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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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The LimFlow Vector is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.

The LimFlow Vector is a single-use medical device designed to cut venous valves during vascular in-situ bypass procedures. The LimFlow Vector consists of a 4Fr intravascular catheter that has a working length of 120cm. It utilizes a deployment mechanism to deploy the self-expanding nitinol cutting basket mounted at distal tip which self-centers in the vessel to prevent the cutting blades from damaging the vessel wall. The size of the cutting basket and cutting blades adjust to the internal diameter of the vein as the LimFlow Vector is being drawn through the vessel. The LimFlow Vector is compatible with 0.018" standard guide wires. The LimFlow Vector is used in a healthcare facility, such as a catheter lab or hospital. It is in contact with patient tissue for less than 24 hours. The LimFlow Vector is supplied sterile.

The provided text is a 510(k) summary for the LimFlow Vector device. It outlines the device description, intended use, comparison to a predicate device, and performance data. However, it does not include the specific details required to answer your questions thoroughly, particularly regarding acceptance criteria, the statistical design of a study proving the device meets those criteria (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies).

The document focuses on engineering performance tests and biocompatibility, as commonly required for a 510(k) submission for certain device types. It does not describe a clinical study in the format typical for AI/ML device evaluations where performance is measured against human experts or a gold standard on a medical imaging dataset.

Therefore, I cannot extract the information you've requested from the provided text because it is not present. The document lists performance tests such as:

• Dimensional verification
• Simulated Use
• Tensile Strength testing
• Flexibility and Kink resistance
• Torque Strength
• Radiopacity
• Corrosion resistance
• Particulate Evaluation
• Luer and Leak Testing
• Shelf-life Testing
• Sterilization Validation
• Packaging Validation
• Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Hemolysis, PTT, Complement Activation, Thrombogenicity)
• Pre-clinical studies in swine and cadaveric models.

These are primarily engineering and bench-testing parameters, not the clinical performance metrics (like sensitivity, specificity, AUC) typically associated with AI/ML systems evaluated against image-based ground truth established by experts.

There is no mention of:

• A table of acceptance criteria with reported device performance in the context of AI/ML metrics.
• Specific sample sizes for a 'test set' or 'training set' for an AI model.
• Data provenance (country of origin, retrospective/prospective) for a clinical dataset.
• Number/qualifications of experts for ground truth or adjudication methods.
• MRMC studies to evaluate human reader improvement with AI assistance.
• Standalone algorithm performance.
• Type of ground truth used as pathology or outcomes data for clinical performance.

In summary, the provided FDA 510(k) summary is for a physical medical device (valvulotome) and details its engineering and biocompatibility testing, not the evaluation of an AI/ML component.

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The EZE SIT Valvulotome is intended to render venous valves incompetent during in situ bypass procedures. This includes distal infrainguinal bypass when a non-anatomic position is required (e.g., profunda to anterior tibial artery), composite vein infrainguinal bypass, or aorto-renal bypass procedures.

The EZE SIT Valvulotome is a medical device utilized for disruption of venous valves, and is used in patients that suffer from peripheral vascular disease, for which an attending physician determines the relative benefit of in situ bypass to restore blood flow to the extremities. The EZE-SIT Valvulotome is comprised of a catheter with a luer-lock hub at the proximal end and a threaded connector at the distal end. The catheter is designed with a lumen that extends throughout its entire length. The threaded connector allows attachment of 2 mm, 3 mm and 4 mm diameter cutting heads. These cutting heads are also configured with a central lumen. This design allows the physician to select the cutter head diameter that is best suited for the particular vessel being prepared. The central lumen allows irrigation during the procedure. The cutting head design minimizes vessel wall contact while effectively disrupting valve leaflet tissue. The EZE SIT Valvulotome is surgically invasive and intended for less than 24-hour use. This medical device has no software components. This device is not an in vitro diagnostic device.

The provided document is a 510(k) premarket notification for a medical device called the EZE SIT Valvulotome. It asserts substantial equivalence to a predicate device (Tru-Incise Valvulotome K930011).

Crucially, this document states that no performance data, including clinical studies or data demonstrating adherence to acceptance criteria for an AI/algorithm-driven device, were required or provided. The submission is intended "to simply indicate a new manufacturer for a currently cleared device design that has not changed since its clearance (K930011)."

Therefore, the acceptance criteria and study proving the device meets those criteria, as requested in the prompt, are not present in this document. This device does not have software components and is not an in vitro diagnostic device, and thus the type of AI/algorithm performance study envisioned by the prompt is not applicable to this submission.

