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The Distal Access Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The Distal Access Catheter is a single lumen, flexible, variable stiffness composite catheter which has a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The Distal Access Catheter has a radiopaque marker on the distal tip that is visible under fluoroscopy. The Distal Access Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The catheter has a straight tip. The catheter is offered in various lengths to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.

The provided text describes information for a Distal Access Catheter, specifically related to its 510(k) premarket notification for FDA clearance. It details the device's characteristics, intended use, and comparisons to a predicate device, along with non-clinical performance testing (bench testing, biocompatibility, sterility, and shelf-life).

However, the prompt asks for acceptance criteria and a study that proves a device meets acceptance criteria, with specific questions related to AI/Machine Learning (ML) performance, such as:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done and its effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The provided FDA 510(k) document is for a physical medical device (catheter) and does NOT describe any AI/ML components or studies. Therefore, it does not contain the information necessary to answer the questions about AI/ML acceptance criteria, test sets, ground truth establishment, or clinical studies involving AI.

Based on the provided document, here is a summary of acceptance criteria and performance for the physical device:

Acceptance Criteria and Device Performance (for the physical catheter)

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

The document lists various non-clinical (bench) tests and biocompatibility tests. The "Result" column effectively indicates whether the device met the pre-defined acceptance criteria for each test.

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

• The document describes bench testing and biocompatibility testing only. It does not mention any clinical data, patient data, retrospective, or prospective studies.
• The sample sizes for these tests are not explicitly stated in numerical values (e.g., "n=X units were tested"), but implied by "test articles," "devices," or descriptions like "all bonding points."

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 question is irrelevant for the provided document as it concerns a physical catheter, not an AI/ML product requiring "ground truth" from experts interpreting medical images or data. The "ground truth" for this device's performance is established by objective engineering and biocompatibility test standards and measurements.

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

• This question is irrelevant for the provided document as it concerns a physical catheter, not an AI/ML product requiring clinical adjudication of interpretations.

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 or any clinical effectiveness studies were performed or described. The document explicitly states: "No clinical studies were deemed necessary to demonstrate substantial equivalence."

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

• Not applicable. This is a physical device, not an algorithm.

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

• For the physical device, the "ground truth" is defined by established engineering standards (e.g., ISO standards), physical measurements, chemical analyses, and biological assays. It's not based on expert clinical consensus or pathology in the context of diagnostic interpretation.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI/ML product that undergoes "training."

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

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

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The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The Distal Access Catheter is also indicated for use as a conduit for retrieval devices.

The Distal Access Catheter is a sterile, single lumen, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the peripheral and neurovascular systems. The catheter comes in Straight (with no shaping of the catheter tip) and Curved (curved catheter tip) models based on the distal end. The catheter shaft has a hydrophilic coating on the distal end of the shaft to reduce friction during use. The catheter includes a radiopaque marker on the distal end for angiographic visualization and a luer hub on the proximal end.

This document is a 510(k) summary for a medical device called the "Distal Access Catheter." It describes non-clinical performance testing and biocompatibility testing conducted to demonstrate that the device is substantially equivalent to a predicate device.

1. Table of acceptance criteria and the reported device performance:

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

The document describes non-clinical (bench and in vitro) and biocompatibility testing. It does not mention a "test set" in the context of patient data or clinical images. Therefore, questions regarding data provenance (country of origin, retrospective/prospective) are not applicable here.

For the non-clinical and biocompatibility tests, the sample sizes are not explicitly stated for each individual test. The document generally states "test sample" or refers to the number of cycles/animals without specifying the exact number for statistical power. The tests are performed on the device itself or its extracted components, not on patient data.

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

Not applicable. This is a submission for a physical medical device (catheter) based on non-clinical and biocompatibility testing, not an AI/software device that requires expert-established ground truth for image interpretation or diagnosis.

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

Not applicable. As noted above, there is no "test set" in the context of clinical data for 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 not an AI/software device, so MRMC studies are not relevant.

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

Not applicable. This is not an AI/software device. The performance reviewed here is the physical device's standalone performance under various bench and in vitro conditions.

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

The "ground truth" for the non-clinical and biocompatibility tests are defined by the established industry standards and test methods (e.g., ISO 10555-1:2013, ISO 10993 series, ASTM F640-12). The acceptance criteria outlined within these standards serve as the "truth" against which the device's performance is measured. For example, for cytotoxicity, the ground truth is "Viability > 70%."

8. The sample size for the training set:

Not applicable. There is no training set as this is not an AI/software device.

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

Not applicable. There is no training set for this type of device.

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The Distal Access Catheter is indicated for general intravascular use, including the neuro and peripheral vasculature. It can be used to facilitate introduction of diagnostic agents or therapeutic devices. It is not intended for use in coronary arteries.

