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The S-Mono is intended to use in the treatment of missing mandibular central and lateral incisors to support prosthetic device, such as artificial teeth, in order to restore chewing function in partially edentulous patients. S-Mono is intended for single use only. It is intended for delayed loading.

The S-Mono is made of Titanium Alloy (ASTM F136) as the raw material. This device supports dental prosthesis such as an artificial tooth by surgically implanting it in the alveolar bone of the mandibular anterior region with a narrow tooth gap, and is intended to restore the patient's chewing function. It is one-body type which includes fixture and abutment. The surface of the fixture is treated using RBM (Resorbable Blast Media). It is roughened by blasting with hydroxyapatite powder and then pickling with nitric acid. The Temporary Cap is made of POM (Polyoxy Methylene) and intended to relieve the patient's foreign body sensation and protect the abutment part while the dental prosthesis is being manufactured. This cap is placed over the abutment part and is used temporarily before the dental prosthesis is placed. The material, dimension, and intended use of the subject devices are similar to devices currently marketed worldwide.

This document describes a 510(k) premarket notification for a dental implant system called S-Mono. The provided text, however, does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or performance study involving human subjects or AI algorithm performance metrics.

The document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of proving the device meets certain performance metrics through standalone testing, the manufacturer compares the new device (S-Mono) to existing, legally marketed devices (predicates) and argues that it is as safe and effective because of similar intended use, materials, and technological characteristics.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details because this information is not present in the provided text.

The "Non-Clinical Testing" section describes several tests performed on the S-Mono, but these are primarily material, sterilization, shelf-life, and biocompatibility tests, not performance studies that would typically define "acceptance criteria" through clinical outcomes or diagnostic accuracy.

Non-Clinical Testing Information Provided:

• Sterilization validation testing: Performed according to ISO 11137 (gamma sterilization) and ISO 11737, ISO 17665-1, ISO 17665-2 (steam sterilization).
• Shelf-life testing: Performed according to ASTM F1980, ASTM F1929, and ISO 11737-2.
• Fixture surface characteristics evaluation: EDS (Energy-dispersive X-ray spectroscopy), SEM Analysis, and Surface Roughness Analysis were performed after RBM treatment.
• Biocompatibility tests: Performed according to ISO 10993-1, 3, 5, 6, 10, 11, 12, and 33.
• MR Conditional labeling: A non-clinical worst-case MRI review was conducted using scientific evidence and published literature (Woods, Terry O., et al., 2019). Titanium alloy (Ti-6A1-4V, ELI) properties were assessed according to magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119).

In summary, the provided text describes the regulatory filing for a dental implant and focuses on demonstrating substantial equivalence, not on providing the results of a performance study with acceptance criteria.

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