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The Proximal Seal System is intended for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.

The HEARTSTRING® III Proximal Seal System delivers a hemostatic seal device designed to enable the proximal anastomosis of an aortic graft without the need for an aortic clamp during coronary artery bypass graft (CABG) surgery. The Proximal Seal System is comprised of the Proximal Seal, Delivery Device, Loader and the Aortic Cutter. The proximal Seal is a semi-spherical shaped device that is delivered into the aorta via the punch hole site and provides a sealed region to facilitate the proximal anastomosis. The Loader is a mechanism that rolls the Proximal Seal and loads the Seal into the Delivery Device. The Delivery Device is a plastic injected molded device that is used to deploy the Seal inside of the aorta. The HEARTSTRING® Aortic Cutter creates the aortotomy and hole opening in the aorta for the anastomosis.

This 510(k) summary for the HEARTSTRING® III Proximal Seal System does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and a definitive study proving the device meets those criteria. The provided text primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's description and intended use.

Here's what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The results of the verification testing demonstrate that the Guidant HEARTSTRING® III Proximal Seal System meet the established acceptance criteria and performs in a manner equivalent to the predicate devices."

However, the actual specific acceptance criteria (e.g., maximum allowable blood leakage, deployment success rate, seal integrity under specific pressures, etc.) and the quantifiable reported device performance against those criteria are not provided in this summary.

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

This information is not available in the provided text. The summary mentions "verification testing" but does not detail the sample size (number of tests, number of devices/simulations, patients, etc.) or the provenance (e.g., country of origin, retrospective/prospective).

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

This information is not available in the provided text. The nature of this device (a surgical tool for hemostasis) suggests that "ground truth" would likely be established through physical performance testing rather than expert review of data like images.

4. Adjudication Method for the Test Set

This information is not available in the provided text.

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

A MRMC study is typically performed for devices that involve human interpretation of medical images or data where the AI assists in that interpretation. The HEARTSTRING® III Proximal Seal System is a physical surgical device. Therefore, a MRMC study is not applicable and was not performed.

6. Standalone (Algorithm Only) Performance Study

The HEARTSTRING® III Proximal Seal System is a physical medical device, not an algorithm or AI. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed. The performance data mentioned refers to the physical device's performance through "verification testing."

7. Type of Ground Truth Used

Based on the nature of the device (a surgical tool for hemostasis), the ground truth for performance testing would likely be based on objective physical measurements and observations during simulations, bench testing, and potentially animal or cadaveric studies. For example, ground truth could involve:

• Absence of bleeding/hemostasis.
• Integrity of the seal under specified pressure.
• Successful deployment.
• Ease of use or deployment time.
• Mechanical strength and durability.

However, the specific methods for establishing ground truth are not detailed in this summary.

8. Sample Size for the Training Set

This information is not applicable as the HEARTSTRING® III Proximal Seal System is a physical device and does not involve AI or machine learning that would require a "training set."

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

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

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The Guidant Microwave Ablation System is indicated for the surgical ablation of soft tissue, and striated, cardiac, and smooth muscles. The System is a device indicated for use, under direct visualization, in surgical procedures, including minimally invasive cardiac surgery procedures. The probes ablate the target tissue by creating an inflammatory response, or thermal necrosis.

The Guidant Microwave Ablation System consists of a microwave generator and handheld ablation probe accessories. The probe is available in two versions: the FLEX 4 and the FLEX 10. The ablation probe contains the microwave antenna that emits the microwave energy.

The microwave generator's output (2450 MHz) is conducted through the output cable, into the cabling of the Probe, and out the antenna at the distal section of the Probe. Energy is expressed in a pattern that is radial to the orientation of the ablating tip. Shielding in the ablating tip inhibits microwave energy expression into non-targeted tissue. The target tissue contains polar molecules (most notably water), which vibrate in response to the induced electromagnetic microwave field. This vibration creates heat through friction, raising the temperature of the tissue throughout the area being ablated. Upon reaching a certain temperature, the tissue becomes necrotic, and thus fully ablated.

FLEX 4 has a flexible antenna fixed at the distal end of the probe. FLEX 10 has a flexible antenna that can be moved along the distal end of the probe.

