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The ONE Snare endovascular snare system is intended for use in the coronary and peripheral vascular system or hollow viscous to retneve and manipulate foreign objects. Retrieval and manipulation procedures include indivelling venous catheter repositioning, indwelling venous catheter fibrin sheath stripping, and central venous access veripouncture procedure assistance.

The ONE Snare Endovascular Snare System is a snare system that is designed for use in the coronary and peripheral vascular system or hollow viscous to retrieve and manipulate foreign objects. The One Snare wire consists of a Nitinol core with a ground tapered distal section, a formed nitinol cable covered with a gold-plated tungsten coil. The formed cable with coil is attached to the core wire and then covered with a PTFE polymer sleeve. The wires are packaged with an introducer, torque device and guiding catheter – this makes up the “One Snare Endovascular Snare System”.

The provided text describes the regulatory clearance for the ONE Snare™ endovascular snare system (K193507) and references its substantial equivalence to a predicate device (K122088). However, it does not contain information about a study that proves the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning product.

The document details the physical characteristics and performance testing of a medical device (an endovascular snare system), focused on demonstrating its mechanical and functional equivalence to a previously cleared device. The "acceptance criteria" and "device performance" described are related to physical specifications and mechanical testing, not algorithm performance.

Therefore, many of the requested items (e.g., sample size for test/training sets, data provenance, ground truth establishment, expert adjudication, MRMC studies, standalone algorithm performance) are not applicable to the information provided.

Here's the relevant information that can be extracted, interpreted within the context of a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several performance attributes that were tested. The general statement is that "All test results were comparable to the predicate devices and the subject One Snare Endovascular Snare System met the predetermined acceptance criteria." Specific, quantitative acceptance criteria are not explicitly detailed in the provided text.

2. Sample size 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 as the tests are for physical device performance, not AI/ML model performance on data. The tests performed are listed as:

• Snare Size Designation
• Catheter Size Designation
• Catheter Surface Inspection
• Catheter OD Inspection
• Catheter Tip Length of Angle
• Catheter Angle
• Catheter Tip ID Inspection
• Simulated Use (design validation)

The provenance of this testing data (e.g., country of origin, retrospective/prospective) is not specified.

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 information is not applicable as the tests relate to the physical properties and simulated performance of a medical device, not to the interpretation of medical images or data requiring expert-established ground truth.

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

This information is not applicable for the reasons stated in item 3.

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

An MRMC comparative effectiveness study is not applicable as this is not an AI/ML device for diagnostic or assistive interpretation.

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

This information is not applicable as this is a physical medical device, not an algorithm.

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

For the physical tests conducted (e.g., Catheter OD Inspection, Catheter Angle), the "ground truth" would be the engineering specifications and tolerances of the device. This is inherent to the manufacturing and design process and not explicitly detailed in terms of "expert consensus," "pathology," or "outcomes data."

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device.

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

This information is not applicable as this is not an AI/ML device.

In summary, the provided document describes a 510(k) clearance for a physical medical device and its performance testing to demonstrate substantial equivalence, not an AI/ML product's validation study. Therefore, most of the requested information related to AI/ML evaluation criteria is not present.

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The ONE 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 venipuncture procedure assistance.

The ONE Snare™ System contains: (1) Snare, (1) Snare Catheter, (1) Introducer and (1) Torque Device. The snare is constructed of nitinol cable and a gold plated tungsten loop. The pre-formed snare loop can be introduced through catheters without risk of snare deformation because of the snare's super-elastic construction. The snare catheter is constructed of polyether block amide (Pebax®) and contains a platinum/iridium radiopaque marker band.

The provided text describes a traditional Premarket Notification 510(k) for the Merit ONE Snare™ system. This type of submission focuses on demonstrating substantial equivalence to a predicate device through performance testing rather than clinical study data. Therefore, many of the requested data points related to clinical trials, ground truth, expert adjudication, and separate training/test sets are not applicable or explicitly stated in this type of submission.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "a battery of tests performed on the Merit ONE Snare™ system were designed to demonstrate that the device meets critical design specifications as well as clinical performance attributes for its intended use." It then lists numerous safety and performance tests. However, specific numerical acceptance criteria and their corresponding reported device performance values are NOT provided in this summary. The summary only states that these tests were "successfully completed."

Below is a table summarizing the types of tests performed. Note that specific quantitative acceptance criteria and performance metrics are not detailed in the provided text.

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

The text describes a "battery of tests" performed to demonstrate the device meets critical design specifications and clinical performance attributes. These are bench and laboratory tests, not typically clinical trials involving human subjects or extensive clinical data sets. Therefore:

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients." The sample size would refer to the number of individual devices or components tested for each specific bench test. This information is not detailed in the summary.
• Data Provenance: The tests are laboratory-based, implying the data is generated in a controlled testing environment, consistent with product development and regulatory submission requirements for a device of this nature. It is not clinical data in the sense of patient records or imaging. Likely, the tests were conducted at Merit Medical's facilities or accredited testing labs. It is not retrospective or prospective clinical data.

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

This question is not applicable in the context of this 510(k) summary. The "ground truth" for bench and lab testing of a medical device like a snare system involves meeting engineering specifications, material properties, and functional performance metrics established by industry standards (e.g., ISO, ASTM) and internal design requirements. There typically isn't a need for "experts" to establish a clinical ground truth in the way it's done for diagnostic AI.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or expert reviews of complex diagnoses, particularly for AI performance evaluation. For bench testing of a device, performance is evaluated against predefined pass/fail criteria for each test, not by expert consensus or adjudication on clinical cases.

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 question is not applicable. The Merit ONE Snare™ system is a physical medical device (a retrieval snare), not an AI algorithm or a diagnostic tool that assists human "readers" in interpreting data. Therefore, an MRMC study or AI assistance effect size is irrelevant to this device.

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

This question is not applicable as the Merit ONE Snare™ system is a physical medical device, not an algorithm.

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

For this device, the "ground truth" refers to the established engineering specifications, material properties, and functional performance requirements (e.g., tensile strength, flexibility, biocompatibility, dimensions, seal integrity). These are defined by relevant international (ISO) and national (ASTM, FDA guidance) standards, as well as the manufacturer's internal design controls. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This question is not applicable. Bench testing for a medical device like this does not involve a "training set" in the context of machine learning or AI. Performance is evaluated against predefined criteria, not by training a model.

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

This question is not applicable for the same reasons as #8.

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