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The Vasoview Hemopro 3 System is indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The Vasoview Hemopro 3 Power Supply is used in conjunction with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System.

The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube, and Vasoview Hemopro 3 Harvesting Tool for cutting and cauterization of vessel branches. The C-Ring with the built-in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring cradles the vessel and delivers the saline that washes the distal tip of the Endoscope.

The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port.

The Harvesting Tool is powered by direct current only; it does not utilize radiofrequency energy. The Harvesting Tool cuts and cauterizes through a process of heat and pressure. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting and cauterization and spot cautery. There are three heating elements: two cauterization elements and a cutting element between them. Both Jaws have insulation protecting the adjacent tissue. The concave side of the Jaws has a larger buffer of insulation and should, therefore, be positioned toward sensitive tissue during Jaw activation. An area near the tip of the convex side of the Jaw can be used for spot cautery to cauterize tissue contacted by that area of the Jaw.

The Activation Toggle is used to control the Jaws and to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. This device is intended for specific use with the Vasoview Hemopro 3 Power Supply.

This FDA 510(k) clearance letter is for an electrosurgical cutting and coagulation device and its accessories, specifically the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System.

Based on the provided document, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are related to design verification and validation testing of a material change to a component of an existing device, rather than a new AI/software-based device. Therefore, many of the typical acceptance criteria and study aspects for AI/ML devices (like MRMC studies, ground truth establishment for a test set, expert consensus for imaging interpretation) are not applicable here.

The document states that the subject device incorporates a material change to the C-Ring component of the Hemopro 3 Endoscopic Vessel Harvesting System Cannula. The purpose of the submission and the testing was to demonstrate that this specific material change does not affect the device's ability to perform as intended and does not raise new questions of safety or effectiveness.

Here's an interpretation of the information based on the document:

Understanding "Acceptance Criteria" and "Study" in this Context

For this device, "acceptance criteria" primarily refer to the established performance specifications and safety requirements for the electrosurgical device and its components. The "study" is the design verification and validation testing conducted to prove that the modified device (with the new C-Ring material) continues to meet these existing performance and safety criteria.

The focus is on ensuring the new C-Ring material behaves equivalently to the previous one in terms of:

• Mechanical properties (strength, durability)
• Thermal properties (heat resistance, effects of heat exposure)
• Overall device functionality (e.g., maintaining proper vessel cradling, saline delivery, not interfering with cutting/cautery).

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a material change to a Class II electrosurgical accessory, the "acceptance criteria" are implied to be the established performance and safety requirements for the existing device as per the predicate. The document doesn't provide specific numerical acceptance criteria values but states the purpose of the testing was to demonstrate that the change "does not affect the device's ability to perform as intended" and "does not raise new safety or effectiveness issues."

The reported "device performance" is the successful outcome of the conducted bench tests, which presumably met the internal performance specifications for mechanical and thermal integrity, and functionality.

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

• Sample Size for Test Set: The document does not specify the exact sample sizes (e.g., number of C-Rings, number of cadaveric dissecions, number of test repetitions) for the bench tests. It lists the types of tests performed.
• Data Provenance: The tests are bench tests and cadaver testing, which are types of prospective experimental data collected specifically for this regulatory submission. The country of origin for the data is not specified, but typically this testing would occur at the manufacturer's R&D facilities or contracted labs. These are nonclinical data.

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

• Not Applicable in the traditional sense for AI/ML or diagnostic imaging studies.
• For an electrosurgical device and a material change, "ground truth" would be defined by engineering specifications, material science principles, and functional requirements. Expert involvement would be in the form of qualified engineers, material scientists, and potentially surgeons (for the cadaver testing) who designed, executed, and interpreted the bench tests against established performance criteria. These are not "interpreting images" but rather evaluating physical performance.

4. Adjudication Method for the Test Set

• Not Applicable in the traditional sense of consensus reading for human interpretation.
• For bench testing, "adjudication" would refer to the process by which test results are reviewed and determined to meet (or not meet) the predefined acceptance criteria. This typically involves review by quality assurance, design engineers, and regulatory personnel against established protocols and acceptance limits. There wouldn't be a 2+1 or 3+1 expert review panel as seen in imaging studies.

