(78 days)
The Aquamantys3 9.5 XL Bipolar Sealer is a single use, sterile, bipolar device intended to be used in conjunction with the Aquamantys3 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 Aquamantys3 9.5 XL Bipolar sealer represents a line extension to the predicate Aquamantys 9.5 XL Bipolar Sealer (cleared as the Double Cone Bipolar Sealer in K101057) and the Aquamantys product family. Similar to the predicate devices, it is a sterile, single-use hemostatic sealing device. The device employs bipolar radio-frequency (RF) energy and saline for blunt dissection and for hemostatic sealing and coagulation. The device is equipped with a dual electrode tip with saline apertures at its distal end. Saline and RF energy are supplied to the device from lines on the proximal end of the handpiece and connection to the Aquamantys3 Pump Generator via the distally attached cassette interface.
This document describes the Aquamantys3 9.5 XL Bipolar Sealer, a medical device, and its acceptance criteria based on non-clinical testing. This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than a novel AI system. As such, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable to this submission.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All testing met the acceptance criteria" for the listed tests. However, the specific quantitative acceptance criteria for each test are not provided in the summary. The reported performance is implicitly that the device successfully passed all tests.
| Test Type | Acceptance Criteria (Quantified) | Reported Device Performance |
|---|---|---|
| Static cable pulls | Not specified in document | Met acceptance criteria |
| Dynamic cord pulls | Not specified in document | Met acceptance criteria |
| Static saline tube pulls | Not specified in document | Met acceptance criteria |
| Air leak and flow | Not specified in document | Met acceptance criteria |
| Hipot testing | Not specified in document | Met acceptance criteria |
| Saline flow testing | Not specified in document | Met acceptance criteria |
| Continuity | Not specified in document | Met acceptance criteria |
| Biocompatibility assessment | Not specified in document | Met acceptance criteria |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample size for each bench performance test. It broadly states that the device "has undergone bench performance testing."
- Data Provenance: The testing was "bench performance testing," implying it was conducted in a laboratory setting by Medtronic Advanced Energy. The country of origin of the data is not explicitly stated but would likely be the location of the submitter (Portsmouth, NH, USA). The data is prospective in the sense that these tests were performed on the device to assess its performance before market approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation was based on bench performance testing against device specifications, not expert interpretation of clinical data or imagery. Therefore, there was no "ground truth" in the context of expert consensus that needed to be established.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation was based on bench performance testing against objective specifications, not subjective interpretation requiring adjudication.
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
This is not applicable. This device is a surgical instrument (Electrosurgical Bipolar Sealer), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation was based on engineering specifications and performance standards for electrosurgical devices. The bench tests measured objective physical and electrical properties of the device.
8. The Sample Size for the Training Set
This is not applicable. The device is not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable. The device is not an AI model that requires a "training set."
§ 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.