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The Estech COBRA® Genesis Bipolar Clamp is intended for the coagulation of soft tissue during general surgery. The system may also be used to coagulate blood and soft tissue to produce hemostasis.

The Estech COBRA® Genesis Bipolar Clamp is a sterile, single-use device designed to guide RF energy to the target tissue via electrodes in the jaws of a surgical clamp style device. RF energy is delivered in a bipolar mode, with one jaw of the device as the ablative electrode and the other jaw as the indifferent electrode.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Estech COBRA® Genesis Bipolar Clamp:

Please note: The provided document is a 510(k) summary, which is typically a high-level overview. It states that detailed testing information is available in "Section 18" and "Sections 15 and 17," but these sections are not included in the provided text. Therefore, several of the requested details about specific study methodologies (like sample sizes for specific tests, expert qualifications, adjudication methods, or MRMC studies) are not present in this summary.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list performance acceptance criteria in a quantifiable table format. Instead, it asserts that the device is "substantially equivalent" to a predicate device (Estech COBRA Bipolar System II, K100224) based on various assessments. The "acceptance criteria" are implicitly met by demonstrating this substantial equivalence.

Here's a table summarizing the areas of comparison:

Details of the Study/Testing That Proves the Device Meets Acceptance Criteria:

The provided document describes the types of studies performed but lacks specific quantitative details about their methodology, sample sizes, or outcomes.

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

   • Mechanical Integrity & Ablation Performance: The document states "The testing supplied in Section 18 demonstrates that the joints and other mechanical aspects... are adequate for use. Additionally, the data demonstrates that the ablation performance... is equivalent to that of the predicate."
     • Sample Size: Not specified in this summary. The detailed report in "Section 18" would contain this information.
     • Data Provenance: Not specified (e.g., in-vitro, ex-vivo, animal model, specific country, etc.). This would likely be found in "Section 18."
     • Retrospective/Prospective: Not specified.

2. 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 the summary. For mechanical and ablation performance, "ground truth" would likely be established through objective measurements against predefined standards or comparative measurements against the predicate device, rather than expert consensus on a test set.

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

   • Not applicable/not specified for mechanical and ablation performance testing described. These are typically objective measurements.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC study is not mentioned or applicable. This device is an electrosurgical clamp, not an AI-powered diagnostic or assistive tool for human readers.

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

   • Not applicable. This is a physical medical device. The "standalone" performance would be its direct mechanical and electrical function.

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

   • For Mechanical Integrity and Ablation Performance: Ground truth would likely be established through objective physical and functional measurements and comparisons to the predicate device's established performance specifications, rather than clinical outcomes or pathology.
   • For Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and specific biological testing (e.g., cytotoxicity, sensitization, irritation).
   • For Electrical Safety: Ground truth is established by adherence to IEC 60601-2-2 standards and electrical testing.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning. The design and manufacturing processes are established based on engineering principles and regulatory standards.

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

   • Not applicable for this type of device.

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The ESTECH Clearview™ MV Atrial Depressor is intended to remove excess fluids from the surgical field for filtering and return to the patient during cardiopulmonary bypass of up to 6 hours. It can also be used to retract tissue to increase visibility.

The Estech Clearview™ MV Atrial Depressor is a sterile, single use, surgical instruments intended for the collection of blood and other fluids from the surgical field for return through the cardiotomy system during open heart surgery. The a molded polymer proximal connector is intended to connect into cardiopulmonary bypass system to return blood and fluids into the extracorporeal circulation circuit, most typically during stoppedheart surgical procedures. The Estech Clearview™ MV Atrial Depressor has an integrated shaft designed to connect to the Estech Small Incision Retractor. The retractor creates access to the surgical field via thoracotomy or mini-sternotomy. When mounted to the retractor, the Estech Clearview™ MV Atrial Depressor can also be used to retract tissues while collecting fluids.