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

• No, an MRMC comparative effectiveness study was not done.
• Such studies are relevant for software/AI devices that assist human readers in tasks like image interpretation to demonstrate improved diagnostic accuracy. This device is a physical electrosurgical tool, and the submission is for a material change, not an AI enhancement.

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

• Not Applicable. This is not an algorithm or software device. The "performance" is that of a mechanical and electrosurgical system, not a computational algorithm.

7. The Type of Ground Truth Used

• Engineering Specifications and Functional Performance Benchmarks: The "ground truth" for this kind of device and material change is defined by the established performance characteristics and safety profile of the predicate device, as well as general medical device safety standards. The testing aims to confirm that the modified device's performance aligns with these known and accepted parameters.
  • Bench Test Results: Physical measurements, stress tests, thermal analyses are directly compared to design specifications.
  • Cadaver Testing Observations: Direct observation of device function in a simulated surgical environment by qualified personnel.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a "training set" for model development.

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

• Not Applicable. As there is no training set.

In summary, the provided document details a 510(k) submission for a physical medical device (an electrosurgical accessory) with a material change to a component, not an AI/ML or software device. Therefore, the "acceptance criteria" and "study" described are in the context of demonstrating continued safety and effectiveness through design verification and validation testing per engineering and regulatory standards, rather than clinical efficacy or diagnostic performance based on human interpretation or AI algorithms.

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The Vasoview Hemopro 3 Power Supply is used in conjunction with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System, which is indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The Vasoview Hemopro 3 Power Supply is a reusable. AC-powered device intended to be used only with the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System. The Vasoview Hemopro 3 Power Supply provides DC current to the Vasoview Hemopro 3 Harvesting Tool to enable cutting and coagulation of vessels and tissue during vessel harvesting procedures. The Vasoview Hemopro 3 Power Supply is positioned outside the sterile field, and can be placed on a flat, non-sterile surface or may be suspended from a nearby IV pole. The Vasoview Hemopro 3 Power Supply does not make contact with the patient, nor does it deliver energy directly to the patient; energy to the patient is delivered by the Vasoview Hemopro 3 Harvesting Tool. The Vasoview Hemopro 3 Power Supply is intended to be used by healthcare professionals in an operating room environment.

The Vasoview Hemopro 3 Power Supply underwent several nonclinical tests to demonstrate its substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance

The FDA summary does not provide a table of acceptance criteria and reported device performance with specific numerical values for each test. Instead, it offers a high-level summary that "The results of the verification testing demonstrate that the Vasoview Hemopro 3 Power Supply meets the established acceptance criteria and performs in a manner equivalent to the predicate device."

However, the types of tests conducted and the standards they comply with can be inferred as acceptance criteria:

2. Sample Size for Test Set and Data Provenance

• Electrical Safety & EMC Testing: The report does not specify the sample size for devices tested, nor does it explicitly state the data provenance (e.g., country of origin, retrospective/prospective). This type of testing typically involves a small number of production units.
• Human Factors / Usability Study: The report does not specify the sample size of users (healthcare professionals) involved in the summative human factors validation study. It also does not explicitly state the data provenance. Such studies are typically conducted in a simulated clinical environment.
• Bench Testing (Electrical Life Cycle, Mechanical Life Cycle, etc.): The report does not specify the sample sizes for these tests. These generally involve a limited number of test units to assess durability and performance. Data provenance for bench testing is inherently laboratory-based.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided for any of the nonclinical tests described. For a human factors study, "users" are typically healthcare professionals, but their specific qualifications and number are not detailed. For the other bench tests, ground truth is established through engineering specifications and standards, not expert consensus.

4. Adjudication Method for Test Set

This information is not applicable to the nonclinical studies described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of images or data to establish a ground truth when there might be discrepancies. The listed tests establish compliance through direct measurement against pre-defined engineering standards or through usability observations.

