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The AnastoClip GC is intended for use in the creation of everting anastomoses in blood vessels and other small tubular structures when tissue penetration is desired. The Applier is also intended for approximation of durotomies following open craniotomy and open spinal laminectomy procedures.

AnastoClip GC Closure System is designed to create everting anastomoses of tissue. It includes the applier, clip remover, and atraumatic forceps. The AnastoClip GC applier consists of a rotating shaft and an integral cartridge containing titanium clips. As the levers of the applier are squeezed together, the clip is closed around the everted tissue edges. As the levers are released, a new clip is automatically loaded into the clip applier jaws. It is recommended, with each procedure, to use the atraumatic everting forceps to aid in the everting of the tissue edges. It is also recommended, with each procedure, to use the AnastoClip Remover for the removal of any AnastoClip GC clips when needed.

The provided text describes the AnastoClip GC Closure System, a medical device. Based on the information presented, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state quantitative "acceptance criteria" in a table format with corresponding "reported device performance" values for a specific study. Instead, it describes a preclinical study that aimed to demonstrate safety and substantial equivalence to a predicate device for an expanded indication. The "acceptance criteria" can be inferred from the successful outcomes of this study.

Here's an inferred table based on the preclinical study's reported findings:

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

• Test Set Sample Size: 6 porcine models.
• Data Provenance: The study was a "Pre-clinical GLP safety evaluation" performed in porcine models. The country of origin is not specified, but it's a prospective animal study.

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)

The document does not specify the number of experts or their qualifications for establishing ground truth. It states that a "comprehensive necropsy was performed" and "histomorphologic evaluation" of cranial and spinal implant sites was conducted. These evaluations would typically be done by veterinary pathologists, but their number and specific qualifications are not detailed.

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

The document does not provide details on any adjudication method for the test set. It simply states that a "comprehensive necropsy" and "histomorphologic evaluation" were performed.

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

The document describes a preclinical animal study for a medical device (surgical clip system), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed and is not applicable.

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 surgical closure system, not an algorithm or AI system.

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

The ground truth for the preclinical study was established through a combination of:

• Direct observation: Absence of CSF leaks.
• Clinical observation: Body weight, body condition score, clinical pathology parameters in animals.
• Laboratory analysis: CSF sample analysis (for inflammation/infection).
• Imaging: CT scan evaluations (for hydrocephalus/abnormalities).
• Pathology/Histomorphology: Microscopic evaluation of cranial and spinal implant sites.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device and does not involve AI or machine learning that requires a training set.

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

This question is not applicable as the device is a physical medical device and does not involve AI or machine learning that requires a training set.

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The Pruitt F3-S Polyurethane Carotid Shunt is in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

The Pruitt F3-S Polyurethane Carotid Shunt is designed to serve as an artificial passage connecting two blood vessels allowing blood flow from one vessel to another. This is accomplished by using a clear, plastic, sterile conduit that is held in place by a stabilization technique (balloons) on both ends of the conduit. devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. The Pruitt F3-S Polyurethane Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon. The Pruitt F3-S Polyurethane Carotid Shunt is not made of natural rubber latex.

This document is a 510(k) premarket notification for a medical device (Pruitt F3-S Polyurethane Carotid Shunt) and does not contain information about the performance of an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for an AI-powered device cannot be extracted.

The document focuses on demonstrating substantial equivalence to a predicate device, as required for 510(k) submissions. This involves comparing the new device's technological characteristics, indications for use, and performance data (e.g., sterilization, biocompatibility, functional testing) to those of the predicate device. The functional testing described is for the physical device itself (shunts and balloons), not an AI algorithm.

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The Pruitt F3-S Carotid Shunt is indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow between the common and internal carotid arteries.

