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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 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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