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The Aquamantys Endo DBS 8.7 Dissecting 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 at the operative site. It is intended for. but not limited to, abdominal, and thoracic surgery, endoscopic, laparoscopic, and thoracoscopic procedures.

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

The Aquamantys Endo DBS 8.7 device is a handheld "wand-like" disposable that, when connected to the Aquamantys Pump Generator, uses bipolar radio-frequency energy concurrent with saline for hemostatic sealing and coagulation. The device is equipped with dual electrodes at the distal tip. Saline and electrical lines enter from the opposite end (proximal end) of the device's hand piece from the distal electrodes. The device's hand piece is equipped with a blue button that activates bipolar RF energy concurrent with saline flow for blunt dissection and for hemostatic sealing and coagulation. The long, stainless steel shaft allows for the device to be used in laparoscopic, endoscopic and thoracoscopic procedures. A saline fluid delivery line is provided with the device, which includes a drip chamber/spike for insertion into saline bags. The proposed device connects to the Aquamantys Pump Generator using a three-pronged connector.

This document describes the Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer, a device intended for surgical hemostasis and coagulation. The provided text, a 510(k) summary, outlines the device's characteristics and the studies performed to demonstrate its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists several bench performance tests conducted to verify and validate the Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer. However, specific quantitative acceptance criteria or detailed performance results (e.g., pass/fail thresholds, numerical outcomes) for each test are not explicitly stated in the provided text. The summary only broadly confirms that the device "has undergone bench performance testing to verify and validate the performance features and specifications."

2. Sample Size Used for the Test Set and Data Provenance:

The document states that the device "has undergone bench performance testing" and "animal tissue testing." However, the exact sample size used for these test sets and the data provenance (e.g., country of origin, retrospective or prospective) are not specified in this 510(k) summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The summary does not mention using experts to establish ground truth for the test set. The testing described appears to be primarily engineering and physical performance testing, and animal tissue testing, rather than human-expert-reviewed clinical or image-based evaluations.

4. Adjudication Method for the Test Set:

Given that expert-established ground truth is not mentioned, an adjudication method is not applicable and not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it discussed in the document. The submission explicitly states: "Clinical testing was not required to establish substantial equivalence between the proposed and predicate devices." This device is a surgical instrument, not an AI or diagnostic imaging device that would typically undergo MRMC studies.

6. Standalone Performance Study:

A standalone performance study (algorithm only without human-in-the-loop) was not applicable and not performed. The device is a surgical instrument and not an AI algorithm. The performance testing conducted was on the device itself (bench and animal tissue).

7. Type of Ground Truth Used:

For the bench performance tests, the "ground truth" would be established by engineering specifications and validated test methods. For the animal tissue testing, the "ground truth" for hemostatic sealing and coagulation would be assessed through direct observation and measurement of the tissue response during and after device application. The document does not specify if these assessments were quantitative or qualitative, or who performed them.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable as this is a physical medical device (electrosurgical accessory), not an AI algorithm requiring training data.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no training set mentioned for this device.

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