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

No MRMC comparative effectiveness study was done. The submission explicitly states "No clinical testing was conducted in support of this submission." The device is a power supply for an existing system, and the evaluation focused on non-clinical performance and equivalence to predicate devices.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

This question is not directly applicable as the device (Vasoview Hemopro 3 Power Supply) is a hardware component that provides power to a surgical tool. It does not involve an algorithm or AI. Its performance is evaluated in conjunction with the harvesting tool, but its role is as a power source, not an intelligent system that operates independently from human control or interpretation.

7. Type of Ground Truth Used

• Electrical Safety & EMC: The ground truth used is established by recognized international and national consensus standards (e.g., ANSI/AAMI ES60601-1, IEC 60601-1-2). Compliance with these standards indicates the device meets safety and performance requirements.
• Human Factors / Usability: The ground truth for usability is typically established through observation of user interaction, identification of use errors, and ergonomic assessment against human factors principles and guidelines (FDA guidance, IEC 62366-1). The "success" of the study indicates that users can operate the device safely and effectively without unacceptable risks.
• Bench Testing: The ground truth for electrical, mechanical, durability, cleaning, packaging, and labeling tests is established by documented design specifications, engineering requirements, and relevant consensus standards (e.g., ISO, ASTM). The device's performance is measured against these predefined and objective criteria.

8. Sample Size for the Training Set

This question is not applicable as this device is a hardware power supply and does not involve AI/machine learning algorithms that require a training set.

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

This question is not applicable as this device does not involve AI/machine learning algorithms that require a training set and associated ground truth.

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The Vasoview Hemopro 3 System is indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The Vasoview Hemopro 3 Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and Vasoview Hemopro 3 Harvesting Tool for cutting and cauterization of vessel branches. The C-Ring with the built-in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring cradles the vessel and delivers the saline that washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, and retracted from the main Harvesting Cannula through the Tool Adapter Port. The Harvesting Tool is powered by direct current (DC) only; it does not utilize RF (radio frequency) energy. The Harvesting Tool cuts and cauterizes through a process of heat and pressure. The Harvesting Tool has two curved Jaws. One of the Jaws contains the heating elements for branch cutting and cauterization and spot cautery. There are three heating elements: two cauterization elements and a cutting element between them. Both Jaws have insulation protecting the adjacent tissue. The concave side of the Jaws has a larger buffer of insulation and therefore should be positioned toward sensitive tissue during Jaw activation. An area near the tip of the convex side of the Jaw can be used for spot cautery to cauterize tissue contacted by that area of the Jaw. The Activation Toggle is used to control the Jaws and to activate the heating elements. Positioning of the device, cutting, and cauterization are performed under endoscopic visualization. This device is intended for specific use with the Vasoview Hemopro Power Supply and Vasoview Hemopro 3 Power Adapter.

The provided text pertains to the FDA 510(k) clearance for the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System, Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield, and Vasoview Hemopro 3 Power Adapter. This clearance is based on substantial equivalence to a predicate device, which means the focus of the documentation is on demonstrating that the new device is as safe and effective as the existing, legally marketed device.

Therefore, the document describes design verification and validation testing rather than a study proving the device meets specific performance criteria in a clinical diagnostic context as one might find for an AI/ML medical device. The acceptance criteria and "device performance" in this context refer to the successful completion of various engineering and safety tests, not diagnostic metrics like sensitivity or specificity.

Based on the provided text, I can infer the following about the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not present a single table explicitly listing quantitative acceptance criteria and corresponding reported device performance values in a diagnostic sense. Instead, it describes various tests performed and states that the device "meets the established acceptance criteria and performs in a manner substantially equivalent to the predicate device." The "acceptance criteria" for each test are implicitly the successful completion and compliance with the relevant standards or design specifications.

