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The CAPERE® Thrombectomy System is indicated for:

• Non-surgical removal of soft emboli and thrombi from blood vessels.
• Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.

The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.

The CAPERE® Thrombectomy System primarily consists of a Delivery Catheter and Guide Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.

The provided text does not contain information about an AI/ML powered device, but rather a medical device for thrombectomy. Therefore, it's not possible to extract the requested information regarding acceptance criteria, study details, and AI/ML specific metrics.

The document describes the CAPERE Thrombectomy System, a device for non-surgical removal of soft emboli and thrombi from blood vessels. It details the device's characteristics, intended use, and provides evidence of substantial equivalence to a predicate device based on nonclinical performance testing.

Here's the information that is available in the provided text regarding the device performance and acceptance criteria for this non-AI/ML device:

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

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

• The document states "nonclinical performance testing has been conducted...In all instances, the CAPERE® Thrombectomy System functioned as intended under the previously established test methods." However, specific sample sizes for the nonclinical tests are not provided.
• Data provenance is not explicitly stated, but it can be inferred that the testing was conducted by Vascular Medcure, Inc. or a contracted lab, as it refers to "established test methods used in the cleared predicate device" and "simulated-use test method." No country of origin for the data is mentioned, nor is it specified if the tests were retrospective or prospective, though bench and simulated-use testing are inherently prospective in nature.

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

• This information is not applicable as the described tests are nonclinical bench and simulated-use tests, not studies involving expert adjudication of data like images or patient cases.

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

• This information is not applicable as the described tests are nonclinical bench and simulated-use tests, not studies requiring expert adjudication methods.

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:

• This information is not applicable as the device is not an AI-assisted diagnostic tool but a physical thrombectomy system.

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

• This information is not applicable as the device is not an AI algorithm.

7. The type of ground truth used:

• For the nonclinical performance testing, the "ground truth" was established by predetermined technical specifications and performance characteristics of the predicate device, as well as by compliance with relevant international standards (ISO 10555-1 and ISO 594-2). For example, the ability to capture clot was evaluated against the "complete capture and removal of simulated clot."

8. The sample size for the training set:

• This information is not applicable as the device is not an AI algorithm and does not have a "training set."

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

• This information is not applicable as the device is not an AI algorithm.

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The CAPERE® Thrombectomy System is indicated for:
-Non-surgical removal of soft emboli and thrombi from blood vessels.
-Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.

The CAPERE® Thrombectomy System primarily consists of an 9Fr Delivery Catheter and 12Fr Guide Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.

Here's a breakdown of the acceptance criteria and the study information for the CAPERE® Thrombectomy System, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, so some of the requested information (like MRMC studies, training set details, and expert qualifications for ground truth) is not applicable or not provided in this regulatory document. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

Acceptance Criteria and Reported Device Performance

Study Details

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

   • The document does not specify a "sample size" in terms of number of devices or number of tests for each specific functional bench test. It mentions "functional bench testing was conducted" and describes the types of tests.
   • Data Provenance: The studies are non-clinical, in-vitro bench tests conducted to evaluate device performance against established standards and predicate device characteristics. No information on geographical origin is typically relevant or provided for this type of testing.

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

   • This is not applicable as this is a non-clinical, physical device. "Ground truth" in the context of expert review for diagnostic AI/ML is not relevant here. The acceptance criteria are based on engineering standards (ISO) and performance equivalence to a legally marketed predicate device.

3. Adjudication method for the test set:

   • Not applicable. The tests are objective measurements against defined standards and predicate performance, rather than subjective interpretations requiring adjudication.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This is a physical medical device (thrombectomy system), not a diagnostic AI/ML system that would involve human readers interpreting cases.

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

   • Not applicable, as this is a physical medical device, not a software algorithm.

6. The type of ground truth used:

   • The "ground truth" for the performance evaluation is based on engineering standards (ISO 10555-1, ISO 594-2) and the established performance characteristics of the predicate device. For clot capture, the "ground truth" is complete capture and removal of a simulated clot.

7. The sample size for the training set:

   • Not applicable. This device does not use machine learning, so there is no training set in the sense of data used to train an algorithm.

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

   • Not applicable, as there is no training set.

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The CAPERE® Thrombectomy System is indicated for:

• Non-surgical removal of soft emboli and thrombi from blood vessels.
• Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
  The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.

The CAPERE® Thrombectomy System primarily consists of an 12Fr Delivery Catheter and 15Fr Guide Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.

The provided text describes the 510(k) premarket notification for the CAPERE® Thrombectomy System, focusing on its substantial equivalence to a predicate device (K180722). However, it does not contain a specific acceptance criteria table with reported device performance metrics in the format requested.

The document primarily discusses the nonclinical performance testing conducted to support substantial equivalence. It does not detail a clinical study with human patients for AI/device performance evaluation as implied by some of the questions (e.g., MRMC studies, standalone algorithm performance, AI improvement for human readers). The device described is a medical device for thrombectomy, not an AI/ML algorithm requiring ground truth from experts or large datasets for training and testing in the typical sense of AI product evaluation.

Based on the provided information, I can answer the following:

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

The document states that "the CAPERE® Thrombectomy System functioned as intended under the previously established test methods" and "demonstrated that the CAPERE® Thrombectomy System maintained the predicate characteristics." It also mentions "preestablished acceptance criteria" but without listing them explicitly or providing specific numerical results.

However, based on the descriptions of the tests, we can infer some of the implicit acceptance criteria:

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

The document describes nonclinical performance testing (bench and simulated use testing) rather than a clinical study with human patient data. Therefore, the concept of a "test set" and "data provenance" in the context of human data is not directly applicable here. The testing involved device components and simulated clots. No information is provided regarding the specific number of devices or simulated clots used for each test.

