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The HydroMID 5F Dual Lumen Midline Catheter is indicated for short term access (

The HydroMID catheter is a 5 French, dual lumen, midline catheter comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tubing made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the respective clinical environments.

HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

Catheter and accessories are supplied sterile. Product is sterilized by ethylene oxide (EO) except where labeled otherwise. Product should be stored in a cool, dry, dark place. The HydroMID Catheter is supplied in a dry state and must be hydrated before use.

The provided text describes a 510(k) summary for the HydroMID 5F Dual Lumen Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device through bench testing. The document does not contain information about a study proving the device meets acceptance criteria in the context of an AI/human reader study or clinical performance with ground truth established by experts/pathology/outcomes data.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to engineering and performance bench testing of a physical medical device (a catheter), not a medical device software or AI algorithm. Therefore, many of the requested categories in the prompt (e.g., number of experts for ground truth, adjudication methods, MRMC study, standalone algorithm performance, training set details) are not applicable to this type of device submission.

However, I can extract the information relevant to the device's performance and the "acceptance criteria" as described in the 510(k) summary for this physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance (Bench Testing):

The document states: "All tests passed the acceptance criteria specified for both the subject and predicate devices." It does not provide specific numerical acceptance criteria or numerical reported performance values for each test. Instead, it lists the types of tests conducted.

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

• Sample Size: The document states: "Testing was identical to the predicate in standard conformance, sample size, methods, and acceptance criteria." However, the specific numerical sample size for each test is not provided.
• Data Provenance: The tests are described as "Bench Data" conducted internally by the manufacturer, Access Vascular Inc. The country of origin for the data is not explicitly stated, but the company address is Billerica, MA, which implies the testing was conducted in the United States. The data is prospective in the sense that it was generated for this 510(k) submission to demonstrate the performance of the new device design.

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

• Not Applicable. This is a physical medical device. Ground truth for its performance is established by engineering and material science testing against predefined specifications, not by human expert review of images or clinical outcomes in the typical sense of AI/image analysis.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3. Testing results are objective measurements against established engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• Not Applicable. This is a physical medical device (catheter), not a software or AI device intended to assist human readers.

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

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

7. The Type of Ground Truth Used:

• Engineering Specifications and Standardized Test Methods: The "ground truth" for this device's performance revolves around its physical and functional properties meeting predetermined engineering specifications and validated test methods (e.g., pressure resistance, flow rates, dimensional accuracy, material properties like tensile strength and kink resistance, sterility, and MRI compatibility). These are objective criteria, not based on expert consensus, pathology, or outcomes data in a clinical trial sense.

8. The Sample Size for the Training Set:

• Not Applicable. This is a physical medical device; there is no "training set" in the context of machine learning. The device design and materials are based on established engineering principles and prior device iterations.

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

• Not Applicable. See point 8.

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The HydroMID is indicated for short term access (

The HydroMID catheter is a 4 French, single lumegemidfifie catheter comprised of a radiopaque, hydrophilic catheter with a suture wing, Luer lock hub, and extension tube made from materials commonly used in the manufacture of catheters. Catheters are provided packaged in kit configurations with the appropriate accessories for placement in the appropriate clinical environments. The maximum power injection flow rate for the lumen is indicated on the extension tube clamp.

HydroMID has been shown to be effective in reducing thrombus accumulation and thrombotic occlusions. Reduction of thrombus accumulation and thrombotic occlusions were evaluated using in vitro and in vivo models. Pre-clinical in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.

The provided text describes the 510(k) summary for the HydroMID 4F Single Lumen Midline Catheter. It focuses on demonstrating substantial equivalence to a predicate device (HydroMID 4F Single Lumen Catheter, K203069) rather than presenting a performance study with specific acceptance criteria and reported device performance in the format requested.

Therefore, for aspects like "Table of acceptance criteria and the reported device performance," "Sample size used for the test set and data provenance," "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Standalone performance," "Type of ground truth," "Sample size for the training set," and "How the ground truth for the training set was established," the document does not provide the requested quantitative information typically found in clinical or AI algorithm performance studies.

Instead, the document primarily addresses the following:

1. Acceptance Criteria and Device Performance (Qualitative Description):

The device is deemed to meet its intended purpose and be substantially equivalent to the predicate device based on various bench tests and biocompatibility testing. The "acceptance criteria" are implied to be adherence to various consensus standards and FDA guidance.

The document states, "All necessary performance testing has been conducted on the HydroMID to assure substantial equivalence to the predicate devices and to demonstrate the device performs as intended. All testing was performed on test units representative of finished devices."

