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The ClotTriever Thrombectomy System consists of the ClotTriever Catheter and ClotTriever Thrombectomy System is indicated for:

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

The ClotTriever Thrombectomy System is a single-use, sterile medical device system designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port with tubing clamp, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include a clot reservoir, a flush port adapter, an aspiration insert, funnel loading tool, and a 60 cc syringe. The ClotTriever Catheter consists of four pre- assembled polymeric coaxial catheters terminating in an expandable coring element and thrombus collection bag. At the proximal end of the catheter is a handle used to enable tensioning of the coring element. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the dilator and ClotTriever Catheter distal tips are radiopaque, and radiopaque marker bands are located on the coring element shaft at the proximal end of the expandable coring element, and at the distal ends of the ClotTriever Sheath and ClotTriever Catheter outer shaft.

The prompt asks to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text. However, the provided text does not contain details about specific acceptance criteria (e.g., numerical thresholds for performance metrics) or a study with detailed results that explicitly "prove" the device meets these criteria. Instead, it describes non-clinical testing performed to establish substantial equivalence to a predicate device.

Therefore, many of the requested details cannot be extracted directly from the provided document. I will answer based on what is available, and explicitly state when information is missing.

Here's the breakdown of what can be inferred/extracted:

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

The document lists various non-clinical tests conducted but does not provide a table with specific acceptance criteria (e.g., "Deployment Force < X N") or reported numerical device performance results for these criteria. It only states that "Test results demonstrated that all acceptance criteria were met," implying that such criteria and results exist internally but are not disclosed in this summary.

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

• Sample Size for Test Set: Not specified in the document. The testing described is non-clinical bench testing.
• Data Provenance: Not applicable in the context of clinical data. For non-clinical testing, the location and methods would be internal to Inari Medical, Inc. The document does not specify the country where these non-clinical tests were performed.

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 question is not applicable as the study was non-clinical bench testing and did not involve human expert assessment of outcomes or imaging, nor did it establish ground truth in a clinical sense.

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

• Not applicable, as this was non-clinical bench testing, not a clinical study requiring adjudication of clinical outcomes or interpretations.

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

• Not applicable. The document explicitly states: "Clinical testing was not required for the determination of substantial equivalence." Therefore, no MRMC or clinical comparative effectiveness study was conducted or reported here.

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

• Not applicable. This is a medical device for physical removal of clots, not an AI algorithm. The testing described is physical, non-clinical performance testing of the device itself.

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

• For the non-clinical testing, the "ground truth" would be defined by the pre-established engineering specifications and performance standards for each test (e.g., a certain force measurement, a successful deployment, a specified amount of clot removed in a simulated environment). The document does not specify the exact methods for defining this "ground truth" or the criteria for success beyond stating that "all acceptance criteria were met."

8. The sample size for the training set

• Not applicable as this is a physical medical device, not an AI model requiring a training set.

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

• Not applicable as this is a physical medical device, not an AI model requiring a training set and associated ground truth.

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