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The Aquamantys Double Cone Bipolar Sealer is a single use, sterile, bipolar device, intended to be used in conjunction with the Aquamantys Pump Generator for delivery of radio-frequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, open abdominal, orthopaedic, and thoracic surgery.

The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys Double Cone Bipolar Sealer is a 6. disposable, single-use, sterile, bipolar device. The device employs radio-frequency (RF) energy and saline irrigation for hemostatic sealing and for coagulation and blunt dissection. The device is equipped with a dual electrode tip. Saline and electrical lines exit the opposite end of the handpiece from the electrodes. The handpiece is equipped with an on-off button that simultaneously activates both RF and saline flow. A saline fluid delivery line is provided with the device, and includes a section of pump tubing and a drip chamber or spike. The three-pin electrical connector is designed to be plugged into the Aquamantys Pump Generator.

The provided text does not contain specific acceptance criteria for a device, nor does it detail a study proving the device meets said criteria in a structured manner that allows for the extraction of the requested information. The document focuses on regulatory submission (510(k) summary) for the Aquamantys Double Cone Bipolar Sealer, describing its intended use, comparison to predicate devices, and pre-clinical evaluations in a general sense.

Specifically, the document states:

• "9. Pre-Clinical Evaluation: Where applicable, non-clinical testing of the proposed device relied upon to determine substantial equivalence to the predicate were as follows: o In-vivo porcine testing, including: o Tissue resection showing depth versus fluence o Stationary depth of effect on tissue versus time o Moving depth and diameter of effect versus time o Usability · Angle of usage · Various tissue usage states · Compatibility with appropriate generator . a Finger switch o Electromagnetic Compatibility per IEC 60601-1-2 as modified by IEC . 60601-2-2 o Visual and Dimensional ."
• "Testing has confirmed the proposed device's performance for blunt dissection and for haemostatic sealing and coagulation is at least as safe and effective as that of the predicate devices."

However, it does not provide:

1. A table of acceptance criteria and reported device performance: No quantifiable acceptance criteria (e.g., specific depth of coagulation, time for hemostasis) are mentioned, and therefore, no reported performance metrics against such criteria are present.
2. Sample size for the test set and data provenance: While porcine in-vivo testing is mentioned, the number of animals or specific samples is not provided, nor is the country of origin or whether it was retrospective/prospective.
3. Number of experts and qualifications for ground truth: No information about experts or how ground truth was established for the in-vivo tests.
4. Adjudication method: Not mentioned.
5. MRMC comparative effectiveness study: No such study is described.
6. Standalone performance study: The pre-clinical evaluation seems to be focused on the device's functional characteristics rather than a standalone clinical performance study with human subjects.
7. Type of ground truth used: Not specified, but likely based on direct observation of tissue effects in porcine models.
8. Sample size for the training set: There is no mention of a "training set" as this device is not an AI/ML product. The pre-clinical testing would be considered verification and validation.
9. How ground truth for the training set was established: Not applicable, as there's no training set for an AI/ML model.

In summary, the provided text describes the type of pre-clinical evaluation performed (in-vivo porcine testing, electrical, visual, and dimensional) which broadly aimed to demonstrate substantial equivalence to predicate devices. However, it lacks the detailed quantitative acceptance criteria and study particulars asked for in the prompt, especially those related to AI/ML device evaluations.

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