torque strength"), or detailed study methodologies that would allow for a comprehensive answer to the requested questions.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|
| Not explicitly stated as acceptance criteria. The submission relies on establishing substantial equivalence to predicates. | "high torque strength for AIDI Dental Implants" (current submission). "The predicates IDI (K081806) implants and previous AIDI implants (K101755) resembled the same torque strength." |
Missing Information: The document does not explicitly define acceptance criteria in terms of quantitative thresholds or specific metrics. It focuses on demonstrating equivalence to predicate devices, particularly regarding "torque strength." The exact measurement or quantitative comparison of "high torque strength" is not provided.
2. Sample sized used for the test set and the data provenance
Missing Information: The document states, "The nonclinical test data of the currently submitted AIDI Dental Implant System Torque Test Report revealed high torque strength for AIDI Dental Implants." However, it does not specify:
- The sample size used for the torque test set.
- The data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: This section is not applicable to the provided document. The submission pertains to a medical device (dental implant system) for which performance is assessed through nonclinical engineering tests (like torque strength), not by expert interpretation of images or other data that would require "ground truth" established by experts in a clinical context.
4. Adjudication method for the test set
Missing Information: Not applicable. As mentioned above, this is an engineering performance test, not a clinical study involving human interpretation with adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Missing Information: Not applicable. This document describes a dental implant system, not an AI-powered diagnostic or assistive tool that would necessitate an MRMC study or assessment of human reader improvement with AI. No clinical studies were submitted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: Not applicable. The device is a physical medical implant, not an algorithm.
7. The type of ground truth used
Missing Information: For the "Torque Test," the "ground truth" would be the measured torque strength itself, comparing the subject device to predicate devices. However, the exact methodology and quantitative results are not detailed in this summary.
8. The sample size for the training set
Missing Information: Not applicable. There is no mention of a "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Missing Information: Not applicable.
Study Summary (Based on Section 4 & 6):
The device's performance was evaluated through a nonclinical Torque Test.
- Objective: To demonstrate that the AIDI Dental Implant System (current submission) possesses comparable or superior torque strength to its predicate devices.
- Methodology (limited detail): The "Torque Test Report" was submitted, which presumably details the experimental setup and measurements.
- Findings: The test "revealed high torque strength for AIDI Dental Implants (current submission)." Furthermore, the study concluded that "The predicates IDI (K081806) implants and previous AIDI implants (K101755) resembled the same torque strength."
- Conclusion: Based on this nonclinical testing, among other comparisons of materials, design, and technical characteristics, the manufacturer concluded that the "AIDI Dental Implant System (current submission) is substantially equivalent for its intended use and performs as well as the predicates."
In essence, the entire submission hinges on demonstrating "substantial equivalence" through nonclinical testing (specifically, a torque test) and comparison of technical characteristics, rather than establishing performance against defined acceptance criteria via comprehensive clinical studies or expert-driven evaluations.
§ 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.