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The Boomerang™ Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.

The Boomerang™ Valvulotome is a sterile, single-use, non-coated intravascular catheter designed to disrupt or cut venous valves. Both models of the Boomerang™ Valvulotome consist of a flexible 4F catheter shaft, with a working length of either 80cm (BMGVT080) or 125cm (BMGPVT125). Both models utilize a self-expanding nitinol basket with shielded blades that is mounted at the distal end of the catheter which self-centers in the vessel to prevent the blades from damaging the vessel wall. When deployed, the size of the basket adjusts to the internal diameter of the vein as the device is tracked through the vessel. The Boomerang™ Valvulotome is compatible with standard 0.018" vascular guidewires. The device is used by a physician in a healthcare facility such as a hospital or catheterization lab. The device is in contact with the patient for a short duration (

The FDA 510(k) Clearance Letter for the Boomerang™ Valvulotome does not detail specific acceptance criteria or study results in a format that would allow for a direct numerical comparison of performance, as is typical for AI/Software as a Medical Device (SaMD) clearances. This is primarily a Class II mechanical device (External Vein Stripper) rather than a software-based diagnostic or AI-driven system.

The "Performance Data" section lists various types of tests conducted (e.g., Dimensional Measurements, Tensile Strength, Simulated Use, Biocompatibility, Cadaveric studies), but it does not provide the quantitative acceptance criteria for each test or the reported device performance against those criteria. It also does not discuss an AI component, MRMC study, or expert ground truth adjudication in the context of diagnostic accuracy, which would be relevant for an AI/SaMD.

Therefore, many of the requested points below cannot be fulfilled from the provided document as they relate to AI/SaMD performance evaluation rather than a traditional medical device's physical and functional performance.

Based on the provided document, here's an attempt to address your request, noting where the information is absent:

Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the Boomerang™ Valvulotome

The provided FDA 510(k) clearance letter for the Boomerang™ Valvulotome indicates that a substantial equivalence determination was made based on various performance testing. However, the document does not explicitly state quantitative acceptance criteria or the specific numerical results of these tests. Instead, it lists categories of tests performed to demonstrate the device's safety and effectiveness compared to the predicate device.

The "Conclusion" states that "The information supplied in this premarket notification confirms that the Boomerang™ Valvulotome has the same intended use as the legally marketed predicate device. The performance testing data demonstrates that the Boomerang™ Valvulotome is substantially equivalent to the legally marketed predicate device." This implies that the device met internal design specifications and performance standards aligned with the predicate device, although these specific values are not disclosed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

As per the provided 510(k) summary, specific quantitative acceptance criteria and their corresponding reported device performance values are not detailed. The document lists the types of performance tests conducted. For a traditional medical device like this, acceptance criteria would typically involved:

• Dimensional Accuracy: Device dimensions falling within specified tolerances.
• Tensile Strength & Torque Strength: Ability to withstand forces without breaking or deforming.
• Flexibility: Ability to navigate venous anatomy without kinking or fracturing.
• Radiopacity: Visibility under fluoroscopy.
• Simulated Use: Functionality in a simulated environment (e.g., successful valve disruption without vessel damage).
• Corrosion Resistance: No degradation when exposed to physiological fluids.
• Biocompatibility: Absence of adverse biological reactions (cytotoxicity, sensitization, irritation, etc.).
• Sterilization Validation: Assurance of sterility after processing.
• Packaging Validation: Integrity of packaging to maintain sterility and device function.

The document states that these tests were "completed under specified test conditions to support a determination of substantial equivalence," implying that the device met the pre-defined acceptance criteria for each, but the specific numerical targets and results are proprietary and not included in this public summary.

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

The document does not specify the sample sizes used for each of the performance tests (e.g., number of devices tested for tensile strength, number of simulated uses, or number of cadaveric studies).

• Data Provenance: The studies are described as "performance testing," which typically occurs in a lab environment. The "Cadaveric studies" imply the use of human cadaveric tissue, but the geographical origin of these cadavers or whether the studies were retrospective or prospective observational studies is not stated. These are likely prospective studies conducted specifically for regulatory submission.

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

Given this is a mechanical device, the concept of "ground truth" established by experts (like radiologists for imaging) is not directly applicable in the sense of diagnostic accuracy. However, for "Simulated Use" and "Cadaveric studies," the "experts" would likely be the engineers conducting the tests, potentially with oversight or input from medical professionals (e.g., surgeons performing the cadaveric procedures) to validate the device's functional performance and intended use. The number of such professionals and their specific qualifications are not stated.

4. Adjudication Method for the Test Set

As this is not an AI/SaMD diagnostic study, an adjudication method (like 2+1, 3+1 for consensus reads) is not applicable or described in the context of device performance testing. Performance tests typically have objective pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or mentioned. This type of study is relevant for AI/SaMD products that assist in interpretation of medical data (e.g., radiology images). The Boomerang™ Valvulotome is a physical medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a "standalone" algorithm performance study was not done or mentioned. This device does not have an AI algorithm component in the described functionality.

7. The Type of Ground Truth Used

For a mechanical device:

• Objective Measurements: E.g., dimensional measurements against blueprints, force measurements against specifications.
• Functional Success: E.g., successful disruption of valves in simulated or cadaveric models, successful tracking through simulated vessels.
• Material Properties: E.g., verification of material composition and properties against established standards.
• Biocompatibility Standards: Compliance with ISO 10993 series for biological safety.

The "cadaveric studies" would involve an anatomical "ground truth" to assess the device's physical interaction, such as successful valve disruption without vessel wall damage. However, the specific methodology for defining and assessing this "ground truth" within the cadaveric study is not detailed.

8. The Sample Size for the Training Set

This device does not involve a "training set" in the context of machine learning or AI. Therefore, this question is not applicable.

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

As there is no "training set" in the AI/ML context, this question is not applicable.

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