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The Cobra Bipolar System (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 Cobra Bipolar System device is comprised of two components; a reusable surgical clamp and an associated coagulating device BSC/ EP Technologies has named the Cobra Bipolar Insert. The Bipolar Insert is a sterile, single use device that transmits radiofrequency (RF) energy to coagulate soft tissues. The Bipolar Clamp will be used with a Cobra Electrosurgical Unit (ESU). The ESU delivers 460 kHz RF energy to selected Bipolar Clamp electrodes, modulates the RF energy to keep all selected Bipolar Clamp 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 submission describes the Cobra Bipolar System, an electrosurgical probe intended for the coagulation of soft tissue and blood to produce hemostasis during general surgery. The submission is a 510(k) premarket notification, indicating the applicant is seeking to demonstrate substantial equivalence to a predicate device rather than undergoing a full clinical trial for safety and effectiveness.

Therefore, the provided text does not contain acceptance criteria for device performance or a study demonstrating the device meets such criteria. The document focuses on establishing substantial equivalence to a predicate device, as is typical for 510(k) submissions. There is no mention of specific performance metrics (e.g., coagulation time, temperature control accuracy), ground truth establishment, expert adjudication, or sample sizes related to a performance study.

Here's a breakdown of why the requested information cannot be provided from the given text:

1. A table of acceptance criteria and the reported device performance:

• Not present. The document does not define specific performance acceptance criteria (e.g., a target coagulation depth, a maximum tissue temperature) for the Cobra Bipolar System. Instead, the "Modified Device" column in the comparison table states "Same" for "Intended Use" and "Device Description" as the "Predicate Device," implying that its performance is expected to be equivalent to the predicate, rather than measured against new, specific criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not present. There is no mention of any test set, participants, or data provenance as this is not a clinical study report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Not present. Establishing ground truth for device performance typically requires specific experiments or clinical data reviewed by experts. This document is not a report of such an activity.

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

• Not present. No test set or adjudication method 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 an electrosurgical probe, not an imaging or diagnostic device that involves human readers or AI assistance.

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

• Not applicable. This device is a surgical instrument and does not involve algorithms or AI in the sense of a standalone diagnostic or assistive system.

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

• Not present. Ground truth is not discussed as no performance study is described. The "ground truth" for a 510(k) submission is typically the performance characteristics and safety profile of the predicate device, which the new device aims to match.

8. The sample size for the training set:

• Not applicable. There is no training set for this type of device.

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

• Not applicable. There is no training set mentioned.

Summary based on the provided text:

The submission focuses on establishing substantial equivalence of the Cobra Bipolar System to a legally marketed predicate device (Cobra Electrosurgical Probe, K013783). This is achieved by demonstrating that the new device has the same intended use, device description, and classification, and is similar in principle of operation. The FDA's letter confirms that the device is "substantially equivalent" to the predicate, allowing it to proceed to market under the general controls provisions of the Medical Device Amendments. This process generally relies on comparison to a predicate, and often involves engineering verification and validation testing to ensure the device performs as intended, but these details are typically presented in separate technical documents, not in the public 510(k) summary itself.

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