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The Estech COBRA® Genesis Bipolar Clamp 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® Genesis Bipolar Clamp is a sterile, single-use device 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.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Estech COBRA® Genesis Bipolar Clamp:

Please note: The provided document is a 510(k) summary, which is typically a high-level overview. It states that detailed testing information is available in "Section 18" and "Sections 15 and 17," but these sections are not included in the provided text. Therefore, several of the requested details about specific study methodologies (like sample sizes for specific tests, expert qualifications, adjudication methods, or MRMC studies) are not present in this summary.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list performance acceptance criteria in a quantifiable table format. Instead, it asserts that the device is "substantially equivalent" to a predicate device (Estech COBRA Bipolar System II, K100224) based on various assessments. The "acceptance criteria" are implicitly met by demonstrating this substantial equivalence.

Here's a table summarizing the areas of comparison:

Details of the Study/Testing That Proves the Device Meets Acceptance Criteria:

The provided document describes the types of studies performed but lacks specific quantitative details about their methodology, sample sizes, or outcomes.

1. Sample sizes used for the test set and the data provenance:

   • Mechanical Integrity & Ablation Performance: The document states "The testing supplied in Section 18 demonstrates that the joints and other mechanical aspects... are adequate for use. Additionally, the data demonstrates that the ablation performance... is equivalent to that of the predicate."
     • Sample Size: Not specified in this summary. The detailed report in "Section 18" would contain this information.
     • Data Provenance: Not specified (e.g., in-vitro, ex-vivo, animal model, specific country, etc.). This would likely be found in "Section 18."
     • Retrospective/Prospective: Not specified.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the summary. For mechanical and ablation performance, "ground truth" would likely be established through objective measurements against predefined standards or comparative measurements against the predicate device, rather than expert consensus on a test set.

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

   • Not applicable/not specified for mechanical and ablation performance testing described. These are typically objective measurements.

4. 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:

   • No, an MRMC study is not mentioned or applicable. This device is an electrosurgical clamp, not an AI-powered diagnostic or assistive tool for human readers.

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

   • Not applicable. This is a physical medical device. The "standalone" performance would be its direct mechanical and electrical function.

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

   • For Mechanical Integrity and Ablation Performance: Ground truth would likely be established through objective physical and functional measurements and comparisons to the predicate device's established performance specifications, rather than clinical outcomes or pathology.
   • For Biocompatibility: Ground truth is established by adherence to ISO 10993 standards and specific biological testing (e.g., cytotoxicity, sensitization, irritation).
   • For Electrical Safety: Ground truth is established by adherence to IEC 60601-2-2 standards and electrical testing.

7. The sample size for the training set:

   • Not applicable. This device does not involve a "training set" in the context of machine learning. The design and manufacturing processes are established based on engineering principles and regulatory standards.

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

   • Not applicable for this type of device.

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