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Intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered in straight and angled tip shapes, standard and stiff wire configurations, and in various wire lengths and wire diameters.

Unfortunately, the provided document {0} - {6} does not contain the information required to answer the prompt.

The document is a 510(k) premarket notification for a medical device (Merit Hydrophilic Guide Wire). While it details the device's characteristics, intended use, and the types of safety and performance tests conducted, it does not include a table of acceptance criteria with reported device performance or information about a study involving AI assistance or human reader performance.

Specifically, the document discusses:

• Acceptance Criteria: It mentions that tests were shown to "meet the acceptance criteria that were determined to demonstrate substantial equivalence." However, it does not list these criteria or the numerical results for each.
• Study Design/Results: The document lists various performance and biocompatibility tests (e.g., Torqueability, Lubricity, Cytotoxicity), but it does not provide:
  • Specific performance metrics against acceptance criteria.
  • Sample sizes for these tests (beyond stating "a battery of testing").
  • Details about how ground truth was established, or involving expert readers, or multi-reader multi-case studies, as these types of studies are typically associated with AI/imaging device evaluations, not mechanical guidewires.
  • Any information regarding human readers, AI assistance, or comparative effectiveness studies of that nature.

This document is from 2020 and pertains to a physical medical device (guidewire) that is unlikely to involve AI or a diagnostic imaging component where such detailed study information (like MRMC or human-in-the-loop performance) would be relevant. The questions in your prompt are highly specific to AI/imaging device evaluations.

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The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered in straight, angled, standard and stiff configurations, in various lengths.

The provided text describes a 510(k) premarket notification for the "Merit Hydrophilic Guide Wire." This document is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study proving the device meets specific acceptance criteria in the sense of a clinical or academic study reporting performance metrics like sensitivity, specificity, or reader improvement with AI.

Instead, the document details a series of engineering and biocompatibility tests conducted to show that the new device (Merit Hydrophilic Guide Wire with a "Benzene Free" coating material) performs comparably to its predicate device (Merit Hydrophilic Guide Wire with the previous coating material) and meets established industry standards and FDA guidance.

Therefore, many of the requested items related to "AI performance," "ground truth," "expert adjudication," and "effect size of human readers with AI assistance" are not applicable to this type of device submission.

Here's an analysis based on the provided text, focusing on the available 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 provide the specific numerical acceptance criteria or quantitative performance results for each test. It only lists the types of tests performed and states that all tests were "successfully completed" and "met the predetermined acceptance criteria."

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

• Test Set Sample Size: The document mentions that "Most of the performance testing was performed on the 0.018" and 0.038" diameter wires only, as these represent the minimum and maximum wire diameters within the cleared device range... The exception to this is Biocompatibility, where the 0.035" OD variant of the wire was chosen for testing." The exact number of units tested for each specific test is not provided.
• Data Provenance: The tests are conducted internally by Merit Medical Systems, Inc. (or related entities). This is a manufactured product, so the "data provenance" refers to the results of in-vitro and potentially in-vivo (for biocompatibility, such as the canine thrombolysis study) testing. The document does not specify the country of origin for the testing facilities, but the company itself has addresses in the US and Ireland. The testing is prospective in the sense that it's performed specifically for this submission.

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

Not applicable. This is a medical device engineering and biocompatibility assessment, not an AI performance study requiring expert ground truth for interpretation of medical images or data. The "ground truth" here is established by the standardized test methods themselves and their predefined pass/fail criteria.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication in this type of testing. The results are physical/chemical measurements or biological responses against established criteria.

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

Not applicable. This is not an AI device, and therefore no MRMC study was performed comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI algorithm. The device, a guide wire, is used directly by a human clinician.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance validation is:

• Engineering Standards and Specifications: Adherence to defined physical, mechanical, and functional specifications established by industry standards (e.g., ISO, ASTM) and FDA guidance for guide wires.
• Biocompatibility Standards: Compliance with established biological safety standards (e.g., ISO 10993 series) for medical devices.
• Comparative Performance to Predicate: Demonstrating that the subject device performs comparably to the legally marketed predicate device (K141295) in various performance attributes.

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm, so there is no training set in the machine learning sense.

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

Not applicable, as there is no AI training set.

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The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered in straight and angled configurations in various lengths.

