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The Multiple Instrument Guide (MIG) is used for surgical instrument and choledochoscope access into the common bile duct during laparoscopic common bile duct exploration (LCBDE).

The Multiple Instrument Guide ("MIG") is a three-lumen plastic extension that has a curved J-tip configuration. The MIG in its entirety is 13 inches in length. The largest lumen is 3.4mm in diameter and will allow the passage of a choledochoscope through it. The other two lumens are 1.8mm and 2.0mm in diameter. The MIG itself is composed entirely of polyethylene. The sheath which aids the introduction of the MIG into the patient is composed of a clear rigid, non-toxic vinyl compound developed especially for the medical industry. The sheath is 8.0 inches in length, a hollow end diameter of .320 inches, and a wall thickness of .035 inches. It is a simple hollow tube in which the MIG is passed through, into the patient. The MIG is also accompanied by a small plug (which does not come into contact with the patient) to prevent leaking of the carbon dioxide used in laparoscopic procedures. The plug is composed of polyethylene, is .069 inches in diameter, and is 1.5 inches long. The MIG requires no form of electrical or battery power, it is operated manually by a laparoscopic surgeon. The MIG, sheath, and plug are all sterile, single use items. The MIG is coated with a Hydromer, Inc. hydrophilic coating which becomes lubricious when activated with water. Its purpose is to reduce friction when the MIG enters the sheath and the patient. The coating is a completely inert, non-leeching, non-extractable material. It alleviates the need for the physician to use other water-based lubricants, because it is permanently coated onto each MIG.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device called the "Lap Surgical Systems Multiple Instrument Guide" (MIG). It primarily discusses the device's substantial equivalence to a predicate device and its intended use.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance. While it describes the device's function and composition, there are no specific performance metrics or acceptance criteria mentioned.
2. Details about a study that proves the device meets acceptance criteria. There's no mention of any clinical or performance study, sample sizes, data provenance, ground truth establishment, or expert reviews.
3. Information on MRMC comparative effectiveness studies or standalone algorithm performance. The device is a physical instrument, not an AI or software-based system, so these types of studies are not applicable.
4. Any discussion of ground truth.
5. Sample size for training sets. Again, this is a physical device, not an AI model.

The document is a regulatory filing focused on establishing substantial equivalence to a legally marketed predicate device, rather than providing detailed study results.

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