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The EN Snare® Endovascular Snare System is intended for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. Retrieval and manipulation procedures include, indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veupuncture procedure assistance.

The EN Snare Endovascular Snare System consists of four individual components: snare: catheter: insertion tool and torque device. Systems are available in various sizes and lengths. The snare is comprised of 3 interlaced stranded cables of platinum and super-elastic nitinol that form 3 loops and are mechanically secured with a crimp collar to a nitinol shaft wire. The superelastic nitinol construction enables the loops of the snare to be introduced through a catheter without the risk of deformation. The catheter is manufactured with a Pebax outer layer and a PTFE inner layer with an embedded iridium/platinum markerband at the distal end, a Pebax hub and a polycarbonate luer. A snare insertion tool is also included for optional back-end loading of the snare into a preplaced catheter. The snare insertion tool is manufactured from polypropylene. The snare is inserted into an intravascular catheter and manipulated by use of an external torque device. The snare is offered in sizes ranging from 2mm to 45mm, with catheter sizes of 3.2F, 6F, and 7F.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "EN Snare Endovascular Snare System." It focuses on demonstrating substantial equivalence to a predicate device through various performance and safety tests.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that a "battery of testing was conducted in accordance with protocols based on requirements outlined in guidance's and industry standards and these were shown to meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not explicitly list specific numerical acceptance criteria for each test. Instead, it lists the types of tests performed and concludes that the device "met the acceptance criteria applicable to the safety and effectiveness of the device."

Therefore, a table cannot be constructed with specific numerical acceptance criteria. The performance is reported as meeting these (unspecified in detail) criteria.

Note: For medical devices, acceptance criteria are typically well-defined in the test protocols, but these are often considered proprietary and not included in publicly available 510(k) summaries beyond broad statements of compliance.

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of devices tested for kink resistance). It reports a "battery of testing" was conducted.

Moreso, this is a premarket notification for a medical device (EN Snare Endovascular Snare System), and the studies described are engineering and bench testing rather than clinical trials with human subject data. Therefore, concepts like "country of origin of the data" (for human subjects) or "retrospective or prospective" do not directly apply in the typical sense. The data provenance would be from laboratory and bench testing environments, likely performed at the manufacturer's (Merit Medical Systems, Inc.) facilities or certified testing labs.

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

This question is not applicable to the type of studies described. The "ground truth" for these engineering and biocompatibility tests is established by objective measurements against predefined engineering specifications, international standards (e.g., ISO, ASTM), and regulatory guidance documents, not by expert human consensus (like in diagnostic AI studies). The "experts" involved would be engineers, material scientists, and microbiologists who design and execute the tests and interpret the results against those standards.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where human readers are making subjective diagnoses or assessments which then need to be reconciled. For device performance testing, the results are objective measurements from instruments or standardized observations which either meet or fail the specified acceptance criteria.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms, often in comparison to human readers, and involves multiple human readers assessing medical cases.

The document describes pre-market testing for a physical medical device (an endovascular snare system), focusing on its mechanical, material, and biological safety characteristics, not its diagnostic or interpretative capabilities.

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

This is not applicable. The device described, the "EN Snare Endovascular Snare System," is a physical medical instrument used for retrieving foreign objects and manipulating catheters. It is not an algorithm, software, or AI system requiring standalone performance evaluation in that context.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the EN Snare Endovascular Snare System is constituted by:

• Engineering Specifications: Explicit design requirements and performance parameters set by the manufacturer.
• International Standards: Compliance with relevant ISO (e.g., ISO 10555-1, ISO 594-1/2, ISO 11135, ISO 10993-1, ISO 2233) and ASTM (e.g., ASTM F1980-07) standards.
• FDA Guidance: Adherence to FDA guidance documents (e.g., Coronary and Cerebrovascular Guide Wire Guidance, FDA Modified ISO 10993 Test Profile FDA Memo G95-1).

The tests confirm that the device physically functions as intended, is safe in terms of materials and interactions with the body, and meets required structural integrity, rather than confirming a medical diagnosis.

8. The Sample Size for the Training Set

This question is not applicable. The studies described are physical performance, material, and biocompatibility tests for a medical device. There is no "training set" in the context of machine learning or AI algorithms. The device's design and manufacturing processes are informed by engineering principles, material science, and regulatory requirements, not by training data in the AI sense.

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

This question is not applicable, as there is no "training set" for physical device testing in the context of AI. The "ground truth" for the device's design and manufacturing relies on established scientific and engineering principles, verified material properties, and adherence to quality control standards, rather than a labeled dataset.

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The EN Snare Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects. Manipulation procedures include indwelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veni-puncture procedure assistance.

The EN Snare ® Endovascular Snare System consists of four individual components: snare; catheter; snare introducer; and torque device. The snare is comprised of 3 cable loops which are secured to a shaft wire. The construction of the snare enables it to be introduced through a catheter and manipulated by use of an external torque device. A snare introducer is also included for optional back-end loading of the snare into a pre-placed catheter.

This document is a 510(k) Premarket Notification for the EN Snare® Endovascular Snare System. It aims to demonstrate substantial equivalence to a predicate device, rather than providing a study proving a device meets specific acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC).

Therefore, many of the requested categories are not applicable or cannot be answered from the provided text, as this type of submission focuses on demonstrating equivalence in design, materials, and intended use, not on a clinical performance study with predefined acceptance criteria for diagnostic accuracy.

Here's an analysis based on the provided text, addressing the applicable points:

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

This information is not present in the document. The submission is for a medical device that aims to be substantially equivalent to a predicate device, not a device that reports performance against specific diagnostic acceptance criteria. The document explicitly states: "No safety or performance testing is required to establish the safety and efficacy of the subject device" due to its identical nature to the predicate.

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

Not applicable. No performance study with a test set was conducted or reported for this 510(k) submission.

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. No ground truth establishment by experts was part of this submission.

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

Not applicable. No test set or adjudication method was described.

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 not an AI-assisted device, and no MRMC study was conducted or reported.

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

Not applicable. This is a medical instrument (snare system), not an algorithm.

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

Not applicable. No ground truth was established as no performance study was conducted.

8. The sample size for the training set

Not applicable. This is a medical instrument, not an AI/ML algorithm requiring a training set.

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

Not applicable.

Summary of the document's approach:

The core of this 510(k) submission (K097343) for the EN Snare® Endovascular Snare System is to demonstrate substantial equivalence to a previously cleared predicate device (K021606). The key argument for substantial equivalence is that the subject device is "manufactured with identical design, materials and processes as that of the currently marketed EN Snare® Endovascular Snare System."

Therefore, the "acceptance criteria" for this submission are met by demonstrating that:

• Intended Use is identical: "The EN Snare Endovascular Snare and Catheter is intended for use in the cardiovascular system or hollow viscous to retrieve and manipulate foreign objects."
• Technological Characteristics are identical: "There are no technological differences between the subject and predicate devices. The system is manufactured with identical design, materials and processes..."
• Safety & Performance Testing: The submission explicitly states, "No safety or performance testing is required to establish the safety and efficacy of the subject device," because it is identical to a device already on the market with a proven safety and efficacy profile.

In essence, the "study" proving the device meets its "acceptance criteria" here is the analysis demonstrating identicality to the predicate device, which itself was cleared based on its own safety and performance pathway.

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