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The AccuCath® Midline Catheter System is a midline catheter that is inserted into a patient's vascular system for short term use (

The AccuCath® Midline Catheter System has a usable length catheter of 3.1 inches in multiple Gauge sizes. The device(s) are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This longer AccuCath® Midline is substantially equivalent functional characteristics and design to the predicates [Bard Access PowerGlide™ Device (K121073) and AccuCath® BC (K140504)]. The AccuCath® Midline catheter hub is identical in design to that of the AccuCath® BC's catheter's hub. including the built-in blood control septum. Additionally, the AccuCath® Midline, like the AccuCath® BC (K140504) predicate, consists of a radiopaque catheter with a blood control valve mechanism that is delivered over a guidewire with atraumatic coiled tip design; a notched needle to enhance flashback visualization, and a body / handle that serves as an integrated safety container to mitigate the risk of sharps injuries. The AccuCath® Midline is identical to the AccuCath BC® in that it features a septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after the needle retraction until a secure male luer connection is made. The flow path will remain opened once a secure male luer connection has been made.

This document is a 510(k) summary for the AccuCath® Midline Catheter System, seeking substantial equivalence to existing predicate devices. It focuses on the device's design, intended use, and bench testing to demonstrate its safety and effectiveness.

Based on the provided text, there is NO study described that assesses the device's clinical performance in terms of acceptance criteria, such as accuracy, sensitivity, or specificity, which would be typical for an AI/algorithm-driven device. The document primarily discusses the device's physical and functional characteristics and bench testing against established standards for medical devices.

Therefore, I cannot provide the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics for an AI device.

However, I can provide information based on the "Performance Data" section of the document, which focuses on bench testing and adherence to standards for medical devices.

Here's an analysis based on the provided document, focusing on the absence of information relevant to AI-driven device performance and the presence of information related to traditional medical device testing:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of an AI study (e.g., sensitivity, specificity, accuracy). Instead, it lists standards against which the device was tested. The "performance" mentioned refers to the device successfully meeting the requirements of these standards.

Note: The document states "Biocompatibility and functional bench testing performed by Vascular Pathways, Inc. demonstrates the AccuCath® Midline Cather is substantial equivalence, in terms of the safety and effectiveness, to the referenced predicate devices." This implies that the device met the requirements of the listed standards, but specific numerical results are not provided.

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 applicable/not provided as the "performance data" refers to bench testing against engineering and material standards, not a clinical study on a patient test set for an AI/algorithm.

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/not provided. Ground truth in the context of expert review for diagnostic/AI performance is not relevant to the bench testing described.

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

This information is not applicable/not provided. Adjudication methods are used for resolving disagreements in expert ground truth, which is not relevant to the bench testing 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

This information is not applicable/not provided. No MRMC study or study involving human readers with or without AI assistance is mentioned.

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

This information is not applicable/not provided. This device is a physical medical catheter, not an algorithm, so a standalone algorithm performance study is not relevant.

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

This information is not applicable/not provided for the type of "performance data" presented. The "ground truth" for the bench testing would be the specifications and requirements defined by the referenced ASTM and ISO standards.

8. The sample size for the training set

This information is not applicable/not provided. This is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable/not provided. Not an AI/ML algorithm.

In summary: The provided document is a 510(k) summary for a physical medical device, the AccuCath® Midline Catheter System. The "performance data" described pertains to standard bench testing and compliance with material, manufacturing, and design standards, not to the performance of an AI/algorithm-driven device or clinical outcomes. Therefore, most of the requested points, which are highly specific to AI/ML device evaluation, are not applicable to this document.

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The AccuCath BC Intravascular Catheter System is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath BC is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL/second.

The AccuCath BC Intravascular Catheter System has a usable length catheter of 2.25 inches in 18, 20 and 22 Gauge sizes. The devices are single use, sterile intravascular catheters designed to be inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This longer AccuCath BC catheter is identical to the AccuCath with the addition of needle echogenicity and a septum with plunger integrated into the catheter hub. The AccuCath BC catheter's hub has a built in blood control septum. The blood control feature is a single-use septum that automatically activates to stop the blood flow in the catheter hub when the needle is removed from the catheter during initial insertion by the clinician. Blood flow from the catheter hub will be restricted immediately after the needle retraction until a secure luer connection is made. The flow path is permanently opened once a secure luer connection has been made. Similar to the original AccuCath system, the device is provided with a safety mechanism which allows the needle to be shielded following placement of the catheter. All devices have the basic structure of a protective cover, a catheter with a bier lock fitting, an echogenic needle connected to a flashback chamber, a safety container, a guide wire within the lumen of the needle which is connected to a slider and a spring and release button.

The provided text is a 510(k) summary for a medical device called the "AccuCath BC Intravascular Catheter System." This type of document focuses on demonstrating substantial equivalence to a predicate device through performance testing, rather than establishing acceptance criteria and conducting a study to prove the device meets them in the way clinical trials for new drugs or de novo medical devices would.

Therefore, the information requested in your prompt regarding acceptance criteria, specific study design, sample sizes for training/test sets, expert qualifications, and ground truth establishment is not directly available in the provided text. The document describes a performance testing approach against recognized standards and predicate devices rather than a standalone clinical study to meet specific performance metrics.

