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The Vascular Retrieval Snare is intended for use in the cardiovascular system to manipulate and retrieve foreign objects, including, but not limited to, wire guides, coils, balloons, catheters, and filters.

The Vascular Retrieval Snare consists of four petals composed of nitinol and tantalum. It is packaged with a coaxial sheath system and a dilator. Each of the sheaths of the coaxial system has radiopaque tips incorporated to identify the location of the distal tip of each sheath.

The Cook Incorporated FourSnare Vascular Retrieval Snare is a medical device intended for use in the cardiovascular system to manipulate and retrieve foreign objects. The 510(k) submission for this device outlines several tests performed to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample sizes for each of the tests performed. It states "The following tests were performed to demonstrate that the Vascular Retrieval Snare meets applicable design and performance requirements."
The data provenance is from testing conducted by Cook Incorporated for the purpose of demonstrating substantial equivalence for regulatory clearance. The document does not specify a country of origin for the data or if the tests were retrospective or prospective, though performance testing for medical devices is typically prospective relative to the submission.

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

The document does not mention the use of experts to establish ground truth for the test set. The tests described are primarily engineering performance tests measuring physical characteristics and functional capabilities of the device against predefined specifications. These types of tests typically rely on objective measurements rather than expert human interpretation.

4. Adjudication Method for the Test Set

Since the tests described are objective engineering and performance tests, no adjudication method (e.g., 2+1, 3+1) was used or required for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed or is mentioned in the provided document. The submission focuses on demonstrating substantial equivalence to predicate devices through design, intended use, materials, fundamental technology, principal of operation, and performance testing, rather than evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study

The testing described is primarily for the standalone performance of the device itself (algorithm only without human-in-the-loop performance, though applicable to a medical device's functional integrity). The tests assess various physical and functional attributes of the snare, such as tensile strength, liquid leakage, kinking, radiopacity, and ability to retrieve objects. These are inherent device characteristics and do not involve human-in-the-loop performance evaluation in the context of diagnostic interpretation or AI assistance.

7. Type of Ground Truth Used

The ground truth for the device's performance was established by predetermined acceptance criteria for each test. These criteria are based on recognized standards (e.g., ISO 11070, ISO 10555-1) and expected performance for safe and effective clinical use, rather than expert consensus, pathology, or outcomes data in the traditional sense of clinical studies evaluating diagnostic accuracy.

8. Sample Size for the Training Set

The document does not describe a "training set" as would be relevant for machine learning or AI algorithms. The tests performed are engineering and performance validation tests for a physical medical device.

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

As there is no mention of a "training set" in the context of AI or machine learning for this device, the question of how ground truth was established for a training set is not applicable. The ground truth for the device's performance was defined by the predetermined acceptance criteria for each physical and functional test.

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The Retrieval Snare is indicated for use in grasping and retrieval of foreign body within the alimentary tract. These foreign bodies may include guidewires, pullwires, or plastic stents.

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The provided text is a 510(k) summary for a medical device called the "Retrieval Snare." This type of document is for premarket notification of a device claiming substantial equivalence to a predicate device, not typically a study designed to prove acceptance criteria for an AI/software as a medical device (SaMD). Therefore, much of the requested information (related to AI performance, sample sizes for training/test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not contained within this document.

However, I can extract the closest analogous information regarding "acceptance criteria" and "device performance" as presented in this regulatory submission by looking at the device's indications for use and comparisons to predicate devices. In the context of a 510(k), "acceptance criteria" relate to demonstrating substantial equivalence, and "device performance" is typically described through functional specifications and intended use.

Here's a breakdown based on the provided text, while acknowledging the inherent limitations for answering AI-specific questions:

1. Table of "Acceptance Criteria" and Reported Device Performance

In a 510(k), "acceptance criteria" aren't explicitly stated in the conventional sense of numerical thresholds for a specific study outcome (like sensitivity/specificity for an AI). Instead, the acceptance is based on demonstrating the device is substantially equivalent to a legally marketed predicate device. This involves showing similar intended use, technological characteristics, and safety/effectiveness. The table below attempts to translate the provided information into this framework.

Details of the "Study" (510(k) Submission):

The provided text is a 510(k) premarket notification. This is not a clinical study in the typical sense of testing a hypothesis with patient data. Instead, it's a regulatory submission used to demonstrate "substantial equivalence" to a predicate device. The "study" that proves the device meets the "acceptance criteria" (i.e., is substantially equivalent and safe/effective) is the comparison to legally marketed predicate devices.

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

• Sample Size for Test Set: Not applicable. This document does not describe a test set for performance evaluation in the context of an AI/SaMD. The "test set" here would implicitly be the specifications and characteristics of the device itself, compared against those of predicate devices.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. No clinical data from patients is presented. The "data" used are primarily the specifications and regulatory history of the device and its predicate devices.

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

• Not applicable. Ground truth for an AI/SaMD test set is not relevant to a 510(k) submission for a physical medical device. Decisions within the 510(k) process are made by regulatory bodies based on documented evidence and comparisons.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

• Not applicable. There is no "test set" and no human adjudication process involved in comparing performance in the way described for AI/SaMD.

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 physical device, not an AI/SaMD. No MRMC study was performed or is relevant to this submission.

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

• Not applicable. This is a physical device, not an algorithm.

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

• Not applicable. For a physical device 510(k), the "ground truth" for substantial equivalence is derived from established regulatory standards, predicate device characteristics, and the device's own specifications/testing (e.g., biocompatibility guidance, mechanical testing, etc., though details are not in this summary).

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/SaMD; there is no "training set."

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

• Not applicable. There is no "training set" and therefore no ground truth to establish for one.

In summary: The provided document is a regulatory filing for a physical medical device. It focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics, rather than presenting a performance study for an AI/SaMD. Therefore, most of the questions related to AI/SaMD performance criteria, study design, and ground truth are not applicable.

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