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The ARTLINE Device is intended to permit access to the peripheral arterial circulation system for short term access (less than 30 days).

The ARTLINE is a single lumen peripherally inserted catheter device designed to perform short term access to the peripheral arterial circulatory system for less than 30 days. The catheter, made of radiopaque polyurethane tubing, echogenic needle, guidewire with slide advancer. Each ARTLINE has a kink resistant catheter design. The catheter is inserted over the needle into the peripheral arterial vessel, the guide wire is advanced and the catheter is threaded over the guide wire. The catheter is supplied sterile and non-pyrogenic. The ARTLINE is indicated for dwell times shorter than 30 days. The ARTLINE is a 20ga single lumen catheter. The catheter is approximately 4.45 cm long. The catheters are attached to an injectionmolded polyurethane hub with Luer lock fittings for access attachment.

The provided document is a 510(k) premarket notification for a medical device called ARTLINE, a percutaneous catheter. It describes the device, its intended use, and a comparison to a predicate device. The document also lists performance tests conducted.

Here's the breakdown of the information requested, based on the provided text:

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

The document states, "The ARTLINE met all established acceptance criteria for performance testing and design verification testing." However, the specific numerical acceptance criteria for each test are not provided in this document. Only the types of tests performed are listed. Therefore, a complete table with criteria and performance cannot be generated from the given text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the performance tests, nor does it provide information about the data provenance (country of origin, retrospective or prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The performance tests described are engineering/material tests, not clinical studies requiring expert ground truth establishment in the medical sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document. As these are physical performance tests, an adjudication method for "ground truth" in a clinical context is not applicable.

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

The document does not mention an MRMC comparative effectiveness study, nor does it refer to any AI assistance. The ARTLINE is a physical medical device (catheter), not an AI-powered diagnostic tool.

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

This is not applicable as the ARTLINE is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance tests listed, the "ground truth" would be established by engineering and industry standards for medical device components and materials (e.g., ISO standards for conical fittings, established methods for tensile strength or flow rate measurement). The document implies adherence to these standards by stating "met all established acceptance criteria." However, it does not detail which specific standards were used as the "ground truth."

8. The sample size for the training set

This is not applicable. The ARTLINE is a physical medical device, not a machine learning algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

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The Arrow Arterial Catheterization Device permits access to the peripheral arterial circulation or to other small vessels.

The Arrow® Quickflash Arterial Catheterization Device, which is a sterile, single use arterial catheterization device, is designed to permit access to the peripheral arterial circulation or to other small vessels. The Arrow® Quickflash Arterial Catheterization Device is an all-in-one design consisting of a translucent polyurethane, radiopaque single lumen arterial catheter-over-needle device that includes a clear chamber as part of the needle hub which allows visualization of blood flashback. The needle has openings to enhance flashback visibility and the hub is connected proximally to a slotted housing that contains the integral spring wire guide. A handle projects through the slotted housing to permit the advancement of the spring wire guide through the introducer needle into the vessel. This design allows for quick and simple catheter insertion since all of the devices required for insertion are provided together.

The Arrow Quickflash Arterial Catheterization Device is available with and without integrated molded suture wings in 20 gauge configurations with usable lengths of 3.81 cm (1 ½").

The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML systems.

Instead, the document is a 510(k) summary for a medical device (Arrow Quickflash Arterial Catheterization Device) and focuses on demonstrating substantial equivalence to a predicate device. The information provided pertains to:

• Substantial Equivalence: The primary goal is to show the new device is substantially equivalent to an older, legally marketed predicate device (Arrow Radial Artery Catheterization Set K810675). This is achieved through comparisons of indications for use, technological characteristics, and non-clinical testing.
• Technological Characteristics Comparison: A table compares design features of the predicate and subject device (e.g., catheter body OD and length, material, blood flashback visualization, integrated guidewire, sterilization method).
• Nonclinical Testing: A list of bench tests performed for design verification (e.g., biocompatibility, corrosion resistance, leakage, tensile testing, luer testing, simulated use, penetration/insertion force, kink resistance, dimensional verification, needle flexing, spring wire guide flexing, catheter resistance to collapse).

Therefore, I cannot provide the requested information about acceptance criteria and device performance as this document does not contain such details relevant to AI/ML or comparative effectiveness studies.

