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The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices. Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.

The Bendit21 Microcatheter is a steerable microcatheter with a steerable distal tip. The tip's deflection is controlled using the Steering Slider on the proximal Steering Handle. The tip can be rotated bi-directionally while deflected by turning the Torque Knob on the Steering Handle. The total working length of the Bendit21 Microcatheter is 157 cm. It is comprised of two Nitinol hypo tubes that are welded together at their distal ends, with proprietary laser -cut patterns along the 36 cm distal section. The laser cuts give the Bendit21 Microcatheter its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 12 mm section is steerable using the proximal Steering Handle. The device includes two radiopaque markers, one at the tip and a radiopaque band located 30 mm from the tip. The distal portion of the catheter shaft (75 cm) is covered with a hydrophilic coating. Sliding the Steering Slider forward moves the hypo tubes so that the distal tip deflects. When the Steering Slider is released, the tip shape is locked. The Bendit21 lumen can accommodate compatible guidewires (≤ 0.018 ''). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle. The Bendit21 Microcatheter is compatible with the following types of therapeutic devices: Embolization particles with maximum particle size of 500 µm, Coils with maximum coil wire size of 0.018", Stents/Stent Retrievers/Flow Diverters.

This document is an FDA 510(k) summary for the Bendit21 Microcatheter, demonstrating its substantial equivalence to a predicate device. It is not an AI/ML device, therefore, the information requested about AI/ML specific criteria (such as training data, ground truth establishment methods for training data, expert adjudication, MRMC studies, and standalone performance) cannot be provided from this document.

However, based on the provided text, here's a breakdown of the acceptance criteria and the studies conducted for the Bendit21 Microcatheter:

The acceptance criteria for the Bendit21 Microcatheter are demonstrated through various in vitro bench tests and animal testing, confirming its safety, performance, and substantial equivalence to the predicate device. The general acceptance criterion for all tests is that the device must Pass, meaning its performance met pre-defined acceptance criteria, or it was comparable to the predicate device.

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

Since specific quantitative acceptance limits for each metric are not explicitly stated in a table format with performance results, I will create a table summarizing the Test Name, the General Acceptance Criteria (inferred from "Results" column), and the Reported Device Performance.

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

• Sample Size for In Vitro Bench Testing: "Sample sizes for all tests were established to demonstrate 95%/90% confidence/reliability in the test results." The exact number for each test is not specified, but this statement indicates a statistically sound sample size was used for each.
• Sample Size for Animal Testing: Not explicitly stated as a number of animals, but refers to "a porcine vascular model" where "Interventionalists used both the Bendit21 and the predicate Headway 21 microcatheters on opposite sides of the same animal." This suggests a comparative study design within each animal.
• Data Provenance: The document implies the data was generated prospectively during the development and testing phase for FDA submission. The country of origin of the data is not explicitly stated, but the submitter (Bend It Technologies Ltd.) is located in Petach Tikva, Israel. The testing itself would likely have occurred in laboratories or facilities globally that comply with regulatory standards.

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

This is a medical device (microcatheter), not an AI/ML diagnostic or prognostic tool. Therefore, the concept of "ground truth" and "experts establishing ground truth" in the AI/ML sense (e.g., radiologist consensus for image labeling) does not directly apply.

For this device:

• Ground Truth for Bench Testing: Established by standardized test methods (e.g., ISO standards, internal test methods) and objective measurements.
• Ground Truth for Animal Testing: Established through direct observation during procedures ("Interventionalists used..."), angiography for vessel patency, and post-mortem gross pathology and histologic evaluation of targeted vessels and downstream organs.
• Experts: "Interventionalists" are mentioned as performing the animal studies. Their specific qualifications (e.g., "vascular surgeon with X years of experience") are not detailed, but it's implied they are qualified professionals for such procedures. For pathology and histology, the "ground truth" would be established by veterinary pathologists.

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

Not applicable in the context of this traditional medical device study. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human subject data, particularly in imaging studies where multiple readers interpret cases and disagreements need resolution (common in AI/ML performance evaluation). For a physical medical device, performance is measured against objective laboratory standards or physiological responses in animal models.

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 traditional medical device (microcatheter), not an AI-assisted diagnostic or therapeutic system.

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 algorithm. Its performance is inherent to its design and material properties, and it is intended for use by a human operator.

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

As discussed in point 3, the "ground truth" for this device's performance evaluation was primarily based on:

• Objective Measurement against Pre-defined Specifications: For in vitro bench tests (e.g., dimensions, forces, flow rates, cycle counts before failure).
• Pathology and Histology: For animal testing (assessment of vessel damage, inflammation, etc.).
• Physiological Observations/Outcomes: In animal testing (e.g., animal's overall clinical status, occurrence of vasospasm, vessel patency through angiography).

8. The sample size for the training set:

Not applicable. This is a traditional medical device, not an AI/ML algorithm that requires a "training set."

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

Not applicable, for the same reasons as point 8.

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The Bendit2.7 Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic materials into the vasculature.

The Bendit2.7 is not intended to be used in intracranial or coronary vessels.

The Bendit2.7™ is a steerable microcatheter with a steerable distal tip. The tip's deflection is controlled using the Steering Slider on the proximal Steering Handle. The tip can be rotated bi-directionally while deflected by turning the Torque Knob on the Steering Handle.

The total working length of the Bendit2.7™ is 130 cm. It is comprised of two Nitinol hypo tubes that are welded together at their distal ends, with proprietary laser-cut patterns along the 28-centimeter distal section. The laser cuts give the Bendit2.7™ its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 12 mm section is steerable and includes a radiopaque atraumatic tip. The distal 80 cm of the shaft is covered with a hydrophilic coating.

