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The MaxZero™ extension set with needle-free connector(s) is for single use only. The MaxZero™ extension set with needle-free connector(s) may be used for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids.

The MaxZero™ Extension Sets with Needle-Free Connector(s) are intravascular extension sets intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion continuous infusion or aspiration of drugs, blood and fluids. The MaxZero™ Extension Sets with Needle-Free Connector(s) are sterile single patient devices that can be used for up to seven (7) days and 200 activations. All extension sets included in this submission are not made from natural rubber latex or DEHP.

The provided text describes a 510(k) premarket notification for a medical device, the MaxZero™ Extension Sets with Needle-Free Connector(s). This type of submission relies on demonstrating "substantial equivalence" to a predicate device, rather than proving independent effectiveness through clinical trials in the same way a new drug or novel medical device might.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and performance tests performed to demonstrate that the new device (subject device) is as safe and effective as the previously cleared predicate device, despite some differences.

Here's an analysis of the provided information within the framework of your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative table with corresponding numerical results in the provided document. Instead, the document discusses various performance tests conducted according to established ISO standards and FDA guidance, with a general statement that "All test results met their acceptance criteria." The table provided on pages 5-6 outlines various characteristics of the subject device and compares them to the predicate device, indicating "Equivalence" or "Different" with explanations.

Based on the information, the acceptance criteria are implicitly derived from the relevant ISO standards and FDA guidance documents, which define the expected performance metrics for intravascular administration sets. The "reported device performance" refers to the fact that the device passed these tests.

Implied Acceptance Criteria and Reported Performance (extracted from comparison and performance discussion):

Note: The document explicitly states "Design Control activities have been conducted and have confirmed the different technological characteristics of the proposed device do not raise different questions of safety and effectiveness" for the characteristics where the subject device differs from the predicate (e.g., device length, materials, configurations, physical specifications, filter size, tubing bore, bonding agent, priming volume, vacuum integrity, maximum pressure, shelf life, light resistance of amber tubing). This indicates that the differences were evaluated and found to be acceptable for substantial equivalence.

Study Details (as applicable to a 510(k) for a Class II device)

1. Sample sized used for the test set and the data provenance:

• Sample Size: Not explicitly stated in the provided abstract for each specific test. However, typical non-clinical performance testing for medical devices involved in 510(k) submissions would use a predetermined number of samples for each test type (e.g., n=3, n=5, n=10, or more, depending on the test and statistical rationale).
• Data Provenance: The data is from non-clinical bench testing ("CareFusion performed design verification performance testing"). There is no mention of country of origin for the testing itself, but given it's an FDA submission, the testing would be expected to adhere to international and potentially US-specific standards. The nature of the testing is prospective as it's part of design verification for a new device.

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

• Not applicable in this context. This is a non-clinical, engineering/performance study assessing a physical medical device's functional characteristics (e.g., leakage, tensile strength, flow rate, material compatibility). "Ground truth" established by human experts (like radiologists for image analysis) is not relevant to this type of device and study. The "ground truth" here is the pass/fail criteria defined by the recognized consensus standards (e.g., ISO, ASTM, USP) and the device's design specifications.

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

• None. This is not a study involving human interpretation or subjective assessment that would require an adjudication method. The test results are quantitative physical measurements or qualitative pass/fail outcomes against pre-defined engineering and material standards.

4. 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 a medical device (intravascular administration set), not an AI/imaging device. Therefore, MRMC studies are not applicable.

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

• Not applicable. As stated, this is a physical medical device, not an algorithm.

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

• The "ground truth" (or more accurately, the acceptance criteria) for this type of device performance study is based on recognized consensus standards (like various ISO standards for medical devices, ASTM standards, USP for particulate matter) and the predicate device's established performance and safety profile. The testing verifies that the subject device meets these established engineering, material, and functional benchmarks.

7. The sample size for the training set:

• Not applicable. There is no "training set" in the context of this traditional 510(k) submission for a physical medical device. This is not an AI/machine learning product. The design and manufacturing process are subject to Quality System (QS) Regulation (21 CFR Part 820), which involves process validation and quality control, but not a "training set" in the computational sense.

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

• Not applicable. (See point 7).

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