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The FLEX Vessel Prep™ System is indicated for use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the femoral and poplited arteries and treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature.

The FLEX Vessel Prep System™ is an over-the-wire sheathed catheter with a three-strut treatment element near the distal tip.

The FLEX Vessel Prep™ System is advanced over a 0.014" or 0.018" quidewire until distal to the lesion to be treated. The Treatment Element is unsheathed and expanded. The Treatment Element consists of three independent flexible struts, each with a precision blade, mounted on the proximal end. As the device is pulled back in a retrograde fashion through the target lesion, the Treatment Element "flexes" providing continuous engagement along the lesion to create controlled-depth microincisions.

The Flex Vessel Prep™ System is available in 2 lengths, 120cm and 40cm. The device has a 2mm crossing profile and is compatible with 6 French introducer sheaths. It is recommended to use a 150 cm+ guidewire with the 40cm product and a 300cm guidewire with the 120cm product.

The device consists of three integrated components. The Control Handle, which contains a Guidewire Port for quidewire insertion, a Flush Port to flush with saline to remove air from the device, the Sheath Actuator and Treatment Element Actuator.

The Sheath Actuator is located on the flat surface of the handle below the word FLEX. When the Sheath Actuator is pulled back and held in place, the sheath covering the Treatment Element is retracted and the Treatment Element is exposed. A click verifies the sheath is fully retracted.

The Treatment Element Actuator is located on the curved aspect of the handle, above the word FLEX. When the Treatment Element Actuator is pulled back and held in place, the Treatment Element expands the 3 flexible struts of the Treatment Element.

The Reinforced Braided Shaft, which is enclosed within a clear polymer sheath, provides strength to enhance deliverability and torque performance of the device.

The distal end of the device contains a radiopaque marker to aid in positioning the catheter and the Treatment Element.

The Treatment Element consists of three precision blades. 10 thousandths of an inch (0.010") in height and mounted on the proximal end of each of the three independent flexible struts. The expansion of the Treatment Element allows the three precision blades to independently engage the lesion.

During the retrograde pull-back of the device, each strut of the protective Treatment "flexes" independently to provide continuous engagement along and through complex lesions to create controlled-depth micro-incisions along the lesion. These micro-incisions modify the plaque in the lesion and enable dilatation of the target lesion using percutaneous angioplasty balloons at lower inflation pressures, minimizing barotrauma to the vessel.

Here's a breakdown of the acceptance criteria and study information for the FLEX Vessel Prep System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device. This type of document is intended to demonstrate substantial equivalence to a predicate device, not necessarily to present a full clinical study with specific acceptance criteria and performance metrics against those criteria in the way a clinical trial report would. Therefore, much of the requested information (like specific quantitative acceptance criteria, human reader improvement from AI, exact sample sizes for training/test sets with ground truth details, etc.) is not explicitly available in this document. The focus here is on bench testing and material safety.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary focusing on substantial equivalence and bench testing, "acceptance criteria" are implied by the various tests conducted to ensure the device meets its specifications and safe performance. Exact quantitative acceptance criteria, in terms of specific percentages or thresholds for clinical outcomes, are not explicitly listed in the document for the new indication (in-stent restenosis) or material change. The performance reported is that the device "meets all its physical and performance specifications."

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "bench testing," which implies a set of test articles (devices) were used, but the specific number is not provided.
• Data Provenance: The testing was "bench testing" and focused on physical, functional, and safety attributes of the device itself, rather than patient data. Therefore, notions of country of origin or retrospective/prospective data do not apply in the context of this 510(k) summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. This document describes bench testing and material characterization, not studies involving expert evaluation of clinical data for ground truth.

4. Adjudication Method

• Not applicable. This document describes bench testing and material characterization, not studies requiring adjudication of clinical outcomes or images.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. The device described is a physical medical device, not an AI or imaging diagnostic tool.

6. Standalone (Algorithm Only) Performance

• No, standalone algorithm performance was not done. This device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used

• The "ground truth" for the testing described here is based on engineering specifications, material science standards, and established biocompatibility testing protocols. For example, the "ground truth" for cytotoxicity is a standardized test result indicating non-toxicity, rather than human expert consensus or pathology on a biological sample from a patient. The "ground truth" for physical dimensions would be the engineering drawing specifications.

8. Sample Size for the Training Set

• Not applicable. This document describes bench testing of a physical device, not an AI or machine learning model that requires a training set.

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

• Not applicable, as there is no training set for an AI/ML model.

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The FLEX Scoring Catheter is indicated for use with percutaneous transluminal angioplasty (PTA) catheters to facilitate dilation of stenoses in the femoral and poplited arteries and treatment of obstructive or synthetic arteriovenous dialysis fistulae.

The FLEXTM Scoring Catheter is a sterile, single use, disposable device designed to facilitate the dilation of stenoses. The device has a working length of 120cm and is comprised of three scoring elements at the distal end. The distal end also contains an atraumatic tip and radiopaque maker band to aid in proper placement of the catheter. When the device is unsheathed the scoring elements are expanded to contact the plaque. The device scores the plaque as it is retracted. Once the desired plaque is scored the device is exchanged for a PTA balloon. The device is compatible with 0.18" guidewires.

This document is a 510(k) Summary for the FLEX™ Scoring Catheter. It does not describe a study to prove acceptance criteria in the typical format of a clinical trial for an AI/ML medical device. Instead, it focuses on demonstrating substantial equivalence to a predicate device through bench testing, animal testing, and cadaveric studies.

Therefore, the requested information elements such as sample sizes for test sets (in the context of an AI/ML model), number of experts for ground truth, adjudication methods, MRMC studies, or training set details are not applicable in this document's context, as it's not evaluating an AI/ML algorithm.

However, I can extract the acceptance criteria (performance requirements) and the reported performance based on the information provided regarding the functional and safety testing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• This document does not specify a "test set" in the context of an AI/ML algorithm or a clinical trial with human subjects for performance evaluation.
• For bench testing: "representative samples of the device underwent bench testing." The exact number of samples is not specified.
• For In Vivo GLP animal testing / Cadaveric studies: Conducted, but specific sample sizes are not provided in this summary.
• Data Provenance: These are pre-clinical studies (bench, animal, cadaveric). No indication of specific country of origin, but generally, GLP (Good Laboratory Practice) studies follow international standards. These would be prospective studies (designed and conducted specifically for this submission).

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

• Not applicable as this is a device approval based on substantial equivalence, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is adherence to engineering and biological performance standards, verified through testing.

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

• Not applicable for this type of device submission.

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. This is not an AI/ML device.

7. The type of ground truth used:

• The "ground truth" in this context is the established engineering standards, biological safety standards, and functional performance requirements. These are verified through various tests, including:
  • Compliance with ISO 10555-1 (General Requirements for Intravascular Catheters), which sets performance specifications.
  • Compliance with ISO 10993-1 (Biological evaluation of medical devices), focusing on biocompatibility.
  • Compliance with ISO 11135-1 (Sterilization of Health Care Products).
  • Verification against user needs and intended use through simulated use, animal, and cadaveric studies.

8. The sample size for the training set:

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

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

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

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