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The ESTECH Cobra Adhere XL2 is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical Unit (ESU).

The ESTECH Cobra Adhere XL 2 may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external pacemaker or recording device.

The Estech COBRA Adhere XL 2 is a sterile, single use device intended for the ablation of The Esteon CODIA Cranel to deliver RF energy to the target tissue via electrodes in the device when connected to the COBRA Electrosurgical Unit (ESU).

When the COBRA Adhere XL 2 is connected to an auxiliary temporary external pacemaker or recording device it can be used to provide temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery. The COBRA Adhere XL 2 must be disconnected from the ESU and connected to a temporary external pacemaker or recording device using the accessory cable provided.

The provided text is a 510(k) summary for the Estech COBRA Adhere XL 2, a surgical device for ablation of cardiac tissue. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, the document does NOT contain information about specific acceptance criteria or a detailed study proving the device meets acceptance criteria, as one would find in a clinical trial report or a performance study summary with quantified results.

The text focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and general non-clinical testing. It states that "Appropriate testing, included in this application, has been performed to ensure that the ESTECH COBRA Adhere XL 2 meets its product specifications" and that "In-vitro and in-vivo testing demonstrate that the COBRA Adhere XL2 is able to pace, sense, and stimulate and ablate cardiac tissue as safely and effectively as the predicate devices."

Without quantitative performance metrics, sample sizes for test sets, ground truth details, expert qualifications, or comparative effectiveness studies, it is impossible to complete a table of acceptance criteria versus reported device performance or address most of the requested points.

Therefore, the following points cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set
• Data provenance for the test set
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study
• Information on a standalone (algorithm only) performance study
• Type of ground truth used for the test set
• Sample size for the training set
• How the ground truth for the training set was established

The document focuses on non-clinical testing for safety and effectiveness in establishing substantial equivalence to prior devices, rather than a detailed clinical performance study with specific acceptance criteria as you've requested.

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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 ThermaShield is a flat, bell-shaped silicone pad that is designed to reliably fill the anatomic space between the target tissue of an RF ablation and adjacent non-target tissue. Its thickness and rounded edges provide tactile feedback to the surgeon and facilitates confidence in proper placement. The ThermaShield is primarily designed for use in open chest cardiac surgery. The addition of the ThermaShield to the ESTECH Cobra Surgical System provides a more convenient option for the physician to thermally insulate surrounding non-target tissue during RF ablations. The ThermaShield is intended to improve upon circumstances where no insulation is used or to replace the current use of a surgical glove as a thermal insulator between target and surrounding tissues.

The provided text describes an update to an existing medical device, the ESTECH Cobra Surgical System, with the addition of a ThermaShield accessory. This is a special 510(k) submission, meaning the changes are not significant enough to warrant a new full review but rather an amendment to an existing clearance. As such, the study described is a bench test to demonstrate substantial equivalence, not a clinical trial with human subjects.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format. However, it indicates the criteria were met by demonstrating the ThermaShield's performance.

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

• Sample Size for Test Set: Not explicitly stated as this was a bench test, not a clinical study involving human or animal subjects. The "bench data" would refer to a series of experimental setups to measure thermal insulation properties.
• Data Provenance: Bench test data, not explicitly stated origin (likely internal company testing). It is retrospective in the sense that it evaluates the performance of the newly designed accessory.

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

Not applicable. This device is an accessory to an electrosurgical system, and the evaluation was based on objective thermal insulation measurements, not expert interpretation of images or symptoms.

4. Adjudication Method for the Test Set

Not applicable. The "test set" here refers to bench testing, and data would be gathered and analyzed by technical personnel, not adjudicated by experts in the context of clinical interpretation.

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 document describes a physical medical device accessory, not an AI-based diagnostic or assistive technology.

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

Not applicable, as this is not an algorithm-based device. However, "standalone" in a different context could refer to the ThermaShield's performance when incorporated into the Cobra Surgical System, which was indeed evaluated in the bench tests.

7. The Type of Ground Truth Used

The ground truth used was objective physical measurements of thermal insulation properties during bench testing, as well as compliance with established biocompatibility and electrical safety standards. This is not ground truth in the pathology/outcomes sense.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set."

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

Not applicable. As there is no training set for an AI/ML model, no ground truth was established for it.

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The ESTECH Cobra Bipolar II System 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 Bipolar System is 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.

The provided text does not describe a study involving a medical device with acceptance criteria and reported performance in the context of an AI/algorithm-based system. Instead, it is a 510(k) premarket notification for a traditional medical device, the ESTECH Cobra Bipolar II System.

