(71 days)
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
| Category/Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Integrity | Adequacy for use of joints and other mechanical aspects. | "The bench testing supplied in Section 18 demonstrates that the joints and other mechanical aspects of the design of the ESTECH Cobra Bipolar II System are adequate for use." |
| Electrode Performance | Performance equivalent to the predicate device (ESTECH Cobra Bipolar System). | "Additionally, the data demonstrates that the performance of the ESTECH Cobra Bipolar II System electrodes is equivalent to that of the predicate." |
| Biocompatibility | Conformance with ISO 10993: Biological Evaluation of Medical Devices. | "The patient contacting materials of the ESTECH Cobra Bipolar II System have been demonstrated to be biocompatible, in accordance with ISO 10993: Biological Evaluation of Medical Devices..." |
| Electrical Safety | Conformance with pertinent sections of IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment. | "...and the safety of the electrical design is in conformance with the pertinent sections of IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment." |
| Substantial Equivalence (Overall) | The device is "identical in indications for use, technology, manufacture, packaging and sterilization" to the predicate, with design differences not altering performance. | "ESTECH concludes that the ESTECH Cobra Bipolar II System is substantially equivalent to the predicate ESTECH Cobra Bipolar System (K053100)." (FDA concurred with this conclusion). |
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.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.