Sliding the Steering Slider forward moves the hypo tubes so that the distal tip deflects. When the Steering Slider is released, the tip shape is locked. The Bendit2.7™ lumen can accommodate compatible guidewires (≤0.018"). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle.

This document describes the Bendit2.7 Steerable Microcatheter and its substantial equivalence to a previously cleared device (K190126) following design changes.

The focus here is not on an AI/ML device, but rather a medical device with mechanical and material changes. Therefore, much of the requested information regarding AI/ML studies (such as MRMC studies, ground truth establishment for training, expert qualifications for ground truth in test sets, and separate training/test sets) is not applicable to this submission.

Here's the breakdown based on the provided text, addressing only the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that "All test results met the pre-defined test acceptance criteria." However, the specific acceptance criteria values are not explicitly detailed in the provided document, nor are the quantitative results for each test. Instead, the document lists the types of tests performed to verify the design changes:

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

The document does not specify the sample sizes used for each of the listed tests. The data provenance is derived from in vitro bench testing performed by the manufacturer (Bend It Technologies, Ltd, Israel). It is not clinical data, nor does it involve human subjects or retrospective/prospective studies.

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

This question is not applicable as the evaluation involved in vitro bench testing of a physical medical device, not an AI/ML system requiring expert-derived ground truth.

4. Adjudication method for the test set

This question is not applicable as the evaluation involved in vitro bench testing of a physical medical device, not an AI/ML system requiring 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

This question is not applicable as the device is a physical microcatheter, not an AI/ML diagnostic tool. No MRMC study was performed.

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

This question is not applicable as the device is a physical microcatheter, not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is established by engineering specifications and recognized industry standards for medical devices (e.g., ISO 10993-17-2020 for biocompatibility, and internal specifications for physical properties like tensile strength, kink resistance, etc.). The tests verify that the device meets these pre-defined engineering and safety specifications.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device.

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

This question is not applicable as this is not an AI/ML device.

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The Bendit2.7 Steerable Microcatheter is intended for general intravascular use in the peripheral vasculature. The microcatheter can be used for the delivery of diagnostic, embolic, or therapeutic materials into the vasculature.

The Bendit2.7 is not intended to be used in intracranial or coronary vessels.

The Bendit2.7™ is a steerable microcatheter with a steerable distal tip. The tip's deflection is controlled using the Steering Slider on the proximal Steering Handle. The tip can be rotated bi-directionally while deflected by turning the Torque Knob on the Steering Handle.

The total working length of the Bendit2.7™ is 130 cm. It is comprised of two Nitinol hypo tubes that are welded together at their distal ends, with proprietary laser-cut patterns along the 28-centimeter distal section. The laser cuts give the Bendit2.7™ its flexibility while maintaining the Nitinol torsional rigidity for a high torque response. The distal 12 mm section is steerable and includes a radiopaque atraumatic tip. The shaft is covered with a hydrophilic coating.

Sliding the Steering Slider forward moves the hypo tubes so that the distal tip deflects. When the Steering Slider is released, the tip shape is locked. The Bendit2.7™ lumen can accommodate compatible guidewires (≤0.018"). A standard Luer lock port for attachment of accessories is located at the proximal end of the Steering Handle.

The provided text describes the Bendit2.7™ Steerable Microcatheter and its FDA 510(k) clearance. However, it does not contain information about acceptance criteria in terms of performance metrics (sensitivity, specificity, AUC, etc.) from a clinical study, nor does it detail a study that proves the device meets such criteria in the context of an AI/ML device.

The document focuses on the substantial equivalence of a physical medical device (a microcatheter) to a predicate device, primarily through bench testing and animal studies to demonstrate its functional and safety performance, rather than an AI/ML component's diagnostic or predictive accuracy.

Therefore, many of the requested categories in your prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set size, etc.) are not applicable to the data provided in this document, as it pertains to a physical medical device.

I can, however, extract related information from the document as best as possible, focusing on the available "acceptance criteria" through the lens of device performance testing.

1. Table of Acceptance Criteria and Reported Device Performance (based on the provided document):

Study that proves the device meets the acceptance criteria:

The primary studies conducted to demonstrate that the Bendit2.7™ Steerable Microcatheter meets its acceptance criteria for substantial equivalence are:

• In Vitro Bench Testing: This involved testing finished, sterilized, unaged, and accelerated-aged samples of the device against predefined design inputs.
• Animal Testing: This involved evaluating the device's performance in reaching target vessels and delivering materials.
• Sterilization Validation: This involved validating the ethylene oxide sterilization process.
• Biocompatibility Testing: This involved testing for various biological responses to patient-contacting materials.
• Package Testing: This involved testing package integrity after aging and simulated transportation.

Details requested that are NOT APPLICABLE to this document (as it concerns a physical medical device, not an AI/ML diagnostic/predictive system):

• 2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical devices and animal models, not a dataset for an algorithm.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of diagnostic "ground truth." For the animal studies, four interventional radiologists evaluated performance, which could be considered expert evaluation, but not for establishing a "ground truth" for diagnostic labels.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: 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: Not applicable. This is not an AI/ML device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the animal studies, the "ground truth" was the observed performance of the device by interventional radiologists against the predicate devices in terms of handling, tracking, and radiopacity/tip visualization. For bench tests, "ground truth" was meeting design specifications.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable.

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