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The Medcomp® Pro-Lock™ CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sample through implanted vascular access ports. The Medcomp® Pro-Lock™ CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles.

The 20G x 5/8" (15mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to prevent accidental needle sticks and automatically activate during needle removal. The needle is connected to a conventional style extension set. The proximal end of the extensions tubing attaches to a female Luer connector with removable cap creating a fluid path to the port. A non-removable pinch clamp is located between the female Luer and needle cannula which is designed to restrict fluid flow through the extension tubing when engaged.

The needle cannula is constructed with a Huber style needle. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.

The provided text is related to a 510(k) premarket notification for a medical device called the "Pro-Lock CT Safety Infusion Set." This document describes the device, its intended use, and a comparison to a predicate device, along with a list of performance tests conducted.

However, the document does not describe a study that uses a test set, ground truth established by experts, or any of the metrics (like sensitivity, specificity, or AUC) typically associated with AI/ML device performance. It also does not mention an AI algorithm, human readers, or any multi-reader multi-case (MRMC) comparative effectiveness study.

The document focuses on the mechanical and material performance of a physical medical device (an infusion set) against established international standards for medical devices and biocompatibility. The acceptance criteria are the successful completion of these specified tests according to the outlined standards.

Therefore, I cannot provide the requested information about acceptance criteria and study details related to an AI/ML device's performance because the provided text is about a physical medical device and its traditional regulatory submission.

Here's what I can extract from the provided text regarding the performance evaluation of the physical device:

The document describes the performance testing of the Pro-Lock™ CT Safety Infusion Set to demonstrate its substantial equivalence to a predicate device.

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly present a table of acceptance criteria alongside reported numeric device performance results. Instead, it lists the tests performed and the standards adhered to, implying that meeting these standards constitutes the acceptance criteria. The narrative states that the results of these tests "effectively demonstrate the proposed device... is equivalent to the predicate device."

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

• Sample Size: Not specified in the provided text for individual tests. The testing seems to be laboratory-based verification and validation.
• Data Provenance: Not applicable in the context of clinical data provenance. The data comes from "non-clinical testing performed" at Medcomp®.

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

• This is not applicable to the type of device and testing described. Performance is based on meeting engineering and biocompatibility standards, not expert clinical assessment of diagnostic output.

4. Adjudication method for the test set:

• Not applicable. Performance is measured against physical standards, not through expert 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:

• Not applicable. This is a physical medical device, not an AI/ML diagnostic tool.

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

• Not applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used:

• The "ground truth" here is adherence to national and international engineering and biocompatibility standards (e.g., ISO, ASTM, FDA Guidance). These standards define acceptable physical properties and safety profiles for the device.

8. The sample size for the training set:

• Not applicable. There is no AI/ML algorithm that requires a training set.

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

• Not applicable. There is no AI/ML algorithm requiring a training set and its associated ground truth establishment.

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The Medcomp® Pro-Lock CT Safety Infusion Set is intended for use in the administration of fluids and drugs as well as blood sampling through implanted vascular access ports. The Medcomp Pro-Lock CT Safety Infusion Set is also indicated for power injection of contrast media into the central venous system with implanted vascular access ports indicated for power injection. The maximum recommended infusion rate at 11.8 cPs is 5ml/sec for 20 gauge non-coring Huber style needles.

The 20G x ¾" (19mm) Pro-Lock™ CT Safety Infusion Set is composed of a Huber style needle for port septum access having a safety feature designed to aid in the prevention accidental needle sticks when manually activated during needle removal. The needle is connected to a conventional style extension set. The proximal end of the extensions tubing attaches to a female Luer connector with removable cap creating a fluid path to the port. A nonremovable pinch clamp is located between the female Luer and needle cannula which is designed to restrict fluid flow through the extension tubing when engaged. The needle cannula is constructed with a Huber style needle. The cannula is stainless steel and is shielded by a removable star needle guard of plastic construction.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device (Pro-lock™ CT Safety Infusion Set). It focuses on demonstrating substantial equivalence to a predicate device through performance testing and biocompatibility.

Therefore, many of the requested criteria, such as those related to AI algorithm performance studies (e.g., sample size for training set, number of experts for ground truth, MRMC studies, standalone performance), are not applicable to this type of device submission. This document describes a physical medical device, not an AI/ML software device.

However, I can extract information related to the device's acceptance criteria and studies to demonstrate its performance where applicable from the document.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion of the listed tests and the demonstration of substantial equivalence to the predicate device. The document does not explicitly state quantitative acceptance limits for each test in a table, but rather lists the tests performed to ensure the device meets relevant standards and performs similarly to the predicate.

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

The document does not specify the exact sample sizes (number of units tested) for each of the performance and biocompatibility tests. It only lists the tests performed and the relevant standards. These tests are laboratory-based, non-clinical tests.

• Data Provenance: The tests are "bench / performance data / non-clinical testing" conducted by the manufacturer, Medcomp®, located in Harleysville, Pennsylvania, USA. The data is retrospective in the sense that it was generated prior to the 510(k) submission to demonstrate the device's characteristics.

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

This question is not applicable. The "ground truth" here is established by the accepted international and internal test methods and standards (e.g., ISO, ASTM), not by expert consensus in a clinical scenario. The tests are designed to objectively measure physical, chemical, and biological properties.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials, particularly for imaging studies where subjective interpretation is involved. These are objective, quantitative, non-clinical laboratory tests where the results are measured against defined criteria within the standard.

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 question is not applicable. This is a physical medical device (an infusion set), not an AI/ML diagnostic or assistive device. No human-in-the-loop study with AI was performed.

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

This question is not applicable. This is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" or basis for evaluation is defined by:

• Established Industry Standards: ISO and ASTM standards (e.g., ISO 10555-1, ISO 10993 series, ASTM F2052, etc.) that specify test methods and acceptable limits for medical devices of this type.
• Internal Test Methods: Where no specific external standard exists, internal test methods are used, and their validity is implicitly accepted by the FDA's clearance.
• Substantial Equivalence: The primary "ground truth" for 510(k) clearance is demonstrating that the new device is as safe and effective as a legally marketed predicate device (K132880) through comparison of design, materials, indications for use, and performance testing.

8. The Sample Size for the Training Set

This question is not applicable. This device does not involve a "training set" for an AI/ML algorithm.

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

This question is not applicable, as there is no training set for an AI/ML algorithm.

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