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The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. An introducer sheath and shaping mandrel are also provided.

The provided text describes the MicroVention, Inc. Headway 27 Microcatheter and its substantial equivalence to a predicate device (Headway 27 Microcatheter, K110813). The document primarily focuses on bench testing and biocompatibility testing to demonstrate this equivalence.

Here's an analysis of the acceptance criteria and study data based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Flexural fatigue: simulated use, tip shaping testing
• Hoop stress fatigue: flow rate, dynamic burst, liquid leakage | Passed |
  | Catheter Particle Testing | Per USP - less than 25 particles greater than 10 microns and less than 3 particles greater than 25 micron | Passed |
  | Dead Space | Reference data | N/A (Reference data, not performance against a specific criterion for this submission) |
  | Torque Test | 50 rotations without catheter breakage or equivalent to competitive product catheters. | Passed |
  | DMSO Test | Functional performance and chemical stability | Passed |
  | Biocompatibility (Cytotoxicity MEM Elution) | Cell culture tested with test article exhibited slight reactivity (Grade 1) | Non-toxic |
  | Biocompatibility (Cytotoxicity Cell Culture Agar Overlay) | Grade 2: zone limited to under specimen | Non-toxic |
  | Biocompatibility (Sensitization Guinea Pig Maximization Test) | Grade 0: No visible change | Non-irritant |
  | Biocompatibility (Irritation Intracutaneous Reactivity Evaluation Test) | Comparative between control and test article 10%. No reaction found. | Non-toxic effects |
  | Biocompatibility (Systemic Toxicity Rabbit Pyrogen Test) | Temperature increases was 0.0℃ from baseline. | Non-pyrogenic |

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

The document describes general bench testing and biocompatibility testing. It does not specify the sample sizes (number of units tested) for each individual bench test or the biocompatibility studies.

The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. Given the context of a 510(k) submission, this data would typically be generated by the manufacturer (MicroVention, Inc., USA) as part of their device development and validation process, likely in a controlled laboratory environment.

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

This information is not provided in the document. The studies performed are primarily physical and chemical bench tests, and in vitro and in vivo biocompatibility tests, which do not typically involve human expert interpretation for "ground truth" establishment in the way, for example, a diagnostic image review would. For "rated 3 or higher," "passed," etc., these would be based on predefined objective criteria in test protocols, not subjective expert consensus.

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

This information is not applicable and not provided in the document. Adjudication methods are typically used in studies involving human interpretation or decision-making, such as clinical trials or diagnostic accuracy studies, to resolve discrepancies among multiple reviewers. The tests described are objective, physical, chemical, and biological assessments.

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 is not applicable and not provided. The device in question is a microcatheter, a physical medical device used for intravascular delivery. It is not an AI-powered diagnostic or assistive technology that would involve "human readers" or "AI assistance" in the sense of an MRMC study.

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

This is not applicable and not provided for the same reasons as point 5. The device is a physical tool, not an algorithm.

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

The "ground truth" for the bench tests are the pre-defined engineering specifications and performance criteria for the physical properties of the catheter (e.g., length, diameter, burst pressure, kink resistance, force at break). For the biocompatibility tests, the "ground truth" is established by standardized ISO 10993 biological evaluation test methods which define acceptable biological responses (e.g., non-toxic, non-irritant, non-hemolytic).

8. The sample size for the training set:

There is no mention of a "training set." This concept is relevant to machine learning or AI algorithms. The Headway 27 Microcatheter is a physical medical device, and its development and testing involve traditional engineering and biological validation, not machine learning model training.

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

This is not applicable as there is no training set for this device.

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The Headway 27 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neurovasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the Microcatheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Microcatheter hub is used for the attachment of accessories.

Section 1:

Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The provided document states "Pass" for each test, implying that the device met the pre-defined acceptance criteria for that specific test. The specific numerical or qualitative thresholds for each criterion are not explicitly stated in this summary.

Section 2:

• Sample size used for the test set: Not specified. The document summarizes the results of various bench and biocompatibility tests, but does not provide details on the number of units tested for each criterion.
• Data provenance: Not specified. This document pertains to pre-market notification (510(k)) for a medical device and describes laboratory and in-vitro testing. There is no indication of clinical trial data or data from human subjects in this summary. Therefore, the concepts of "country of origin" and "retrospective or prospective" do not directly apply to the reported tests.

Section 3:

• Number of experts used to establish the ground truth for the test set: Not applicable. The "ground truth" concept is typically associated with clinical studies or diagnostic artificial intelligence, where expert consensus or pathological findings define the true state. The described tests are primarily engineering and biological performance evaluations. These tests rely on established scientific methods and validated measurement techniques rather than expert interpretation of complex clinical cases.
• Qualifications of those experts: Not applicable. (See above explanation).

Section 4:

• Adjudication method: Not applicable. The tests described are objective, quantitative or qualitative industrial and laboratory tests. They do not involve interpretation of ambiguous data requiring adjudication for ground truth establishment.

Section 5:

• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI algorithms in clinical settings, often in comparison to human readers. The provided document details the pre-market submission for a physical medical device (microcatheter) and focuses on bench testing and biocompatibility, not diagnostic performance or AI effectiveness.
• Effect size of how much human readers improve with AI vs without AI assistance: Not applicable. (See above explanation).

Section 6:

• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm performance study was not done. This document describes the performance of a physical medical device, not an algorithm.

Section 7:

• The type of ground truth used: Not applicable in the traditional sense of clinical diagnostic ground truth (e.g., pathology, outcomes data, expert consensus). For the bench and biocompatibility tests, the "ground truth" or reference standard is derived from:
  • Validated test methods and specifications: Standards like ISO 10993 for biocompatibility provide the framework for evaluating the device's interaction with biological systems.
  • Engineering specifications and design parameters: For bench tests, the device's design requirements define what constitutes a "pass" result (e.g., specific tensile strength thresholds, flow rates, burst pressures).
  • Chemical and material analysis: Compatibility tests (like DMSO compatibility) rely on known material properties and reactions.

Section 8:

• The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI algorithm that would require a training set.

Section 9:

• How the ground truth for the training set was established: Not applicable. (See above explanation).

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