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Manually operated minimally invasive General & Plastic Surgery Instruments designed to perform specific functions such as aspirating, clamping, cutting, dissecting, draining, grasping, ligating, or suturing during open, mini-open, or endoscopic surgical procedures such as thoracoscopy and laparoscopy.

Sontec Instruments are a family of manual, instruments consisting of Clamps, Forceps, Knot Tiers, Needle Holders, Knot Pushers, Scissors and Suction Tips. These reusable devices are packaged non-sterile and are steam sterilizable.

This document is a 510(k) premarket notification from the FDA, which determines substantial equivalence for medical devices. It does not contain information about the acceptance criteria or a study proving device performance in the way requested for an AI/CADe device.

The requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, and training data) is typically found in performance studies for diagnostic or AI/CADe devices, which this document is not describing.

This 510(k) document is for "General & Plastic Surgery Instruments," which are manual surgical tools like clamps, forceps, and scissors. The substantial equivalence is based on their intended use, design, material, chemical composition, and energy source compared to existing predicate devices.

Therefore, I cannot provide the requested table and study information because this document does not pertain to an AI/CADe device or a study demonstrating diagnostic performance.

Instead, the document focuses on:

• Device Description: Manual, reusable surgical instruments (Clamps, Forceps, Knot Tiers, Needle Holders, Knot Pushers, Scissors, Suction Tips).
• Indications for Use: Performing specific functions (aspirating, clamping, cutting, dissecting, draining, grasping, ligating, probing, or suturing) during open, mini-open, or endoscopic surgical procedures.
• Technological Characteristics: Materials used (Stainless Steel, Titanium, Aluminum 5052, Tungsten Carbide G4) and their conformance to ISO/ASTM standards; cleaning and sterilization procedures (ASTM A380, ASTM F1744, ANSI/AAMI ST79).
• Non-clinical tests: Cleaning, Thermal Disinfection and Steam Sterilization Validations.
• Clinical tests: None (as explicitly stated).
• Substantial Equivalence: Concluded based on intended use, design, material, chemical composition, and energy source being similar to predicate devices, and not introducing new issues of safety or effectiveness.

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