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The KSEA MVM 7.5 French Choledochoscope is designed to be used by qualified surgeons and physicians for general cholecystic and choledochal surgical procedures.

This instrument is indicated for examination of the gall bladder and bile duct, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The KSEA MVM 7.5 French Choledochoscope is comprised of a video module, and a endoscope module. The endoscope module is a flexible, fiber optic endoscope. The video module is an imaging device which connects to a camera control unit. The body contact portions of the KSEA MVM 7.5 French Choledochoscope are composed of medical grade polyurethane, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

This 510(k) submission for the KSEA MVM 7.5 French Choledochoscope does not contain information regarding detailed acceptance criteria or a study proving the device meets said criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel performance testing data. The key points from the provided text are:

• Device Identification: KSEA MVM 7.5 French Choledochoscope
• Indication: Used by qualified surgeons and physicians for general cholecystic and choledochal surgical procedures, including examination of the gall bladder and bile duct, and, with accessories, various diagnostic and therapeutic procedures.
• Device Description: Comprised of a video module and a flexible, fiber optic endoscope module.
• Substantial Equivalence Claim: The device is substantially equivalent to predicate devices because basic features, design, and intended uses are the same. Minor differences are claimed to raise no new issues of safety and effectiveness as they do not affect performance, function, or intended use.

Therefore, I cannot provide the requested information in the table or address the specific study parameters for the following reasons:

1. No Acceptance Criteria or Performance Data: The document states that "minor differences... raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices," but it does not specify what those "performance" criteria are, nor does it provide any data to support this claim for the new device.
2. Focus on Substantial Equivalence: This type of submission relies on the performance of a predicate device to establish safety and effectiveness. It typically does not involve a new, detailed performance study with acceptance criteria for the new device itself, unless there are significant technological differences.
3. No Clinical Study Details: There is no mention of a clinical study, test sets, ground truth, expert opinions, or any other elements that would be part of a robust performance study.

In summary, based solely on the provided text, the information required to answer your questions is not present. The 510(k) summary is a regulatory document asserting equivalence, not a detailed technical report of device performance testing against predefined acceptance criteria.

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