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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 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. TraX may be used with its prepackaged Aspiration Catheter to facilitate access to 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, introducer, and TraX. TraX compatibility is limited to its prepackaged Aspiration Catheter. The INDIGO Separator may be provided with an introducer and torque device.

The provided document is a 510(k) Premarket Notification from the FDA for the Penumbra, Inc. Indigo® Aspiration System - Aspiration Catheter 6X. It details the device, its intended use, and its substantial equivalence to predicate devices based on non-clinical (bench-top) performance testing.

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as it is related to a physical medical device (catheter) rather than a diagnostic algorithm or AI. Instead, it lists various bench-top performance tests conducted. For each test, the implicit acceptance criterion is that the device met all requirements.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench-top testing for a physical device. It does not mention a "test set" in the context of data used for an algorithm or AI. Therefore, concepts like sample size for a test set, country of origin, retrospective or prospective data are not applicable. The data provenance would be from internal laboratory testing conducted by Penumbra, Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes bench-top performance testing of a physical medical device (catheter), not a diagnostic algorithm or AI that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable for the same reason as point 3.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study was not done. The study described is for a physical medical device, not an AI or diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance study in the context of an algorithm or AI was not done. The performance evaluation was of the physical device's mechanical, material, and functional properties on a test bench.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench-top tests, the "ground truth" would be defined by engineering specifications, material science standards, and functional performance benchmarks for the device. For example, a tensile test would measure the force required to break the catheter, with the "ground truth" being the specified minimum tensile strength that the device must meet according to its design requirements. Similarly, biocompatibility is assessed against ISO 10993-1 standards.

8. The sample size for the training set

This information is not applicable as the document describes bench-top performance testing of a physical medical device, not an AI or algorithm that uses a training set.

9. How the ground truth for the training set was established

This information is not applicable for the same reason as point 8.

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