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The ClotTriever Thrombectomy System is indicated for:
• The non-surgical removal of 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 including deep vein thrombosis (DVT).
The ClotTriever Sheaths are indicated for use as a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

The ClotTriever Thrombectomy System ("ClotTriever System") is a single-use over-the-wire catheter-based system used for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system consists of ClotTriever Catheters, ClotTriever Sheaths and Protrieve Sheath, each packaged separately. The ClotTriever Sheath consist of a polymeric shaft with a distal self-expanding nitinol mesh funnel, a proximal hub with a hemostasis valve and a sideport tubing. The mesh funnel is deployed by retracting the slide actuator back until it snaps into place. The mesh funnel self-expands to the diameter of the vessel and serves as a backstop as clot is removed through the lumen of the sheath. A hemostasis valve is integrated into the proximal hub of the sheath to prevent blood loss from devices passing through it. The sideport tubing has a large-bore stopcock and a terminal quick-disconnect coupling for connection to the Large Bore 60 cc Syringe for the aspiration of clot. A pre-dilator is provided with the ClotTriever Sheaths, to expand the target vessel prior to sheath insertion. A dilator is provided to aid insertion and positioning of the sheath, while the loading tool facilitates insertion of the mesh funnel into the dilator.

Here's an analysis of the provided FDA 510(k) summary regarding the ClotTriever Sheath, focusing on "acceptance criteria" and "study that proves the device meets the acceptance criteria."

Important Note: The provided document is a 510(k) clearance letter and summary for a medical device (ClotTriever Sheath). It is not a typical AI/Software as a Medical Device (SaMD) submission that would involve performance metrics like sensitivity, specificity, AUC, or a comparative effectiveness study with human readers assisting AI. Therefore, most of the requested information (sample size for test set, expert qualifications, MRMC study, standalone performance, training set details) will either be explicitly stated as "not applicable" or inferred from the nature of the device submission.

The "device" in this context is a physical medical device (catheter sheath), not an AI algorithm. The "acceptance criteria" and "performance" relate to its physical and functional characteristics, and its "study" refers to non-clinical (bench) testing, not clinical trials with human readers or AI algorithms.

Acceptance Criteria and Device Performance for ClotTriever Sheath

The acceptance criteria for the ClotTriever Sheath, as described in this 510(k) submission, are primarily centered around demonstrating substantial equivalence to a predicate device (Protrieve Sheath) through non-clinical performance characteristics, and the safety and effectiveness of the device for its indicated uses.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device and not an AI algorithm, the "acceptance criteria" are typically defined by engineering specifications, material properties, and functional performance benchmarks to ensure safety and effectiveness for its intended use. The "reported device performance" is demonstrated through verification testing.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not applicable. For a physical device like a sheath, the "test set" would typically refer to the number of devices or components tested during non-clinical verification. This number is not specified in the provided summary, as it's typically found in detailed test reports, not the 510(k) summary itself. The summary only refers to "Verification testing provided in K180329 and K192036."
• Data Provenance: Not applicable in the context of human data. The testing mentioned in the previous 510(k)s (K180329 and K192036) would be non-clinical (bench and potentially animal) testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Not applicable. This submission is for a physical medical device, not an AI/SaMD. "Ground truth" in this context refers to engineering specifications and performance benchmarks, not expert annotations of medical images or data.

4. Adjudication Method for the Test Set

• Not applicable. This relates to expert review for AI/SaMD and is not relevant for this physical device submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size (e.g., human readers improve with AI vs without AI assistance)

• No, not applicable. This is a physical device, not an AI-assisted diagnostic tool.

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

• No, not applicable. This is a physical device, not a standalone algorithm.

7. The Type of Ground Truth Used

• Engineering specifications and documented performance characteristics. For medical devices, the "ground truth" for non-clinical testing refers to established engineering standards, material properties, functional requirements, and safety benchmarks (e.g., burst pressure, tensile strength, flow rates, biocompatibility results), along with performance observed in simulated-use environments (e.g., flow models). The comparison to the predicate device also establishes a "ground truth" of already cleared and accepted performance.

8. The Sample Size for the Training Set

• 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

• Not applicable. There is no "training set" as this is not an AI/Machine Learning device.

In summary, this 510(k) pertains to a non-active, physical medical device (catheter sheath). The "acceptance criteria" and "proof" primarily stem from demonstrating substantial equivalence to a legally marketed predicate device (Protrieve Sheath) based on shared intended use, similar technological characteristics, and prior non-clinical verification testing, without raising new questions of safety or effectiveness. The questions about AI-specific validation metrics are not applicable here.

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The Intri24 Sheath is indicated to provide a conduit for the insertion of endovascular devices into the vasculature while minimizing blood loss associated with such insertions.

The Intri24 Sheath is a single-use, sterile medical device for use in the peripheral vasculature. The Intri24 Sheath is an introducer sheath consisting of a short single lumen catheter with a hydrophilic coating, proximal hemostasis valve, and stopcock with flush port. A radiopaque marker is positioned near the distal tip of the sheath to aid with fluoroscopic visualization. The Intri24 Dilator is compatible with a 0.035" guidewire and has a tapered leading edge which aids insertion and positioning of the Intri24 Sheath.

