MISTI Silicone Implant

• K Number: K241150
• Device Name: MISTI Silicone Implant
• Manufacturer: Keosan Trading Co.
• Date Cleared: 2024-07-24 ( 90 days)
• Product Code: MIB , FWP , FZE , LZK , MIC
• Regulation Number: 874.3620
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: K052504 , K052505 , K952708 , K200610 , K171851

Intended Use

MISTI Silicone Implant is intended for the augmentation of the nasal, malar, chin, gluteal, calf and/or pectoral contour.

Device Description

The MISTI Silicone Implant offers various types including Nasal, Chin, Mid-face, Forehead, Block, Temple, Gluteal, Calf and Pectoral. The Nasal, Chin, Mid-face, Forehead, Gluteal, Calf and Pectoral are used for the areas indicated in the type names. The Block type is used for various areas during plastic and reconstruction surgeries. The Temple type can be used on a juncture where four skull bones fuse together so called the temple region. It is made of implant grade silicone elastomer, and the design characteristic minimizes carving and promotes natural line.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA regarding the MISTI Silicone Implant. This document outlines the manufacturer's claim of substantial equivalence to existing predicate devices, primarily based on material, design, function, and performance data from non-clinical tests.

However, the document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of diagnostic accuracy, which is typically what these questions relate to for AI/Software as a Medical Device (SaMD).

Therefore, I cannot provide the requested table and detailed information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these types of studies were not conducted or reported in this 510(k) submission.

This 510(k) focuses on demonstrating the physical and biological safety of the MISTI Silicone Implant by comparing its characteristics and performance in non-clinical tests (material properties, biocompatibility, sterilization) to legally marketed predicate devices, rather than on diagnostic accuracy or clinical effectiveness studies in humans with defined acceptance criteria for AI performance.

The "Performance Data (Non-Clinical)" section lists various tests performed, such as:

• Sterilization Validation
• Appearance
• Dimensional inspection
• Extraction
• Hardness (ASTM D2240 (Type A))
• Tensile strength (ASTMD412)
• Elongation (ASTM D412)
• Tear strength (ASTM D624)
• Cytotoxicity (ISO 10993-5)
• Skin Sensitization (ISO 10993-10)
• Intracutaneous Reactivity (ISO 10993-23)
• Pyrogen (ISO 10993-11)
• Acute Systemic Toxicity (ISO 10993-11)
• Subchronic Toxicity (ISO 10993-11)
• Implantation (ISO 10993-6)
• Genotoxicity (Ames) (ISO 10993-3)
• Genotoxicity (In vitro) (ISO 10993-3)

These tests are primarily focused on the safety and material properties of the implant, not on evaluating an AI algorithm's diagnostic performance.

Regulation Number and Section

§ 874.3620 Ear, nose, and throat synthetic polymer material.

(a)
Identification. Ear, nose, and throat synthetic polymer material is a device material that is intended to be implanted for use as a space-occupying substance in the reconstructive surgery of the head and neck. The device is used, for example, in augmentation rhinoplasty and in tissue defect closures in the esophagus. The device is shaped and formed by the suregon to conform to the patient's needs. This generic type of device is made of material such as polyamide mesh or foil and porous polyethylene.(b)
Classification. Class II.