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510(k) Data Aggregation
(273 days)
The MOST-T Autoclave is a table-top autoclave designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, medical clinics; and in first aid rooms.
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The provided text is a 510(k) premarket notification letter from the FDA to Shinva Medical Instrument Co., Ltd. regarding their MOST-T Autoclave. The document outlines the FDA's determination of substantial equivalence for the device and details the indications for use and various sterilization cycles.
However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study results such as MRMC comparative effectiveness or standalone performance. The text focuses on regulatory approval, general controls, and the labeling of the device's intended use and cycle parameters.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions about the study design and results based on the provided input. The document does not describe such a study or its findings.
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