(168 days)
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, 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 and epidural vein sealing at the operative site. Its indications for use include but are not limited to, orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery.
The device employs radio-frequency (RF) energy and saline irrigation for hemostatic sealing and coagulation. The effect of RF energy applied to tissues concurrent with a flow of saline results in hemostatic sealing and coagulation of soft tissue and bone without charring; this result has been trademarked "Transcollation® Technology" by Salient Surgical Technologies.
The saline helps couple the electrical energy output from the electrosurgical generator to the tissue, increasing the contact area and limiting the surface to a consistent temperature range. (approximately 100 degrees C).
The vascular system is primarily made up of collagen types I and III. The effect of heat on these fibrous collagens has been well studied. (1, 8) When regularly oriented collagen shrinks along a direction parallel to the dominant direction of fiber orientation, the shrinkage is accompanied by swelling in a direction perpendicular to the fiber orientation. (5, 6) This effectively results in reduction of the vessel lumen diameter and in most cases closure of the vessel lumen. (7-8) References cited follow below.
The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is equipped with dual polished stainless steel electrode tips. The electrodes are housed in a two position insulating polymer sheath. The two positions of the sheath are manually established by the surgeon's hand and defined by positive mechanical detents that are detected by the touch. In the sheath open position, the electrodes are fully exposed allowing the surgeon to make use of a majority of their area to contact incised tissue in order to deliver hemostatic sealing and coagulation therapy to broad tissue planes. In the sheath closed position the electrodes are surrounded by the insulating sheath along their length and only exposed at their tips. The closed position allows the surgeon to work adjacent delicate structures while delivering therapy to small areas of incised tissue, or preventing or stopping epidural veins from bleeding. Regardless of sheath position, when the electrodes are activated saline is concurrently delivered from apertures located within the electrode sheath housing. 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 with spike. The three-pin electrical connector is designed to be plugged into the Aquamantys Pump Generator.
The provided text describes the Aquamantys SBS 5.0 Sheathed Bipolar Sealer and its 510(k) summary (K111732). However, it does not contain explicit acceptance criteria in the form of quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or specific thresholds for hemostatic sealing efficacy) nor a detailed study that directly proves the device meets such criteria for a specific AI-driven task.
Instead, the document focuses on establishing substantial equivalence to predicate devices through non-clinical performance data, primarily bench testing and in vivo animal data. It explicitly states that clinical data was not necessary for this 510(k) submission. Therefore, many of the requested items related to clinical studies, ground truth establishment, expert adjudication, and AI-specific metrics are not applicable or not present in this document.
Here's an analysis based on the provided information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance, nor does it provide a table of performance metrics meeting those criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests. The "performance" assessment is qualitative, focusing on proving the device's functionality and safety are comparable to existing, legally marketed devices.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Substantial equivalence to predicate devices in: | Assessed through: Construction (structure, materials), Principles of operation, Mechanisms of action, Performance on live tissues (GLP-compliant in vivo animal studies). |
| - Intended and Indications for Use | Found "substantially equivalent" to predicate devices (Aquamantys 2.3 Bipolar Sealer (K052859) and Aquamantys SS4.0 Bipolar Sealer (K063639)). |
| - Construction | Not specifically detailed, but "assessed and compared." |
| - Principles of Operation and Mechanisms of Action | Not specifically detailed, but "assessed and compared." |
| - Performance of intended and indications for use on live tissues | Conducted per GLP requirements in GLP certified facilities, using in vivo animal data. |
| Compliance with relevant standards: (e.g., sterilization, packaging, biocompatibility, electrical safety) | "Test protocols and reports of results demonstrate that...the design, labeling, packaging and sterilization of the Aquamantys SBS 5.0 Sheathed Bipolar Sealer is compliant with the following standards:" (followed by a comprehensive list of ISO, ASTM, and AAMI standards). |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not explicitly stated in terms of number of cases or animals, but refers to "bench testing and in vivo animal data collection." No human test set was used for this stage of approval.
- Data provenance: In vivo animal data and bench testing. The country of origin for the animal studies is not specified, but they were conducted in "GLP certified facilities."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device is not an AI/diagnostic device that relies on expert interpretation for ground truth.
- For the in vivo animal studies, the "ground truth" would be established by direct observation of hemostatic sealing effectiveness by the study investigators/veterinarians, following established protocols. The number and qualifications of these individuals are not specified in this summary.
4. Adjudication method for the test set
- Not applicable in the context of an AI device requiring expert adjudication for ground truth. The performance in animal studies would be assessed directly against predefined endpoints in the test protocols.
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 is a surgical device, not an AI diagnostic/assistance system for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a conventional medical device; there is no AI algorithm involved.
7. The type of ground truth used
- For the in vivo animal data, the ground truth would be direct observational evidence of hemostatic sealing and coagulation of soft tissue and bone in the operative site, evaluated by study personnel based on predefined criteria within the study protocols. Macroscopic and microscopic evaluation of tissue effects might also be part of this.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.