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The PhasTIPP System is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins. The Illuminator is also indicated for use without the Resector for visualization of varicose veins and infusion of tumescent solution during an ambulatory phlebectomy procedure.

The PhasTIPP System consists of an Illuminator and a Resector. During the surgical procedure, the illuminator shaft is placed through an incision under the skin with its light-emitting end to provide intense light for a better visualization of the varicose veins. A port that runs along the illuminator shaft is used to infuse tumescence solution to cause the contraction of varicosities, which aids vein visualization by creating a subcutaneous fluid pocket through which the illuminator's light can disperse. A powered resector, positioned through a different incision can then be used to morcellate and aspirate the varicosities.

The PhasTIPP Illuminator consists of two devices: a reusable Illuminator Handpiece and a disposable Illuminator.

The Handpiece provides illumination controls and contains an LED to provide intense light. The Handpiece is powered with new batteries for each new surgical procedure (Duracell CR 123a cell). The handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Illuminator in the sterile field before the procedure begins.

The Disposable Illuminator includes, in addition to the microbial barrier sheath, a distal stainless steel fiber optic light shaft. When connected to a peristaltic pump, the Disposable Illuminator can also infuse tumescence.

The PhasTIPP Resector consists of two devices: a reusable Resector Handpiece and a Resector Disposable (available in two diameters, 4.5mm and 5.5mm). The Disposable Resector also connects to a peristaltic suction pump to remove the resected varicosities.

The Resector Handpiece provides controls for the operation of the rotation blades on the Disposable Resector and is powered with a set of new batteries (TLM-1550 HPM cell), for each surgical procedure. The Resector Handpiece is provided non-sterile and must be covered with the microbial barrier sheath attached to the Disposable Resector in the sterile field.

The Control Unit that was a large equipment in the predicate device is displaced in the subject device. Instead, the Resector Handpiece and the Illuminator Handpiece control the disposable resector and illuminator in the subject device.

This document describes the PhasTIPP System, an external vein stripper. The FDA's 510(k) summary provides details about the device, its intended use, and the testing conducted to establish its substantial equivalence to a predicate device.

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

The provided document doesn't explicitly state "acceptance criteria" in a tabulated format alongside "reported device performance" in the way one might expect for a clinical study with primary endpoints. Instead, it lists various design validation, system validation, and performance tests that were completed to demonstrate the device meets product performance specifications and for substantial equivalence.

For the purpose of this request, I will infer the "acceptance criteria" from the types of tests performed and the "reported device performance" as the overall statement that the device meets these specifications.

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The XenoSure Biologic Patch is intended for use as a surgical patch material for cardiac reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.

The XenoSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. XenoSure patch is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution.

The provided text is a 510(k) summary for the XenoSure Biologic Patch, which is a medical device. This document details the pre-clinical testing performed to demonstrate substantial equivalence to a predicate device, specifically to support a labeling change allowing the device to be exposed to temperatures below 0°C (i.e., frozen).

The request asks for information typically associated with the acceptance criteria and proof of performance for an AI/ML-driven medical device, including aspects like human reader studies, training/test set sample sizes, and ground truth establishment by experts. However, the provided document does not describe an AI/ML device; it is for a physical biologic patch used as surgical material. Therefore, information about AI-specific aspects (like MRMC studies, human-in-the-loop performance, training/test set ground truth for AI, number of experts for ground truth, etc.) is not applicable to this document.

Instead, the document details laboratory and animal studies to prove the physical and biological characteristics of the XenoSure Biologic Patch are not adversely affected by freezing.

Here's an analysis of the provided text in the context of the device's performance and acceptance criteria:

Acceptance Criteria and Study for XenoSure Biologic Patch

The study described here aims to demonstrate that a frozen XenoSure Biologic Patch is substantially equivalent to the unfrozen predicate XenoSure Biologic Patch. The acceptance criteria are based on mechanical properties and biological performance, ensuring the frozen device retains its intended function and safety.

1. Table of Acceptance Criteria and Reported Device Performance:

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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 DuraSure Biologic Patch is intended for use as a surgical patch material to close dura mater during neurosurgery.