The document states that the new device is "identical in indications for use, technology, manufacture, packaging and sterilization" to a predicate device (ESTECH Cobra Bipolar System, K053100). The "acceptance criteria" and "study" described are primarily related to demonstrating equivalence to the predicate device and ensuring the safety and basic functionality of the new design.

Therefore, many of the requested fields are not applicable to this type of submission. Below is a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. The "study" here involves bench testing of device components and performance characteristics, not a clinical study with a "test set" of patient data or images.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical "test set" is not relevant for this type of device submission. The "ground truth" for the device's performance is established by established engineering and international standards (e.g., ISO, IEC).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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 device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is based on established engineering principles, international standards (ISO 10993 for biocompatibility, IEC 60601-2-2 for electrical safety), and comparison to the well-understood performance of the predicate device.

8. The sample size for the training set: Not applicable. There is no AI model or algorithm being trained.

9. How the ground truth for the training set was established: Not applicable.

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The ESTECH EasyFlow Cannula with Guidewire is intended for use with cardiopulmonary bypass as an arterial return or venous drainage cannula for up to 6 hours.

The ESTECH EasyFlow Cannula with Guidewire is a sterile, single-use device. The single-lumen wire reinforced polymer tube incorporates multiple perforations at the distal end to provide a diffuse flow pattern. 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. Each cannula is provided with a flexible obturator to assist with the placement and positioning of the cannula and an optional stylet which inserts into the obturator to provide additional column strength for insertion. The product also comes with a 0.035" diameter guidewire, up to 3 vessel dilators, an 18 gauge. needle, and scalpel for introduction

The provided text describes the ESTECH EasyFlow Cannula with Guidewire and its premarket notification for substantial equivalence, but it does not contain information related to acceptance criteria, specific device performance numbers, or a study design with sample sizes, ground truth establishment, or expert involvement.

The document states:

• "Bench testing has demonstrated that the device meets the proposed product specifications."
• "Biocompatibility analysis demonstrates that the device is in compliance with ISO 10993"

However, it does not provide details on:

1. A table of acceptance criteria and the reported device performance: The document mentions "proposed product specifications" and "compliance with ISO 10993" but does not detail what these specifications or the outcome of the compliance testing were.
2. Sample size used for the test set and the data provenance: No sample sizes or data provenance are mentioned for any testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no ground truth creation process is described.
4. Adjudication method for the test set: Not applicable as no ground truth creation process is described.
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 device is a medical cannula, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical cannula, not an algorithm.
7. The type of ground truth used: Not applicable. The "ground truth" for a medical device like this would typically involve engineering specifications, material properties, and functional performance metrics, not diagnostic "ground truth."
8. The sample size for the training set: Not applicable as there is no mention of a "training set" for this type of device.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on establishing substantial equivalence to predicate devices based on design, materials, manufacturing, packaging, and intended use, along with general statements about bench testing and biocompatibility. It does not present a detailed study with specific acceptance criteria and performance data in the format requested.

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The Hawkeye™ Introducer Systems, and accessories, are intended for use in minimally invasive surgery allowing access for delivery and placement of surgical instruments (e.g., ESTECH COBRA Adhere XL, AFfirm Pacing Probe). They are indicated for patients requiring blunt dissection of tissue including structures in the thoracic space.

The Hawkeye family consists of two products; the ESTECH Hawkeye Magnetic Introducer System and the ESTECH Hawkeye Scope System.

The Hawkeye Magnetic Introducer System is comprised of three main components:

• 1. Hawkeye Magnetic Cannula Assembly
• 2. Magnetic Introducer
• 3. Malleable Stylet

Both Systems allow for endoscopic visualization within the thoracic cavity, blunt dissection, and facilitate the placement of surgical equipment. These pieces may be packaged, sterilized and sold separately. They are single-use only.

Please provide the acceptance criteria and the study that proves the device meets the acceptance criteria. The requested information is specific to clinical performance, interpretability, or diagnostic accuracy studies.

The provided document describes the Hawkeye™ Introducer Systems, a device intended for minimally invasive surgery to allow access for delivery and placement of surgical instruments and for blunt dissection of tissue.