   Test Category	Acceptance Criteria (Implied)	Reported Device Performance (Implied)
   Biocompatibility	Compliance with ISO 10993-1 and FDA Guidance for externally communicating devices with limited contact.	Successful completion of Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, and Pyrogenicity tests.
   Electrical Safety & EMC	Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, and IEC 60601-2-18.	The subject device complies with all listed electrical safety and EMC standards.
   Sterilization/Shelf-Life	Achieves a Sterility Assurance Level (SAL) of 10⁻⁶ using gamma irradiation; supports a two-year shelf life.	Validated to achieve SAL of 10⁻⁶ using gamma irradiation (ISO 11137). Designated shelf life of two years.
   Mechanical/Bench Testing	Device performs as intended and claimed; comparable technological characteristics to the predicate device.	Successful completion of Tool/Cannula Mechanical Evaluation, Tool Electrical Evaluation, Packaging/Sterile Barrier Evaluation, Power Adapter Evaluation, Thermal Spread Evaluation, and Vessel Burst Pressure.
   Animal Testing (GLP)	Meets end-user needs and does not raise additional safety or performance concerns.	Evaluation demonstrated the subject device meets end-user needs and did not raise additional safety or performance concerns in porcine models.
   Human Factors Validation	Device is adequately designed, safe, and effective for intended users, interfaces, and environments; no unacceptable residual risks.	Study demonstrated adequate design, safety, and effectiveness. No unacceptable residual risks from usability perspective remain.

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

   • Biocompatibility: Not specified, but typically involves laboratory testing on material samples.
   • Electrical Safety & EMC: Not specified, but involves testing representative units of the device and power supply.
   • Sterilization/Shelf-Life: Not specified, but involves multiple samples for validation of sterilization and aged samples for shelf-life.
   • Mechanical/Bench Testing: Not specified for each individual test, but typically involves multiple units to ensure repeatability and robustness.
   • Animal Testing: "porcine models" (multiple animals implied for a "study"). Data provenance is in-vivo (animal model).
   • Human Factors Validation: Not specified, but typically involves a representative number of prospective users. Data provenance is prospective (participants performing tasks with the device).

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

   This information is not provided in a typical diagnostic device context. For a substantial equivalence claim, the "ground truth" is often established by adherence to engineering specifications and performance comparable to the predicate device. For animal and human factors studies, the "experts" would be the study investigators and end-users, but their specific number or detailed qualifications are not listed beyond "end user evaluation" and "intended users."

4. Adjudication method:

   Not applicable in the context of this 510(k) submission. Adjudication methods like "2+1" or "3+1" are typical for resolving discrepancies in expert interpretations (e.g., radiologists reading images) for diagnostic algorithms.

5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

   No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic devices to measure the improvement in human reader performance. The device described, the Vasoview Hemopro 3 Endoscopic Vessel Harvesting System, is a surgical tool, not a diagnostic imaging device.

6. Standalone (algorithm-only) performance:

   Not applicable. This device is a physical surgical tool, not a standalone algorithm.

7. Type of ground truth used:

   The "ground truth" for the various tests corresponds to:

   • Biocompatibility: Established scientific standards (ISO 10993-1).
   • Electrical Safety & EMC: International electrical safety and EMC standards (IEC 60601 series).
   • Sterilization/Shelf-Life: Sterilization validation standards (ISO 11137).
   • Mechanical/Bench Testing: Engineering specifications and performance metrics compared to the predicate device.
   • Animal Testing: Clinical observation and evaluation in a controlled in-vivo setting.
   • Human Factors Validation: User performance metrics and subjective feedback against usability engineering standards (IEC 62366-1) and FDA guidance.

8. Sample size for the training set:

   Not applicable. This is a medical device, not an AI/ML algorithm that requires a "training set."

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

   Not applicable, as there is no "training set" for this type of medical device.

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The 7 mm Extended Length Endoscope with Dissection Tip is indication of a surgical cavity and dissection in endoscopic procedures and other minimally invasive surgical procedures allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients requiring endoscopic tissue separation of the extraperitoneal or subcutaneous extremity and thoracc space. Extremity procedures include tissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The 7 mm Endoscope is a reusable product which consists of a stainless steel shaft housing optical and illumination components. The proximal end has an eyepiece for camera adapter attatchment, and a light post for light cable connection; the camera adapter and light cable are not included with the 7 mm Endoscope. The 7 mm Endoscope is supplied non-sterile, and must be cleaned and sterilized prior to each use.

This appears to be a 510(k) summary for a medical device (7 mm Extended Length Endoscope), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data for a novel AI/software component.

