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INDIGO Aspiration Catheters and Separators: As part of the INDIGO Aspiration System, the INDIGO Aspiration Catheters and Separators are indicated for the removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems, and for the treatment of pulmonary embolism. INDIGO Aspiration Tubing: As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO Aspiration Catheters to the Penumbra Aspiration Pump. Penumbra Aspiration Pump: The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.

The INDIGO® Aspiration System is comprised of the several devices: INDIGO Aspiration Catheter, Penumbra Aspiration Pump, INDIGO Aspiration Pump Canister, INDIGO Aspiration Tubing, INDIGO Separator. The INDIGO Aspiration System is designed to remove thrombus from the vasculature using mechanical aspiration. The INDIGO Aspiration Catheter targets aspiration from the pump directly to the thrombus. The INDIGO Separator may be used to clear the lumen of the INDIGO Aspiration Catheter should it become blocked with thrombus. The INDIGO Aspiration Catheter is introduced through a guide catheter or vascular sheath into the peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO Aspiration Catheter is used with the Penumbra Aspiration Pump to aspirate thrombus from an occluded vessel. As needed, an INDIGO Separator may be deployed from the INDIGO Aspiration Catheter to assist with thrombus removal. The INDIGO Separator is advanced and retracted through the INDIGO Aspiration Catheter at the proximal margin of the primary occlusion to facilitate clearing of the thrombus from the INDIGO Aspiration Catheter tip. The devices are visible under fluoroscopy. For the aspiration source, the INDIGO Aspiration Catheter is used in conjunction with the Penumbra Aspiration Pump, which is connected using the INDIGO Aspiration Tubing and the INDIGO Aspiration Pump Canister. The INDIGO Aspiration Catheter may be provided with a steam shaping mandrel, rotating hemostasis valve, Select Catheter, and introducer. The INDIGO Separator may be provided with an introducer and torque device. The Select+ Catheter is an accessory within kitted configurations of the INDIGO Lightning Flash Aspiration System. The Select+ Catheter is used to aide in access to the site of occlusion and is removed prior to initiating aspiration with the aspiration catheter. The use of the Select+ Catheter to facilitate access to the site of the occlusion is an optional procedural step for INDIGO Lightning Flash Aspiration Catheters. The device is provided sterile and intended for single use only.

The provided text is a 510(k) summary for the Indigo® Lightning Flash Aspiration System - Select+™ Catheter. It does not describe a study involving an AI device or software, nor does it provide the detailed information requested in the prompt regarding acceptance criteria and performance of an AI-powered device.

Instead, this document focuses on establishing substantial equivalence of a new catheter (Select+™ Catheter) to a previously cleared predicate device (Indigo Aspiration System – Lightning Flash Select Catheter) and a reference device (Neuron Max System - Select Catheter).

Therefore, I cannot provide the requested information from the given text. The text does not contain:

1. A table of acceptance criteria and reported device performance for an AI device.
2. Sample size used for a test set for an AI device or data provenance.
3. Number and qualifications of experts for ground truth establishment for an AI device.
4. Adjudication method for an AI device.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study for an AI device.
6. Standalone performance details for an AI algorithm.
7. Type of ground truth used for an AI device.
8. Sample size for the training set of an AI device.
9. How ground truth for the training set of an AI device was established.

The document states, under "7.5 Summary of Performance Data – Animal, Clinical", that "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes." This further confirms that the information requested for an AI-based study is not present.

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