However, the document does not contain information regarding:

• Any specific acceptance criteria related to the device's clinical performance, interpretability, or diagnostic accuracy (e.g., sensitivity, specificity, accuracy thresholds).
• Details of a study that tested the device against such criteria. The "Summary of Supporting Data" only mentions:
  • Biocompatibility analysis (compliance with ISO 10993)
  • Bench testing (met proposed product specifications)
  • Animal testing
  • Cadaver testing

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance for a clinical or diagnostic accuracy study. The document focuses on establishing substantial equivalence based on material properties, design, and intended use compared to a predicate device, rather than providing clinical performance data.

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May be used in conjunction with an electrosurgical generator for endoscopic resection of a polypoid lesion.

The ConMed Deuce Polypectomy Snare is a sterile, single patient use, disposable device used in conjunction with an electrosurgical generator for the delivery of electrosurgical current through a flexible endoscope to a stainless steel wire snare at the operative site for endoscopic resection of a polypoid lesion.

The snare consists of a non-detachable handle with a sliding finger ring mechanism for retracting/extending the distal snare loop. An external sheath covers the snare loop cable and is attached to the distal portion of the snare handle. Within the handle, an electrode completes the circuit between the electrosurgical unit and the snare loop.

The polypectomy snares are manufactured in 230cm sheath lengths with a 2.3mm outer diameter in a variety of different loop configurations.

The provided document describes the 510(k) premarket notification for the ConMed Deuce Polypectomy Snares. It states that "Bench testing has been performed to demonstrate equivalence of the ConMed Polypectomy Snares to their predicate devices. All testing passed the predetermined performance specifications." However, it does not provide details on the specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or any advanced study designs such as MRMC comparative effectiveness or standalone performance studies.

Therefore, most of the requested information cannot be extracted from this document.

Here's a summary of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. (Bench testing typically does not involve expert ground truth in the same way clinical studies do.)

4. Adjudication method for the test set: Not applicable for bench testing as described.

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 a medical device (polypectomy snare), not an AI diagnostic tool. An MRMC study is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is hardware. "Bench testing" can be considered a form of standalone performance measurement for the device itself.

7. The type of ground truth used: For bench testing, the "ground truth" would be the engineering specifications and performance standards of the predicate devices or general industry standards for such devices. The document implies comparison to predicate devices as the basis for equivalence.

8. The sample size for the training set: Not applicable, as this is a hardware device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established: Not applicable.

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The Axcess Papillotome is designed and recommended for transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.

The ConMed Axcess Papillotome is a multi-directional wire-guided tapered radiopaque tip catheter capable of accepting a .035" (.889 mm) guidewire. The Axcess Papillotome is a triple lumen device tapered from 7 to 4.5F over the distal 5mm. It has a 5mm tip and distal flexible section running from the proximal to the distal end of the cutting wire that allows multi-directional control of the device distal tip. The working length is 190cm.

The provided text is a 510(k) summary for the ConMed Axcess Papillotome, which describes a medical device and its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance metrics. Therefore, many of the requested elements for a study on acceptance criteria and device performance cannot be extracted directly from this document.

However, I can extract information related to what was provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not explicitly stated. The document mentions "in-vitro testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).

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

• Not applicable/Not stated. This information is typically relevant for studies involving human interpretation or clinical endpoints, which are not detailed here.

4. Adjudication method for the test set

• Not applicable/Not stated. This detail is usually found in studies involving human readers or expert consensus on interpretations.

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 a medical device clearance document, not a clinical study involving AI or MRMC.

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

• Not applicable. The device described is a physical medical instrument (papillotome), not an algorithm or AI system.

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

• For electrical safety, the ground truth would be compliance with established electrical safety standards.
• For in-vitro performance, the ground truth would be pre-defined performance specifications for the device's mechanical and functional characteristics.

8. The sample size for the training set

• Not applicable. This document describes a physical medical device, not a machine learning model that requires a training set.

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

• Not applicable. As above, no training set is relevant to this device's clearance.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes performance testing which included:

• Electrical safety standards compliance.
• In-vitro testing to demonstrate the device meets its performance specifications.

The exact details of these tests (e.g., specific protocols, number of samples tested, specific "performance specifications") are not elaborated in this 510(k) summary but would have been part of the more extensive 510(k) submission to the FDA. The basis for clearance is substantial equivalence to predicate devices (Bard Apollo Papillotome K982557 and Boston Scientific Corporation Autotome K013153), rather than extensive clinical efficacy trials typically associated with AI or novel therapeutic devices. The document explicitly states: "The Axcess Papillotome meets electrical safety standards. In addition, in-vitro testing was conducted which demonstrated that the device meets its performance specifications." and "The Axcess Papillotome is substantially equivalent in design, materials, construction and intended use as that of the predicate."

