(305 days)
The Biogenesis Implant System –Kisses is 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.
The Biogenesis Implant System - Kisses is for single and two stage surgical procedures. It is for delayed loading.
The Biogenesis 110 Implant System - Kisses is a dental implant system made of titanium intended to be surgically placed in the bone of the upper or lower jaw arches. This product is a substructure of a dental implant system to replace a single tooth, partial 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.
The Biogenesis™ Implant System offers bone level implants in the size range of 3.8 – 5.5 mm diameter with 7 – 14.5mm length.
The Biogenesis TM Implant System also offers the following components.
- · Duplex Abutment
- Duplex Milling Abutment
- Simplex Abutment
- Temporary Abutment
- · Solid Screw Abutment
- · Ball Abutment
- Ball Cap
The implants are intended for use with straight implant only straight implants are included in the submission.
The provided text is a 510(k) summary for the Biogenesis™ Implant System - Kisses, a dental implant system. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through the kind of studies you describe.
Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training/test sets cannot be fully extracted from this document. This kind of detailed study information is typically found in the full submission, not in the public 510(k) summary.
However, I can provide the limited information available regarding non-clinical testing and general acceptance of performance.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "the test results met the pre-set criteria" for various performance tests. However, it does not explicitly list quantified acceptance criteria or specific numerical reported device performance values. It only confirms conformance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sterilization Validation | Met pre-set criteria (according to ISO 17665-1/2 and ANSI/AANI ST79) |
| Shelf Life Testing | Met pre-set criteria (according to ASTM F1980) |
| Biocompatibility Testing | Met pre-set criteria (per ISO 10993-1) |
| FDA Guidance Conformance | Conformed to FDA Guidance Document for Endosseous Dental Implants and Abutments |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on:
- Specific sample sizes used for the non-clinical tests (e.g., sterilization, shelf life, biocompatibility).
- Data provenance (e.g., country of origin, retrospective or prospective) for any test sets. Non-clinical studies like these are typically lab-based and not derived from clinical patient data in the same way clinical trials are.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the non-clinical bench testing described. These tests involve laboratory measurements and standards conformance, not expert assessment of clinical data to establish ground truth.
4. Adjudication Method for the Test Set
This information is not applicable to the non-clinical bench testing described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through comparison of technical characteristics and non-clinical bench testing to predicate devices, not on evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm-only) performance study was not mentioned. The device is a physical dental implant system, not a software algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests, the "ground truth" or reference points were established by recognized international and national standards:
- ISO 17665-1/2 and ANSI/AANI ST79 for sterilization validation.
- ASTM F1980 for shelf life testing.
- ISO 10993-1 for biocompatibility testing.
- FDA Guidance Document for Endosseous Dental Implants and Abutments for overall conformance.
These standards define methods and acceptable limits for the performance characteristics being evaluated.
8. The Sample Size for the Training Set
This information is not applicable. This document describes a physical medical device (dental implant), not an AI/ML algorithm that would typically require a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no mention of a training set for an AI/ML algorithm.
§ 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.