This document is a 510(k) premarket notification for the Guidant Microwave Ablation System. It primarily addresses a labeling change to refine the indication statement for the device. The document explicitly states that no new testing was performed for this specific 510(k) submission (K041340) because the product's design, technology, materials, manufacturing, performance, specifications, and method of use were unchanged from previous submissions (K003978 and K013946).

Therefore, based on the provided text, it's not possible to provide the detailed information requested regarding new acceptance criteria or a new study proving the device meets those criteria, as no new study was conducted for this submission. The document relies on the substantial equivalence to previously cleared devices and studies.

However, I can extract the information available from the document regarding the device and its regulatory status:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on this 510(k), no new acceptance criteria or specific performance data are reported as this submission is for a labeling change and relies on previous clearances. The document implies that the device's performance, as established in prior 510(k)s (K003978 and K013946), meets the necessary standards, but those specific criteria and performance metrics are not detailed here.

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

• Sample Size for Test Set: Not applicable as no new testing was performed for this submission. The previous 510(k)s (K003978, K013946) would contain this information.
• Data Provenance: Not applicable for new data in this submission.

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

• Not applicable as no new testing was performed for this submission.

4. Adjudication method for the test set:

• Not applicable as no new testing was performed for this submission.

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 MRMC study was done, nor is AI involved. This device is a microwave ablation system, not an AI-powered diagnostic or assistive technology.

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

• Not applicable. This is a medical device for direct surgical use, not a standalone algorithm.

7. The type of ground truth used:

• Not applicable as no new testing was performed for this submission.

8. The sample size for the training set:

• Not applicable.

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

• Not applicable.

Summary of Device and Regulatory Context (Based on the document):

• Device Name: The Guidant Microwave Ablation System
• Intended Use: Surgical ablation of soft tissue, and striated, cardiac, and smooth muscles, under direct visualization, including minimally invasive cardiac surgery procedures. The probes ablate target tissue by creating an inflammatory response or thermal necrosis.
• Mechanism of Action: Emits 2450 MHz microwave energy. This energy causes polar molecules (like water) in the tissue to vibrate, creating heat through friction. This raises the tissue temperature to a necrotic level, leading to ablation.
• Regulatory Status: Cleared via 510(k) (K041340) as substantially equivalent to predicate devices (AFx Microwave Ablation System and Accessories K003978, FLEX 10 Accessory K013946, CryoGen Cardiac Cryosurgery System K974320, Heartport™ Maze System: Cryoprobe Set K970496).
• Key Point of K041340: This specific submission is primarily a labeling change to update the product name and make the indication statement more precise and consistent with predicate devices, particularly regarding surgical access. No changes were made to the device's design, technology, materials, manufacturing, performance, or method of use. Therefore, no new testing was deemed necessary.

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The ESSeX Aspiration/Irrigation and Positioning Guide is intended for use by surgeons during endoscopic abdominal and thoracic surgical procedures to deliver and remove irrigation fluid to and from the operative site, localizing and removal of irrigation, feeding, drainage, and chest tubes.

The ESSeX Aspiration/Irrigation Instrument with Positioning Guide is a reusable stainless steel irrigation/aspiration instrument with a positioning guide. The instrument is designed to for use during endoscopic surgical procedures. ESSeX Aspiration/Irrigation Instrument with Positioning Guide is The manufactured from surgical grade stainless steel. The instrument has an overall operating length of 35.6cm and an outer diameter of 7.5 mm. The instrument functions as a standard suction/irrigator and provides for the localization and removal of a variety of irrigation, feeding, drainage, and chest tubes. The positioning quide component of the instrument is attached in such a manner that allows for the delivery or capture of irrigation or drainage tubes.

The provided document focuses on the 510(k) submission for the ESSeX Aspiration/Irrigation Instrument with Positioning Guide, demonstrating its substantial equivalence to a predicate device. It primarily discusses the device description, intended use, and substantial equivalence, but does not contain information about specific acceptance criteria or a study that proves the device meets such criteria.

The document states: "All necessary testing will be performed on the ESSeX Aspiration/Irrigation Instrument with Positioning Guide and packaging to ensure that the product is substantially equivalent to the predicate devices and to ensure the safety and effectiveness of the device." However, it does not elaborate on what these tests entailed, what the acceptance criteria were, or what the results of those tests were.

Therefore, I cannot provide the requested information, specifically:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This 510(k) summary is focused on establishing substantial equivalence based on comparative characteristics to a predicate device rather than presenting detailed performance study results against specific criteria.