Therefore, the requested information regarding acceptance criteria, a specific study proving device meets acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment methods for an AI/software device cannot be extracted from the provided text.

The document discusses the device's technological characteristics, indications for use, and reprocessing methods. It states that "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the previously cleared 7 mm Extended Length Endoscope." However, it does not provide the specific acceptance criteria for these in-vitro tests, the detailed performance results, or any of the other information typically associated with AI/software performance studies.

In summary, the provided text does not contain the information requested in your prompt regarding acceptance criteria and performance studies for an AI/software device. This document is for a traditional medical device demonstrating substantial equivalence.

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The subject Cables (VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance and Active Return Cord) are accessories to the VASOVIEW Endoscopic Vessel Harvesting System. They are supplied non-sterile and must be sterilized prior to each.

The VASOVIEW HEMOPRO Extension Cable (P/N VH-3030), is a reusable cable designed for use with the VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System and the VASOVIEW HEMOPRO Power Supply. The Extension Cable is supplied non-sterile and must be sterilized prior to each use.

The VASOVIEW HEMOPRO 2 Extension Cable (P/N VH-4030), is a reusable cable designed for use with the VASOVIEW HEMOPRO 2 Endoscopic Vessel Harvesting System and the VASOVIEW HEMOPRO Power Supply and the HEMOPRO 2 Adapter Cable. The Extension Cable is supplied non-sterile and shall be sterilized prior to each use. The Extension Cable connects to the VASOVIEW HEMOPRO Power Supply via the Adapter Cable.

The Active/Return extension cord with banana plugs (P/N 1838), is a reusable cord designed for use with the VASOVIEW Endoscopic Vessel Harvesting System VV6 Pro/VV7. Each cord is supplied non-sterile and must be sterilized prior to each use.

The Bipolar Extension Cable, Fixed Distance (P/N 2838) is a reusable cable designed for use with the VASOVIEW Endoscopic Vessel Harvesting System VV6 Pro /VV7. Each cable is supplied non-sterile and must be sterilized prior to each use.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:

Device: VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, and Active Return Cord (accessories to the VASOVIEW Endoscopic Vessel Harvesting System)

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner as one might expect for a clinical study on diagnostic accuracy or efficacy. Instead, it describes a series of performance qualifications and verifications undertaken to demonstrate substantial equivalence to predicate devices, particularly regarding reprocessing methods.

The "acceptance criteria" here are implied to be the successful completion and passing of these performance qualifications, demonstrating that the proposed cables perform equivalently or better in terms of safety and functionality under the specified reprocessing conditions.

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

The document does not specify exact sample sizes for each "Performance Qualification" test. These are typical engineering and laboratory tests, not clinical trials. The "test set" would refer to the physical devices (cables) subjected to the various cleaning and sterilization cycles. It's common for such tests to use a statistically representative number of devices to demonstrate reproducibility and worst-case scenarios, but specific numbers are not provided.

The data provenance is from laboratory testing (likely internal to the manufacturer or conducted by contract labs), rather than clinical data from a specific country, retrospective or prospective.

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

This type of testing (performance qualification for cleaning, sterilization, and biocompatibility of medical device accessories) typically does not involve human experts establishing a "ground truth" in the way a clinical study with medical image interpretation would. Instead, highly trained laboratory personnel, quality engineers, and microbiologists follow standardized protocols (e.g., ISO, AAMI standards) to perform the tests and interpret the results against predefined acceptance criteria from those standards. The "ground truth" is defined by the objective pass/fail criteria of these validated testing methods. Therefore, no information on the number or qualifications of "experts" for ground truth establishment in this context is provided or expected.

4. Adjudication method for the test set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. For laboratory performance testing of device reprocessing, results are generally objective and determined by validated methodologies, not subjective interpretation 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

No. This is not an AI-assisted diagnostic device, nor is it a device that requires human interpretation of medical cases. Therefore, an MRMC study is not relevant to this submission.

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

No. This device is an accessory to an electrosurgical system, not an algorithm or an AI-powered device.