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The ESTECH Aortic Easy Flow Cannula is intended for use in the perfusion of the aorta during cardiovascular surgery procedures reguiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours.

The Estech Aortic Easy Flow Cannula is a sterile, single-use, device. The single-lumen polymer tube incorporates wire-wrapping with multiple perforations at the distal end to provide a diffuse flow pattern. 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. Each cannula is provided with a flexible obturator to assist with the placement and positioning of the cannula.

The Estech Aortic Easy Flow Cannula is a medical device intended for use in cardiovascular surgery procedures requiring extracorporeal cardiopulmonary bypass (CPB) up to 6 hours. The documentation provided focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device based on clinical outcomes.

Here's an analysis of the provided information:

Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or a table of performance metrics for the ESTECH Aortic Easy Flow Cannula. Instead, the core of the submission relies on demonstrating substantial equivalence to predicate devices.

The acceptance criteria implied are:

• Biocompatibility: The device must meet the criteria for biocompatibility consistent with ISO 11193.
• Labeled Performance Claims: The device must be able to meet its labeled performance claims.
• Substantial Equivalence: The device must be demonstrated to be substantially equivalent to the predicate devices in terms of intended use, technology, design, materials, manufacture, and packaging.

The reported device performance is:

Study Information

Based on the provided text, the "study" conducted is a preclinical performance data assessment and biocompatibility testing to support the claim of substantial equivalence. This is typical for a 510(k) submission where a new device is compared to existing legally marketed devices. There is no mention of a human clinical trial or a study designed to quantify device performance in terms of clinical outcomes, sensitivity, specificity, accuracy, or similar metrics typically associated with AI/diagnostic device evaluations.

Given this context, most of the requested information regarding sample size, expert involvement, and ground truth establishment (which are common for AI/diagnostic device studies) is not directly applicable or explicitly detailed in this 510(k) summary.

1. Sample size used for the test set and the data provenance: Not explicitly stated as a separate "test set" in the context of a clinical trial. The "preclinical performance data" would involve bench testing or possibly animal studies, but no specific sample sizes or data provenance (country of origin, retrospective/prospective) are detailed in this summary.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for this type of submission is typically based on established engineering principles, regulatory standards (like ISO 11193 for biocompatibility), and comparison to the known performance characteristics of the predicate devices. Expert consensus in the context of human data interpretation (e.g., radiology reads) is not relevant here.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used for establishing ground truth in human subject studies, which are not detailed here.
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 a cardiopulmonary bypass vascular cannula, not an AI-powered diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the preclinical performance data would be derived from:
   • Regulatory Standards: ISO 11193 for biocompatibility.
   • Engineering Specifications: Performance characteristics (e.g., flow rates, pressure drops, durability) measured against design specifications and predicate device performance.
   • Predicate Device Data: Performance characteristics of the legally marketed predicate devices serving as benchmarks.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that would require a "training set."
8. How the ground truth for the training set was established: Not applicable.

Conclusion

The provided document details a 510(k) summary for a cardiopulmonary bypass vascular cannula, focusing on demonstrating substantial equivalence to predicate devices through biocompatibility testing and preclinical performance data. It does not contain the kind of detailed information about acceptance criteria, test sets, expert involvement, or ground truth establishment that would be relevant for an AI/diagnostic device performance study.

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

The Estech Cobra Cardiac Electrosurgical Unit and Estech Cable comprise a system that is identical to the Boston Scientific Cobra Cardiae Electrosurgical System. Both Systems are comprised of three components: the (radiofrequency) RF Probe, Flectrosurgical Unit (ESU) and Instrument (Cobra) Cable is an accessory to the ESC. The Estech RF Probes have been the subject of previous premarket notifications. The ESU is a software controlled high frequency electronic instrument, provided with controls for set temperature, power limit, and number of active electrodes. The ESU delivers 460 kHz of RF energy to selected Probe electrodes. The ESU measures temperatures from the Probe thermocouples and modulates the RF encrgy to keep all sclected electrodes' temperatures essentially the same; it adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point. The ESU has readouts for temperature, time of energy delivery, and delivered power. Front panel connectors include connections for the Instrument Cable, and third party dispersive or indifferent (DIP) electrodes. The Instrument Cable (Cobra Cable) connects the ESU to the RF Probe. It is supplied sterile to the user. The User can resterilize the Cable.