The Pruitt F3-S Carotid Shunt is designed to serve as an artificial passage connecting two blood vessels, allowing blood flow from one vessel to another. This is accomplished by using a clear, plastic, sterile conduit that is held in place by a stabilization technique (balloons) on both ends of the conduit. The Pruitt F3-S Shunts are multi-lumen devices with balloons on both the distal (internal carotid) and proximal (common carotid) ends of the shunt. The balloons, when inflated independently, act as a stabilization mechanism to maintain the position of the shunt when it is placed within the common and internal carotid arteries. The Pruitt F3-S Carotid Shunt has features to aid the user during shunt insertion and balloon inflation. The inflation path of the proximal (common carotid) balloon is color-coded. Sterile saline is injected from the blue stopcock, through the blue lumen and into the blue common carotid balloon.

The provided document describes the LeMaitre Vascular Pruitt F3-S Carotid Shunt (K143454) and its substantial equivalence to a predicate device. This is a medical device submission, not a study of an AI algorithm, so many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set sample size) are not applicable or do not directly translate. However, I can extract information related to the device's performance testing and acceptance criteria as described in the summary.

Acceptance Criteria and Device Performance for Pruitt F3-S Carotid Shunt

The document focuses on demonstrating substantial equivalence to a predicate device (Pruitt F3 Carotid Shunt K051067) by comparing technological characteristics and performing functional/safety testing. It does not provide explicit numerical acceptance criteria values or specific performance results for each test in a table format, but rather states that the device "meets the product performance requirements of the device specifications."

However, based on the "Summary of Product Testing," we can infer the aspects of performance that were evaluated.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" for a statistical study in the way an AI algorithm might. The testing described is pre-clinical functional and safety testing on the device itself.

• Sample Size: Not explicitly stated for each test, but typically these tests involve a representative sample of devices.
• Data Provenance: The tests are performed by the manufacturer, LeMaitre Vascular, Inc., likely at their facilities in Burlington, MA, USA, as part of their internal verification process. The data is prospective, generated specifically for this submission.

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

This concept is not directly applicable. The "ground truth" for a medical device's functional integrity is established by engineering specifications, recognized industry standards (like ISO 11135-1 for sterilization), and comparison to predicate devices, rather than expert consensus on a diagnostic outcome. The "experts" involved would be the engineers and quality assurance personnel at LeMaitre Vascular.

4. Adjudication Method for the Test Set

Not applicable. This type of testing relies on objective measurements against predefined engineering specifications, not subjective interpretation requiring adjudication.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret patient data (e.g., images) with and without AI assistance. The Pruitt F3-S Carotid Shunt is a physical medical device, not a diagnostic AI algorithm.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable, as this is not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on engineering specifications, design requirements, and established performance characteristics of the predicate device. For biocompatibility, it's the known biocompatibility profile of the materials used in the predicate device. For sterilization, it's compliance with an international standard (ANSI/AAMI/ISO 11135-1:2007).

8. The Sample Size for the Training Set

Not applicable, as this is not an AI algorithm requiring a training set.

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

Not applicable, as this is not an AI algorithm requiring a training set.

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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 UnBalloon Non-Occlusive Modeling Catheter is intended to assist in the modeling of self-expanding endoprostheses in large diameter vessels.

The UnBalloon Non-Occlusive Catheter is a silicone surface coated (medical grade) modeling Catheter with an expandable Nitinol mesh in a retractable sheath. The Nitinol mesh design allows for expansion without occluding blood flow. The Nitinol mesh and radiopaque markers are highly visible under fluoroscopy and assist in the positioning of the device. The inner lumen allows for a 0.035 or 0.038 inch guidewire for over-the-wire access. Side ports and clear handle/luer allow the device and guidewire lumen to be flushed. The blue handle allows the device to be sheathed/unsheathed while the clear handle/luer controls the expansion of the Nitinol mesh. This submission modifies the current UnBalloon Non-Occlusive Modeline Catheter to be able to deliver higher radial outward force in order to improve stent graft modeling effectiveness (i.e., apposition of the stent graft with the vessel lumen). this device modification increases the outer diameter of the thoracic models from 14 Fr to 16 Fr.