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

The "ground truth" for the performance qualifications is based on objective measurements and pass/fail criteria derived from recognized industry standards (e.g., ISO 10993-1 for biocompatibility, and validated cleaning/sterilization protocols). For instance, a cleaning qualification's ground truth would be the measurable reduction of protein, hemoglobin, or other contaminants below a specified threshold, as determined by laboratory assays. Biocompatibility ground truth is determined by the absence of cytotoxic effects in cell cultures or adverse reactions in animal models, according to standard test methods.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-based device, so there is no training set in that sense.

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

Not applicable. No training set as described in the context of AI/ML.

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The VASOVIEW HEMOPRO System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and perioheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System is designed for use in conjunction with the 7 mm Endoscope. The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VASOVIEW HEMOPRO Harvesting Tool for cutting and sealing of vessel branches. The C-Ring/distal lens washer is independently controlled by a C-Ring Slider on the handle of the device that retracts the vessel and washes the distal tip of the Endoscope. The Harvesting Tool can be extended/retracted from the main cannula by inserting it into the Tool Adapter Port, and rotated independently. The Harvesting Tool has two curved Jaws. One Jaw contains the heating elements for branch cutting and sealing; the second Jaw is longer and has a serrated inner edge. Cutting and sealing of vessel branches is achieved in two steps: (1) capture of the branch between the HEMOPRO Jaws, and (2) simultaneous coagulation and ligation of the branch with the Jaws using direct current. Both steps are achieved by mechanical application of the Activation Toggle. Positioning of the device, cutting, and sealing are performed under endoscopic visualization. This device is intended for specific use with the VASOVIEW HEMOPRO Power Supply.

This document describes a 510(k) submission for the MAQUET VASOVIEW HEMOPRO Endoscopic Vessel Harvesting System, seeking substantial equivalence to a predicate device (K052274). The submission focuses on device modifications to address specific Medical Device Report (MDR) issues related to self-activation/overheating. Since this is a submission for substantial equivalence based on modifications to an existing device, the "acceptance criteria" and "device performance" are primarily demonstrated through specific performance and safety testing, rather than novel clinical performance metrics against a medical condition.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the types of tests conducted and the conclusion that the device's functionality and performance characteristics are "comparable" to the predicate device. The document does not explicitly state numerical acceptance thresholds for these tests, but rather indicates that the tests successfully demonstrated comparable performance and addressed the identified issues.

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

The document does not specify the exact sample sizes for the "in-vitro tests" conducted. The provenance of the data is not explicitly stated beyond being "in-vitro tests." This typically implies laboratory testing using simulated conditions or excised tissue, rather than human clinical data. The document focuses on bench testing.

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

This information is not applicable and not provided in the document. The study is an in-vitro engineering and performance verification study, not a clinical study requiring expert ground truth for diagnostic or clinical outcome evaluation.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human subject data and multiple reviewers to reach a consensus on diagnoses or outcomes. This document describes technical 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

This information is not applicable. This submission is for a physical medical device (endoscopic vessel harvesting system), not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness metrics would be part of this type of submission.

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

This information is not applicable. As mentioned above, this is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the performance and safety tests, the "ground truth" would be established by the test standards and specifications themselves. For example, for "burst pressure testing," the ground truth is the specified pressure the device must withstand without failure. For "electrical testing 60601-1," the ground truth is compliance with the detailed requirements of the ISO 60601-1 standard. There is no biological "ground truth" in the sense of pathology or outcomes data in this in-vitro testing context.

8. The Sample Size for the Training Set

This information is not applicable and not provided. Training sets are relevant for machine learning or AI algorithms. This is a traditional medical device submission.

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

This information is not applicable for the same reason as point 8.

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FUSION Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access.

FUSION Vascular Grafts are synthetic vascular grafts constructed of two layers. The inner layer is comprised of extruded, expanded polytetrafluoroethylene (ePTFE). The outer layer is comprised of knit polyester textile. These two layers are fused together with a proprietary polycarbonate urethane adhesive.