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The Guidant SYNCRUS™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.

The Syncrus System consists of three components:

• Three temporary heart wires sutured onto the heart during open-heart surgery. The wires include a unipolar defibrillation heart wire (left atrium), a bipolar pacing/sensing heart wire (right or left ventricle) and a tripolar defibrillation and pacing and sensing heart wire (right atrium).
• An attenuator box (External Defibrillator Interface Module EDIM). The EDIM attenuates the delivered energy from a standard, low energy defibrillator by 97% (50 - 360 Joules to 1.3 - 11.5 Joules).
• A cardioversion extension cable, which connects the defibrillation heart wires to the EDIM.
  The user must supply an external, low-energy defibrillator that is capable of synchronized cardioversion, an external pacemaker, and temporary patient cables to connect the pacemaker to the patient. The Syncrus System is designed to perform the following cardiac rhythm management functions:
• Atrial pacing and electrocardiogram sensing
• Ventricular pacing and electrocardiogram sensing
• Atrial defibrillation using low energy, synchronized cardioversion.

The provided text is a 510(k) summary for the Guidant Syncrus Internal Cardioversion System. It details an acceptance of a Special 510(k) application, which typically focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than explicit acceptance criteria and performance studies in the same way a de novo or PMA application might.

Based on the document, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) or numerical thresholds that the device had to meet to be deemed acceptable. Instead, the focus of this Special 510(k) is on demonstrating substantial equivalence to a predicate device (Syncrus System K020701).

The "device performance" reported is that the device "met specified requirements" in bench testing, confirming its compatibility with a biphasic defibrillator. However, these "specified requirements" are not detailed in the document.

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

The document mentions "bench testing" was performed. This typically refers to laboratory testing, not human or animal studies with a "test set" in the context of clinical data. Therefore, information about a "sample size" for a test set (e.g., number of patients, cases) or its "data provenance" (country of origin, retrospective/prospective) is not applicable or not provided in this type of submission.

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

As the evaluation was based on bench testing and comparison to a predicate device, there was no "ground truth" to be established by human experts in a clinical context for a "test set" of cases. Therefore, this information is not applicable or not provided.

4. Adjudication Method for the Test Set

Again, given the nature of bench testing and substantial equivalence, a formal "adjudication method" in the clinical sense (e.g., 2+1, 3+1 for resolving discrepancies in expert opinions) for a clinical "test set" is not applicable or not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This question is entirely not applicable. The device described is a medical hardware system (internal cardioversion system), not an AI algorithm designed to assist human readers (e.g., in medical image interpretation). Therefore, an MRMC study or an assessment of AI assistance is irrelevant to this device.

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

This question is also entirely not applicable for the same reasons as point 5. The device is a hardware system, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this submission was primarily established through:

• Bench Testing Results: Verifying the electrical and functional performance of the device components, such as the energy attenuation of the EDIM and compatibility with biphasic defibrillators. The "ground truth" here is the physical and electrical measurements obtained during testing against predefined engineering specifications.
• Substantial Equivalence to a Predicate Device: The primary "ground truth" for regulatory approval in a 510(k) is the demonstration that the new device is as safe and effective as a legally marketed predicate device. This involves comparing intended use, indications, device characteristics, method of use, labeling, materials, and safety features.

There was no "expert consensus, pathology, or outcomes data" used to establish ground truth in the context of a clinical study for this 510(k) submission.

8. The Sample Size for the Training Set

Since this involves bench testing and substantial equivalence to a predicate device, there is no "training set" in the context of machine learning. Therefore, the sample size is not applicable or not provided.

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

As there is no training set, this information is not applicable or not provided.

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The Essex Dissection Cannula is intended for use in dissection of tissue and introduction of surgical instruments in endoscopic surgical procedures.
The Essex Dissection Cannula is indicated for dissection of tissue and introduction of surgical instruments in endoscopic surgical procedures including percutaneous thoracic and pericardial surgery.

The Essex Dissection Cannula is a reusable device designed for dissection of tissue and introduction of instruments for visualization and manipulation during endoscopic surgical procedures. The device consists of two tubular cannulae for introduction of instrumentation into the surgical site. One lumen allows insertion of an endoscope for illumination and visualization of the procedure. Another lumen provides access for surgical instruments. A disposable Dissection Tip may be attached to the end of the cannula for dissection of tissue.

