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The K-Shield Port Access Infusion Set with High Pressure Tubing is an intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The high pressure tubing allows for the injection of contrast media with a power injector to 300 psi into an implanted port indicated for use with a power injector. The device is supplied sterile, non-pyrogenic and for single use. The port access infusion sets are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the needle is activated during removal from the patient's implanted medication port.

The K-Shield Port Access Infusion Set with High Pressure Tubing is a sterile, single use device with a non-coring Huber needle (90 degree), non-DEHP polyvinyl chloride tubing with or without Y connector which incorporates an integral antineedle stick protector used to prevent accidental needlestick injuries. The set can withstand injection pressures to 300 psi for use with power injectors to inject contrast media into implanted ports designed for use with power injectors.

Here's an analysis of the acceptance criteria and study information for the Kawasumi Laboratories Port Access Infusion Set with High Pressure Tubing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical testing data to determine the safety and effectiveness of the high-pressure tubing and its substantial equivalence to predicate devices. The acceptance criteria are implied by the "Pass" result for each test, indicating the device successfully met the established standards.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: The document does not explicitly state the sample size used for each specific test. For non-clinical tests like material and performance evaluations, typically multiple samples are subjected to each test.
• Data Provenance: The tests were performed internally by Kawasumi Laboratories, or according to international standards (ISO, ASTM, ISTA, EN). The country of origin for the studies is implied to be Japan, where Kawasumi Laboratories, Inc. is based, or potentially other locations if testing was outsourced. The data is retrospective in the sense that it was generated prior to the 510(k) submission, but it represents prospective testing conducted to evaluate the device's performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This section is largely not applicable as the studies described are non-clinical engineering and materials tests, not studies involving human subjects or expert assessment of clinical images/diagnoses. The "ground truth" for these tests is defined by the specific parameters and requirements of the international standards (e.g., ISO, ASTM) and Kawasumi's internal validation protocols. No human experts were involved in establishing "ground truth" in the way understood for medical diagnostic devices.

4. Adjudication Method for the Test Set:

This section is not applicable as the tests are objective, pass/fail engineering and material science evaluations against defined standards. There is no subjective interpretation or need for adjudication.

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:

This is not applicable. The device is an infusion set with high-pressure tubing, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study was conducted, and the concept of "human readers improve with AI" does not apply.

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

This is not applicable. The device is a physical medical device (infusion set), not an algorithm or software. No standalone algorithm performance study was done.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical tests is based on:

• Defined Standards and Specifications: The reference to ISO, ASTM, ISTA, and EN standards indicates that the ground truth is the performance criteria established within these internationally recognized specifications.
• Engineering Specifications: Kawasumi's internal tests (flow rate, pinch clamp pressure) would have had pre-defined, measurable specifications as their ground truth.
• Essentially, the ground truth is quantifiable, objective measurements against established benchmarks for material properties, pressure resistance, and functionality.

8. The Sample Size for the Training Set:

This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are validated against established engineering principles and standards.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the reasons stated above. The "ground truth" for the device's design and manufacturing is established through adherence to recognized engineering standards, material science principles, and quality control processes, not through a "training set" with established ground truth in the AI sense.

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The Port Access Infusion Set with Antineedle Stick Protector is a safety intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The port access infusion sets are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the needle is activated during removal from the patient's implanted medication port.

The Port Access Infusion Set with Antineedle Stick Protector is sterile, single use device with a non-coring Huber needle (90 degree), non-DEHP polyvinyl chloride tubing with or without Y connector or a needleless access connector which incorporates an integral antineedle stick protector used to prevent accidental needlestick injuries. The device is used for accessing an implanted medication port by puncturing the septum of the medication port and is used for the delivery of medication and for blood sampling. Fluid administration through the non-DEHP polyvinyl chloride fluid pathway of the port access infusion set are those generally used in hospitals and for delivery of chemotherapy. The device includes an integral antineedle stick device that when used prevent clinician's needle stick injuries.

This document is a 510(k) premarket notification for the Kawasumi Laboratories Port Access Infusion Set with Antineedle Stick Protector (K060580). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independently proving safety and effectiveness through extensive clinical trials. Therefore, the information provided for acceptance criteria and studies is limited and different from what would be expected for a novel device requiring a PMA (Premarket Approval).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for simulated use study or clinical evaluation.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to have been conducted by Kawasumi Laboratories. Given they are based in Japan with a U.S. agent, the studies could have been conducted in either region. The studies were likely prospective as they were specifically conducted for this submission.

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

This information is not provided in the document. The "simulated use study" and "clinically evaluated" phrases do not detail the methodology for expert involvement or ground truth establishment.

4. Adjudication method for the test set:

This information is not provided in the document.

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 MRMC study or AI component: This device is a physical medical device (infusion set with a safety mechanism), not an AI/software device. Therefore, an MRMC study or AI-related effectiveness is not applicable and was not performed.

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

• Not applicable: As noted above, this is a physical device, not an algorithm.

7. The type of ground truth used:

• For Biocompatibility and Pyrogenicity: Established by laboratory test standards and methodologies for these specific tests (e.g., ISO standards for biocompatibility).
• For Antineedle Stick Protector Efficacy: Based on the results of the "simulated use study" and "clinical evaluation." The specific "ground truth" for these would likely be defined by the study protocols themselves, such as absence of needlestick injuries in the simulated tasks or real-world use for the clinical evaluation. The document states the device was found "acceptable for use to minimize accidental needlestick injuries" and that it "successfully been clinically evaluated." The ultimate ground truth is implied to be actual prevention of needlestick injuries.

8. The sample size for the training set:

• Not Applicable: There is no "training set" in the context of this physical device.

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

• Not Applicable: As there is no training set, this question is not applicable.

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