Regarding the other requested information:

• Sample size used for the test set and the data provenance: Not specified. The document mentions "test units representative of finished devices" for bench testing.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not specified. This type of information is typically for AI/diagnostic device studies.
• Adjudication method: Not applicable or not specified.
• 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 diagnostic device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical catheter, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical characteristics, the ground truth would be engineering specifications and measurements. For biocompatibility, it's the results of standardized biological assays.
• The sample size for the training set: Not applicable. This is a physical medical device, not an AI model requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Summary of what the document focuses on instead:

The document focuses on demonstrating substantial equivalence to a predicate device (HydroMID 4F Single Lumen Catheter, K203069) by highlighting:

• Identical intended use, principle of operation, and similar technological characteristics.
• Minor differences (e.g., removal of certain warnings for midline therapies, addition of Copper Phthalocyanine Blue 15:1 material for catheter markings, addition of catheter markings) are addressed and supported by bench testing and biocompatibility data.
• Adherence to various international and FDA consensus standards for medical devices (ISO 10555, ISO 11135, AAMI TIR28, ISO 15223, ISO 10993).

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The HydroMID is indicated for short term access (

The HydroMID catheter is a short term (

This document is a 510(k) Pre-Market Notification from the FDA, specifically concerning the HydroMID intravascular catheter. It details the device's characteristics, intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the provided text, the device in question is a physical medical device (intravascular catheter), not an AI/ML powered medical device. Therefore, the information requested in the prompt regarding acceptance criteria, study details, human reader improvement, multi-reader multi-case studies, ground truth establishment for AI/ML models, and sample sizes for training/test sets for AI/ML models is not applicable to this document.

The document describes the non-clinical testing performed for the HydroMID catheter to demonstrate its substantial equivalence to predicate devices. This testing primarily focuses on physical and performance characteristics relevant to a catheter, rather than the diagnostic or interpretation capabilities of an AI/ML algorithm.

Here's what can be extracted from the document regarding the device's performance and supporting studies, framed within the context of a physical medical device's acceptance rather than an AI/ML one:

1. Acceptance Criteria and Device Performance (for a physical medical device):

The "acceptance criteria" for a physical medical device like the HydroMID catheter are typically met by demonstrating comparable performance and safety to existing legally marketed predicate devices, along with meeting relevant industry standards.

2. Sample Size and Data Provenance for Device Testing (Non-Clinical):

The document does not specify sample sizes for the non-clinical tests. It refers to "in vitro and in vivo models" for thrombus accumulation and states that "Non-Clinical Test Conclusion" indicates that "the non-clinical testing of the proposed device was leveraged from the reference device."

• Data Provenance: The studies are pre-clinical (in vitro and in vivo models). Explicit geographical provenance is not given, but the manufacturer is based in Bedford, Massachusetts, USA. The studies are assumed to be prospective in design (i.e., conducted specifically for this submission).

3. Number of Experts and Qualifications for Ground Truth:

This is not applicable as the document describes a physical medical device, not an AI/ML system that requires expert interpretation for ground truth establishment.

4. Adjudication Method:

This is not applicable for the same reason as above.

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

This is not applicable as the device is a physical catheter, not an AI/ML diagnostic aid for human readers.

6. Standalone Performance:

While not framed as "algorithm-only performance," the document describes standalone physical testing of the HydroMID catheter itself for characteristics like power injection flow rate, length, and potentially the repeated EO/ECH residuals test. The studies on thrombus accumulation ("in vitro and in vivo models") were also standalone performance evaluations of the device's material properties.

7. Type of Ground Truth Used:

For a physical device, "ground truth" refers to established scientific and engineering principles, material properties, and performance standards.

• Engineering Specifications/Standards: The device was tested against "Internal product specification," and according to FDA Guidance Documents, EN ISO 10555-1:2013, and EN ISO 10555-3:2013.
• Biological/Physiological Models: In vitro and in vivo models were used to evaluate thrombus accumulation. The "effectiveness in reducing thrombus accumulation" is the specific performance claim being substantiated.
• Reference Device Data: A significant portion of the supporting data (e.g., sterility, biocompatibility, MRI compatibility) was "leveraged" from the previously cleared HydroPICC device (K193015), which serves as a form of "ground truth" or a validated baseline for those shared characteristics.

8. Sample Size for Training Set:

This is not applicable as it's a physical device, not an AI/ML model.

9. How Ground Truth for Training Set was Established:

This is not applicable as it's a physical device, not an AI/ML model.

In summary, the document details the substantial equivalence of a physical medical device (intravascular catheter) to predicate devices through non-clinical performance testing against established standards and internal specifications, rather than the evaluation of an AI/ML-powered diagnostic tool.

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