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Huber Needle Infusion Set: The Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

Safety Huber Needle Infusion Set: The Safety Huber Needle Infusion Set is a device with a non-coring right angle needle intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids and drugs, as well as blood sampling into the port. The safety feature is manually activated during needle removal, and in the prevention of accidental needle sticks. The 19G-22G needles of device are also suitable for power injection of contrast media to a maximum pressure of 325psi. When used with ports indicated for power injection, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G, 2ml/s for 22G.

The Huber Needle Infusion Set and Safety Huber Needle Infusion Set non-coring angled needle are single use, sterile and non-pyrogenic device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through the port. The Huber Needle Infusion Set and Safety Huber Needle Infusion Set are available in different gauge sizes (25G, 24G, 22G, 20G, 19G) and length (0.5", 0.75", 1.0", 1.24", 1.5"). The 19G-22G needles of device are suitable for power injection of contrast media into the central venous system only through an implanted port that is indicated for power injection at a maximum pressure of 325psi. For power injection of contrast media, the maximum recommended infusion rate is approximately 5ml/s for 19G and 20G and 2ml/s for 22G.The 24G and 25G needles of device should not be used with power injectors. The Huber Needle Infusion Set is available in five models (S-1, S-2, Y-1, Y-2, D-1), and the Safety Huber Needle Infusion Set is available in four models (S-1s, S-2s, Y-1s, Y-2s). The safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlestick. After activation, the non-coring needle is locked in the safety mechanism-plate. The device also have Y-sites with Y-needleless adapters or Y-needle adapters for secondary access. The needleless adapters eliminate the risk of needlestick.

The provided text describes a 510(k) premarket notification for a medical device, the Huber Needle Infusion Set and Safety Huber Needle Infusion Set. This document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective.

The provided text does not contain information about an AI/ML powered medical device. Therefore, the specific details requested regarding acceptance criteria and study proving an AI/ML device meets acceptance criteria (such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment) are not present in this document.

The document focuses on the physical and functional equivalence of the Huber Needle Infusion Set to its predicate device through a series of non-clinical tests (performance testing and biocompatibility testing).

Here's what can be extracted, interpreted based on the provided document, and why the other AI/ML related questions cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance (Focus: Non-AI/ML Physical Device)

The document primarily outlines performance tests and biocompatibility tests to prove substantial equivalence of a physical medical device (Huber needle). It doesn't explicitly list "acceptance criteria" in a table format with "reported device performance" in the way one might for an AI/ML algorithm's effectiveness metrics (e.g., sensitivity, specificity thresholds). Instead, it states that tests were conducted to verify that the proposed device met all design specifications and test results demonstrated compliance with related standards requirements.

However, we can infer some "acceptance criteria" based on the tests performed:

Regarding AI/ML specific questions:

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

• Not applicable for AI/ML. This document describes testing of a physical medical device. The "test set" here refers to physical samples of the device and test media (e.g., liquids for flow rate, materials for penetration/coring). No medical imaging or patient data is involved.

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

• Not applicable for AI/ML. Ground truth for a physical device is established through verified measurement techniques and standardized testing protocols, not expert consensus on medical images.

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

• Not applicable for AI/ML. Adjudication relates to resolving disagreements among experts for ground truth labeling in AI/ML studies. For physical device performance, tests are objective and measurable against established standards.

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 device is a physical infusion set, not an AI/ML algorithm intended to assist human readers (e.g., radiologists). Therefore, no MRMC study was performed.

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

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

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

• Not applicable for AI/ML diagnostic/interpretive purposes. For this physical device, "ground truth" is defined by the established physical, chemical, and biological properties of the materials and function of the device as measured by validated laboratory methods and adherence to international standards (e.g., ISO, ASTM, USP).

8. The sample size for the training set:

• Not applicable for AI/ML. This refers to a physical medical device, not an AI model requiring a training set.

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

• Not applicable for AI/ML. See point 8.

In summary: The provided document is a 510(k) submission for a non-AI/ML medical device (Huber Needle Infusion Set). The "acceptance criteria" discussed are performance and material standards for the physical device, and the "study" consists of a comprehensive suite of non-clinical, laboratory-based tests to demonstrate compliance with these standards and substantial equivalence to a predicate device. None of the questions specifically pertaining to AI/ML device validation are addressed because the device is not an AI/ML product.

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