The provided text is a 510(k) summary for the Essex Dissection Cannula. It outlines the device description, intended use, and substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

510(k) submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) submission would for novel, high-risk devices. For lower-risk devices like this cannula, the "proof" often lies in the argument that the new device is fundamentally similar to a device already deemed safe and effective.

Therefore, I cannot provide the requested information from the given text.

This document does not contain the information required to populate the following sections:

1. A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data is presented.
2. Sample size used for the test set and the data provenance: No test set information is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No test set or adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: This is a physical medical device, not an algorithm, so this concept is not applicable.
7. The type of ground truth used: No ground truth is mentioned.
8. The sample size for the training set: This is a physical medical device, not a machine learning model, so no training set is relevant.
9. How the ground truth for the training set was established: Not applicable.

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The VasoView® 6 Harvesting Cannula is intended for cutting and coagulation of tissue and providing access in minimally invasive vessel harvesting procedures for patients undergoing coronary artery bypass grafting.

The VasoView® 6 Harvesting Cannula has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery for vessel harvesting. It is indicated for cutting tissue and controlling bleeding through coagulation in general and cardiothoracic surgery including minimally invasive direct coronary artery bypass (MIDCAB), lower extremity and thoracoscopic procedures. Lower extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass. 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 6 Harvesting Cannula is a disposable device designed to perform endoscopic cutting and coagulation, including vessel isolation and division of vessel branches. The device has a tubular cannula for introduction of instrumentation into the surgical site with a proximal handle to hold and control the device during procedures. A lumen of the cannula allows insertion of an endoscope for illumination and visualization of the procedure. Extension, retraction and actuation of the transector cutting and coagulation tool is achieved with controls located on the handle.

The provided text describes a 510(k) premarket notification for the VasoView®6 Harvesting Cannula. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The document primarily focuses on establishing substantial equivalence to a predicate device (VasoView 5 Harvesting Cannula) based on:

• Intended Use: Identical.
• Technological Characteristics: Similar, with minor modifications (blades, electrode configuration, bipolar tool rotation, insufflation capability).
• Materials, Manufacturing Processes, and Components: Identical.

Therefore, I cannot fulfill your request for the tables and study details as they are not present in the provided text. The submission is a regulatory filing, not a clinical study report.

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The Guidant Syncrus™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.

The Syncrus Heart Wires and Connectors are used for atrial and ventricular pacing and electrocardiogram sensing to diagnosis and treat atrial (type I) flutter and some forms of tachycardia. The wires are also used to treat post-operative arrhythmias, particularly atrial fibrillation, when used in conjunction with the Syncrus Cardioversion Extension Cable and Syncrus External Defibrillator Interface Module (EDIM). The EDIM is a passive device. The EDIM when used with a compatible external monophasic defibrillator reduces the energy to approximately 3% and delivers the low-energy cardioversion shock directly to the atria. The cardioversion is achieved by delivering a synchronized electrical pulse of approximately 11.1 Joules or less to the atrial chambers of the heart. There are three types of Heart Wires:

• A tripolar atrial wire, capable of pacing and sensing, and cardioversion, when used in conjunction with the unipolar wire.
• A unipolar atrial wire, capable of cardioversion when used in conjunction with the cardioversion electrode on the tripolar wire.
• A bipolar ventricular wire, capable of pacing and sensing.
  The wires are comprised of curved needle(s), attached to lead(s) on the proximal end. The wires are insulated for long length. A straight needle is attached to the leads on the distal end of the wires. Cardioversion connectors are provided that attach to the appropriate heart wire leads. Pacing connector pins are pre-assembled onto the appropriate heart wire leads.
  The Syncrus Heart Wires are intended to be affixed to the surfaces of their respective heart chambers, during or immediately following open-heart surgery, before the median sternotomy is closed. Temporary pacing heart wires are routinely implanted in a similar manner. The unipolar atrial wire is placed on the left atrium, the tripolar atrial wire is placed on the right atrium, and the bipolar ventricular wire is placed on either ventricle. If all of the Heart Wires are implanted, the atrial and ventricular temporary sensing and pacing ability can be used, and only if the patient develops post-operative AF would the cardioversion feature be used. Both the unipolar atrial wire and the tripolar atrial wires are required in order to perform a cardioversion. When only the capability to treat post-operative AF is desired, the ventricular wire is not required.
  When the pacing feature is used, the pacing lead is inserted into the myocardial tissue of the atrium using the curved needles. Location and pattern of the lead is not critical, as the lead simply requires tissue contact. The "bullet" (define) on the ground wire is then pulled through the hole formed by the curved needle, and is thus buried in the myocardial wall.