The provided text describes a medical device, the ESTECH Clearview™ MV Atrial Depressor, and its regulatory submission. It does not contain information about acceptance criteria for device performance, nor details of a study (clinical or otherwise) proving it meets such criteria. The document is primarily a 510(k) summary for regulatory approval, focusing on substantial equivalence to predicate devices, biocompatibility, and preclinical performance data.

Therefore, I cannot provide the requested information. The text explicitly states "Preclinical performance data was supplied to demonstrate that the Estech Clearview™M MV Atrial Depressor can meet its labeled performance claims, and to demonstrate substantial equivalence with the predicate device," but it does not provide the details of this data or the specific acceptance criteria.

The questions you've asked (about sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, etc.) are typical for studies assessing the diagnostic accuracy or effectiveness of AI/imaging devices. The device described here is a surgical instrument for fluid collection and tissue retraction, and its performance evaluation would likely focus on different metrics (e.g., fluid collection rate, suction integrity, material strength, biocompatibility, ease of use in a surgical setting) rather than accuracy against a ground truth in an AI context.

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The ESTECH Remote Access Perfusion Femoral Venous Cannula is intended for use as a venous drainage cannula during cardiopulmonary bypass up to 6 hours.

The Estech Remote Access Perfusion (RAP™) Femoral Venous Cannula is a sterile, single-use, open-ended, hollow polymer tube with multiple perforations at the distal end. The barbed proximal end is intended to connect into cardiopulmonary bypass tubing to provide extracorporeal circulation of the blood, most typically during stopped-heart surgical procedures. The RAP FV cannula is provided with a flexible obturator to assist with the placement. The RAP FV cannula can be guided over a 0.035" guidewire. The RAP FV cannula has depth markers to assist the physician with placement. The RAP FV cannula ranges in outside diameter from 18 - 26 Fr, and in length from 60 -76 cm.

The provided document is a 510(k) premarket notification for a medical device (ESTECH Remote Access Perfusion FV Catheter). The information requested pertains to the acceptance criteria and the study proving the device meets those criteria, which is typical for AI/ML device submissions. However, this document does not contain any information about an AI/ML device.

The document describes a physical medical device (a cardiopulmonary bypass cannula) and its substantial equivalence to predicate devices. It discusses:

• Device Description: A sterile, single-use, open-ended, hollow polymer tube with multiple perforations.
• Intended Use: As a venous drainage cannula during cardiopulmonary bypass.
• Comparison to Predicate Device: Substantially equivalent in terms of sterile, single-use, open-ended, hollow polymer tubes inserted into the vena cava via the femoral vein.
• Supporting Data: Biocompatibility testing consistent with ISO 11193 and preclinical performance data to demonstrate labeled performance claims and substantial equivalence.

Therefore, I cannot provide the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, standalone performance) because these concepts are not applicable to the non-AI/ML device described in the provided text.

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The Estech Cobra Surgical System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

The Estech Cobra Surgical System is a family of devices including RF Ablation Probes, with either a malleable or flexible shafts, used in conjunction with the Cobra Electrosurgical Unit (ESU) and other accessories, including the Estech Cobra Bipolar Recording Electrode. The System is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedures.

This device (Estech Cobra Surgical System) is an electrosurgical device, and the submission is a 510(k) premarket notification for an amendment to the existing device. The information provided heavily focuses on regulatory comparisons to predicate devices rather than a detailed clinical study for acceptance criteria.

Based on the provided text, the "acceptance criteria" for this amendment are primarily based on substantial equivalence to existing predicate devices.

Here's an analysis of the provided text in relation to your questions, noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied to be substantial equivalence to predicate devices in terms of intended use, technology, design, and materials, and satisfactory preclinical performance data for any modifications. Specific numerical performance metrics (e.g., coagulation depth, lesion size) are not explicitly stated as "acceptance criteria" in a table format with corresponding reported performance, as would be typical for a new device's clinical study.

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

The document does not describe a clinical "test set" with human subjects or a specific sample size for a study proving acceptance criteria. The performance data mentioned is "preclinical performance data." This usually refers to bench testing or animal studies.