The DuraSure consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. The DuraSure is liquid chemical sterilized and packaged in a plastic jar containing sterile glutaraldehyde storage solution. The DuraSure is designed to repair the body's natural organs.

Here's a breakdown of the acceptance criteria and the study details for the DuraSure Biologic Patch, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document focuses on "pre-clinical" testing, which includes both in-vitro (bench) testing and an in-vivo animal study.

• Bench Testing (Tensile, Elongation, Burst Strength, Suture Retention, Thickness):

  • Sample Size: Not explicitly stated for each test (e.g., "All DuraSure patches passed the acceptance criteria"). However, results are given as "mean" values, implying multiple samples were tested for each characteristic.
  • Data Provenance: Not specified, but generally refers to laboratory testing conducted by the manufacturer or contracted labs. The country of origin is not mentioned. This is retrospective data collected for the 510(k) submission.

• In-vivo Animal Study:

  • Sample Size: Forty-nine (49) rabbits.
  • Data Provenance: Not explicitly stated, but implies a controlled laboratory setting for animal research. This is prospective data collected during the study.

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

• Bench Testing: No experts are typically used to establish ground truth for this type of quantitative functional testing. The "ground truth" is defined by the physical measurement methods and the device specifications.
• In-vivo Animal Study:
  • Number of Experts: At least one. The document states, "All slides were evaluated by a veterinary pathologist for neuropathological changes in brain tissue, dural integrity, neoduralization and local tissue reaction according to ISO 10993-6 and FDA Guidance."
  • Qualifications: "veterinary pathologist." No further details on years of experience or specific sub-specialties are provided.

4. Adjudication Method for the Test Set

• Bench Testing: Not applicable. These are objective measurements following established test methods.
• In-vivo Animal Study: Not explicitly described. It states "All slides were evaluated by a veterinary pathologist." This implies a single expert assessment. If multiple pathologists were involved, no method for resolving disagreements (e.g., 2+1, 3+1) is mentioned.

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

No, an MRMC comparative effectiveness study was not done. The studies presented are pre-clinical (bench and animal studies) and do not involve human readers evaluating cases.

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

No, this question is not applicable. The DuraSure Biologic Patch is a physical medical device (surgical patch material), not an AI algorithm or software device. Therefore, a standalone performance evaluation of an algorithm is not relevant.

7. The Type of Ground Truth Used

• Bench Testing: The ground truth is based on objective quantitative measurements obtained using standardized test methods (e.g., Instron for tensile/elongation/suture retention, pressure sensors for burst strength, thickness gauges).
• In-vivo Animal Study: The ground truth for the animal study was established through histopathological evaluation by a veterinary pathologist, based on internationally recognized standards (ISO 10993-6) and FDA guidance for dural substitute devices. This includes macroscopic and microscopic evaluations, with scoring.

8. The Sample Size for the Training Set

This question is not applicable. The DuraSure Biologic Patch is a physical medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

This question is not applicable, as there is no training set for a physical medical device.

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The Pruitt F3 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 Carotid Shunt is used in patients with carotid artery disease in instances where removal of vascular occlusions is the therapeutic objective. The Pruitt F3 Carotid Shunt is employed in Carotid Endarterectomy (CEA), where the shunt is used as a short-term conduit for blood flow between the common carotid and the internal carotid arteries. The Pruitt F3 Shunt is provided sterile for single use, and is provided with two 3 ml syringes used to inflate the balloons (accessory syringes have been previously cleared in K051067).

The Pruitt F3 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 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 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 K182916 document for the Pruitt F3 Carotid Shunt is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies.

The document primarily describes bench test data for engineering parameters, not clinical performance metrics tied to specific acceptance criteria.

Here's what can be extracted, and what is explicitly not available:

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

• Not Available directly in the provided text. The document lists "Bench Test Data" items like "Main Lumen Flow Test," "Inflated Common Balloon Diameter," "Deflation Time," etc. However, it does not provide the specific acceptance criteria (e.g., "Deflation Time shall be

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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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