(343 days)
I Do is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate Abutment support for fixed bridgework. I Do is dedicated for two stage surgical procedures and for immediate loading when there is good primary stability and an appropriate occlusal load. Also, implants with diameters larger than 5mm are indicated for molar regions.
The I Do Fixtures consist of two types of fixtures, Fixture-MT ACTIVE. Both fixtures are a thread type implant made of Ti CP4 according to ASTM F67 which will be placed in the alveola bone to replace the function of the missing tooth. This device has connection between the upper prosthesis and the internal hex. Fixtures' surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). It is only part to be implanted into bone, and to provide connection of prosthetic devices or other components of a dental implant set with human body (mandibular or maxillary bone).
Fixture-S and Fixture MT-Active have same connection but different design.
Fixture S has 2 type of screw bite 0.45mm and 0.35mm in coronal part. Fixture MT-ACTIVE has use only one screw bite of 0.59mm is more tapered.
| Device Component | Diameters (Ø) | Lengths (mm) |
|---|---|---|
| Fixture-S | 3.8 | 8.5/10.0/11.5/13.0/15.0 |
| 4.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 4.5 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 5.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 5.5 | 7.3/8.5/10.0/11.5/ | |
| 6.0 | 7.3/8.5/10.0 | |
| 7.0 | 7.3/8.5/10.0 | |
| Fixture-MT ACTIVE | 3.8 | 8.5/10.0/11.5/13.0/15.0 |
| 4.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 4.5 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 5.0 | 7.3/8.5/10.0/11.5/13.0/15.0 | |
| 5.5 | 7.3/8.5/10.0/11.5/ | |
| 6.0 | 7.3/8.5/10.0 | |
| 7.0 | 7.3/8.5/10.0 |
Tolerance of dimension shall be within ± 1% range. I Do fixtures are provided sterilized.
The provided FDA 510(k) summary (K192294) describes the "I Do" dental implant system. This document is a premarket notification for a new device claiming substantial equivalence to a predicate device, not a study proving the device meets specific acceptance criteria for performance through clinical trials or extensive standalone algorithm testing.
The document focuses on demonstrating that the "I Do" dental implant system is substantially equivalent to a previously cleared predicate device (IS-III active System, K181138) based on material, design, manufacturing, and non-clinical testing. It does not present a study with performance metrics in the typical sense of accuracy, sensitivity, or specificity for an AI/ML device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable as this is not a performance study of an AI/ML diagnostic or therapeutic device.
Here's an interpretation based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are based on demonstrating substantial equivalence to the predicate device through non-clinical testing and comparison of technical characteristics. The "reported device performance" refers to the outcomes of these non-clinical tests meeting the relevant standards.
| Acceptance Criteria (from applied standards, implicitly) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|
| Biocompatibility (ISO 10993 standards) | "The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device." "Biocompatibility Testing was conducted for the subject devices, and it demonstrates that the subject device is biocompatible and substantial equivalence with the predicate device, K181138." |
| Sterilization Validation (ISO 11137 standards) | "The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device." |
| Shelf Life (ASTM F1980) | "The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device." |
| Bacterial Endotoxin (ANSI/AAMI ST72, USP , ) | "The results of the above tests have met the criteria of the standards, and demonstrated the substantial equivalence with the predicate device." |
| Implant-to-Abutment Compatibility (Dimensional Analysis) | "The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate device." |
| Surface Modification (Roughness, Chemical Analysis, SEM) | "To compare surface modification between the subject and predicate devices, surface roughness, chemical analysis for residuals, and SEM imaging were provided and it demonstrated substantial equivalence." |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. This is a technical equivalence review based on non-clinical testing (biocompatibility, sterilization, dimensional analysis, material characterization), not a clinical performance study with a "test set" of patient data in the context of an AI/ML algorithm.
- Data Provenance: Not applicable for a clinical test set. The data originates from laboratory testing performed on the device components and comparisons to the predicate device specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" established by experts in a clinical context for this type of submission. The evaluation relies on standardized laboratory testing protocols and engineering comparisons.
4. Adjudication method for the test set
- Not applicable.
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
- Not applicable. This is not an AI-assisted diagnostic or therapeutic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
- Not applicable for a clinical ground truth. The "ground truth" or reference standards are defined by the accepted international and national standards for materials, biocompatibility, sterilization, and mechanical compatibility of dental implants (e.g., ISO 10993, ISO 11137, ASTM F1980, ANSI/AAMI ST72, ASTM F67, ISO 14801 implicitly for angled abutments but noted as not needed for this device).
8. The sample size for the training set
- Not applicable. This is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.