• Sample Size: Not specified for preclinical performance tests.
• Data Provenance: "Preclinical performance data" implies laboratory or animal testing, not human clinical trials. No country of origin for such data is specified, but it would typically be conducted by the manufacturer or a contract research organization. The context suggests that the submission is from the US, implying data generated or submitted to the US FDA.
• Retrospective or Prospective: Not applicable as it's not a clinical study involving patients. Preclinical data would be generated prospectively as part of the validation process.

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

This information is not provided. Since the described data is "preclinical performance data" and not a clinical study with a human "test set" requiring ground truth established by experts, this section is not applicable.

4. Adjudication Method for the Test Set

Not applicable, as there is no described clinical "test set" requiring expert adjudication.

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

No MRMC study is mentioned. The device is a surgical tool, not an imaging or diagnostic device that typically undergoes MRMC studies.

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

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

7. Type of Ground Truth Used

For the preclinical data provided, the "ground truth" would be established by:

• Engineering specifications: Performance of the device (e.g., power output, temperature control, lesion size) compared against predefined engineering targets derived from the predicate device's performance.
• Compliance with standards: Meeting the requirements of AAMI HF-18.
• Predicate device performance: The "ground truth" for the new XL version is the established performance characteristics and safety profile of the predicate device.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm. There's no concept of a "training set" in this context.

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

Not applicable, as there is no training set for a physical electrosurgical device.

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The Estech Cobra Adhere Surgical System is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The System can be used during general surgery to coagulate soft tissues. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

The Cobra Adhere Surgical System is an Electrosurgical Probe, with either a malleable or flexible shaft, used in conjunction with the Cobra Electrosurgical Unit (ESU). The System is intended for use by surgeons for the coagulation of cardiac and soft tissues during open surgical procedures.

This 510(k) submission does not contain a study to prove acceptance criteria for device performance. Instead, it relies on a "substantial equivalence" argument by asserting that the device is identical to an already legally marketed predicate device.

Here's why and what's present in the provided text:

• No Acceptance Criteria or Performance Data: The submission explicitly states: "No data supporting equivalence between the Estech Cobra Adhere Surgical System and the Boston Scientific Cobra Adhere Surgical System is necessary because both are the same device." This indicates that no new performance studies (and therefore no new acceptance criteria) were established for this specific device because it is considered a re-branding of an existing one.

• Reliance on Predicate Device: The core of the submission is the claim that the "Estech Cobra Adhere Surgical System is identical in nearly every way to the Boston Scientific Cobra Adhere Surgical System." The only difference cited is "labeling changes necessary to list a different final manufacturer." This implies that the Estech device inherits the performance and safety profile of the predicate device.

Given this, I cannot fill out the table and answer the study-specific questions as they pertain to a new performance study. However, I can summarize the information provided in the context of this "substantial equivalence" claim:

Summary of Device Equivalence Claim

The Estech Cobra Adhere Surgical System claims substantial equivalence to the Boston Scientific Cobra Adhere Surgical System. The basis for this claim is outlined below:

Study-Specific Information (Based on the "Identical Device" Claim)

1. Sample sized used for the test set and the data provenance: Not applicable. No new test set or data provenance is mentioned as this device is stated to be identical to the predicate.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new ground truth establishment for a test set was performed.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No new test set for performance comparison was conducted.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an electrosurgical probe, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electrosurgical probe, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No primary ground truth was established for this submission, as it relies on the predicate device's established safety and effectiveness.
7. The sample size for the training set: Not applicable. This device is an electrosurgical probe; there is no mention of a "training set" in the context of machine learning or algorithms.
8. How the ground truth for the training set was established: Not applicable.

Explanation of the "Identical Device" Argument:

• Manufacturing: "Both devices are manufactured by Boston Scientific on the same assembly line in San Jose of the exact same materials, processes and specifications."
• Sterilization: "Both are EtO sterilized in processes validated to ISO 11135."
• Indications for Use: "Both devices have identical indications for use."

