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The EZ Huber Safety Infusion Set is a device used to administer fluids from a container to a patient's vascular system through an implanted port. The EZ Huber Safety Infusion Set incorporates an active safety feature that aids in the prevention of accidental needle sticks. The EZ Huber Safety Infusion Set is a safety needle designed with an anti-coring needle tip configuration. The primary use for Huber Needles is to deliver solutions to implanted ports. The safety feature is designed to protect the practitioner from accidental needle sticks. The EZ Huber Safety Infusion Set is compatible with power injection procedures up to 300 psi.

The EZ Huber Safety Infusion Set is used to access implanted septums for the purpose of drug and IV infusion. The Needle is constructed so that after patient use and upon needle removal, the needle can be removed and the safety mechanism will be activated. The product is designed so that the practitioner activates the safety mechanism during normal needle removal following typical removal procedures used for non-safety Huber needles. Upon activation of the safety mechanism, the total function of the EZ Huber Safety Infusion Set is complete and the unit is discarded in accordance with hospital protocol. Components will be assembled into standard configurations or configurations specified by the customer and packaged. Types of components that may be contained in a set include: Huber Housing, Huber Wing, Spring, Needle Cannula, Needle Sheath Tubing, PE lined Foam Pad, Pinch Clamp, Female Luer Dust Cap, Y-site, Swabable Y-site, Medegen.

The provided text is a 510(k) Summary of Safety and Effectiveness for the EZ Huber Safety Infusion Set. This document is for a medical device (intravascular administration set) and primarily focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a performance study with detailed acceptance criteria and statistical analysis.

Therefore, the information required to populate the requested table and answer the specific questions about acceptance criteria and study details for device performance is largely not present in the provided text. The document describes the device, its intended use, and biocompatibility, but it does not include a clinical study or performance testing with quantitative acceptance criteria.

Here's what can be extracted based on the provided text, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document states that the safety feature "aids in the prevention of accidental needle sticks" and that the device is "compatible with power injection procedures up to 300 psi." However, it does not provide specific quantitative acceptance criteria (e.g., a certain percentage of needle-stick prevention, or a specific performance metric for pressure) or the results of a study that objectively measured these performances against such criteria. The biocompatibility claim is a general statement, not a specific performance outcome against a numerical criterion.

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

• Test set sample size: Not specified.
• Data provenance: Not specified. The document does not describe a performance study with a test set.

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

• Not applicable. No performance study with ground truth establishment is described.

4. Adjudication method for the test set

• Not applicable. No performance study with adjudication is 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

• Not applicable. This device is not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

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

7. The type of ground truth used

• Not applicable. No performance study requiring ground truth is described.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable. As above, this is for a physical device, not a machine learning model.

Summary of what is present:

• Device Name: EZ Huber Safety Infusion Set
• Intended Use: Administer fluids to a patient's vascular system through an implanted port, with an active safety feature to prevent accidental needle sticks. Compatible with power injection up to 300 psi.
• Equivalency: The submission establishes substantial equivalence to existing predicate devices (PFM Medical, Inc. K040533 and CR Bard, Inc. K060812).
• Biocompatibility: Materials are "used in legally marketed devices under comparable conditions of use," suggesting reliance on prior art and established material safety rather than new biocompatibility testing for this specific device.

The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. While performance data may be submitted, the provided summary focuses on the descriptive aspects and regulatory classification rather than a detailed performance study with quantitative acceptance criteria.

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