The document only includes:

• Nonclinical data: Sterilization, Shelf Life/Aging, and Biocompatibility, all of which confirmed substantial equivalence to the predicate device.
• Sterilization: Validated with half-cycle using ISO 11135-1: 2014, achieving a Sterility Assurance Level (SAL) of 10-6. Residuals measured: 0.6 mg EtO,

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The LeMills Valvulotomes are intended to cut venous valves.

The Antegrade LeMills Valvulotome consists of small metal antegrade cutting blade with atraumatic distal edge. The blade is a part of a long stainless steel wire that allows it to be inserted into the venous anatomy. It is held by a plastic handle. It is designed for cutting the venous valves. Once the valves have been rendered ineffectual, the vein can then be utilized as an arterial conduit.

The provided document is a 510(k) premarket notification for the Antegrade LeMills Valvulotome, a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive details on novel performance studies and acceptance criteria as would typically be found for AI/ML-based devices or those requiring clinical trials for efficacy.

Based on the content provided, it is not possible to extract the information requested regarding acceptance criteria and a study proving the device meets them in the context of AI/ML performance, multi-reader multi-case studies, or complex ground truth establishment. This is because the device is a physical surgical tool (a valvulotome) designed to cut venous valves, and its approval relies on bench testing and comparison to existing predicate devices, not on diagnostic performance or AI algorithm validation.

However, I can extract the available information related to performance testing that was conducted:

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

The document mentions "Functional/Safety Testing" and "Summary of Product Testing" but does not provide a specific table with acceptance criteria and corresponding reported device performance values. It generally states that the device meets performance requirements.

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

• Test Set Sample Size: Not specified in the document. The tests appear to be bench-top physical tests performed on the device itself, rather than studies involving patient data.
• Data Provenance: Not applicable as it's not a data-driven diagnostic or AI device. The tests are for the physical properties and function of the surgical tool.

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

• Number of Experts/Qualifications: Not applicable. Ground truth for physical device testing is typically established through engineering specifications, material standards, and functional performance benchmarks, not expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable. This concept is relevant for interpreting ambiguous clinical data, not for physical device testing.

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:

• MRMC Study: No. This device is a surgical tool, not a diagnostic imaging device or an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used:

• Ground Truth Type: For the physical tests mentioned (Dimensional Comparison, Sharpness Test, Visual Inspection, Joint Tensile Strength), the 'ground truth' would be the engineering specifications and design requirements for the device. For biocompatibility and sterilization, the ground truth is adherence to recognized standards (ISO 10993, ANSI/AAMI/ISO 11135-1:2007).

8. The sample size for the training set:

• Training Set Sample Size: 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:

• Ground Truth Establishment for Training Set: Not applicable.

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It is used for the treatment of vascular disorders, and more particularly for excising or disrupting venous valves.

The 1.5mm HYDRO Expandable LeMaitre Valvulotome is a self-centering and self-sizing valvulotome device used for cutting vein valves. The centering hoops keep the device centered in the vein. The size of the centering hoops and cutting blades adjust to the internal diameter of the vein as the valvulotome is being drawn through the vessel cutting the valves and rendering them ineffectual. The modifications to the predicate device - Expandable LeMaitre Valvulotome (ELV)- include the addition of hydrophilic coatings and co-extruded sheath to create 1.5mm HYDRO Expandable LeMaitre Valvulotome. The hydrophilic coatings provide increased lubricity and allow the device to navigating veins easier.

The provided document describes a 510(k) submission for the 1.5mm HYDRO Expandable LeMaitre Valvulotome. This is a medical device, and the submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving performance against specific acceptance criteria in the way a new diagnostic or AI-driven device often does.

Therefore, the structure of the response will be tailored to the information provided in a 510(k) summary for a physical medical device. Many of the requested categories (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, training set details) are not applicable to this type of submission because it's not a diagnostic or AI device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are implied by meeting product performance specifications and not raising additional safety issues, as compared to its predicate device. Specific quantitative acceptance criteria with corresponding performance values are generally not provided in this type of 510(k) summary for functional device modifications. The tests performed are primarily engineering and bench tests, with a cadaver study, to show that the modified device functions similarly and safely.

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

• Test Set Sample Size: Not explicitly stated for specific tests (e.g., how many devices for dimensional, fatigue, force tests). For the Cadaver Study, the sample size is not specified.
• Data Provenance: Not specified. Standard practice for bench testing is typically done in a lab environment. Cadaver studies are usually conducted by the manufacturer or a contract research organization (CRO) in a controlled setting. No country of origin for the data is mentioned. The study is prospective for the device's performance given the modifications.

