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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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