The provided text refers to a medical device, the "Merit Hydrophilic Guide Wire," and its substantial equivalence to predicate devices, rather than an AI/ML powered device. Therefore, many of the requested details about acceptance criteria, study design, and ground truth for an AI/ML model are not applicable.

However, I can extract information related to the device's performance testing and how it met acceptance criteria for substantial equivalence to predicate devices.

Summary of Acceptance Criteria and Device Performance (for the Merit Hydrophilic Guide Wire):

Study Information (Based on Substantial Equivalence Evaluation):

1. Sample sizes used for the test set and data provenance:
   This information is not provided in a way that is applicable to an AI/ML model. The "test set" in this context refers to a series of physical tests performed on the guide wire samples. The document does not specify the number of guide wires tested for each attribute or their provenance. The "data provenance" mentioned in your request (country of origin of data, retrospective/prospective) is relevant for clinical data, not for material property testing of a medical device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable. "Ground truth" in this context would typically refer to expert consensus on clinical diagnoses for AI/ML. For a physical device, testing against defined engineering specifications serves as the "ground truth." The document states "protocols based on requirements outlined in guidance's and industry standards," implying established engineering and scientific methods rather than expert clinical consensus on individual test results.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in clinical studies, particularly for AI/ML evaluation. This document describes laboratory testing against established standards.

4. 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, as this is not an AI/ML device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable, as this is not an AI/ML device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For this medical device, the "ground truth" for the performance tests was established by industry standards (e.g., ISO 11070:1998, ISO 11135-1:2007, ASTM F1980-07, ISO 10993-1:2009) and FDA guidance (Coronary and Cerebrovascular Guide Wire Guidance January 1995, FDA Modified ISO 10993 Test Profile FDA Memo G95-1). The device's performance was compared to a "predicate device" (Terumo Radiofocus® Glidewire® K863138) for various attributes.

7. The sample size for the training set:
   Not applicable, as this is not an AI/ML device, and therefore no "training set" in that sense was used. The device underwent physical and chemical testing.

8. How the ground truth for the training set was established:
   Not applicable, as this is not an AI/ML device.

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The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered in straight and angled configurations in various lengths.

The provided text does not describe a study involving an AI/algorithmic device. The document is a 510(k) premarket notification for a Merit Hydrophilic Guide Wire, which is a physical medical device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and AI-specific metrics is not applicable in this context.

The document discusses the substantial equivalence of the subject guide wire to predicate devices based on various performance attributes and safety tests.

Here's a breakdown of what is provided, as it relates to the physical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a table of specific acceptance criteria values and corresponding device performance data for each test. Instead, it states that:

Tests Performed (implied acceptance criteria for each):

• Tensile Strength
• Torque Strength
• Torquability
• Tip Flexibility
• Coating Adherence/Integrity (including Evaluation using Anatomical Model)
• Catheter Compatibility (Durability)
• Surface
• Fracture Test
• Flex test
• Size Designation/Dimensions
• Radiopacity

The acceptance criteria for these tests were based on:

• FDA guidance: Coronary and Cerebrovascular Guide Wire Guidance January 1995.
• ISO 11070: 1998, Sterile Single-Use Intravascular Catheter Introducers.
• ISO 11135-1: 2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
• ASTM F1980-07 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
• ISO 10993-1: 2009, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and the FDA Modified ISO 10993 Test Profile FDA Memo G95-1.

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

Not applicable for an AI device. For the physical guide wire, the sample sizes for each specific test (e.g., tensile strength, flex test) are not explicitly stated in this summary. The tests were likely conducted on a sufficient number of samples to statistically demonstrate compliance with the acceptance criteria, as is standard practice for medical device testing. The provenance of the "data" (i.e., the physical test results) would be from in-house laboratory testing conducted by Merit Medical Systems, Inc. in Ireland.

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

Not applicable. Ground truth as typically defined for AI models (e.g., expert consensus on medical images) does not apply to the performance testing of a physical guide wire. The "ground truth" for these tests would be the established engineering and biological standards and guidances mentioned above.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1, 3+1" are used for resolving disagreements among multiple human readers in image interpretation, which is not relevant to this physical device.

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. This is irrelevant to a physical medical device.

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

No. This is irrelevant to a physical medical device.

