Search Results

The Artix AX aspiration catheter is indicated for:

• The non-surgical removal of emboli and thrombi from blood vessels.
• Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  The Artix AX aspiration catheter is intended for use in the peripheral vasculature.

The Artix AX is a single-use, over-the-wire catheter used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system comprises two catheter lengths, 85 cm and 115 cm, packaged separately.
The Artix AX is inserted over a pre-placed guidewire and advanced to the thrombus, which can then be removed via aspiration with the provided 30 mL Large Bore Vacuum Syringe. The Artix MT may also be deployed through the Artix AX to engage thrombus before being retracted through the Artix AX. Additional clot may be removed by aspiration through the Artix AX as necessary. After the procedure is complete, the Artix AX is removed from the patient.

The provided text describes the regulatory clearance for the Artix AX aspiration catheter and details several non-clinical tests conducted to support its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria or study results related to AI/algorithm performance, human reader improvement with AI assistance, MRMC studies, or any form of AI ground truth establishment. The tests listed are primarily related to the physical and functional characteristics of the medical device itself, not an AI component.

Therefore, I cannot fulfill the request to describe acceptance criteria and study proving an AI device meets those criteria, as the provided text pertains to a traditional medical device (a catheter) and not an AI-powered one.

Based on the provided text, the device in question is a medical catheter, not an AI/algorithm-powered device. The acceptance criteria and study details discussed in the document relate to the physical and functional performance of the catheter itself, to demonstrate its "substantial equivalence" to a predicate device.

Here's what the document does say about acceptance criteria and testing, in relation to the Artix AX catheter:

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

The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." However, it does not provide a specific table listing the acceptance criteria and the numerical performance results for each test. It simply states that they were met.

2. Sample sized used for the test set and the data provenance:

The document lists various non-clinical bench tests (e.g., Pouch Seal Visual Inspection, Kink Radius, Clot Burden Removal Validation, etc.). For these types of non-clinical tests, "samples" would refer to physical units of the device. The exact sample sizes for each specific test are not explicitly stated in this document. The data provenance is also not applicable in the context of clinical/radiological data as these are bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the tests performed are non-clinical, bench-top tests of the physical device's performance, not diagnostic assessments requiring expert interpretation or ground truth establishment in a clinical sense.

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

This question is not applicable as there is no clinical test set requiring adjudication.

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:

No, an MRMC study was not conducted. The document explicitly states: "Neither animal testing nor clinical testing were required for the determination of substantial equivalence." This device is a catheter, not an AI diagnostic tool.

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

No, this is not an AI algorithm.

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

This question is not applicable. The "ground truth" for the non-clinical tests would be the established engineering specifications and physical properties that the device must meet to function as intended (e.g., a specific flow rate, a certain burst pressure, absence of leaks). There is no clinical or pathological "ground truth" involved in these specific tests.

8. The sample size for the training set:

This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This question is not applicable. There is no "training set" or "ground truth" in the context of an AI model for this device.

In summary, the provided document is a 510(k) clearance letter for a medical device (a catheter) and details non-clinical bench testing to demonstrate "substantial equivalence." It does not contain any information related to AI or algorithmic performance evaluation.

Ask a specific question about this device

The INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4 As part of the INDIGO Aspiration System, the INDIGO CAT RX Aspiration Catheters and INDIGO Separator 4 are indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature. The INDIGO Aspiration Tubing As part of the INDIGO Aspiration System, the INDIGO Sterile Aspiration Tubing is indicated to connect the INDIGO CAT RX 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 several devices: - INDIGO CAT RX Aspiration Catheter . - INDIGO Separator 4 ● - . INDIGO Aspiration Tubing - . INDIGO Pump Canister/Tubing - . Penumbra Aspiration Pump The INDIGO Aspiration System is designed to remove thrombus from the vasculature using continuous aspiration. The INDIGO CAT RX Aspiration Catheter is a dual lumen rapid exchange catheter that targets aspiration from the Pump directly to the thrombus, removing it via the INDIGO Aspiration Tubing and depositing it in the Pump Canister. The INDIGO Separator 4 may be used, if needed, to clear the lumen of the INDIGO CAT RX Aspiration Catheter should it become blocked with thrombus. The INDIGO CAT RX Aspiration Catheter is introduced through a guide catheter or long introducer sheath and into the coronary or peripheral vasculature and guided over a guidewire to the site of the primary occlusion. The INDIGO CAT RX Aspiration Catheter may be provided with a rotating hemostasis valve and a peelable sheath. The INDIGO Separator 4 is provided with an introducer and torque device. The INDIGO CAT RX Aspiration Catheter and INDIGO Separator 4 are visible under fluoroscopy.

The provided text is a 510(k) summary for the Penumbra INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4). It is a submission to the FDA for market clearance, asserting substantial equivalence to a previously cleared predicate device.

Crucially, this document does not contain information about acceptance criteria or a study proving the device meets those criteria from an AI/ML perspective. The device in question is a medical aspiration system, not an AI/ML diagnostic or therapeutic device.

The "Performance Data - Non-Clinical" and "Performance Data - Clinical" sections explicitly state:

• "The subject and predicate Indigo System (CAT RX Aspiration Catheter and Separator 4) devices are identical. Therefore, previous device performance data regarding substantial equivalence described below remain unchanged." (Section 1.10)
• "No clinical study was conducted as previously performed bench and animal testing was determined sufficient for verification and validation purposes for substantial equivalence determination." (Section 1.16)

The submission leverages prior testing and clearance of an identical predicate device. Therefore, there are no new studies or acceptance criteria specifically for this 510(k) submission to describe. The original predicate device (K180412 and reference K163618) would have had its own performance data and acceptance criteria, but those are not detailed in this document.

Therefore, it is not possible to answer the requested questions based on the provided text. The text does not describe an AI/ML device, nor does it present new performance data or acceptance criteria for a study demonstrating adherence to such criteria. The entire premise of the 510(k) is that the device is identical to a predicate and thus no new performance testing is required for this submission.

Ask a specific question about this device