Here's a breakdown of the acceptance criteria and study information for the UnBalloon Non-Occlusion Modeling Catheter, based on the provided text:

Important Note: The provided text is a 510(k) summary and FDA clearance letter for a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical trial or AI model validation study. Therefore, many of the typical acceptance criteria and study details for AI/software-as-a-medical-device (SaMD) are not applicable or not present in this type of submission. The device described is a physical catheter, not an AI model.

Acceptance Criteria and Reported Device Performance

Given that this is a physical medical device and not an AI/software device, the "acceptance criteria" are related to its physical performance, safety, and functional equivalence to a predicate device. There are no explicit, quantifiable acceptance criteria presented in the format often seen for AI model performance (e.g., sensitivity, specificity thresholds). Instead, the document summarizes various tests performed to ensure the device meets its specifications and is substantially equivalent.

Study Details (Applicable to a Physical Medical Device Submission)

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

   • The document mentions "Animal testing (ovine study)" as one of the completed tests. However, the specific sample size (number of animals) for this study is not provided.
   • Data provenance for the animal study is "ovine" (sheep), which is a common animal model for cardiovascular devices. It would be considered prospective for the purposes of the animal study itself.
   • For the other listed tests (e.g., dimensional analysis, fatigue), these are typically in-vitro (benchtop) tests, and the "sample size" would refer to the number of devices or components tested. This information is not specified in the summary.

2. 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 device is a physical catheter, not an AI/software device that generates outputs requiring expert interpretation to establish ground truth (e.g., image classifications). The "ground truth" for a physical device is its measurable physical properties and performance in specified tests.

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

   • This is not applicable to a physical device submission of this nature. Adjudication methods are typically used for establishing ground truth in human-AI studies or for resolving discrepancies in expert interpretations, neither of which is relevant here.

4. 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 is not applicable. This device is a physical catheter, not an AI assistance tool for human readers. No MRMC study was performed.

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

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

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

   • For this physical medical device, the "ground truth" is established by:
     • Physical measurements and engineering specifications: For tests like dimensional analysis, radial outward force, apposition length, and force at break.
     • Standardized test methods/protocols: For tests like freedom from leakage, fatigue and simulated use, interaction with stent graft materials, sterilization, and biocompatibility.
     • Physiological observation/measurement in animal models: For the ovine animal study.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" as this is a physical device, not a machine learning model.

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

   • This is not applicable for the same reason as above.

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The LeMaitre 8F Occlusion Catheter is indicated for temporary vessel occlusion.

The 8F Occlusion Catheters is offered in two balloon sizes; 28 mm or 45mm. It is a single lumen catheter with a latex balloon specifically designed and sized for use in the outlined general procedures. The single lumen (inflation lumen indicated by the white stopcock) is used for balloon inflation. The stop-cock is to maintain balloon inflation level throughout the procedure. The device has radiopaque marker bands at the proximal and distal ends of the balloon to enhance visibility of the balloon location when used under fluoroscopy.

The provided text describes a medical device, the LeMaitre 8F Occlusion Catheter, and its 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. However, it does not contain information about a study that establishes acceptance criteria and then proves the device meets those criteria, especially in the context of an AI/algorithm-driven device.

The document outlines functional and safety testing, but these tests are for the physical catheter's performance (e.g., inflation volume, burst volume) rather than for an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot fulfill your request for the following information based on the provided text, as it describes a physical medical device clearance, not an AI/algorithm-based one:

1. A table of acceptance criteria and the reported device performance: The document only lists types of tests, not specific acceptance criteria (e.g., a minimum inflation pressure value) or detailed performance results that would be typically found for an AI system (e.g., sensitivity, specificity, AUC).
2. Sample size used for the test set and the data provenance: No test set information for an algorithm is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no algorithm test set.
4. Adjudication method 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.
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): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on:

• Device Description: Physical characteristics of the LeMaitre 8F Occlusion Catheter.
• Intended Use: Temporary vessel occlusion.
• Predicate Device: Fogarty Occlusion Catheter (K093911).
• Substantial Equivalence: Claiming similar intended use and fundamental scientific technology as the predicate.
• Functional/Safety Testing: Mentioning tests like "Volume Required to Inflate Balloon to IFU Indicated Diameter," "Inflation Pressure," "Radial Force," "Contact Area," "Inflation Time," "Deflation Time," and "Burst Volume." These are physical device performance tests.
• Sterilization and Biocompatibility: Confirming compliance with relevant standards.

