(221 days)
The TS Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restorations such as crowns, bridges, or overdenture.
The TS Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. Fixture is made of pure titanium metal and supplied sterile. The surface is SA, Sandblasting and Acid etching, treated. Abutment is device made of titanium alloy and Plastic and it is intended for use to make temporary prosthesis. It consists of Abutment and Abutment Screw.
This document is a 510(k) premarket notification for the "TS Implant System" by OSSTEM Implant Co., Ltd. It seeks to establish substantial equivalence to previously marketed predicate devices, not to prove performance against specific acceptance criteria for a new AI/software-driven medical device. Therefore, the information typically required for an AI/software device's acceptance criteria and study proving its performance is not present in this document.
The document focuses on comparing the design, materials, and intended use of the TS Implant System to existing dental implants (predicate devices) to demonstrate that it is "substantially equivalent" and thus safe and effective.
Here's why the requested information cannot be extracted from this document:
- Nature of the Device: The TS Implant System is a physical dental implant made of titanium metal and does not appear to incorporate artificial intelligence or sophisticated software for diagnosis or treatment.
- Type of Submission: A 510(k) Pre-market Notification primarily assesses "substantial equivalence" to a predicate device, rather than requiring extensive clinical trials or performance studies against predefined acceptance criteria like a PMA (Pre-market Approval) or De Novo submission for novel AI/software devices.
- Absence of Clinical Studies: The document explicitly states under "7. Summary of clinical testing": "No clinical studies are submitted." This confirms that no clinical data was presented to establish performance metrics against acceptance criteria.
- Lack of AI/Software-Specific Information: There is no mention of algorithms, data sets (training or test), ground truth, expert readers, or adjudication methods, which are standard for AI/software device evaluations.
In summary, this document does not contain the information needed to answer your request regarding acceptance criteria and performance studies for an AI/software device because the device described is a physical dental implant, and the submission type does not necessitate such detailed performance data as would be required for a novel AI/software medical device.
§ 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.