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The device is indicated for use in the introduction of diagnostic and interventional devices inserted into the peripheral and coronary vasculature.

Major components of the Super Sheath (Proposed) are a sheath and a dilator. In addition, a guidewire is covered under this premarket notification. The guidewire is placed in the guidewire case including the inserter. The sheath for the Super Sheath (Proposed) is named as the Super Sheath (Proposed) Introducer Sheath and is available in 4F- 9F diameters and in lengths ranging from 7 to 25 cm. Some types of sheaths have radiopaque markers. The Super Sheath (Proposed) are provided sterile and are intended for one procedure use only. The one-piece construction of the sheath shaft and hub allows smooth passage of concomitantly used interventional medical devices. The sheath shaft and hub are made from Ethylene Tetrafluoro ethylene (ETFE) and polyamide. The hubs contain a hemostatic valve to minimize blood leakage during a procedure. A side tube equipped with a three-way stopcock is attached to the sheath hub. The side tube extension may be used for fluid and medication administration, as well as blood sampling. Some types of sheaths contain a marker band that is embedded in the shaft approximately 2.0 mm from the distal tip. The dilator is an open tapered plastic tube with an integral luer hub for guidewire insertion. The dilator is inserted into the introducer sheath. The dilator is longer than the sheath with a rounded tapered distal tip. The dilator facilitates and supports the entry of the sheath into the patient's vasculature. Once the sheath is in place, the dilator is removed. There are two different dilator distal tip sizes, 0.038" and 0.035" guidewire compatible. The 4F dilators are only available with a 0.035"guidewire lumen dilator. The 5-9F dilators are available with a 0.035" or 0.038" guidewire lumen. The 4-8F dilator tubes are made from Polypropylene (PP). The 9F dilator tubes are made from Fluorinated Ethylene Propylene. The dilator tubes are attached to the inner hub with a metal bush. The dilator is locked into the sheath by rotating motion. The Super Sheath (Proposed) has a polypropylene suture wing which is color coded by French size. The suture wing is a small projection near the hub with a hole in it for correct placement of the sheath using sutures. The uncoated guidewire is made of a stainless steel coil wrapped tightly around an inner mandrel that tapers at the distal tip. The flexible tip is J-shaped available in diameters of 0.035" and 0.038". The guidewire, with inserter, is available in 45 cm and 80 cm lengths. The inserter is used strictly for guiding the guidewire into a cannula or introducer.

The provided text describes a 510(k) submission for a medical device called "Super Sheath" (Proposed), which is a vessel dilator for percutaneous catheterization. The submission aims to demonstrate substantial equivalence to a predicate device, also named "Super Sheath" (K141070).

This document does not include information about AI/ML algorithms, human-in-the-loop performance, or the establishment of ground truth by expert consensus. Therefore, many of the requested elements for describing the acceptance criteria and study proving device performance will be inapplicable. The study's focus is on non-clinical performance testing to support changes in materials and an extended shelf-life for a physical medical device.

However, I can extract the relevant information regarding the acceptance criteria and the performance testing conducted for this traditional medical device.

1. A table of acceptance criteria and the reported device performance:

The document details performance testing for the "Super Sheath" (Proposed) to support modifications from the predicate device, specifically for an extended shelf-life and changes to the 8F dilator. The acceptance criteria are described as "established methods and acceptance criteria in conformity with ISO 11070:2014 and the submission under the predicate device without deviation."

Table: Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify exact sample sizes for each test. It refers to "testing" performed.
• Data Provenance: The testing was conducted by Togo Medikit Co., Ltd. in Japan. The data is likely from prospective testing, as it was performed to support design modifications and an extended shelf-life for the proposed device before its market introduction.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a physical device with performance testing based on established engineering standards (e.g., ISO 11070:2014) and direct measurements, not expert human interpretation (like radiology image analysis).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. As mentioned above, this is non-clinical performance testing of a physical device against engineering standards, not a study involving human adjudication of clinical output.

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 is not an AI/ML device, nor does it involve human readers or image analysis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is not an AI/ML algorithm.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by engineering standards, material specifications, and physical measurements (e.g., tensile strength, dimensional accuracy, leak integrity, biocompatibility test results). It is based on a comparison to the predicate device's performance and compliance with relevant ISO standards (ISO 10993 for biocompatibility, ISO 11070 for catheter/dilator performance).

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

• Not Applicable. No training set was used.

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