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

For the physical device, the "ground truth" refers to the established scientific and engineering principles, material properties, and biological safety standards (e.g., biocompatibility standards like ISO 10993) against which the device's performance was measured. There's no "ground truth" in the AI sense.

8. The sample size for the training set

No. This is irrelevant to a physical medical device.

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

No. This is irrelevant to a physical medical device.

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The Merit Hydrophilic Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures

The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered in straight and angled configurations in various lengths.

The provided text describes a 510(k) premarket notification for a medical device (Merit Hydrophilic Guide Wire), focusing on its substantial equivalence to predicate devices. The information available pertains to the device's technical characteristics, intended use, and the performance tests conducted to demonstrate substantial equivalence.

However, the document does not contain specific details regarding acceptance criteria in a quantitative table format with reported device performance against those criteria. It states that "all test results were comparable to the predicate devices and all predetermined acceptance criteria for tests were successful."

Furthermore, the document does not provide information relevant to AI/ML device studies, such as:

• Sample size used for the test set or data provenance (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or effect size of human improvement with AI.
• Standalone (algorithm-only) performance.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

This is expected as the document appears to be a traditional medical device submission for a guide wire, not an AI/ML-driven diagnostic or assistive device.

Therefore, I cannot fulfill your request for the comprehensive acceptance criteria and study details related to AI/ML device performance from the provided text. The device is a "Merit Hydrophilic Guide Wire" and the studies described are traditional lab-based performance and safety tests, not clinical studies involving AI.

Ask a specific question about this device

The Merit Hydrophilic Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures.

The Merit Hydrophilic Guide Wire consists of a jacketed core wire with a hydrophilic coating applied to the jacket. The wire will be offered with straight and angled tip configurations in various lengths.

The provided text describes the regulatory submission for the Merit Hydrophilic Guide Wire, asserting its substantial equivalence to a predicate device. However, it does not contain a specific study report with detailed acceptance criteria and reported device performance in the format requested. Instead, it outlines the types of tests performed and the standards referenced to demonstrate safety and efficacy.

Here's an analysis of the requested information based on the provided text, highlighting what is present and what is not:

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

The document does not provide a table specifying distinct acceptance criteria values alongside corresponding reported device performance values for each test. It states that "a battery of tests was performed according to protocols based on the requirements of industry standards and guidances and were shown to meet the acceptance criteria that were determined to demonstrate the safety and efficacy of the device."

The types of tests successfully completed are listed as:

• Coating Adherence/Integrity
• Catheter Compatibility
• Surface
• Fracture Test
• Flex Test
• Size Designation
• Biocompatibility
• Chemical Characterization

For each of these, the document implies that predefined acceptance criteria were met, but the specific criteria and results are not detailed.

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 present in the provided text. The document mentions tests were performed but does not specify sample sizes or data 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)

This information is not applicable as the document describes performance testing of a physical medical device (guide wire) against engineering standards and biocompatibility requirements, not a diagnostic device requiring expert interpretation for ground truth establishment.

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

This information is not applicable for the same reasons as point 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

This information is not applicable. The device is a medical guide wire, not an AI-assisted diagnostic tool.

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

This information is not applicable for the same reasons as point 5.

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

For the performance tests listed, the "ground truth" would be defined by compliance with established industry standards and guidances, such as ISO 11070 for catheter introducers, ASTM F756 for hemolytic properties, and ISO 10993 for biological evaluation. These standards inherently define the acceptable performance parameters. The document also states that the device was compared to a predicate device (K092303) for various performance attributes, implying that the predicate's established safety and efficacy serve as a benchmark.

8. The sample size for the training set

This information is not applicable as there is no mention of a "training set" in the context of this physical device's testing. Machine learning or AI models, which typically use training sets, are not part of this device's evaluation as described.

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

This information is not applicable for the same reasons as point 8.

In summary:

The document focuses on demonstrating that the modified Merit Hydrophilic Guide Wire is substantially equivalent to its predicate based on a battery of tests against recognized industry standards and guidances. It states that these tests met acceptance criteria, thereby demonstrating the safety and efficacy of the device. However, it does not provide the granular details of these criteria or the test results in a tabular format, nor does it involve elements common to AI device evaluations (like ground truth established by experts, reader studies, or training sets).

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