This document describes a 510(k) submission for the Estech Cobra Cardiac Electrosurgical Unit and Cable. The submission argues for substantial equivalence to a predicate device, the Boston Scientific Cobra Cardiac Electrosurgical System (K013873), rather than presenting a study with specific acceptance criteria and performance data for the Estech device itself. Therefore, many of the requested categories are not applicable to this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The submission asserts identity to a predicate device, meaning it is considered to have the same performance characteristics as the predicate. No new performance data or acceptance criteria are provided or required for this type of 510(k).

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

Not applicable. No new test set data was generated for the Estech device as it is asserted to be identical to the predicate.

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

Not applicable. See point 2.

4. Adjudication Method for the Test Set

Not applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

Not applicable. See point 2.

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

Not applicable. This is a hardware device (electrosurgical unit and cable), not an algorithm or AI system.

7. The Type of Ground Truth Used

Not applicable. See point 2. The "ground truth" for this submission is the established performance and safety profile of the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device, not an AI or machine learning system that would require a training set.

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

Not applicable. See point 8.

Summary of the Acceptance Criteria and Study (as presented in the document):

The Estech Cobra Cardiac Electrosurgical Unit and Cable passed acceptance criteria by demonstrating substantial equivalence to a previously cleared predicate device, the Boston Scientific Cobra Cardiac Electrosurgical System (K013873).

The "study" in this context is the comparison of the new device to the predicate device, which concluded they are identical.

Key points from the document regarding this "study":

• Acceptance Criteria (Implicit): The primary acceptance criterion was that the Estech device be identical in intended use, technology, design, materials, manufacture, and packaging to the Boston Scientific Cobra Cardiac Electrosurgical System.
• Reported Device Performance (Implicit): Since the device is stated to be identical to the predicate, its performance is assumed to be identical to the predicate device, which had already met FDA requirements.
• Supporting Data: The submission explicitly states, "Supporting data is not necessary to support this submission since the Estech Cobra Cardiac FSU is identical to the predicate device..." This means no new tests, clinical trials, or performance studies were conducted for the Estech device. The FDA's 510(k) clearance confirms their agreement with this assessment of substantial equivalence.

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The ESTECH Cobra Bipolar System 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 Bipolar System is comprised of two components: a reusable surgical clamp an associated coagulating device known as the Cobra Bipolar Insert. The Bipolar Insert is a sterile, single use device that transmits radiofrequency (RF) energy to coagulate soft tissues and fits in a jaw of the clamp. The Bipolar System will be used with the Boston Scientific Cobra Electrosurgical Unit (ESU). The ESU delivers 460 kHz of RF energy to selected Bipolar Insert electrodes, modulates the RF energy to keep all selected Bipolar Insert electrodes' temperatures essentially the same, and adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point.

This document is a 510(k) Premarket Notification for the ESTECH Cobra Bipolar System, which is essentially a re-filing of an existing device (Boston Scientific Cobra Bipolar System, K023288) due to a transfer of sales and responsibility. Therefore, the information provided focuses on demonstrating substantial equivalence to the predicate device rather than presenting new performance data from a dedicated study.

Based on the provided text, the acceptance criteria and study information are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states that "Supporting data is not necessary to support this submission since the Estech Cobra Bipolar System is identical to the predicate device, the Boston Scientific Cobra Bipolar System (K023288)."

Therefore, there was no dedicated test set or new performance data generated for this specific 510(k) submission. The data provenance relies on the prior approval of the predicate device.

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

Since no new test set was used, no experts were specifically used to establish ground truth for this submission. The assumption is that the predicate device's original approval relied on appropriate expert evaluations as part of its regulatory process.

4. Adjudication Method for the Test Set

As there was no new test set, there was no adjudication method employed for this submission.

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

No MRMC comparative effectiveness study was done for this submission. The device is claimed to be identical to the predicate, implying similar performance.

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

This device is an electrosurgical probe, not a software algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. The Type of Ground Truth Used

The ground truth for this submission is based on the established performance and safety of the predicate device (Boston Scientific Cobra Bipolar System, K023288), which was previously cleared by the FDA. The submission asserts that the new device is identical in all relevant aspects, hence its functionality and safety are equivalent to the pre-existing device.

8. The Sample Size for the Training Set

Since this submission relies on demonstrating substantial equivalence to an identical predicate device and no new performance studies were conducted, there was no new training set used or described for this particular submission.

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

As no training set was used for this submission, there is no description of how its ground truth was established. The regulatory burden was met by declaring the new device identical to the predicate.

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