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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 FlowTriever Retrieval/Aspiration System is intended for use in the peripheral vasculature and for the treatment of pulmonary embolism.
Triever Catheters are also intended for use in treating clot in transit in the right atrium but not in conjunction with FlowTriever Catheters.

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 and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately:
• Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr)
• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)
The FlowTriever Catheter is inserted through the Triever Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever Catheter is retracted into the Triever Catheter to capture the targeted thrombus. Additional clot may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter and FlowTriever Catheter are removed from the patient.

The document provided describes a 510(k) premarket notification for the Inari Medical Triever24 and Triever20 devices. The submission focuses on modifications to existing devices and demonstrates substantial equivalence to a predicate device. This is primarily a mechanical/physical device rather than an AI/software-driven diagnostic tool.

Therefore, the information typically requested regarding acceptance criteria and study design for AI/ML medical devices (such as sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, and training set details) is not applicable to this document.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to biocompatibility and non-clinical performance testing to ensure the modified physical device maintains its safety and effectiveness compared to the predicate device.

Here's an interpretation of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Test results demonstrated that all acceptance criteria were met; therefore, the devices conform to established product specifications."

While a direct table of specific acceptance criteria values and reported performance values is not explicitly presented, the document lists the types of non-clinical tests performed to meet these criteria. Each of these tests would have pre-defined acceptance criteria (e.g., maximum force, minimum flow rate, no leakage). The report confirms that the results of these tests passed these unstated criteria.

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

• This is a medical device modification submission, not an AI/ML study.
• The "test set" refers to physical samples of the modified Triever24 and Triever20 devices. The document does not specify the exact number of units tested for each non-clinical test, but it implies standard engineering and laboratory testing protocols were followed for device verification and validation.
• Data provenance: Not applicable in the context of clinical data for AI/ML. The data comes from internal laboratory testing of the devices.

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

• Not applicable as this is not an AI/ML diagnostic device requiring expert interpretation of medical images/data for ground truth. The "ground truth" here is established by the engineering and manufacturing specifications and established test methods.

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

• Not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic accuracy, to resolve discrepancies in expert readings. Device performance is determined by objective physical and chemical tests.

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 done. This is a physical medical device, not an AI-assisted diagnostic tool. Clinical testing was explicitly stated as "not required for the determination of substantial equivalence."

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

• Not applicable. There is no algorithm for standalone performance. The device is a physical catheter system used by a human operator.

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

• The "ground truth" (or basis for acceptance) for this device is its adherence to established engineering specifications, material properties, biocompatibility standards (e.g., ISO 10993-1), and functional performance requirements as demonstrated through the listed non-clinical tests. This is not derived from medical expert consensus or patient outcomes data in the typical sense of AI/ML validation, but rather from predefined objective test methods.

8. The sample size for the training set:

• Not applicable. There is no AI/ML model that requires a training set. The device is a physical product.

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

• Not applicable as there is no training set for an AI/ML model.

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The ClotTriever Thrombectomy System consists of the ClotTriever Sheath. The 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 designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System is comprised of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath consists of a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include the funnel loading tool and a Large Bore 60 cc syringe. The ClotTriever Catheter consists of reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque.

The provided text describes a 510(k) premarket notification for the ClotTriever Thrombectomy System, focusing on device modifications and non-clinical testing. It explicitly states that "Clinical testing was not required for the determination of substantial equivalence." This means that the information requested regarding acceptance criteria, study details, human reader performance, ground truth establishment for a training set, and sample sizes for training and test sets in a clinical context is not applicable to this submission, as no human clinical study was performed.

The document primarily details non-clinical testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of the available information:

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

The document broadly states: "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications and intended use."

While a specific table of acceptance criteria with numerical performance values is not provided, the following list represents the types of non-clinical tests conducted to meet internal specifications:

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

This information is not provided in a clinical context as no human clinical study was performed. The non-clinical tests would have used physical samples of the device components. The document does not specify the number of samples for each non-clinical test or their provenance.

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)

Not applicable, as no human clinical study was conducted, and therefore no ground truth was established by medical experts for a test set.

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

Not applicable, as no human clinical study was conducted.

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 device is a medical instrument (thrombectomy system), not an AI-assisted diagnostic tool.

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

Not applicable. The device is a medical instrument, not an algorithm.

