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The intended use of Nitinol Medical Technologies, Inc.'s ("NMT") Simon Nitinol Filter™ System ("SNF System") is to prevent pulmonary embolisms from migrating to the pulmonary arteries.

The cleared SNF System and the proposed models of the SNF System are composed of a SN Filter and a delivery system. The SN Filter component is made of a nitinol alloy which has thermal shape memory properties. These properties allow the nitinol alloy wires to be formed into the shape of a filter. When placed in saline, the wires become soft and can be straightened to allow delivery through a small diameter catheter. The SN Filter resumes its original shape, a dome with six legs, when warmed to body temperature in the vena cava.

The SN Filters are delivered via the Seldinger technique, using a 7 French I.D. angiographic introducer sheath and a preliminary venacavogram. The sheath is introduced into the vein and positioned in the vena cava. When the sheath is positioned in the vena cava, the dilator is removed and the delivery system for the SN Filter is attached to the sheath. The SN Filter is then advanced through the sheath using the pusher wire until the SN Filter is at the tip of the sheath in the vena cava. The pusher wire has a stainless steel pusher cup or pad on the distal end of the pusher wire. The pusher wire is held in position while the sheath is withdrawn. This action releases the SN Filter into the vena cava: the SN Filter expands to its original shape which secures it against the vena cava. The sheath is then removed.

NMT intends to make two types of modifications to the cleared SNF System. First, NMT intends to market models of the SNF System with zero, one, and two gold, radiopaque marker bands. Second, NMT intends to expand the device's delivery methods to include subclavian delivery using the same delivery system as used for jugular delivery.

The provided text is a 510(k) summary for a medical device (Simon Nitinol Filter™ System) and does not contain the acceptance criteria, study details, or performance results as requested in your prompt.

A 510(k) summary primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed clinical study report with acceptance criteria and performance data in the way you've outlined for AI/diagnostic devices.

Therefore, I cannot fulfill your request with the information provided. The document describes:

• Device Name: Simon Nitinol Filter™ System
• Intended Use: To prevent pulmonary embolisms from migrating to the pulmonary arteries.
• Modifications: Addition of radiopaque marker bands and expansion of delivery methods to include subclavian delivery (in addition to jugular).
• Predicate Devices: Previous iterations of the Simon Nitinol Filter™ System.
• Claim of Substantial Equivalence: Based on similar intended use, principle of operation, and a determination that the minor technological differences do not raise new questions of safety or effectiveness.

To answer your questions, I would need a different type of document, such as a clinical study report or a detailed premarket approval (PMA) application, which would typically include comprehensive performance data and predefined acceptance criteria.

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