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Olympus LF-DP Gastrointestinal and Sigmoid Fiberscope, accessories and ancillary equipment are inetend for observation of the upper and lower digestive tract including esophagus, stomach, and sigmoid colon.

The subject device, the LF-DP for use in the upper and lower digestive tract, is identical to the predicate device, the LF-DP Tracheal Intubation Fiberscope. The only difference between the subject and predicate devices is the indications for use. There are no other differences in design, materials or specifications. This does not affect the safety or efficacy of the subject.

The provided document is a 510(k) summary for the Olympus LF-DP Gastrointestinal and Sigmoid Fiberscope. It asserts substantial equivalence to a predicate device, the LF-DP Tracheal Intubation Fiberscope, primarily by extending its indications for use.

Based on the provided information, no studies demonstrating device performance against specific acceptance criteria were conducted or reported in this 510(k) summary. The document explicitly states:

"When compared to the predicate devices, "T.F-DP Gastrointestinal and Sigmoidfiberscope" does not incorporate any significant change for safety and efficacy to the predicate device. Therefore clinical data is not necessary for its evaluation of safety and efficacy."

This statement indicates that the submission relies on the established safety and efficacy of the predicate device and the claim that the technological characteristics relevant to safety and efficacy are identical. Therefore, the device's acceptance criteria are implicitly met by its substantial equivalence to the predicate device, which would have undergone its own clearance process.

Given this, I cannot provide the requested information regarding acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment because these types of studies were explicitly deemed "not necessary" for this particular 510(k) submission.

The document focuses on:

• Identifying the device and its intended use (observation of the upper and lower digestive tract).
• Asserting its substantial equivalence to a predicate device (LF-DP Tracheal Intubation Fiberscope).
• Highlighting that the only difference is the indication for use.
• Stating that there are no differences in design, materials, or specifications that affect safety or efficacy.
• Confirming compliance with voluntary safety standards (IEC 60601-1, IEC60601-1-1, IEC60601-1-2, IEC60601-2-18).

In the context of this 510(k), the "acceptance criteria" for the new indications for use are indirectly met by demonstrating that the device is technologically equivalent to a legally marketed predicate device for which safety and efficacy have already been established, and that the expanded indications do not introduce new questions of safety or effectiveness.

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