(155 days)
The S-MiNi Implant System is divided into two types:
Cement Type - The Cement type is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to serve as temporary support prosthetic devices during the healing phase of permanent endosseous dental implant, such as artificial teeth, in order to restore chewing function in partially edentulous patients.
-Ball Type The Ball type is designed for use in dental implant surgery. Ball type is intended for use in partially or fully edentulous mandibles and maxillae, in support of overdentures. Ball type implants are for temporary use, only.
The S-MiNi System has two types, cement type and ball type.
The S-MiNi Implant System is a one-piece endosseous dental implant which is a combination of implant and abutment sections. The implant is a made of Unalloyed Titanium (G4). The surface was granted with microscopic roughness through the RBM surface treatment.
The provided document is a 510(k) summary for the S-MiNi Implant System, a medical device for dental implants. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical results. Therefore, much of the requested information regarding sample sizes, expert involvement, adjudication methods, and ground truth types is not present in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes "Performance Standards" and states that "Bench tests including visual, size, package, package seal efficacy, compressive load, and retention force testing, were performed successfully." However, it does not provide specific quantitative acceptance criteria or detailed results of these tests. Instead, it relies on demonstrating equivalence to predicate devices.
| Acceptance Criteria (Not Explicitly Stated Quantitatively) | Reported Device Performance |
|---|---|
| Bench Tests: | |
| Visual inspection | Performed successfully |
| Size verification | Performed successfully |
| Package integrity | Performed successfully |
| Package seal efficacy | Performed successfully |
| Compressive load | Performed successfully |
| Retention force | Performed successfully |
| Material Composition: | |
| Cement Type: Titanium Grade 4 (ASTM F 67) | S-MiNi Cement Type: Titanium Grade 4 (ASTM F 67) (Identical to reference material, but different from predicate) |
| Ball Type: Titanium Grade 4 (ASTM F 67) | S-MiNi Ball Type: Titanium Grade 4 (ASTM F 67) (Identical to reference material, but different from predicate) |
| Biocompatibility: | Yes |
| Sterilization: | Gamma Sterilization |
| Intended Use: | Identical to predicates |
| Device Design (Dimensions): | Comparable to predicates across various diameters, cuffs/posts, and lengths (See detailed comparison tables in the original document) |
| Surface Treatment: | RBM |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable in this 510(k) submission. This type of submission relies on demonstrating substantial equivalence to legally marketed predicate devices primarily through comparison of technical characteristics and existing performance data for the predicates, rather than de novo clinical testing of the new device. The "successful performance" mentioned refers to bench tests, not a clinical test set that would typically require patient data.
- Data Provenance: The document generally does not refer to clinical data or patient data provenance. The comparison is based on the technical specifications and intended use of the S-MiNi Implant System against its identified predicate devices. The manufacturer is Neobiotech Co., Ltd. from Korea.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Ground truth establishment by experts for a test set is typically associated with clinical studies or performance evaluation where a "true" diagnosis or condition needs to be determined for comparison with the device's output. This 510(k) submission does not include such a study.
4. Adjudication Method for the Test Set:
- Not applicable for the same reasons as #3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or reported in this 510(k) summary. This type of study is more common for imaging or diagnostic devices where human interpretation plays a significant role, and the AI's impact on reader performance is being evaluated. The S-MiNi Implant System is a physical dental implant.
6. Standalone Performance Study:
- No. The document's "Performance Standards" section notes that "Bench tests... were performed successfully." This indicates some standalone testing, but it's not a comprehensive standalone clinical performance study that would typically generate metrics like sensitivity/specificity, etc. The primary method of demonstrating safety and effectiveness in a 510(k) is through comparison to predicates, not solely standalone performance.
7. Type of Ground Truth Used:
- Not applicable in the context of a "test set" as typically understood for diagnostic or AI-driven devices. For the bench tests, the "ground truth" would be the engineering specifications and established test methodologies (e.g., measuring dimensions against design specs, applying forces up to defined limits).
8. Sample Size for the Training Set:
- Not applicable. This is a medical device, not an AI/ML model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI/ML model.
In summary, the provided text is a 510(k) summary for a dental implant, which demonstrates substantial equivalence to predicate devices based on comparable technical characteristics, materials, intended use, and successful bench testing. It does not contain information about clinical studies with human readers, expert ground truth establishment for a clinical test set, or AI/ML model training as requested in the input prompt.
§ 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.