However, I can extract the relevant information about the performance testing conducted and present it in a modified format that aligns with your request where possible.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical performance metrics for the device itself (e.g., accuracy, sensitivity). Instead, the device is deemed to meet acceptance criteria by demonstrating compliance with a series of international and ASTM standards and showing substantial equivalence to predicate devices. The "reported device performance" in this context refers to the successful demonstration of compliance with these standards and the assertion of substantial equivalence.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document refers to "functional bench testing" and "in vitro bench testing," but does not provide numbers of devices or test repetitions for these experimental setups.
• Data Provenance: The testing was "performed by Vascular Pathways, Inc." The data is likely from retrospective bench testing against established standards, specifically designed to demonstrate compliance for regulatory submission. It is not clinical data from a specific country of origin in the way a clinical trial would generate.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This type of information is not applicable to the presented study. The document describes engineering and materials testing against defined standards (e.g., ISO, ASTM) and comparison to predicate devices, not a study requiring expert consensus on a clinical test set or ground truth in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

This is not applicable. There was no "test set" requiring adjudication in the sense of expert review for diagnostic accuracy or clinical outcomes. The performance was assessed against predefined standard specifications and functional requirements.

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. The device is an intravascular catheter, not an AI-powered diagnostic system. No MRMC study was conducted.

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

This is not applicable. The device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on:

• International and National Standards: Compliance with ISO and ASTM standards (e.g., for sterility, biocompatibility, material properties, Luer taper, radiopacity, packaging).
• Predicate Device Performance: The functional performance, safety, and effectiveness of the AccuCath BC are demonstrated to be "substantially equivalent" to already legally marketed predicate devices. This implicitly means the predicate devices' accepted performance serves as a benchmark or "ground truth."
• Design Input Requirements: The testing confirmed that "the output of the design process met all design input requirements." These requirements serve as an internal "ground truth" for the device's intended function.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device's evaluation, as it's not an AI/ML product.

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

This is not applicable. As there is no training set, there is no ground truth established for one.

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The Vascular Pathways RIVS system is indicated for use to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to patient size, appropriateness of the solution being infused, and duration of therapy.

The RIVS 18, 20 and 22 Gauge devices are single use, sterile intravascular catheters designed to provide access to veins. The devices are provided with a safety mechanism which allows the needle to be shielded following placement of the catheter.

All devices have the basic structure of a protective cover, a catheter with a luer lock fitting, a needle connected to a flashback chamber, a safety container, a guide wire within the lumen of the needle which is connected to a slider and a spring and release button.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the "Rapid Intravascular Catheter Start System," based on the user's requested format.

It's important to note that the provided text is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics typically found in a full clinical trial report or a PMA submission. Therefore, some of the requested information may not be explicitly present or might be inferable only to a limited extent.

Acceptance Criteria and Study Details for the Rapid Intravascular Catheter Start System

The provided 510(k) summary for the Rapid Intravascular Catheter Start System (RIVS) focuses on demonstrating substantial equivalence to a predicate device (K073241 - Vascular Pathways, Inc., Rapid Intravascular Catheter Start System) for modified and new gauge devices. As such, the "acceptance criteria" discussed are primarily related to ensuring the modified devices maintain the same performance and safety characteristics as the predicate, rather than establishing de novo clinical performance thresholds. The "study" refers to verification and validation testing to confirm these aspects.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the format requested. Instead, it makes a general statement about meeting design specifications and user needs. The core acceptance criterion for this 510(k) modification is demonstrating substantial equivalence to the predicate device in terms of design, performance, safety, and intended use.

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

The document states that "Verification and validation testing" was conducted. However, it does not specify the sample sizes used for these tests. The provenance of the data (e.g., country of origin, retrospective or prospective) is also not mentioned. Given the nature of a 510(k) for an intravascular catheter, these tests would typically be benchtop (in-vitro) and potentially simulated use tests, rather than human clinical trials.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This submission is for a medical device (intravascular catheter) and focuses on the physical and functional performance of the device itself, not on diagnostic accuracy requiring expert interpretation or "ground truth" establishment in the context of imaging or diagnostic AI. The "ground truth" here would be defined by engineering specifications and objective measurements from the verification and validation (V&V) testing.

4. Adjudication Method for the Test Set

Not applicable. As the "ground truth" is defined by engineering specifications and objective measurements, there's no need for expert adjudication in the typical sense (e.g., 2+1, 3+1 consensus). The V&V testing would involve comparing device performance against predetermined specifications.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., imaging AI) to assess how human reader performance is impacted by AI assistance. The RIVS is an intravascular catheter, a therapeutic/access device, and thus an MRMC study is not relevant to its regulatory submission.

6. Standalone (Algorithm Only) Performance

Not applicable. The RIVS is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm only performance" does not apply. The performance evaluated relates to the physical and functional attributes of the catheter itself.

7. Type of Ground Truth Used

The "ground truth" for the verification and validation testing would be the established design specifications and user needs (as stated in the document). This would involve engineering standards, material specifications, functional requirements (e.g., flow rates, material strength, ease of insertion, needle shielding mechanism effectiveness), and biocompatibility standards.

8. Sample Size for the Training Set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI development. The device design and manufacturing processes are developed through engineering and R&D, not through training on data.

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

Not applicable. Since there is no training set, the establishment of its ground truth is irrelevant.

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