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The Catapult Guide Sheath is indicated to be used for introduction of interventional and diagnostic devices into the peripheral (and coronary) vasculature.

The Catapult Guide Sheath consists of a coil reinforced introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic color coded 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath has a lubricious hydrophilic coating on the outer surface up to 20cm on the distal portion.

The System consists of the following components:

• A One Introducer Sheath) with hemostasis valve
• A One dilator or
• A Two dilators for 15 cm version

The shaft and hemostasis valve are pre-assembled and packaged together with a dilator. Each shaft and each dilator are placed in a separate protection tube, the protection tubes are fixated onto a packaging pad. Products are sealed inside a medical grade Tyvek pouch on which a product label is placed. Devices are packaged in labeled packers containing five units and one Instruction for Use (IFU) booklet.

The Catapult Guide Sheath is a sterile, disposable device. It is a prescription medical device that is used only in healthcare facilities or hospitals. The device is suitable for placement in patients for up to 24 hours.

Devices are sterilized using ethylene oxide. Maximum levels of remaining tested sterilant residuals meet requirement limits EO

The provided document is a 510(k) summary for the Catapult Guide Sheath, a medical device. It describes the device, its intended use, comparison to a predicate device, and performance data. However, the document does not contain any information about an AI/ML-based device.

Therefore, I cannot provide an answer to your request regarding acceptance criteria and a study that proves an AI/ML device meets them, as the provided text pertains to a traditional medical device (Catheter Introducer).

If you can provide a document that describes the acceptance criteria and study for an AI/ML medical device, I would be happy to assist you.

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