Therefore, the review process for this device did not involve new performance studies against acceptance criteria but rather a verification of its sameness to the predicate device.

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The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is intended for use in arterial perfusion of the aorta, via axillary artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). This device is indicated for short term cardiopulmonary bypass (

The ESTECH Remote Access Perfusion Cannula Left Axillary 21 French is a disposable 31 cm long flexible polyurethane tube with three (3) lumens with an inflatable polyurethane balloon at the distal end of the cannula. The inflatable balloon has elastomeric properties designed to provide aortic occlusion in a range of aorta sizes with internal diameters from 22 mm to 34 mm. The outside diameter of the cannula is 21 Fr. (7 mm). The cannula has a central lumen for the delivery of arterial blood through multiple distal outlets at flow rates of 1.0 to 5.0L/min, a lumen that communicates with the aorta in the area of the aortic root for delivery of cardioplegia solution and left ventricle venting, and a small lumen for control of the distal balloon. Radio-opaque arch segment of cannula and insertion depth marks aid in positioning the device. The Cannula are provided sterile in individual packages for single use.

The provided 510(k) summary for the ESTECH Remote Access Perfusion Cannula Left Axillary 21 French describes non-clinical performance data and a comparison to predicate devices to establish substantial equivalence. It does not contain information about acceptance criteria or a study proving the device meets specific performance thresholds in a clinical or analytical efficacy study with human or expert-based ground truth.

Here's an analysis based on the available text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative, pass/fail format typical for clinical or standalone efficacy studies. Instead, it describes various performance tests conducted and generally states that the device "meets performance and safety specifications" or that results were "within specification." The comparison with predicate devices serves as the primary means of demonstrating equivalence rather than meeting independent quantitative acceptance criteria.

The study that proves the device meets the (implied) acceptance criteria:

The "study" consists of a series of non-clinical laboratory and animal tests, designed to demonstrate the safety and effectiveness of the device and its substantial equivalence to predicate devices. These are described in Section G: "Summary of Non-Clinical Performance Data" and Section III: "Device Specifications" (though Section III is not provided in the input).

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

• Sample Size: The document does not specify exact sample sizes for each test (e.g., number of balloons tested, number of flow tests performed, number of animals used). It reports results generally.
• Data Provenance: All data referenced are from "laboratory testing" and "animal testing." This indicates in-vitro (bench testing) and in-vivo (animal) studies. No human data or external (country of origin) data provenance is explicitly stated, which is typical for 510(k) submissions that rely on predicate device equivalence. It explicitly states "The laboratory testing adhered to Good Laboratory Practices guidelines."

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 the document. The tests performed are primarily engineering and simulated physiological tests, not requiring clinical expert ground truth in the way an AI diagnostic device would. For animal testing, veterinary experts would likely be involved in assessing outcomes, but their number and specific qualifications are not detailed.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. The testing described is objective, physical/physiological performance measurement, not subjective expert assessment 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:

This information is not applicable and therefore not provided. The device is a medical instrument (cannula) and not an AI-powered diagnostic or assistive tool.

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

This information is not applicable and therefore not provided. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used:

• Bench Test Performance: For tests like burst pressure, flow rates, and sustained inflation, the "ground truth" is established by the specified engineering and material performance standards relevant to the device's function and safety. These would refer to predefined acceptable ranges or limits established by engineering design, regulatory standards, or comparison to predicate devices.
• Biocompatibility: Established by adherence to material standards and previous testing on identical materials used in predicate devices.
• Animal Testing: The "ground truth" is the observed physiological and mechanical performance in an animal model, validated against expected outcomes for successful device operation (e.g., proper insertion, placement, perfusion, and balloon occlusion without adverse events).

8. The sample size for the training set:

This information is not applicable and therefore not provided. This device is not an AI algorithm and therefore does not have a "training set" in the machine learning sense. The "training" in the context of this device refers to "On-site customized training" for users, which is not a data set.

