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The OES Laparo- Thoraco Videoscope Type V has been designed for endoscopic observation, diagnosis and treatment within the thoracic and abdominal cavity.

The A4907 Lens Cleaning Sheath has been specifically designed to be used with an OES Laparo-Thoraco Videoscope Type V to clean the objective lens surface.

The A4908 Valve has been specifically designed for use in conjunction with the A4907 Cleaning Sheath to provide irrigation and aspiration of liquids when connected to the insertion tube of the Olympus videoscope.

The trocar tubes are intended to provide a passageway for the endoscope or hand instruments, and permit the insufflation of CO, during the endoscopic procedure. The subject trocar tubes are specifically designed to use in conjunction with the OES Laparo-Thoraco Videoscope Type V.

The trocars are intended to pierce the abdominal wall tissue layer during the endoscopic procedure. The subject trocars are specifically designed to use in conjunction with the Laparo-Thoracoscope.

The OES Laparo-ThoracoVideoscope Type V is substantially equivalent in design to the predicate Olympus OES LTF Flexible Tip Thoracoscope/Laparoscope which was cleared in 510(k) # K915857. The predicate LTF Flexible Tip Thoracoscope/Laparoscope is a fiberscope. The only difference between these two endoscopes is that the predicate device which has a image guide (fiber bundle) to transmit an endoscopic image to the surgeon's eye or the CCD of of the video camera. The subject device is a videoscope that places the CCD at the distal end of the endoscope. The subject OES Laparo-Thoraco Videoscope Type V has an 11 mm distal tip, 10.6 mm diameter insertion tube. 70° forward viewing field of view, depth of field of 18mm ~100mm, and 90° angulation in all four (Up-Down-Left-Right) directions. It contains the color Charged Couple Devices (CCD) for image transmission to the video monitor.

The A 4907 Lens Cleaning Sheath has been specifically designed for use in conjunction with the Olympus OES Laparo-Thoraco Videoscope Type V. It will be included in the standard set of Laparo-Thoraco Videoscope and will also be marketed separately. When connected to the main body of videoscope, it offers lens cleaning, irrigation, and suction capabilities to the user during endoscopic procedures.

The A4908 Valve has been specifically designed for use in conjunction with the Olympus OES Laparo-Thoraco Videoscope Type V and A4907 lens cleaning sheath. It will be included in the standard set of the OES Laparo-Thoraco Videoscope Type V and will also be marketed separately. The A4908 Valve is substantially equivalent in intended use, functions, and method of use to the T1020 Multiple Function Tube (Irrigation/Suction Probe) which was approved in 510(k) # K923982. Both devices have separate "plunger-like" valves that permit the operator to control when to activate the suction or irrigation function. The housing of design is such that tubing sets are easily connected to the irrigation/suction source. Additionally, the A4908 Valve is also substantially equivalent in design, material intended use, functions, and method of use to the Olympus MH-325 Valve which was cleared in 510(k) # K915857 with the exception that the A4908 Valve controls the irrigation and suction of liguids. It has separate irrigation port and suction port connections. The irrigation and aspirations are controlled by separate buttons.

The A5822 and A5824 trocar tubes have been specifically designed for use in conjunction with the Olympus OES Laparo-Thoraco Videoscope Type V. The 5 mm trocar tube is designed to deliver endoscopic accessories into the abdominal cavity. The A5822 and A5824 trocar tubes consist of a metal housing, a stopcock for insufflation of CO2 gas, and a sealing valve. The A5820 trocar tubes does not have a stopcock for insufflation. The sealing valve is specifically designed to prevent damages to the insertion tube of the OES Laparo-Thoraco Videoscope Type V. It can also be purchased separately. These trocar tubes are substantially equivalent in intended use, functions, and method of use to the Olympus A5273 and A5276 Trocar Tubes with the exception that the predicate trocar tubes have a metal valve (flap or plunger type) while the subject trocar tubes have a medical grade silicone rubber valve.

The following trocars have been specifically designed for use in conjunction with the trocar tubes listed above: A5821 (5 mm), A5823 (11 mm), A5825 (13 mm).

This 510(k) summary (K955403) for the OLYMPUS OES LAPARO-THORACO VIDEO SCOPE TYPE V does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information, which typically includes:

1. A table of acceptance criteria and the reported device performance: This document does not specify any quantitative acceptance criteria or performance metrics derived from testing the device against such criteria.
2. Sample size used for the test set and the data provenance: There is no mention of a specific test set or data derived from testing for performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document pertains to a medical device (videoscope) from 1995, long before the widespread use of AI in medical imaging interpretation, and no such study is mentioned or implied.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document's primary argument for clearance is substantial equivalence to previously cleared predicate devices (Olympus Flexible Tip Thoracoscope/ Laparoscope K942338 & K942339, and K915857). The key differences highlighted are:

• The subject device (OES Laparo-Thoraco Videoscope Type V) is a videoscope with a CCD at the distal end, whereas the predicate was a fiberscope with a fiber bundle.
• The accessories (Lens Cleaning Sheath, Valve, Trocar Tubes, Trocars) are also compared to existing cleared devices, noting minor design differences (e.g., silicone rubber valve vs. metal valve in trocar tubes) but asserting equivalence in intended use, function, and safety.

The general safety statement at the end reinforces this by saying: "When compared to the predicate devices, Olympus OES Laparo-Thoraco Videoscope Type V, its associated accessories and ancillary equipment do not incorporate any significant change in intended use, method of operation, material, or design that could affect the safety or effectiveness. device."

Therefore, the "study" proving the device meets criteria, in this context, is the comparison to predicate devices and the assertion that the differences do not raise new questions of safety or effectiveness, rather than a formal performance study against specific acceptance criteria.

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