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. The study described is nonclinical performance testing of a physical medical device, not an AI algorithm evaluated against expert-established ground truth.

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

This question is not applicable. There was no clinical study with expert readers 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document does not describe a study involving human readers or AI assistance.

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

This question is not applicable. The CAPERE® Thrombectomy System is a physical medical device, not a standalone algorithm.

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

The "ground truth" for the nonclinical performance tests would be defined by the engineering and quality standards for device functionality. For example:

• Biocompatibility: Confirmation against established biological safety standards.
• Packaging: Ability to maintain sterility and physical integrity as per accelerated aging and handling protocols.
• Functional Bench Testing: Compliance with ISO standards (e.g., ISO 10555-1 for sterile single-use catheters, ISO 594-2 for conical fittings) and maintenance of mechanical characteristics (e.g., bond strength, dimension).
• Simulated Use Testing: Successful retrieval of simulated clots without device failure (rupture, damage) as per predefined criteria.

8. The sample size for the training set

This question is not applicable. There is no mention of a "training set" for an AI algorithm. The studies are nonclinical performance tests of a physical device.

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

This question is not applicable.

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The CAPERE® Thrombectomy System is indicated for:

• Non-surgical removal of soft emboli and thrombi from blood vessels.
• Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
  The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.

The CAPERE® Thrombectomy System primarily consists of an 8Fr Delivery Catheter and Funnel Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.

The provided text describes the 510(k) clearance for the CAPERE Thrombectomy System. This regulatory submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a specific performance acceptance criteria against a medical outcome (like 'improving diagnostic accuracy'). Therefore, many of the requested categories for AI/diagnostic devices (e.g., multireader-multicase studies, expert consensus for ground truth on a training set) are not applicable to this type of device clearance.

The "acceptance criteria" in this context refer to the device meeting engineering and functional performance specifications, and demonstrating that changes from the predicate device do not introduce new safety or effectiveness concerns.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified in terms of numerical units (e.g., N devices tested). The document states "functional bench testing was conducted" and "Simulated Use Testing was completed." It refers to "the CAPERE® Thrombectomy System" in the singular, but implies testing was performed sufficiently to make general claims. It does not provide the number of devices or iterations tested.
• Data Provenance: The tests are described as "nonclinical performance testing" and "functional bench testing" / "Simulated Use Testing." This indicates laboratory-based, simulated data, not data from human patients or a specific country of origin. The data is implicitly prospective in the sense that the tests were designed and conducted to evaluate the device.

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

• Not Applicable. This is not a study involving human interpretation of data where expert ground truth is established (e.g., radiology image interpretation). The "ground truth" for these tests is defined by the engineering specifications and the ability of the device to perform its mechanical functions in a simulated environment.

4. Adjudication Method for the Test Set

• Not Applicable. No human adjudication method (like 2+1, 3+1) is relevant for this type of mechanical and functional performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is a mechanical device, not an AI/diagnostic software. MRMC studies are not relevant for its clearance.

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

• Not Applicable. This is a hardware medical device, not an algorithm. Its performance is inherent to its design and function. However, the "Simulated Use Testing" could be considered analogous to "standalone performance" in the sense that it evaluates the device's function without a human patient or a full clinical scenario, but within a simulated environment.

7. The Type of Ground Truth Used

• Engineering Specifications and Functional Performance Benchmarks: The ground truth for this device's testing is primarily based on predefined engineering and functional performance criteria. For example, "without capture basket rupture," "without catheter damage," and "maintained predicate characteristics" are the benchmarks.

8. The Sample Size for the Training Set

• Not Applicable. This device is a mechanical thrombectomy system, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's design and manufacturing process are informed by engineering principles, not data-driven training.

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

• Not Applicable. As there is no training set for an AI algorithm, this question is not relevant. The "ground truth" for the device's design (if you were to interpret it broadly as the basis for its creation) would be established through established medical device design principles, biomechanical understanding of fluid dynamics and clot removal, and experience with predicate devices.

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The CAPERE™ Thrombectomy System is indicated for:

· Non-surgical removal of soft emboli and thrombi from blood vessels.

• · Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
  The CAPERE™ Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.

The CAPERE™ Thrombectomy System primarily consists of an 8Fr Delivery Catheter and Funnel Catheter. The CAPERE™ Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE™ System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.

The document provided pertains to a 510(k) premarket notification for the CAPERE Thrombectomy System, a physical medical device (embolectomy catheter), not an AI/ML medical device. Therefore, the information typically required for describing the acceptance criteria and the study proving an AI/ML device meets those criteria (such as ground truth, expert consensus, MRMC studies, training/test set details, etc.) is not present in this document.

The document describes performance data for a physical device, which includes:

• Biocompatibility testing: To ensure the materials are safe for patient contact.
• Package integrity and accelerated aging studies: To demonstrate the sterility barrier and shelf-life.
• Functional bench testing: To ensure the device performs as intended, adhering to standards like ISO 10555-1 and ISO 594-1.
• Simulated Use Testing: To show the device can retrieve simulated clots without damage or adverse effects.
• Confirmatory In vivo testing in an animal model: To confirm usability, ease of use, and interaction within the vascular system.

The acceptance criteria for these tests would be related to specific measurements (e.g., tensile strength, burst pressure, clot retrieval efficiency, absence of damage) that are typically defined in engineering specifications and test protocols for physical medical devices.

Based on the provided text, I cannot extract the specific details requested for an AI/ML device's acceptance criteria and study, as the device in question is a physical thrombectomy system.

Therefore, I cannot fill out the requested table or answer the specific questions about AI/ML device validation.

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