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

This information is not applicable and therefore not provided. As mentioned above, there is no "training set" in the context of an AI algorithm.

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The ESTECH Arterial Remote Access Perfusion Cannula is intended for use in arterial perfusion of the aorta, via a femoral artery, in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB). The device may also be used to occlude the ascending aorta, deliver cardioplegia solution and vent the aortic root.

The ESTECH Arterial Remote Access Perfusion Cannula is a sterile, disposable, flexible polyurethane tube with three integrated lumens and an inflatable polyurethane balloon at the distal end of the cannula. The outside diameter of the cannula is 21 French. The cannula has a central lumen for delivery of arterial blood through multiple distal outlets at a flow rate up to 5 liters per minute, a small lumen for delivery of cardioplegia or venting at the aortic root, and an additional smaller lumen for control of the distal balloon. The blood outlet ports are multiple elongated openings along the cannula proximal to the occlusion balloon. Radiopaque balloon markers and insertion depth marks aid in positioning the device. The cannulas are provided sterile in individual packages for single use.

The provided S510(k) summary for the ESTECH Arterial Remote Access Perfusion Cannula focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of its performance against explicit acceptance criteria. The document describes various tests performed but does not explicitly state quantitative acceptance criteria or report specific performance values from these tests that can be directly compared in a table.

Therefore, many of the requested sections below cannot be fully answered due to the nature of the provided document, which is a regulatory submission for substantial equivalence based on a predicate device, rather than a standalone performance study with defined criteria.

Here's an analysis of the provided information, addressing what can be inferred and highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for the tests performed, nor does it provide specific numerical performance results for the ESTECH Arterial Remote Access Perfusion Cannula that would allow for a direct comparison in a table format.

The document implicitly suggests that the acceptance criterion for most tests was to demonstrate performance comparable or superior to the predicate device or within "ESTECH specifications." However, these specifications are not detailed or quantified.

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

The document does not provide specific sample sizes for the test sets used in any of the described tests (Occlusion Balloon, Hemolysis, Flow, Biocompatibility, Animal Testing, Clinical Investigation).

• Animal Testing: Mentioned as "Animal studies." No number of animals or specifics provided.
• Clinical Investigation: Mentioned as "A Clinical Investigation." No number of participants or specifics provided.

The data provenance is generally implied as laboratory testing conducted by ESTECH. The country of origin for the studies is not specified but the company location is in Danville, CA, USA, and the submission is to the FDA. The studies are prospective in nature, as they were conducted to test the performance of the new 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 the document. The tests described (e.g., balloon inflation, hemolysis, flow) appear to be objective engineering and biological tests that do not typically rely on expert consensus for ground truth but rather on measured physical or chemical properties. For animal and clinical studies, the evaluation would be performed by veterinarians and clinicians, respectively, but their numbers and qualifications are not disclosed.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The tests described are not of a nature that would typically involve an adjudication method like 2+1 or 3+1 (which are common in image interpretation studies).

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 question is not applicable to the provided document. The ESTECH Arterial Remote Access Perfusion Cannula is a medical device (a cannula), not an AI algorithm or a diagnostic tool that involves human readers interpreting cases. Therefore, an MRMC study or the effect of AI assistance on human readers is irrelevant to this submission.

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

This question is not applicable. The device is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the various tests would be based on:

• Engineering Measurements: For occlusion balloon characteristics and flow testing (e.g., pressure, diameter, volume, burst pressure, flow rate).
• Laboratory Assays: For hemolysis testing (e.g., free hemoglobin levels).
• Standardized Biocompatibility Tests: For biocompatibility (e.g., cytotoxicity, irritation, sensitization).
• Clinical Observations/Outcomes: For animal and clinical testing (e.g., successful cannulation, adequate perfusion, absence of adverse events, physiological parameters).

8. The Sample Size for the Training Set

This information is not applicable. This is a physical medical device, not an AI model that requires a training set.

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

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

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