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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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