The provided text is a 510(k) summary for a medical device called the "Intri24 Sheath." It details the device's characteristics, indications for use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.

However, the nature of the device (a catheter introducer sheath) means that the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are based on physical and functional performance tests rather than AI model performance or diagnostic accuracy. Therefore, the questions related to AI-specific metrics (like sample size for test/training sets, experts for ground truth, MRMC studies, standalone algorithm performance, and effect size for human readers) are not applicable to this type of device submission.

The "study" that proves the device meets acceptance criteria in this context refers to the non-clinical testing performed.

Here's how to interpret the provided information in the context of the device:

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

The document describes various non-clinical tests performed and states that "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications." While the specific numerical acceptance criteria values are not provided in this summary, the types of tests conducted represent the areas where acceptance criteria would be set.

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

• Sample Size: The document does not specify the exact sample sizes for each non-clinical test. This information would typically be detailed in the full test reports, not necessarily in a 510(k) summary. For physical device testing, sample sizes are often determined by statistical methods or industry standards (e.g., ISO, ASTM) to provide sufficient confidence in the results.
• Data Provenance: The data is from non-clinical (benchtop) testing conducted by Inari Medical, Inc. The country of origin for the data is implicitly the USA (based on the company's address in Irvine, California, and the FDA submission). It is a prospective generation of data through controlled laboratory experiments.

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

• Not Applicable: For this type of physical medical device, "ground truth" is established by direct measurement against engineering specifications and industry standards, not by expert consensus on, for example, diagnostic images. The performance metrics are objectively measurable (e.g., force, flow rate, dimensions).

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

• Not Applicable: Adjudication methods like 2+1 or 3+1 are used for consensus-based ground truth in AI/imaging studies. Here, the "ground truth" is determined by established measurement techniques and calibrated equipment.

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: This device is a catheter introducer sheath, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.

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

• Not Applicable: This is not an algorithm or AI device.

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

• Objective Measurement/Engineering Specifications/Industry Standards: The "ground truth" for this device's performance is derived from its design specifications, established industry standards (such as ISO 10993 for biocompatibility), and physical measurements using calibrated equipment.

8. The sample size for the training set:

• 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:

• Not Applicable: There is no "training set" or corresponding ground truth establishment process for this device as it is not an AI/machine learning device.

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The Flow Triever Retrieval/Aspiration System consists of the FlowTriever Catheter, Aspiration Guide Catheter, and Retraction Aspirator. The FlowTriever Retrieval/Aspiration System 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 Flow Triever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature. The system is comprised of three main components packaged separately:
Aspiration Guide Catheter
FlowTriever Catheter (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)
Retraction Aspirator
The FlowTriever Catheter is inserted through the Aspiration Guide Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer Delivery Catheter. The hand-lever operated Retraction Aspirator simultaneously aspirates fluids and retracts the FlowTriever Catheter with thrombus into the Aspiration Guide Catheter to capture clot and restore blood flow.

The provided text details a 510(k) summary for the Inari FlowTriever Retrieval/Aspiration System, specifically for a modification to increase the diameter of the disks of the FlowTriever Catheter. The document does not describe an acceptance criteria table or a study proving the device meets specific performance criteria in the context of diagnostic accuracy, which would include metrics like sensitivity, specificity, or AUC usually associated with AI/ML devices.

Instead, the document focuses on non-clinical testing to ensure the modified device still functions as intended and is substantially equivalent to its predicate devices. The "acceptance criteria" here refers to whether the device meets its predefined engineering and safety specifications through various mechanical and material tests.

Here's an breakdown based on the provided text, addressing your points where possible:

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

The document does not provide a formal table with quantitative acceptance criteria and their corresponding reported performance values. It states generally: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use."

The types of tests performed indicate the areas where acceptance criteria would have been set:

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 does not specify sample sizes for each of the non-clinical tests. It refers to these as "verification and validation testing." The data provenance for such tests would typically be from in-house lab testing, not human patient data, and therefore country of origin in that context is not usually relevant. These are benchtop tests.

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 is not applicable to the non-clinical testing described. "Ground truth" in the context of device function and safety for this type of submission is established by engineering specifications and industry standards, not by expert medical interpretation of images or patient outcomes.

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

Not applicable. Adjudication methods are relevant for clinical studies or studies involving human assessment of data (e.g., image interpretation). This submission details non-clinical, benchtop testing.

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. This is a medical device for mechanical thrombus removal, not an AI/ML diagnostic tool. There is no mention of human readers or AI assistance.

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

Not applicable. This device is not an algorithm. It is a physical medical device.

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

The "ground truth" for the non-clinical tests would have been the engineering specifications and intended functional performance criteria established during the device's design and development, as well as adherence to relevant standards for biocompatibility and materials.

8. The sample size for the training set

Not applicable. There is no machine learning or AI component to this device that would require a "training set."

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

Not applicable, as there is no training set for this device.

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