This document is a 510(k) premarket notification for the FUSION Vascular Graft, specifically for an AV Access Indication. The acceptance criteria and study described pertain to the performance of this vascular graft.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria with specific numerical thresholds for "Burst After Repeated Puncture." However, it implies that the device's performance must be "comparable" to the currently marketed FUSION Vascular Graft.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "in-vitro tests" but does not specify the number of grafts or test articles used.
• Data Provenance: The study was "in-vitro testing" conducted as part of Maquet Cardiovascular's development process. The country of origin is not specified, but the applicant (Maquet Cardiovascular, LLC) is based in Wayne, NJ, USA. The study is prospective in the sense that it's conducted to support a new indication for the device.

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

This type of study (in-vitro performance testing of a physical device) does not typically involve human experts establishing "ground truth" in the way an AI diagnostic algorithm would. The "ground truth" is based on established engineering principles and measurement techniques for material and device performance. Therefore, this information is not applicable to this submission.

4. Adjudication Method for the Test Set

Not applicable for this type of in-vitro performance study.

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 510(k) submission for a physical vascular graft, not an AI diagnostic device.

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

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

For this in-vitro performance testing, the "ground truth" is based on the objective measurements obtained from standardized material and device performance tests, such as "Burst After Repeated Puncture." The performance is then compared against established performance of a predicate device (FUSION Vascular Graft) or internal benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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The VASOVIEW System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The Harvesting Cannula has four lumens which house the Endoscope, C-Ring, distal lens washer tube and VASOVIEW Harvesting Tool for cutting and sealing of vessel branches. The C-Ring with the built in distal lens washer is independently controlled by a C-Ring Slider on the handle of the Harvesting Cannula. The C-Ring retracts the vessel and washes the distal tip of the Endoscope. The Harvesting Tool can be inserted, removed, rotated, extended, and retracted from the main Harvesting Cannula through the Tool Adapter Port.

The provided 510(k) summary for the "Harvesting Cannula" (K132743) by MAQUET Cardiovascular LLC does not describe specific acceptance criteria or a detailed study proving the device meets them. Instead, it focuses on demonstrating substantial equivalence to a predicate device (K052274 Guidant VasoView HemoPro Endoscopic Vessel Harvesting System) based on similar intended use, operating principles, labeling, basic design, materials, sterilization processes, and packaging.

The "Safety and Performance" section broadly states that MAQUET Cardiovascular's development process required "• Performance testing" and "• Shelf life testing." It then concludes: "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed Harvesting Cannula."

Without concrete performance metrics or detailed study methodologies, it's impossible to fill in most of the requested fields. However, I can extract the available information.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: Specific quantitative or qualitative acceptance criteria are not detailed in the document. The performance is described as "comparable" to the predicate, but specific metrics of what defines "comparable" are absent.

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

• Test Set Sample Size: Not specified. The document mentions "in-vitro tests" but does not provide details on the number of devices or scenarios tested.
• Data Provenance: The tests were "in-vitro," meaning conducted in a laboratory setting. The country of origin for the data is not specified, but the device owner is in the USA. The study was part of the device development process, making it a prospective assessment of the newly designed device's performance against established benchmarks (implicitly, the predicate device).

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

• Not applicable. This device is a surgical instrument (Harvesting Cannula), not an diagnostic imaging or AI device that requires expert-established ground truth for its performance evaluation in the context of the provided document. Its performance would be evaluated against engineering specifications and functional requirements.

4. Adjudication Method for the Test Set

• Not applicable for a device of this type and the information provided. Performance demonstration would involve engineering and functional testing, not expert adjudication of outputs.

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

• No. This is a surgical instrument, not an AI or diagnostic imaging device that would typically undergo an MRMC study.

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

• Not applicable. This is a physical surgical instrument, not an algorithm.

7. The type of ground truth used

• For a surgical instrument like the Harvesting Cannula, "ground truth" would generally refer to adherence to design specifications, functional requirements (e.g., ability to house components, operate smoothly), material properties, and safety standards. Based on the documentation, the "ground truth" for evaluating the "functionality and performance characteristics" was the performance of the currently marketed Harvesting Cannula (the predicate device).

8. The sample size for the training set

• Not applicable. This is a physical surgical instrument, not a machine learning algorithm that requires a training set.

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

• Not applicable. As above, this is not an ML algorithm.

