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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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