The Distal Access Catheter consists of a catheter and accessories (hemostatic valve, introducer sheath, and a shaping mandrel). The catheter is a single-lumen, flexible catheter designed with coil and braid reinforcement. The distal segment is steamshapeable, and a hydrophilic coating is applied for navigation of the catheter through the vasculature. The radiopaque marker is located at the distal end of the catheter for visualization under fluoroscopy.

The catheter body is constructed with a stainless-steel coil (less 2 cm of the catheter length) over the inner lumen liner comprised of polytetrafluoroethylene (PTFE). To provide additional shaft support, a stainless-steel wire braiding has been added over the stainless-steel coil from the proximal end to distal end. A platinum/iridium alloy radiopaque marker band is located at the distal tip of the catheter. An outer layer of varying durometers and lengths of polyamide (PA), polyether block amide (Pebax) and polyurethane (PU) covers the entire catheter body from proximal to distal end, respectively.

A hub (PC) is attached to the proximal end of the catheter. A strain relief made from polyether block amide (Pebax) is placed at the proximal end of the catheter and distal end of the hub. The hub-strain relief provides for the kink resistance for the proximal end. A luer fitting on the catheter hub is used for the attachment of accessories.

The outer surface of the catheter (distal 60 cm) is coated with a hydrophilic coating to reduce friction during navigation in the vasculature.

A shaping mandrel (stainless steel, 80 mm in length) is provided with the catheter to be used by the physician for tip shaping. An introducer sheath (PTFE) is included to facilitate the introduction of the catheter into guide catheters during clinical use. A hemostatic valve is used to connect to the proximal section of the catheter.

The Distal Access Catheter is provided sterile and for single use only. The catheter is placed in a dispenser tube (HDPE) and is placed on a packaging card (HDPE) that is provided in a sterile barrier PET/PE film and Tyvek pouch and placed in a carton box.

This document describes the regulatory clearance for a medical device called a "Distal Access Catheter," not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, expert ground truth, MRMC studies, and human-in-the-loop performance, are not applicable.

The acceptance criteria and the study that proves the device meets them are based on bench testing (physical and mechanical properties) and biocompatibility testing.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The device met its acceptance criteria through a series of bench tests and biocompatibility evaluations.

Bench Test Study:

• Study Design: The bench testing of the Distal Access Catheter was performed using the applicable sections of the ISO 10555-1 international standard for sterile, single-use intravascular catheters. This standard specifies requirements for sterile, single-use intravascular catheters. The tests covered various physical and mechanical properties crucial for safe and effective device function.
• Methodology: The document lists 24 distinct bench tests (e.g., Surface Inspection, Dimensional Verification, Corrosion Resistance, Peak Tensile Force, Fluid Leakage, Kink Resistance, Simulated Use, Dynamic Burst, Flow Rate, etc.). Each test had specific acceptance criteria derived from the ISO standard or established engineering specifications for the device. The results consistently concluded that the device was "suitable for intended clinical use," "met requirements," or was "equivalent to the predicate device."
• Conclusion: The bench testing demonstrated that "the in vitro behavior of the device is well characterized within design specifications."

Biocompatibility Study:

• Study Design: The biocompatibility evaluation was conducted in accordance with FDA's biocompatibility guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"."
• Methodology: The biological tests were conducted in compliance with the Good Laboratory Practice (GLP) Regulation 21 CFR 58. These tests included Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Hemolytic Properties, Partial Thromboplastin Time (PTT), In Vivo Thrombogenicity, Pyrogen, and Complement Activity tests. Each test had specific criteria for acceptable biological response. The conclusions for these tests consistently indicated that the device was non-cytotoxic, non-sensitizing, non-irritant, non-systemically toxic, had no effect on hemolytic properties or PTT, was equivalent to control/predicate for thrombogenicity and complement activity, and was non-pyrogenic.
• Conclusion: The biocompatibility testing confirmed the device material safety for its intended biological contact.

The following information is not applicable (N/A) as this is a traditional medical device (catheter) and not an AI/ML powered device.

2. Sample size used for the test set and the data provenance: N/A (for AI/ML test sets). These are physical and biological tests, not data-driven evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (for AI/ML expert annotation). Ground truth for physical/biological tests is based on objective measurements against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (for AI/ML 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: N/A (not an AI-assisted device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (not an AI algorithm).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this device, the "ground truth" or acceptance standard is derived from established international medical device standards (e.g., ISO 10555-1, ISO 80369-7, ISO 10993 series, USP <85/>) and internal design specifications, verified through objective bench and biological testing.
8. The sample size for the training set: N/A (not an AI/ML device; no training set in this context).
9. How the ground truth for the training set was established: N/A (not an AI/ML device).

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