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

• This concept is not applicable here as this is a physical device, not an AI or diagnostic device that requires expert-established ground truth on a dataset. The "ground truth" for a medical device's performance is typically established through engineering standards, functional tests, and in vivo/cadaver studies where success is defined by the device performing its intended mechanical function.
• For the cadaver study, it's implied that medical professionals (surgeons or similar) would have conducted or observed the study to assess functionality, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set

• Not applicable in the context of an AI/diagnostic device's performance evaluation. For engineering tests, results are typically assessed against pre-defined engineering specifications. For the Cadaver Study, the "adjudication" would be whether the device successfully performed its function (cutting valves) and navigated the anatomy, likely assessed by the operating physician(s).

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 medical instrument, not an AI system.

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

• Not applicable. This is a medical instrument, not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for this device is based on functional performance metrics derived from engineering tests (e.g., force measurements, dimension checks, fatigue cycles) and observations from the cadaver study confirming the device's ability to navigate and effectively cut venous valves in a simulated biological environment. There is also biocompatibility testing against ISO 10993 guidelines.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

• Not applicable.

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The LeMills Valvulotome is intended to cut venous valves.

The LeMills Valvulotome consists of small metal retrograde cutting blade with atraumatic distal edge. The blade is a part of a long section of wire that allows it to be inserted into the venous anatomy. It is held by a plastic handle. It is designed for cutting the venous valves. Once the valves have been rendered ineffectual, the vein can then be utilized as an arterial conduit.

The LeMills Valvulotome is a medical device designed to cut venous valves. The provided text is a 510(k) summary for its clearance.

Here's an analysis of the provided information, specifically addressing the requested points:

K132047: LeMills Valvulotome

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document references "product performance requirements of the device specifications" and "Summary of Product Testing," but it does not explicitly list quantitative acceptance criteria or detailed reported performance values. Instead, it focuses on demonstrating substantial equivalence to a pre-amendment predicate device (Mills Valvulotome) through functional and safety testing.

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It is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves.

The ELV and OTW-LV are self-centering and self-sizing valvulotome used for blind lysis of vein valves. Once the valves have been rendered ineffectual, it can then be utilized as an arterial conduit. Centering hoops keep the devices centered in the vein and prevent the valve-cutting blades from damaging the vein wall. The size of hoops and blades adjusts to the internal diameter of the vein as the valvulotome is being drawn through the vessel. The OTW-LV facilitates navigation of the vein with the assistance of a guidewire.

This document describes the 510(k) submission for the Expandable LeMaitre Valvulotome (ELV) and Over-the-wire LeMaitre Valvulotome.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided submission does not include specific acceptance criteria or quantitative performance data for the device. Instead, the submission states:

The submission explicitly states: "No additional testing was performed for this submission." and "No preclinical study was performed for this submission." This indicates that the regulatory clearance was based on demonstrating substantial equivalence to a predicate device, rather than new performance studies with pre-defined acceptance criteria.

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

No test set data is provided in this submission for the evaluation of the device's performance. The submission explicitly states "No additional testing was performed for this submission" and "No preclinical study was performed for this submission."

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

Not applicable, as no performance tests or studies requiring ground truth establishment were conducted or reported in this submission to demonstrate the device's efficacy or safety beyond substantial equivalence.

4. Adjudication Method for the Test Set:

Not applicable, as no performance tests or studies requiring adjudication were conducted or reported in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not performed. The submission explicitly states "No additional testing was performed for this submission" and "No preclinical study was performed for this submission." This device is a surgical tool, not an AI or imaging diagnostic device where MRMC studies are typically relevant.

6. If a Standalone (Algorithm Only) Performance Study was done:

No, a standalone performance study was not done. This device is a physical medical instrument (valvulotome), not a software algorithm.

7. The Type of Ground Truth Used:

Not applicable, as no performance studies requiring ground truth were conducted or reported in this submission. The basis for clearance is substantial equivalence to a predicate device.

8. The Sample Size for the Training Set:

Not applicable. This document is for a physical medical device (valvulotome), not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as this is a physical medical device and not an AI or machine learning algorithm.

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The Over-The-Wire Expandable LeMaitre Valvulotome is indicated for cutting saphenous vein valves during in-situ bypass.

The OTW ELV is a self-centering and self-sizing catheter used for cutting valves in the saphenous vein while navigating over a guidewire.

This 510(k) summary (K111884) describes the LeMaitre Vascular OTW-Expandable LeMaitre Valvulotome (OTW-ELV), a device intended for cutting saphenous vein valves during in-situ bypass. The document focuses on demonstrating substantial equivalence to a predicate device (Expandable LeMaitre Valvulotome, K980723) through performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes a series of in-vitro bench-top and in-vitro cadaver tests to demonstrate the safety and performance of the OTW-ELV. While specific quantitative acceptance criteria values are not provided in this summary, the overall conclusion states: "All test results demonstrated that the materials chosen, the manufacturing process, and the design utilized for OTW-Expandable LeMaitre Valvulotome met the established specifications necessary for consistent performance during its intended use as well as substantial equivalence to its predicate." This implies that predefined specifications for each test were met.