The provided text describes a medical device called the Syncrus™ Internal Cardioversion System and its intended use, but it does not contain detailed information about specific acceptance criteria or the study data that "proves" the device meets these criteria in the format requested.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of performance against specific, quantifiable acceptance criteria.

Here's what can be extracted and what is missing, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly states that "All necessary testing was performed on the Guidant Syncrus System to ensure that the system is substantially equivalent to the predicate devices and to ensure that the device is safe and effective."

• Reported Device Performance:

  • Low-energy cardioversion shock: "approximately 11.1 Joules or less to the atrial chambers of the heart."
  • Energy Reduction: When used with the EDIM, a compatible external monophasic defibrillator "reduces the energy to approximately 3%."

  Therefore, a table cannot be fully generated as requested due to the lack of specific, quantifiable acceptance criteria and corresponding detailed performance metrics.

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

• Sample Size: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only mentions "All necessary testing was performed."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Adjudication Method: Not specified.

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: Not applicable. This device is a hardware system for pacing, sensing, and cardioversion, not an AI-assisted diagnostic or interpretative tool.

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

• Standalone Performance: Not applicable. This device is a medical device requiring human intervention for implantation and operation, not an algorithm.

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

• Type of Ground Truth: Not explicitly stated. The testing would likely involve technical performance verification (e.g., electrical output, material biocompatibility, mechanical integrity) and potentially some animal or limited human subject testing to confirm physiological response, but the document does not detail this. The "ground truth" would be related to meeting established engineering and medical device standards.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This is a hardware device, not an AI/machine learning model that requires a training set.

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

• Ground Truth for Training Set: Not applicable, as it's a hardware device.

Summary of what is present:

• Device Name: Syncrus™ Internal Cardioversion System
• Intended Use: For use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.
• Substantial Equivalence: Demonstrated against Medtronic Pacing & Sensing Wires (Model 6500), Physio-Control Internal Paddles (accessory to LifePak 9 External Defibrillator), and the R2 Cable Adapter.
• Performance Claim: Delivers a synchronized electrical pulse of approximately 11.1 Joules or less for cardioversion. Reduces external defibrillator energy to approximately 3% when used with EDIM.
• Conclusion: "All necessary testing was performed... to ensure that the system is substantially equivalent... and to ensure that the device is safe and effective..."

Key Takeaway: The provided document is a regulatory submission summary focused on substantial equivalence rather than a detailed performance study with explicit acceptance criteria and corresponding granular data as would be found in a clinical trial report or a comprehensive engineering validation.

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The VasoView 5 Harvesting Cannula has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery for vessel harvesting. It is indicated for cutting tissue and controlling bleeding through coagulation in general and cardiothoracic surgery including minimally invasive direct coronary artery bypass (MIDCAB), lower extremity and thoracoscopic procedures. Lower extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass. 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 5 Harvesting Cannula is a disposable device designed to perform endoscopic vessel isolation and division of vessel branches. The device has a tubular cannula for introduction of instrumentation into the surgical site with a proximal handle to hold and control the device during procedures. A lumen of the cannula allows insertion of an endoscope for illumination and visualization of the procedure. Opening, closing, extension and retraction of the scissors blades is actuated via controls on the handle.

The provided text is a 510(k) summary for the VasoView™ 5 Harvesting Cannula. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the specific information required to complete the table or the detailed study information as requested in the prompt.

The document states: "All necessary testing was performed on the VasoView 5 Harvesting Cannula to ensure that the product is substantially equivalent to the predicate devices and to ensure that the modified dimensions do not have a significant effect on safety and effectiveness."

This indicates that testing was done, but the details of the acceptance criteria, reported performance, study methodologies, ground truth establishment, or sample sizes are not provided in this summary.

Therefore, I cannot fill out the requested table and answer the study-related questions based on the provided text.

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