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A properly placed ViaValve™ Safety I.V. Catheter provides access to a vein or artery to sample blood, monitor blood pressure, or administer fluids. The needle guard locks over the needle as the catheter is threaded into the vessel to help reduce the risk of accidental needlesticks. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 18 to 24 gauge catheters may be used with power injectors up to 300 PSI.

The Via Valve™ Safety I.V. Catheter provides access to a vein or artery. The ViaValve™ Safety I. V. Catheter incorporates a valve inside the catheter hub which is designed to reduce blood exposure during initial catheter placement. The valve will open and allow flow once the Luer connector is attached and will remain oven after initial activation. The needle assembly incorporates a needle guard which locks over the needle as the ViaValve™ Safety.I.V. Catheter is threaded into the vessel to help reduce the risk of accidental rieedlesticks.

The provided text describes the ViaValve™ Safety I.V. Catheter, an intravascular catheter designed to reduce blood exposure during placement and prevent accidental needlesticks.

Here's an analysis of the acceptance criteria and supporting studies based on the provided information, organized according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for any specific "test set" in terms of how many devices were tested or how many participants were involved in the usability studies.

• Bench Testing & ISO Standard Compliance Testing: No sample size or specific data provenance (e.g., country of origin) is mentioned. This testing is inherently retrospective in nature, as it evaluates the manufactured product.
• Simulated Clinical Use Studies: No specific sample size is provided. The nature of "simulated clinical use" implies prospective data collection in a controlled environment, likely within the manufacturing country (USA, given the company information).
• Human Factors Engineering (HFE) and Usability Testing: No specific sample size is provided. This is typically prospective data collection involving human participants. The provenance is not explicitly stated but would likely be within the USA.

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

The document does not mention the use of "experts" to establish ground truth in the context of the device's technical or clinical performance. The evaluation relies on:

• Bench testing: Against established ISO standards and FDA guidance.
• Simulated clinical use: To confirm operational aspects like needle shielding.
• Human Factors/Usability testing: To assess user interaction for safety and effectiveness.

Therefore, there is no information provided about a specific number of experts or their qualifications for establishing a "ground truth" as it might be understood in an AI/diagnostic context (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set

No adjudication method (e.g., 2+1, 3+1) is mentioned. This type of method is typically used in studies involving expert interpretation of data (like medical images) where there might be inter-reader variability, which is not the primary focus of the described device testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not reported. The information describes testing to demonstrate substantial equivalence to predicate devices and confirm safety and effectiveness, not to compare the performance of human readers with and without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the described medical device. The ViaValve™ Safety I.V. Catheter is a physical medical device, not an algorithm or AI system. Therefore, "standalone" performance in the context of an algorithm is not relevant. The device's performance is inherently "standalone" in its function as a physical catheter, evaluated through bench and simulated clinical tests.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Compliance with validated standards: ISO standards for I.V. catheters and FDA Guidance "Medical Devices with Sharps Injury Prevention Features."
• Engineering specifications and design intent: For features like blood control and needle-stick prevention, confirmed through testing.
• Usability metrics: Derived from Human Factors and Usability testing to ensure the device is "adequately safe and effective for its intended users, uses and use environments."

There is no mention of "expert consensus," "pathology," or "outcomes data" in the typical sense for establishing ground truth for the device's fundamental function.

8. The Sample Size for the Training Set

This question is not applicable. The ViaValve™ Safety I.V. Catheter is a physical medical device, not an AI model that requires a "training set."

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

This question is not applicable, as there is no "training set" for this physical device.

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Passive anti-needle stick devices for venous or arterial access for the infusion of fluids, drugs, and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi.

B. Braun Medical's Introcan Safety IV Catheter is a passive needle stick prevention device used for arterial and venous access for the infusion of fluids, drugs and/or blood components. 14 - 22 gauge catheters may be used with power injectors for which the maximum pressure setting is 300 psi. The Introcan Safety IV Catheter is available in 14 - 24 gauge sizes, and both winged and non-winged versions.

This document is a 510(k) summary for the Introcan® Safety™ IV Catheter and does not contain information about acceptance criteria or a study proving device performance against such criteria in the way typically expected for an AI/CAD/imaging device.

The provided text describes a medical device (an IV catheter) and its regulatory clearance process, focusing on substantial equivalence to predicate devices rather than a performance study with defined acceptance criteria and statistical analysis to demonstrate novel efficacy.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not available in this document.

Here's an attempt to answer the questions based on the provided text, highlighting what is missing:

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

This information is not provided in the document. The document focuses on regulatory clearance based on substantial equivalence for a medical device (intravenous catheter), not an AI/CAD/imaging device with specific performance metrics like sensitivity, specificity, or F1-score.

2. Sample sized 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. The document states "Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the expanded indications for use for the Introcan® Safety™ IV Catheter." However, it does not specify the sample size, data provenance, or whether the study was retrospective or prospective.

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 provided. As this is a physical medical device (IV catheter), the concept of "ground truth" and "experts" for establishing it in the context of an AI/CAD/imaging device's performance study does not directly apply here. The "functional testing" mentioned would typically involve engineering and biocompatibility tests, not expert interpretation of outputs.

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

This information is not provided. Adjudication methods are relevant for studies involving human interpretation or consensus, which is not described for this 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

This information is not applicable/provided. An MRMC study is relevant for AI/CAD systems that assist human readers (e.g., radiologists). This document describes an IV catheter, which is a physical medical device, not an AI system.

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

This information is not applicable/provided. This document describes an IV catheter, which is a physical medical device, not an algorithm.

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

This information is not provided. For physical devices like an IV catheter, "ground truth" would relate to meeting engineering specifications, biocompatibility, and functional requirements (e.g., flow rate, pressure resistance, needle stick prevention efficacy). The document refers to "functional testing" but does not detail the specific ground truth metrics or how they were established.

8. The sample size for the training set

This information is not applicable/provided. A "training set" is relevant for AI/machine learning models. This document describes a physical medical device.

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

This information is not applicable/provided. As above, this concept applies to AI/ML model development, not the regulatory submission for a physical IV catheter.

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