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

• Sample Size: The document does not explicitly state the specific sample sizes for each test in the test set (e.g., number of bond joints, number of cadaver veins, number of in-vitro models). It only lists the types of tests conducted.
• Data Provenance: The tests are described as "in-vitro bench-top testing" and "in-vitro cadaver testing." This indicates the data is from laboratory settings, not from human subjects. The country of origin of the data is not specified, but the submitter is based in Burlington, MA, USA. The data is retrospective in the sense that it was collected as part of the premarket notification process for regulatory submission.

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

Not applicable. The tests performed are engineering and chemical/biological characterizations of the device's physical properties and interactions with simulated tissues/materials. They do not involve expert interpretation or subjective evaluation of medical images or clinical outcomes. Therefore, there is no "ground truth" established by medical experts in the context of this performance data.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are objective measurements of physical, chemical, and biological properties, not subjective assessments requiring 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 a medical device (valvulotome) and the described tests are for its mechanical and biological performance, not for an AI-based diagnostic or assistive 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 or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests would be the pre-defined engineering and safety specifications for each test. For example, for "Tensile testing of all bond joints," the ground truth would be a specific minimum tensile strength value established as acceptable. For "Efficacy cutting of in-vitro vein valves," the ground truth would be a successful and consistent cutting pattern without damage to the surrounding vessel, as defined by the test protocol.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable.

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The Valvulotome by Koven Valvulotome is used for the treatment of vascular disorders and more particularly for excising or disrupting venous valves when performing in-situ vascular procedures, such as lower extremity arterial bypass surgery.

The Valvulotome by Koven is a medical device that has a deployable assembly with multiple deployable cutting blades and guide fins which permit continual centralizing, and alignment of the cutting blades within the lumen of the vein as the valves are being cut. The device includes a handle operatively associated with this deployable assembly through a catheter operated by the handle in a one-handed operation for deploying the guide fins and cutting blades of the deployable assembly having respective outer diameters at each deployment position. The Valvulotome by Koven consists of three main parts; the handle, the catheter and the cutter head.

The provided text describes a medical device, the "Valvulotome by Koven," and its 510(k) summary for FDA clearance. However, it does not contain information about acceptance criteria, device performance metrics, or details of a study that would typically quantify its performance against such criteria.

The 510(k) summary primarily focuses on:

• Device Description: What the device is, its parts, and materials.
• Intended Use: For excising or disrupting venous valves during in-situ vascular procedures.
• Substantial Equivalence: Comparison to a predicate device (Lemaitre Valvulotome II, K946352).
• Testing: It states that testing was done, including "laboratory bond strength testing of all joined elements" and "bench testing for the determination of adequacy and safety of the device for the disruption of valves in blood vessels of the leg." It concludes that the device "successfully completed all testing with positive end points achieved."

Missing Information:

The document explicitly lacks the following information required to answer your prompt adequately:

• Specific Acceptance Criteria: No quantitative thresholds or qualitative standards are defined for "successful completion."
• Reported Device Performance: No specific data (e.g., success rates, force measurements, blade sharpness metrics, time to complete a procedure, etc.) from the testing is provided.
• Study Design Details:
  • No sample size for test sets (e.g., number of valves tested, number of devices tested).
  • No data provenance (country, retrospective/prospective).
  • No mention of experts, ground truth establishment, or adjudication for any performance testing.
  • No MRMC study details or AI components.
  • No standalone algorithm performance (as it's a mechanical device).
  • No details on training set size or ground truth for a training set.

Therefore, based solely on the provided text, I cannot complete the requested tables and details.

The document's statement: "The Valvulotome by Koven successfully completed all testing with positive end points achieved" is a summary of the outcome, but it does not provide the underlying data or the specific criteria for "successful completion" that would be needed to fill the table. It indicates that some form of "adequacy and safety" was determined through bench testing related to disrupting valves, but the metrics are not specified.

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The Geister Valvulotomeare designed to incise the valve cusps of the graft in coronary artery bypass graft (CABG) procedures.

Not Found

This document is not about an AI/ML powered device, therefore, the requested information about acceptance criteria and study details for such a device is not present. The document is a 510(k) premarket notification approval letter for the "Geister Valvulotome", a mechanical surgical instrument.

Therefore I cannot provide the information requested in the format of acceptance criteria and study data for an AI/ML powered medical device.

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