To summarize, the provided text does not contain the type of AI/algorithm performance study details you are asking for.

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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.

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

The document does not specify a sample size for any test set related to performance or clinical evaluation. The tests mentioned (dimensional comparison, sharpness) appear to be bench or lab-based assessments rather than patient-based studies. Therefore, there is no information on data provenance (country of origin, retrospective/prospective).

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

This information is not applicable as the studies described are not clinical trials or diagnostic assessments requiring expert established ground truth. The tests are focused on the physical and functional aspects of the device itself.

4. Adjudication Method for the Test Set:

This information is not applicable as there is no mention of clinical studies or diagnostic assessments where adjudication of results would be required.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical tool, not a diagnostic imaging device typically evaluated with MRMC studies. The approval is based on substantial equivalence to a predicate device, supported by bench testing.

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

This concept is not applicable to the LeMills Valvulotome. This is a manual surgical device; there is no "algorithm only" component.

7. The Type of Ground Truth Used:

For the tests performed:

• Dimensional Comparison: Ground truth would be the design specifications and measurements of the device itself and the predicate device.
• Sharpness Test (Effectiveness Test): Ground truth would likely be established by a defined testing methodology to assess cutting efficacy in a simulated environment (e.g., cutting a specific material mimicking venous valve tissue).
• Sterilization: Ground truth is defined by regulatory standards (ANSVAAMI/ISO 11135-1:2007).
• Biocompatibility: Ground truth is defined by regulatory guidelines (ISO 10993).

There is no mention of pathology, expert consensus from clinical cases, or outcomes data used to establish ground truth for the performance tests in this 510(k) summary.

8. The Sample Size for the Training Set:

This information is not applicable. The LeMills Valvulotome is a physical medical device, not a machine learning or AI-based system that requires a training set.

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

This information is not applicable for the reasons stated above.

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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 LeMaitre LifeSpan ePTFE vascular grafts are indicated for use as a vascular prosthesis only. The grafts are intended for bypass or reconstruction of diseased or occluded blood vessels, or for arteriovenous shunts for blood access.

LifeSpan Vascular Grafts are consisting of a base tube of expanded PTFE that is wrapped with PTFE tape for better strength. Externally supported grafts have a monofilament of PTFE wrapped over the tape for added crush and kink resistance. The stepped and tapered grafts have a small diameter end and a large diameter end. All models of the graft have a printed black orientation line consisting of "LeMaitre LifeSpan" printed repeatedly along the length of the graft. This 510k is to add an alternative ink for the printing the orientation line.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for the LifeSpan ePTFE Vascular Graft. The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the addition of an alternative ink for an orientation line.

The key information presented is:

• Device Description: LifeSpan ePTFE Vascular Graft with an alternative ink for the orientation line.
• Predicate Devices: Baxter reinforced expanded PTFE vascular grafts.
• Study Mentioned: "Biocompatibility test was performed for the alternative new ink. The biocompatibility of the device was tested per ISO10993-1."
• Conclusion: The manufacturer "has demonstrated that the LifeSpan ePTFE Vascular Graft printed with the new ink is substantially equivalent to the predicate devices based on its indications for use and fundamental scientific technology."
• FDA Decision: FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested table and study details as this information is not present in the given text. The document does not describe a clinical study with acceptance criteria, human readers, or ground truth-setting for measuring device performance in the way a diagnostic AI or imaging device might. It's focused on materials biocompatibility and substantial equivalence for a vascular graft.

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