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

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.

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.

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The FITme Customized Silicone Implant is intended for augmentation, reconstructive and cosmetic surgery of the facial regions. The FITme Customized Silicone Implant is pre-shaped to the surgeon's specification to meet the needs of a particular patient.

The FITme Customized Silicone Implant is a patient-specific medical device intended for augmentation, reconstructive and cosmetic surgery of facial region, specifically the nasal contour, the malar cheek contour, and chin contour. The device is a single use implant intended for long term implantation as a space occupying device to form a contoured feature. The customized implant, FITme Customized Silicone Implant, is made of implant grade silicone elastomer, in a range of durometers as specified by the surgeon.

The patient's own medical imaging (e.g., Computed Tomography (CT) scan) is translated into a digital model of the patient's skull using the software, Mimics by Materialise. At the recommendation of the surgeon, the Mimics is used either to 3D-print a skull model for the surgeon to fashion a solid implant model with commercially available plaster or to create a digital implant model as an STL file.

KEOSAN TRADING Co. manufactures the customized molds from the solid implant model provided by the surgeon, or the digital implant model provided by KEOSAN TRADING Co., using plaster molds or 3D-printed molds as appropriate. The FITme Customized Silicone Implant is manufactured from the customized molds and provided to the surgeon, non-sterile.

The provided text is a 510(k) premarket notification for a medical device (FITme Customized Silicone Implant). It asserts substantial equivalence to a predicate device, but does not describe acceptance criteria, a study proving device performance against those criteria, or any details related to AI/algorithm performance.

Therefore, I cannot provide the requested table and information based on the given document. The document describes a traditional medical device (silicone implant) and its manufacturing process, not an AI or software algorithm.

To answer your request, a document detailing the validation of an AI/software as a medical device (SaMD) or an AI-powered medical device would be required. This would typically include performance metrics like sensitivity, specificity, accuracy, and confidence intervals, along with details on test sets, ground truth establishment, and expert involvement.

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