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The MediVision Laparoscope is intended to be used by qualified physicians to provide access, illumination and visualization of body cavities, hollow organs and canals during closed, or minimally-invasive surgical procedures. These include, but are not limited to, laparoscopic, procedures such as cholecystectomy, colon resection or therapeutic thoracoscopy applications with appropriate thoracoscopic cannulas. The laparoscope may be attached to hand --held camera so that the surgical area may be effectively visualized by the physician on a remote color monitor. The laparoscope is designed to pass through standard laparoscopic and thoracoscopic 10mm cannulas to gain access to the subject surgical site.

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I am sorry, but the provided text is a 510(k) premarket notification letter from the FDA for a medical device called "MediVision Laparoscope." It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or expert qualifications. The letter primarily focuses on regulatory approval and indications for use.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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MEDIVISION HYSTEROSCOPE MV400/MV415/MV430/MV470 INDICATIONS for USE NOTE: Hysteroscopes are used as tools for access to the uterine cavity and are not, in and of themselves, a method for surgery. Diagnostic Hysteroscopy - . Abnormal Uterine Bleeding - Infertility & Pregnancy Wastage . - Evaluation of Abnormal Hysterosalpingogram # - Intrauterine Foreign Body - . Amenontiea - Pelvic Pain . - Operative Hysteroscopy - . Directed Blopsy - Removal of Submucous Fibroids and Large Polyps . - . Submucous Myomectorny - . Transection of Intrauterine Adhesions - o Transection of Intrauterine Septa - . Endometrial Ablation Medical disease, cervical stenosis, and pelvic infection may alter the choice of location for hysteroscopy {i.e., office setting vs. Hospital),

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This document is a 510(k) clearance letter from the FDA for Medivision Hysteroscopes. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it confirms that the device is substantially equivalent to a predicate device already on the market.

Therefore, I cannot provide the requested information.

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Indications for use for the MediVision Cystoscope are as follows:

MediVision Cystoscope is for examine of the lower urinary tract, and using additional accessories, to perform various diagnostic and therapeutic procedures. This device is marketed as a reusable device; methods for cleaning, disinfecting, and sterilization are included in latter sections of this submission under Section 5, STERILIZATION INFORMATION.

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I apologize, but the provided text from the FDA 510(k) clearance letter and the "Indications for Use" document does not contain the specific information required to describe acceptance criteria, a study proving device performance, or details about the ground truth, sample sizes, expert qualifications, or adjudication methods.

The documents focus on the regulatory approval for the MediVision Cystoscopes (Models MV400, MV415, MV430, MV470). They state that the device is "substantially equivalent" to previously marketed devices and outline its indications for use (examination of the lower urinary tract and performing diagnostic/therapeutic procedures with accessories).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. This information would typically be found in a separate study report or a more detailed technical submission, not in the FDA clearance letter itself.

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Intended use for the MediVision Sinoscope is to allow direct visualization through the sinoscope or the video monitor of the nasal cavity.

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I am sorry, but based on the provided text, there is no information about the acceptance criteria, device performance, or any study details for the MediVision Sinoscope.

The text is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to a predicate device and can be marketed. It states the intended use of the device: "Intended use for the MediVision Sinoscope is to allow direct visualization through the sinoscope or the video monitor of the nasal cavity."

However, it does not include any performance data, study designs, sample sizes, expert qualifications, or ground truth information. Therefore, I cannot generate the requested table and study description.

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