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The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to surgically implanted port.

The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to a surgically implanted port. This device is designed utilizing a non-coring Huber needle to access the implanted port. The K-Shield Advantage PAIS has an integral safety device intended to protect against accidental needle stick injuries and infection caused by blood borne pathogens. Upon removal from the port, the anti-needlestick protector (ANSP) covers the needle tip protecting against accidental needle stick injuries. The devices are disposable ethylene oxide sterilized medical devices which are constructed from non-coring needle (Huber needle), wing, tubing (either micro bore or standard bore), clamp, female conical fitting and locking cap. The device has optional injection site (needle injection, needleless access connector (NAC), or no injection site) and anti-needle stick protector (ANSP).

The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety device used to administer solutions to surgically implanted ports. The device was modified from a previously cleared version (K123344), with minor enhancements to strengthen the safety device feature, improve the gripping point for easy cannulation, and reduce the bulkiness of the needle cap.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance (Test Set):

• Needle Cap Evaluation: N=30 for each cap type (straw cap and T-cap). The data provenance is not explicitly stated but is implicitly from bench testing conducted by Kawasumi Laboratories, Inc.
• Simulated Use Testing: N=599 "effective samples." Data provenance is from simulated use testing conducted by Kawasumi Laboratories, Inc.

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

This information is not provided in the document. The tests performed are primarily bench and simulated use tests based on established international and in-house standards, not expert assessments of performance.

4. Adjudication method for the test set:

This information is not applicable as the tests are objective measurements against defined criteria, not subjective human assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This device is a physical medical device (infusion set), not an imaging or diagnostic AI device that would typically involve human readers.

6. Standalone (algorithm only without human-in-the-loop performance) study:

No, a standalone study was not done. This refers to algorithmic performance, which is not relevant for a physical medical device. The "standalone" concept applies to AI/software as a medical device (SaMD).

7. Type of ground truth used (test set):

The "ground truth" for the test set is established by objective technical standards and in-house criteria for physical performance characteristics (e.g., tensile strength, leak test, cap removal force) and functional activation (ANSP). For the simulated use testing, the ground truth is the observable proper activation of the ANSP.

8. Sample size for the training set:

This information is not applicable. This device is a physical product, not an AI/machine learning model that requires a training set.

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

This information is not applicable, as there is no training set for a physical medical device.

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The devices are used to administer solutions to a surgically implanted port.

The K-Shield Advantage Port Access Infusion Set (PAIS) is a safety port access device used to administer solutions to a surgically implanted port. This device is designed utilizing a non-coring Huber needle to access the implanted port. The K-Shield Advantage PAIS has an integral safety device intended to protect against accidental needle stick injuries and infection caused by blood borne pathogens. Upon removal from the port, the Anti- Needlestick Protector (ANSP) covers the needle tip protecting against accidental needle stick injuries. The devices are disposable ethylene oxide sterilized medical devices which are constructed from non-coring needle (Huber needle), wing, tubing (either micro bore or standard bore), clamp, female conical fitting and locking cap. The device has optional injection site (needle injection, needleless access connector (NAC), or no injection site) and/or anti-needlestick protector (ANSP).

The provided 510(k) summary for the K-Shield Advantage Port Access Infusion Set (K123344) does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.

The summary describes the device, its intended use, and states that "Bench testing was performed and confirms that the device meets design requirements and specifications." It also mentions compliance with EN ISO 8536-4:2007. However, it does not provide a table of quantitative acceptance criteria, detailed performance metrics, or the specifics of the bench testing study (like sample size, ground truth establishment, or expert involvement) that would allow for a complete answer to your request.

Therefore, I cannot extract the information required to populate the table and answer the specific questions about the study design, sample sizes, expert involvement, or adjudication methods, as this level of detail is not present in the provided text.

Based solely on the provided text, here's what information can be gleaned, though it is limited:

Summary of Available Information Regarding Performance and Testing:

• Acceptance Criteria/Performance: The document broadly states that the device "meets design requirements and specifications" and "complies with the International standard EN ISO 8536-4: 2007-Infusion equipment for medical use -Part 4: Infusion sets for single use, gravity feed mainly". No specific quantitative acceptance criteria or performance metrics are listed in a table.
• Study Type: "Bench testing was performed."
• Safety Feature: The device includes an "Anti-Needlestick Protector (ANSP)" intended to "protect against accidental needle stick injuries." While this is a key safety feature, the document doesn't provide performance data for it (e.g., efficacy rates of the ANSP).
• Biocompatibility: Materials are evaluated per ISO 10993-1:2009 and "have been determined to be biocompatible."
• Sterilization: Validation was conducted per EN ISO 11135-1:2007.

Missing Information:

All the specific points you requested (Table of acceptance criteria and reported device performance, sample size for test set, data provenance, number of experts, adjudication method, MRMC study details, standalone study details, type of ground truth, training set sample size, ground truth for training set) are not present in the provided 510(k) summary. These details are typically part of a more extensive test report that would be submitted to the FDA but are often summarized or omitted from the public 510(k) summary document itself.

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