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The BioFlo Midline Catheter is indicated for short term access (

The BioFlo Midline Catheter is a short term (

The provided text describes a 510(k) premarket notification for the BioFlo Midline Catheter. It outlines the device's characteristics, intended use, and a comparison with predicate and reference devices, along with performance data from non-clinical bench testing. However, the document does not describe a clinical study in the format requested, nor does it provide the detailed acceptance criteria and study results for a device that relies on AI or machine learning.

The acceptance criteria mentioned are general performance aspects for a medical device (intravascular catheter), and the "study" referred to is a series of non-clinical bench tests. The concept of "AI performance," "human reader improvement with AI," "standalone algorithm performance," "ground truth," and "training set" are not applicable to this particular device and its regulatory submission as described.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an attempt to extract relevant information from the document, acknowledging the limitations:

1. Table of acceptance criteria and the reported device performance:

The document lists various non-clinical bench tests performed. These tests implicitly define "acceptance criteria" through their successful completion, demonstrating that the device meets relevant standards for its intended use. Exact quantitative acceptance criteria are not explicitly stated in numerical form within this summary, but the successful completion of the tests implies meeting the required thresholds.

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

• Sample size: Not specified. The document only mentions "non-clinical bench testing." For bench tests, sample sizes can vary significantly depending on the specific test and standard requirements, but these are typically physical units, not patient data sets.
• Data provenance: Not applicable in the context of clinical or image-based data. The tests are non-clinical bench tests.

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

• Not applicable. This device is a physical medical device (catheter) undergoing bench testing, not a diagnostic or AI-driven device requiring expert-established ground truth from patient data.

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

• Not applicable. This concept is relevant for clinical studies or AI evaluations involving human readers and ground truth, not for the described bench tests.

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 not an AI-based device, and no MRMC study was performed or mentioned.

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

• No. This is not an AI-based device.

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

• Not applicable in the context of patient data ground truth. The "ground truth" for bench testing is defined by the technical specifications and performance requirements outlined in the referenced standards (e.g., ISO 10555-1, ISO 594-2).

8. The sample size for the training set:

• Not applicable. This device does not involve an AI algorithm that requires a training set.

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

• Not applicable. This device does not involve an AI algorithm.

Summary of the Study (Bench Testing) that Proves the Device Meets Acceptance Criteria:

The study proving the BioFlo Midline Catheter meets acceptance criteria consists of a series of non-clinical bench tests. These tests were conducted in accordance with several FDA Guidance Documents and international standards, including:

• FDA's "Guidance on Premarket Notification [510(k)] Submissions for Short-Term and Long-Term Intravascular Catheters"
• EN ISO 10555-1:2013 - "Intravascular Catheters - Sterile and Single-Use Catheters - Part 1: General Requirements"
• EN ISO 10555-3:2013 - "Intravascular Catheters Sterile and Single-Use Catheters Part 3: Central Venous Catheters"
• ISO 594-2:1998 - "Conical Fittings with a 6% (Luer) Taper for Syringes, Needles, and Certain Other Medical Equipment - Part 2: Lock Fittings"
• EN ISO 10993-1:2009 - "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process"

The specific tests performed included: Power Injection Flow Rate, Static Burst Strength, Multiple Power Injections, Gravity Flow Rate, Catheter Length, Priming Volume, Midline Identification, Dimensional Verification, Catheter Kink/Flex Resistance, Alcohol Compatibility, Catheter Marking & Identification/Radiopacity Testing, Tensile Testing, and Compatibility Testing with insertion accessories.

The submission concludes that "successful results of non-clinical bench testing" demonstrate that the proposed device is substantially equivalent to the predicate device. This implies that the device met all the required performance specifications and safety criteria as defined by the referenced standards and guidance documents.

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