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PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. Implantable Venous Access Systems: "The PORT-A-CATH® POWER P.A.C. implantable venous access systems are indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. When used with a GRIPPER PLUS® POWER P.A.C. needle, the PORT-A-CATH® POWER P.A.C. implantable venous access system is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec." "The PORT-A-CATH® II POWER P.A.C. implantable venous access system is indicated when patient therapy requires repeated vascular access for injection or infusion therapy and/or venous blood sampling. When used with a GRIPPER PLUS® POWER P.A.C. needle, the PORT-A-A-CATH® II POWER P.A.C. implantable venous access system is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec."

GRIPPER PLUS® POWER P.A.C. Needle: "The GRIPPER PLUS® POWER P.A.C. needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. When used with the PORT-A-CATH® POWER P.A.C. and POWER PORT-A-CATH® II POWER P.A.C. implantable venous access systems, the GRIPPER PLUS® POWER P.A.C. needle is also indicated for power injection of contrast media into the central venous system. The maximum recommended infusion rate is 5 ml/sec. for 19 and 20 gauge needles and 3ml/sec. for 22 gauge needles."

The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are similar to the current PORT-A-CATH® and PORT-A-CATH® II implantable venous access systems. They both are totally implantable venous access systems designed to permit repeated access to the venous system for the parenteral delivery of medications, fluids, nutritional solutions, and for the sampling of venous blood. However, when used with a GRIPPER PLUS® POWER P.A.C. needle, the PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are indicated for power injection of contrast media. The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems can be placed in the chest or arm. The PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are supplied sterile and non-pyrogenic. All PORT-A-CATH® and PORT-A-CATH® II POWER P.A.C. implantable venous access systems are designed and intended for single patient use only. A system consists of a portal with one or two self-sealing septa and a single or dual lumen catheter and is accessible by percutaneous puncture with a non-coring needle.

The GRIPPER PLUS® POWER P.A.C. needle is similar to the current GRIPPER PLUS® needle, with the addition of an added indication. Both are supplied sterile and non-pyrogenic and are intended for the administration into or withdrawal of fluids from implanted ports. In addition, they both have a passive needle stick protection feature that is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission. The difference between the two however, is when used with a PORT-A-CATH® and/or PORT-A-CATH® II POWER P.A.C. implantable venous access system; the GRIPPER PLUS® POWER P.A.C. needle is indicated for power injection of contrast media.

The provided text describes functional testing for the PORT-A-CATH® POWER P.A.C. Implantable Venous Access System, PORT-A-CATH® II POWER P.A.C. Implantable Venous Access System, and GRIPPER PLUS® POWER P.A.C. Needle, but it does not include information about an AI/ML device or its studies. The document is a 510(k) summary for medical devices, not an AI/ML product.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI device. The document states:

• "Functional testing" was performed, and the devices "met all established acceptance criteria for performance testing and design verification testing." (Page 3)
• "Clinical studies... were deemed not necessary" due to similarity to existing devices. (Page 3)

The document does not elaborate on what these specific acceptance criteria were, nor does it detail the results of the "functional testing" beyond stating that the criteria were met. There is no mention of a "test set" or "ground truth" as would be relevant for an AI study.

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The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.

The GRIPPER PLUS™ Needle is similar in design to the current GRIPPER® Needle, with the incorporation of a passive needle stick protection feature. The protection feature is made of a base and arm with a hinge on one end. As the needle is removed from a portal the hinge allows the needle to be pulled back and locked into the capture well in the base. There is an audible "click" when the needle is captured. The device is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission. The needle tip is fully protected after deployment of the needle stick protection feature and will not disengage with normal handling such that the needle tip becomes exposed.

The needle will be offered in various needle gauges and lengths, and with or without a slit-septum injection site cap.

The provided document describes the GRIPPER PLUS™ Needle, a medical device designed to protect against needlestick injuries. Below is an analysis of its acceptance criteria and the study used to demonstrate compliance.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GRIPPER PLUS™ Needle are primarily functional, focusing on the successful activation of the needle-stick protection feature and the biocompatibility of its components.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not explicitly state a numerical sample size for the "simulated use test." Instead, it mentions that the device was "evaluated by health care professionals during a simulated use test."
• Data Provenance: The testing was "in-vitro testing and simulated use testing." The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA, suggesting the testing was conducted to U.S. standards. The study was retrospective in the sense that the testing was performed to support the 510(k) submission after the device's design.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Number of Experts: The document states the device was "evaluated by health care professionals." It does not specify the exact number of professionals involved.
• Qualifications of Experts: The qualifications are broadly stated as "health care professionals." Specific expertise (e.g., years of experience, specific medical field) is not detailed.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus). The assessment appears to be based on the direct observation and feedback from the "health care professionals" during the simulated use test, where the protection feature "successfully activated during all attempts."

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

No multi-reader multi-case (MRMC) comparative effectiveness study was performed or cited. The document does not mention any comparison of human readers' performance with and without AI assistance, as AI is not a component of this device.

6. Standalone Performance Study

Yes, a standalone study was performed. The "functional testing" and "simulated use testing" evaluated the device's inherent performance. The key finding from this standalone testing was that the device's protection feature "successfully activated during all attempts."

7. Type of Ground Truth Used

The ground truth used for the acceptance criteria was primarily based on:

• Functional performance standards: The device's ability to activate its safety mechanism and protect the needle tip.
• Expert evaluation/observation: Healthcare professionals' assessment of the device's acceptability in simulated use.
• Biocompatibility testing: Laboratory results confirming material safety.

8. Sample Size for the Training Set

This device is a mechanical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used for algorithm development.

9. How Ground Truth for Training Set Was Established

Not applicable, as this is not an AI/machine learning device.

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