Summary of what is present:

The 510(k) summary for K132743 focuses on demonstrating substantial equivalence to a predicate device (K052274 Guidant VasoView HemoPro Endoscopic Vessel Harvesting System). The core argument is that despite minor design changes (C-Ring Tube, Blunt Tip, Scope Wash Tube length), these differences are not considered technological and do not affect the safety or effectiveness of the device.

The "Safety and Performance" section states that "Performance testing" and "Shelf life testing" were completed, and "The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed Harvesting Cannula." This highly generalized statement is the extent of the performance data provided in this summary. It relies on the assumption that if the new device performs "comparably" to an already cleared predicate device, it meets the necessary safety and effectiveness standards.

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FUSION™ and FUSION™ Bioline Vascular Grafts are designed to repair or replace peripheral arteries.

FUSION™ Vascular Grafts are synthetic vascular grafts constructed of two layers. The inner layer is comprised of expanded polytetrafluoroethylene (ePTFE). The outer layer is comprised of knitted polyester textile. These two layers are bonded together. The FUSION™ Bioline Vascular Grafts have a heparin/albumin coating on the interior surface of the graft.

Here's an analysis of the acceptance criteria and the studies that support the FUSION™ and FUSION™ Bioline Vascular Grafts, based on the provided text:

Device: FUSION™ and FUSION™ Bioline Vascular Grafts

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed around demonstrating substantial equivalence to the predicate device (EXXCEL™ Soft ePTFE Vascular Grafts), with specific performance targets derived from clinical and bench testing.

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The HEMASHIELD Vascular Grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

The HEMASHIELD Vascular Grafts are Woven Double Velour polvester grafts impregnated with highly purified collagen. The HEMASHIELD Vascular Grafts are designed to reduce . bleeding at implant and thereby eliminate the operative preclotting step. The collagen is designed to be gradually resorbed by the patient. In addition to collagen, the grafts also contain glycerol as a softening agent.

HEMASHIELD Woven Vascular Grafts - Acceptance Criteria and Study Details

The provided document describes the acceptance criteria and study performed to demonstrate substantial equivalence for the HEMASHIELD Woven Vascular Grafts. As this is a 510(k) submission for a predicate device modification, the focus is on non-clinical bench testing rather than clinical trials with human readers or AI algorithms.

1. Acceptance Criteria and Reported Device Performance

The document states that the results of non-clinical tests meet the specified acceptance criteria and are substantially equivalent to the predicate device. However, the exact quantitative acceptance criteria for each test and the reported numerical performance values for the proposed device are not explicitly provided in the given text. The tests performed are listed as:

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not specify the exact sample size (number of grafts) used for each of the bench tests.
• Data Provenance: The data is from bench testing conducted by MAQUET Cardiovascular LLC. The context of a 510(k) submission implies this testing was done internally by the manufacturer to support regulatory submission. No country of origin is explicitly stated, but the company address is in Wayne, New Jersey, USA. The testing is prospective in the sense that it was conducted specifically to evaluate the modified device against predetermined criteria.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• Not Applicable. This study is a non-clinical bench test evaluating physical properties of a vascular graft, not a diagnostic or AI device that requires expert review for ground truth establishment.

4. Adjudication Method for Test Set

• Not Applicable. As this is a non-clinical bench test, there is no need for expert adjudication of results. Each test would have objective measurement outcomes.

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

• No. An MRMC study was not performed. This type of study is relevant for diagnostic devices involving human readers and potentially AI assistance, which is not the nature of this vascular graft evaluation.

6. Standalone (Algorithm Only) Performance Study

• No. This is not an AI algorithm or software-only device. The evaluation focuses on the physical properties of a medical implant.

7. Type of Ground Truth Used

• The "ground truth" for the bench tests would be the objective measurements obtained from established testing standards and methodologies (e.g., ISO or ASTM standards, or equivalent internal validated methods). The results of these measurements were then compared against predetermined acceptance criteria, likely derived from the predicate device's performance or relevant standards.

8. Sample Size for Training Set

• Not Applicable. This is a non-clinical bench test, not a machine learning model that requires a training set.

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

• Not Applicable. As there is no training set, this question is not relevant.

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