(71 days)
The Aquamantys 2.3 Bipolar Sealer is a sterile, single-use, bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Aquamantys Epidural Vein Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Aquamantys Bipolar Sealer is a sterile, single-use bipolar device. The device employs radio-frequency (RF) energy and saline irrigation for hemostatic sealing and coagulation. 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 drip chamber or spike. The three-pin electrical connector is designed to be plugged into the Aquamantys Pump Generator.
The provided text describes a 510(k) summary for the Aquamantys Bipolar Sealers, focusing on demonstrating substantial equivalence to a predicate device. It explicitly states that clinical studies were not required or conducted for the proposed neurosurgical expanded indications. Therefore, the information typically associated with an AI/ML device study (e.g., acceptance criteria, sample size, ground truth establishment, MRMC studies) is not present.
However, I can extract information regarding the non-clinical comparative performance data that was conducted.
Here's the breakdown of the information that can be extracted from the provided text, and the parts that state it's not applicable for this device:
Acceptance Criteria and Device Performance Study for Aquamantys® Bipolar Sealers
This document pertains to the 510(k) submission for the Aquamantys® 2.3 Bipolar Sealer, Aquamantys® EVS 4.0 Epidural Vein Sealer, Aquamantys® Mini EVS 3.4 Epidural Vein Sealer, and Aquamantys® SBS 5.0 Sheathed Bipolar Sealer. The submission aims to demonstrate substantial equivalence to a predicate device, the Codman Irrigated Bipolar Forceps.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance | Thermal Zone Damage (comparability to predicate device) | Thermal zone damage of the Aquamantys Bipolar Sealers was comparable to the thermal zone damage of the Codman Irrigated Bipolar Forceps. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for the non-clinical test.
- Data Provenance: Ex-vivo porcine brain tissue.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The non-clinical test involved objective measurement of thermal zone damage rather than expert interpretation of medical images.
4. Adjudication method for the test set
- Not applicable. The non-clinical test involved objective measurement of thermal zone damage.
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 instrument, not an AI-powered diagnostic or assistive tool for human readers. Clinical studies were explicitly stated as not required or conducted for the neurosurgical indications in this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
- For the non-clinical test, the "ground truth" was derived from objective measurements of thermal zone damage in ex-vivo porcine tissue, compared directly to the predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device 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.