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The Arch-Flo CT Midline is indicated for Short-Term peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. This catheter may be inserted via basilic, cephalic, or median cubital vein.

The Arch-Flo'™ CT Midline is available in a 4F Single Lumen configuration. The catheter lumen terminates through an extension to a female luer-lock connector. The extension has an in-line clamp to control fluid flow and is marked POWER INJECTABLE MIDLINE along with the lumen gauge size. The transition between lumen and extension is housed within a molded hub. The hub is marked MIDLINE to identify that the catheter is not centrally placed. The tip of the lumen is notched to increase the exposed area of the lumen. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.

The provided text describes a 510(k) premarket notification for a medical device called "Arch-Flo CT Midline." This document primarily focuses on establishing substantial equivalence to a predicate device through comparison and performance testing. It does not contain information about acceptance criteria and studies related to the performance of an AI/algorithm-based device.

The device in question is an "Intravascular Catheter," which is a traditional medical device, not an AI or software-based application. Therefore, the specific questions regarding AI device performance (like the number of experts for ground truth, MRMC studies, standalone performance with AI, training set details, etc.) are not applicable to the content provided.

However, I can extract the general "acceptance criteria" (or performance data) for the physical device based on the bench/performance data and comparison to the predicate device.

Here's the information that can be extracted, interpreted based on the context of a traditional medical device submission:

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

The document describes performance data for the Arch-Flo CT Midline and compares it to the predicate device, CT Midline (K141151). The "acceptance criteria" are implied by the standards the device was tested against and by demonstrating similar or superior performance to the predicate device.

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The Symetrex™ Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed for chronic hemodialysis and aphersis. It may be inserted percutaneously or by cut down. Catheters with greater than 37cm implant length are indicated for femoral placement.

The Symetrex™ Long Term Hemodialysis Catheter is a chronic, 15.5 French, dual lumen, radiopaque catheter made of polyurethane. It has a polyester retention cuff and two female luer adapters. The retention cuff promotes tissue ingrowth to arochr the catheter in the subcutaneous tunnel. The luer adapters are identical in color to indicate the reversibility of this catheter. This catheter features symmetrical side channels with a distal tip configuration designed to separate the intake flow from the output flow in both directions.

The provided document is a 510(k) premarket notification for a medical device called the Symetrex Long Term Hemodialysis Catheter. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a predicate device, and thus does not contain information about an AI/ML powered medical device. As such, the requested information regarding acceptance criteria, study details, ground truth, and training data for an AI/ML device cannot be extracted.

The document discusses the substantial equivalence of the new device to a predicate device (K140884), focusing on design, materials, manufacturing, and performance testing against established medical device standards (e.g., ISO, ASTM) for safety and basic functionality.

Therefore, I cannot provide the answer in the requested format because the input document does not pertain to an AI/ML medical device.

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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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