(214 days)
The Kisses Plus Implant System is indicated for use in partially or fully edentulous mandibles and maxilla, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
The Kisses Plus Implant System is for single and two stage surgical procedures. It is for delayed loading.
Kisses Plus Implant System offers three different types of implants: Double Hex, and Kisses Single Hex. The Double Hex type has the doubled hex part to be coupled to the superstructure, whereas, the Single Hex type and Kisses Single Hex type has single hex part.
The Double Hex type fixture is a substructure of a dental implant system. It consists of the hex part to be coupled to the superstructure, the macro thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers double hex type.
The Single Hex type fixture is a substructure of a dental implant system. It consists of the hex part to be coupled to the superstructure, the macro thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers single hex type.
The Kisses Single Hex type fixture is a substructure of a dental implant system. It consists of the hex part to be coupled to the superstructure, the macro thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers single hex type.
Kisses Plus Implant System also includes the following components: Angled abutment, Duplex Abutment, Duplex Milling Abutment, Simplex Abutment, Temporary Abutment, Solid Screw Abutment, Ball Abutment, Ball Cap, Cover Screw, Healing Abutment.
The provided document is a 510(k) premarket notification for a medical device, the "Kisses Plus Implant System," and as such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might find for a novel diagnostic AI algorithm.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement, and ground truth types are not applicable or not explicitly detailed in this type of regulatory submission for a dental implant system.
Instead, the document details physical and functional characteristics to show that the new device is as safe and effective as existing, legally marketed devices.
Here's an attempt to answer your questions based on the provided text, indicating where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a table of acceptance criteria with corresponding device performance metrics in the way you might expect for a diagnostic AI. Instead, it compares the subject device's characteristics to those of predicate devices to establish substantial equivalence. The "performance" here refers to meeting safety and effectiveness standards through material composition, design similarities, and successful non-clinical testing.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary from text) |
|---|---|
| Material Composition | Ti Gr.4 (ASTM F67) - Same as predicates |
| Surface Treatment | SLA Treatment - Same as predicates |
| Sterility | Yes (Gamma Radiation) - Same as predicates |
| Mechanical Integrity | Fatigue (ISO 14801) - Test performed, supported substantial equivalence |
| Mechanical Integrity | Rotational shear strength - Test performed, supported substantial equivalence |
| Mechanical Integrity | Screw loosening torque tests - Test performed, supported substantial equivalence |
| Dimensions | Diameter: 3.8 – 5.5 mm, Length: 7-14.5 mm - Within range of predicate(s) |
| Shelf Life | Five years - Validated through accelerated testing |
| Biocompatibility | Deemed biocompatible due to identical materials/processes as previously cleared predicate (K142813) |
| Sterilization Validation | Conforms to ISO 11137 (gamma) and ISO 17665-1/-2 (steam) |
| General Safety/Function | Visual inspection, Dimension, Packing inspection, Adaption accuracy, Marginal adaptation, Compressive strength - Tests performed, implicitly met criteria |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in terms of a "test set" for performance evaluation of an AI algorithm. The non-clinical tests (e.g., fatigue, rotational shear strength) inherently involve a sample size of physical devices, but the specific number tested for each criterion is not detailed.
- Data Provenance: Not applicable as this is a physical medical device, not an AI algorithm processing patient data. The tests were likely conducted in a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical dental implant device, not a diagnostic algorithm requiring expert-established ground truth from medical images or patient data. The "ground truth" for this device's performance is established through engineering standards, material specifications, and mechanical testing.
4. Adjudication method for the test set
- Not Applicable. This is a physical dental implant device, not a diagnostic algorithm where adjudication of results by multiple experts would typically occur. The non-clinical tests are performed according to established standards.
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 a physical dental implant device and does not involve human readers or AI assistance in the context of diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical dental implant device, not an algorithm.
7. The type of ground truth used
- Engineering Standards and Specifications: The "ground truth" for the performance of this dental implant is based on established international standards (e.g., ISO, ASTM), material properties, and the demonstrated performance of its predicate devices. The non-clinical tests verify that the device meets these engineering and safety benchmarks.
8. The sample size for the training set
- Not Applicable. This is a physical dental implant device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is a physical dental implant device, not an AI algorithm that requires a training set with established ground truth.
§ 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.