Here's why the requested information cannot be extracted from the provided text:

1. AI/ML Context: The device is an "Arterial Catheterization Device" and appears to be a physical medical instrument, not an AI/ML software device.
2. Acceptance Criteria & Performance Metrics: The document lists nonclinical testing to demonstrate safety and performance relative to the predicate, but these are not the "acceptance criteria" and "reported device performance" in the sense of accuracy, sensitivity, specificity, or other statistical measures typically associated with AI/ML model evaluation.
3. Study Details (Sample Size, Ground Truth, Experts): Since it's not an AI/ML product study, there is no mention of training sets, test sets, data provenance, expert ground truth, adjudication methods, or MRMC studies.

In summary, the provided text is a regulatory submission for a physical medical device and does not contain the specifics required to answer your prompt, which seems to imply an AI/ML driven device evaluation.

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The Arrow ® Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.

The Arrow Seldinger arterial catheterization devices are comprised of an introducer needle, a spring wire guide, and an arterial catheter assembly. The catheter assembly consists of a polyurethane arterial catheter molded to a winged catheter juncture hub. An extension tubing segment is molded to the proximal end of the winged catheter hub. The proximal end of the extension tubing segment is molded to a luer-locking hub. A slide clamp is provided on the extension segment.

The provided document is a 510(k) summary for the Arrow® Seldinger Arterial Catheterization Device. It does not describe an AI/ML medical device, but rather a traditional medical device (catheterization device). Therefore, many of the requested categories related to AI/ML device studies (such as sample size for test/training sets, ground truth establishment for training, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract the available information regarding the device's acceptance criteria and the study that supports it within the context of a traditional medical device submission.

Acceptance Criteria and Study for the Arrow® Seldinger Arterial Catheterization Device

Study Overview:
The study performed for the Arrow® Seldinger Arterial Catheterization Device was a series of in-house verification and validation tests to demonstrate the safety and efficacy of the device. The conclusion of this testing was to demonstrate substantial equivalence to a legally marketed predicate device, the Arrow Radial Artery Catheterization Set (K810675).

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify the exact sample sizes (number of units tested) for each of the performance tests.
• Data Provenance: The data is from in-house "Verification and validation testing." This suggests prospective testing conducted by the manufacturer, Arrow International, Inc., likely at their facilities in the USA.

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

• This is not applicable to this type of device and study. The "ground truth" for a physical device like a catheterization kit is established through engineering and quality control specifications, not expert interpretation of outputs like images. Performance is measured against predefined technical specifications.

4. Adjudication Method for the Test Set:

• This is not applicable as the tests are objective physical performance measurements against specifications, not subjective interpretations requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI/ML devices where human reader performance is being evaluated with and without AI assistance. This device is a physical medical instrument.

6. Standalone (Algorithm Only) Performance:

• No, a standalone (algorithm only) performance study was not done. This device is not an algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for this device's performance tests is based on engineering specifications and industry standards for similar medical devices. These specifications would dictate acceptable ranges for parameters like "needle penetration force," "leak rate," "tensile strength," etc. The comparison to the predicate device also forms a "ground truth" for equivalence in fundamental technology and expected performance.

8. Sample Size for the Training Set:

• This is not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

• This is not applicable as there is no training set for this type of medical device.

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The Arrow arterial catheterization device permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.

The proposed device is a sharps-protected version of the Arrow Radial Artery Catheterization Set. It contains a radial artery catheter-over-needle assembly with an integral, passive needle protection feature.

Based on the provided text, here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

Note: The document states that these tests were "performed to demonstrate substantial equivalence," implying that the device met the requirements for each criterion to establish equivalence with predicate devices. However, specific quantitative acceptance thresholds or detailed performance results (e.g., exact deactivation force values, tensile strength measures) are not provided in the summary.

Study that proves the device meets the acceptance criteria:

The study refers to a set of "Performance Tests" conducted by Arrow International, Inc. These tests are listed as:

• Device reliability
• Clinical simulation
• Deactivation force of safety feature
• Safeguard interference fit
• Tensile
• Corrosion

The document does not provide the following information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not explicitly stated. The nature of the tests (e.g., "clinical simulation") suggests some form of testing, but details on the participants or data collection are absent.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this device is a medical instrument (catheterization set) and not an AI/diagnostic tool requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" here would pertain to the physical performance of the device against engineering and safety specifications.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of performance tests described. Adjudication methods are typically used in clinical trials involving subjective assessments or diagnostic interpretations.
4. 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 device is a medical instrument, not an AI diagnostic or assistance tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device would be engineering specifications, safety standards, and functional requirements for a radial artery catheterization set, including regulatory safety features for needle protection.
7. The sample size for the training set: Not applicable. This device is a physical medical instrument and does not involve AI/machine learning models that require a training set.
8. How the ground truth for the training set was established: Not applicable.

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