(418 days)
WINSIX Implant System is indicated for single or multiple tooth replacement, or for use in terminal intermediate edentulous sites in the mandible and/or the maxilla, and for totally edentulous arches. The system is designed to be surgically inserted in the bone structure of the mouth in order to replace missing teeth. It is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The family of WINSIX Implant System is intended for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The family of WINSIX Implant Systems can also be used for immediate or early load implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single tooth and/or appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments). The family of WINSIX Implant System includes the following devices: Fixtures and Abutments. The fixtures are the endosseous dental implantable devices produced in commercially pure titanium (grade 4), available in following models: K Model, KT Model, Conical Model, TTi Model with various diameters and lengths in order to meet diverse anatomical requirements. They are single use devices, supplied sterile and cannot be re-sterilised. The abutments give at the physician a complete prosthetic solutions in order to use the WINSIX implant system as intended. They have been divided in followings main groups: COVER SCREWS, HEALING SREWS, and ABUTMENTS (straight, angulated, millable, and flat shift).
The provided text does not describe an AI medical device. It is a 510(k) premarket notification for a dental implant system (WINSIX Implant System). Therefore, the requested information regarding acceptance criteria, study details, and AI-related performance measures (like human reader improvement with AI or standalone algorithm performance) is not available in the document.
The document discusses the mechanical, biocompatibility, sterilization, and packaging shelf life tests performed on the dental implant system to demonstrate its substantial equivalence to predicate devices. However, these are not directly comparable to the metrics typically used for assessing AI-powered medical devices.
Here's an overview of the performance data presented, which pertains to the physical dental implant device, not an AI system:
1. Table of Acceptance Criteria and Reported Device Performance (for the dental implant system, not an AI device):
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not Cytotoxic; Satisfying requirements for intracutaneous reactivity test. | WINSIX abutments are: Not Cytotoxic; Satisfying the requirements for intracutaneous reactivity test. |
| Surface Validation (MRS) | Chemical composition same as predicate; Absence of accumulations, residuals, stains; Not cytotoxic. | Chemical composition of micro-rough surface is exactly the same as the predicate device. SEM analyses guarantee total absence of accumulations, residuals, and stains. Cytotoxicity test points out micro-rough surface is not cytotoxic. Overall results demonstrate equivalent performance and chemical characteristics as predicate devices. |
| Surface Validation (FCC) | Typical composition of Ti; Absence of accumulations, residuals, stains; Not cytotoxic. | FCC surfaces have the typical composition of Ti; SEM analyses guarantee total absence of accumulations, residuals, and stains. Cytotoxicity test points out FCC surfaces are not cytotoxic. Overall results support technical and performance features. |
| Mechanical Tests | Able to resist 5,000,000 cycles (per ISO 14801:2007 guidance). | Worst case chosen is able to resist to 5,000,000 cycles. |
| Sterilization & Packaging Shelf Life | SAL level of 10^-9; 5-year shelf life. | Sterilized with gamma ray sterilization to assure a SAL level of 10^-9. Shelf life granted is 5 years. |
The following information is not present in the document as it pertains to AI/algorithm-based devices:
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document's purpose is to establish substantial equivalence of a physical dental implant device to existing predicate devices under its 510(k) premarket notification.
§ 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.