(240 days)
The Kisses Mini is indicated for use in partially or fully edentulous maxilla, in support of single or multiple-unt restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The Kisses Mini is for single and two stage surgical procedures. It is for delayed loading.
The intended use of the 3.2 mm Internal Hex fixtures is limited to the replacement of maxillary lateral incisors.
The intended use of the single-piece post type fixture to replacement of mandibular central and lateral incisors.
The ball-type single-piece implant is intended for stabilization and retention of overdentures.
KJ Mini offers three different types of implants: 2-Piece Type, Post Type, and Ball Type.
The 2-piece type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients. It consists of the hex part to be coupled to the superstructure, the single thread part to be fixed to the bone, and the cutting edge part with the self-tapping function. It offers single hex type and double hex type.
The post type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients.
The ball type fixture is a substructure of a dental implant system to replace a single tooth, and the lost root of edentulous patients.
The document is a 510(k) Summary for the "Kisses Mini" dental implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a traditional clinical study with outcome metrics.
Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, type of ground truth) related to a clinical study or AI model evaluation are not applicable in this context, as this is a regulatory submission for a medical device based on showing equivalence to existing devices.
The document discusses non-clinical testing to support substantial equivalence and safety/performance.
Here's a summary of the non-clinical testing performed as described in the document (Section 8):
1. Table of Acceptance Criteria and Reported Device Performance (as related to non-clinical testing for equivalence):
| Test Performed | Acceptance Criteria (Implied/Standard) | Reported Device Performance |
|---|---|---|
| Sterilization (Gamma, Steam) | ISO 11137, ISO 17665-1, ISO 17665-2 compliance | Performed in accordance with standards |
| Shelf Life (Accelerated Testing) | 3 years validated | 3 years validated |
| Fixture Surface Characteristics (SLA treatment) | Similar to predicate / acceptable for intended use | Evaluated through Surface Morphology, Surface Roughness Analysis, and FT-IR Analysis; "test results support it does not affect substantial equivalence" |
| Performance Tests (Visual inspection, Dimension, Packing inspection, Sterility, Adaption accuracy, Marginal adaptation, Compressive strength, Fatigue, Rotational shear strength, Screw loosening torque tests) | Appropriate for dental implants / comparable to predicates | "Other Performance tests" (implies successful completion) |
| Endotoxin Testing (USP ) | Below 0.5 EU/mL | "Will be conducted on every batch," "referenced USP 39 Bacterial Endotoxin Test on the endotoxin limit which is 0.5 EU/mL" |
| Fatigue Test (for Angled Abutment) | Supported substantial equivalence | "Test result of the fatigue test supported substantial equivalence" |
2. Sample size used for the test set and data provenance:
- Not applicable for a clinical study as described. The testing refers to non-clinical (laboratory/bench) tests. Specific sample sizes for each non-clinical test are not provided in this summary, but generalized statements about the tests being performed are made. Data provenance is implied to be from the manufacturer's internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No expert ground truth establishment for a clinical test set is mentioned.
4. Adjudication method for the test set:
- Not applicable. No clinical test set or adjudication is mentioned.
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 document is for a physical dental implant, not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is for a physical dental implant, not an algorithm.
7. The type of ground truth used:
- Not applicable for a clinical study. For non-clinical tests, physical and chemical standards (e.g., ISO for sterilization, USP for endotoxin) serve as the "ground truth" or reference for performance. Specific product specifications and predicate device characteristics also serve as comparators for "ground truth" for substantial equivalence.
8. The sample size for the training set:
- Not applicable. This document does not describe a machine learning model or a training set.
9. How the ground truth for the training set was established:
- Not applicable. This document does not describe a machine learning model or a training set.
In summary: This 510(k) summary is a regulatory submission for a physical medical device (dental implants) and demonstrates substantial equivalence through comparisons to predicate devices and non-clinical bench testing. It does not involve AI, clinical trials with human subjects for performance evaluation (beyond what's typically implicit in dental implant use), or the associated concepts of acceptance criteria tables, sample sizes, expert ground truth, or MRMC studies that would be relevant for an AI/CAD product.
§ 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.