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

For the non-clinical testing, the "ground truth" would be the established engineering and performance specifications for each test (e.g., a specific force for deployment, a tolerance for dimensions, absence of leakage). These are defined internally by the manufacturer during device development.

8. The sample size for the training set

Not applicable, as no algorithm or human reader training set was required for this device's regulatory submission based on non-clinical testing.

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

Not applicable.

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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 FlowTriever 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 and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately:
• Triever Catheters (available in 2 sizes: 16 Fr and 20 Fr)
• FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15-18 mm, and 19-25 mm)
The FlowTriever Catheter is inserted through the Triever Catheter and advanced to the thrombus. Self-expanding wireform disks are deployed to engage thrombus by retracting the outer delivery catheter. The FlowTriever Catheter is retracted into the Triever Catheter to capture the targeted thrombus. Additional clot may also be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter and FlowTriever Catheter are removed from the patient.

This document is a 510(k) Premarket Notification from the FDA regarding the Inari Medical FlowTriever Retrieval/Aspiration System (K191368). It is a submission for a device modification, specifically, providing a Large Bore 60 cc Syringe in the sterile package of the Triever16 catheter.

Based on the provided text, the device in question is a medical device, not an AI/ML powered device. As such, the typical acceptance criteria and study designs relevant to AI/ML device performance (like sensitivity, specificity, MRMC studies, training/test sets, ground truth establishment by experts, etc.) are not applicable here.

The 510(k) submission states:

• "Clinical testing was not required for the determination of substantial equivalence."
• "No modifications have been made to the previously cleared Triever16 nor the Large Bore 60 cc Syringe. Design verification for inclusion of the Large Bore 60 cc Syringe with the Triever16 was limited to packaging evaluation after simulated shipping."
• "Test results demonstrated that all acceptance criteria were met; therefore, the device conforms to established product specifications."

Therefore, I cannot provide the detailed information requested for an AI/ML driven device based on this document. The acceptance criteria and performance data for this submission are focused on the safety and effectiveness of a physical medical device, specifically related to a change in packaging for an already cleared component, rather than the performance of an AI algorithm.

However, I can extract the general "acceptance criteria" and "device performance" in the context of this specific 510(k) submission, understanding that they relate to a non-AI device modification:

Acceptance Criteria and Study for K191368 (FlowTriever Retrieval/Aspiration System Modification)

Since this is a physical medical device and the submission pertains to a packaging change, the "acceptance criteria" and "device performance" relate to the physical integrity, sterility, and functionality of the device components as a result of that change, rather than diagnostic or analytical performance metrics typically associated with AI/ML.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated numerically for the packaging evaluation or shelf-life testing. The document mentions "sample size for design verification testing" was determined based on "risk category" and "confidence/reliability percentages," which is standard for medical device testing but the specific number is not provided.
• Data Provenance: The studies were conducted by Inari Medical as part of their design verification and validation process for a 510(k) modification. The nature of the tests (packaging, shelf-life) implies laboratory-based or simulated environment testing, not patient data from a specific country. The studies are prospective in the sense that they were designed and executed to evaluate the specific modification.

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

• Not applicable. For a physical device modification focused on packaging and shelf-life, "ground truth" as established by medical experts (like radiologists for AI/ML) is not a relevant concept. The ground truth would be the objective physical properties and performance characteristics determined through engineering and materials testing (e.g., package seal integrity, sterility, burst strength, material degradation over time).

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in human expert assessments, typically in diagnostic or clinical settings. This is not relevant for the type of engineering and physical testing described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Improvement with AI vs. without AI Assistance

• No. This is a physical medical device, not an AI/ML device. Therefore, no MRMC study was conducted or is relevant.

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

• Not applicable. This is a physical medical device. There is no algorithm to test standalone.

7. The Type of Ground Truth Used

• For this device modification, the "ground truth" was established through engineering specifications, physical testing standards, and established material science practices. It involves objective measurements and assessments of physical attributes like package integrity, material degradation, and maintenance of sterility, rather than clinical outcomes or expert consensus on a diagnosis.

8. The Sample Size for the Training Set

• Not applicable. This is a physical medical device. There is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

• Not applicable. This is a physical medical device. There is no "training set" or corresponding ground truth establishment in the context of machine learning.

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