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The ICHOR 7F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The device is intended for the peripheral vasculature and is not intended for use in the coronary or neurovasculature.

The ICHOR 7F Embolectomy System is indicated for the non-surgical removal of emboli and thrombi from blood vessels. The System is intended for the peripheral vasculature (nominal size 4-10mm). The ICHOR 7F consists of four components: the Introducer Sheath, the Dilator, the Guide Catheter, and the Balloon Catheter. The outermost catheter is the Introducer Sheath which travels to the occlusion site over the Dilator. The Introducer Sheath is placed proximal to the occlusion and anchored into place by inflating the occluding balloon located at the distal tip. The balloon on the Introducer Sheath also serves to occlude flow. The Guide Catheter, composed of the Basket Catheter telescoped within the Guide Catheter Sheath, is passed through the Introducer Sheath. When in place, the Guide Catheter Sheath, which serves as the capturing sleeve, is retracted proximally allowing a nitinol basket to expand within the vasculature proximal to the occlusion. The Balloon Catheter is passed through the Guide Catheter and extended past the occlusion. The treatment balloon is inflated distal to the occlusion, and the Balloon Catheter is pulled proximally towards the basket until the occlusion is contained inside the basket. If desired the Guide Catheter can introduce aspiration to apply negative pressure to guide embolic material into the basket. The accessories include two 1 cc syringes, two Tuohy Borst with extension lines, two three-way stopcocks, two one-way stopcocks, and one stylet.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device. It outlines the device's indications for use, its components, and compares it to a predicate device. It also lists the non-clinical tests performed, but it does not provide details on the acceptance criteria for these tests nor does it present device performance data against such criteria in the format requested.

Therefore, I cannot fulfill your request to include:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method
5. MRMC comparative effectiveness study details
6. Standalone performance details
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

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