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The intended use of both Systems is to prevent embolisms from migrating to the pulmonary arteries.

The cleared SNF/SL and SNF Systems and the proposed models of the SNF/SL and SNF Systems 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 cooled, the wires 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 The pusher wire is held in position while the sheath is withdrawn.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 modify the gold radiopaque marker band from one which is deposited onto the introducer sheath to one which is mechanically swaged onto the introducer sheath.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the Simon Nitinol Filter™ System and Simon Nitinol Filter/Straight Line™ System, focusing on substantial equivalence to predicate devices. It describes the device's design, intended use, and a minor modification to a radiopaque marker band, but it does not detail any performance studies, clinical trials, or established acceptance metrics for device performance.

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

The cleared SNF/SL System and the proposed models of the SNF/SL 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 reassumes 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 ("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.

This 510(k) summary for the "Simon Nitinol Filter/Straight Line™ System" does not contain the information requested for acceptance criteria and a study proving those criteria are met.

The document primarily focuses on:

• Device identification: Names, classification, product code, and contact information.
• Predicate devices: Listing previously cleared versions of the device.
• Intended use: Preventing pulmonary embolisms.
• Device description and principle of operation: How the filter works and is deployed.
• Substantial equivalence claim: Arguing that the modifications (radiopaque markers, new delivery methods like antecubital and subclavian) do not raise new safety or effectiveness concerns compared to previously cleared versions.

There is no mention of:

• Acceptance criteria: Specific performance metrics (e.g., filter efficacy, complication rates, deployment success rates) that the device must achieve.
• A study or clinical trial: No data is presented from a study to demonstrate the device meets any particular performance criteria. The document states that the minor modifications "do not raise any new questions of safety or effectiveness," which is an argument for substantial equivalence, not a report of a new study to prove efficacy or safety against specific benchmarks.
• Specific performance numbers: There are no reported device performance values against which acceptance criteria could be compared.
• Sample sizes, data provenance, expert qualifications, ground truth methods, MRMC studies, or standalone performance. These details would typically be found in a study report.

Therefore, I cannot populate the requested table or provide the detailed information about a study based on the provided text. The document's purpose is to argue for substantial equivalence based on minor modifications, not to present a new clinical efficacy or safety study.

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