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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:

1. 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.
2. 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.
3. 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.
4. 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.

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