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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.

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.

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The Aquamantys3 Generator is an electrosurgical generator with monopolar and bipolar RF outputs. It is intended to be used with specified disposables for delivery of RF energy for cutting of soft tissue and RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone at the operative site during surgical procedures. The system is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys3 Bipolar Sealer is a bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Generator. The device delivers bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone. It is intended for, but not limited to, orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Aquamantys3 8.2L Bipolar Sealer with Cutting is a monopolar/bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Generator. The device delivers monopolar RF energy for cutting of soft tissue and bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone. It is intended for, but not limited to, orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The Salient Surgical Aquamantys3 Pump Generator System is a general reference term used to describe use of the Salient Aquamantys3 Pump Generator together with specific, design compatible, Aquamantys3 electrosurgical instruments. The Aquamantys3 Pump Generator itself is an electrosurgical generator with, monopolar and bipolar, high frequency current outputs and an internal rotary peristaltic pump for delivery of saline. The Aquamantys3 Pump Generator is for use only with specific, design compatible Aquamantys3 electrosurgical instruments, for delivery of radio frequency (RF) energy for cutting of soft tissue and delivery of RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone at the operative site. Currently included as part of the system in this 510(k) submission are the Aquamantys3 Pump Generator, and two hand-held, sterile, single use disposable electrosurgical devices that are compatible with the Aquamantys3 Pump Generator system. These disposable devices are the Aquamantys3 6.0 Bipolar Sealer and the Aquamantys3 8.2L Bipolar Sealer with Cutting.

The Aquamantys3 Pump Generator is a shelf-top unit consisting of a sheet metal housing and a front LCD control panel. The generator has a peristaltic pump located within the housing, which is capable of transferring saline through the disposable accessory device concurrent with the generator's provision of RF energy. The LCD control panel is touchscreen and serves as the user interface for power and saline settings. The Aquamantys3 Pump Generator has a receptacle in its front panel that provides for the disposable device connection to the generator's RF power and the peristaltic pump. The Aquamantys3 disposable device connection to the Aquamantys3 Pump Generator is configured as a cassette; the configuration is unique to the Aquamantys3 system and ensures only Aquamantys3 disposable devices with the cassette can be used with the Aquamantys3 Pump Generator. The generator accepts designated, commercially available, split-pad patient return electrode pads (neutral electrodes) for monopolar applications, and provides monitoring of the patient return circuit for safety purposes.

The Aquamantys3 6.0 Bipolar Sealer device is a modified disposable, that when connected to the Aquamantys3 Pump Generator, uses bipolar RF energy applied concurrently with saline to the operative site. The effect of RF energy applied concurrently with saline results in haemostatic sealing and coagulation of soft tissue and bone without charring; this result has been trademarked as Transcollation® technology by Salient Surgical Technologies. The proposed Aquamantys3 6.0 Bipolar Sealer shares the same handpiece, shaft and tip configuration as its predicate device, the Aquamantys 6.0 Bipolar Sealer. The proposed and predicate devices differ only in how they connect to their designated generators. The proposed Aquamantys3 device has a cassette to connect it to the Aquamantys3 Pump Generator, allowing the user to connect the device's saline tubing to the peristaltic pump at the same time as the device is connected electrically to the generator. The predicate Aquamantys disposable device, comparatively, has a standard three-prong plug for electrical connection to the Aquamantys Pump Generator and the user is required to manually feed the predicate's saline tubing into the peristaltic pump. The unique cassette connection helps prevent the connection of Aquamantys3 devices to other, unintended or unspecified equipment.

The Aquamantys3 8.2L Bipolar Sealer with Cutting device is a disposable that, when connected to the Aquamantys3 Pump Generator, uses monopolar RF energy for cutting, and bipolar RF energy concurrent with saline for haemostatic sealing and coagulation. The device is equipped with dual electrodes at the distal tip. Saline and electrical lines exit the opposite end (proximal end) of the device's handpiece from the distal electrodes. The device's handpiece is equipped with two activation buttons; the distal yellow button activates monopolar RF energy for cutting, and the proximal blue button simultaneously activates bipolar RF energy concurrent with saline flow for haemostatic sealing and coagulation. A saline fluid delivery line is provided with the device, which includes a spike for insertion into saline bags. The electrical connection of the device to the generator, as well as the saline tubing insertion into the generator's pump, is made via a cassette interface that is part of the disposable device. The cassette assures the unique connection of Aquamantys3 disposable devices with Aquamantys3 Pump Generators.

The provided document is a 510(k) Summary for a medical device called the Aquamantys®3 Pump Generator System. It details the device's description, indications for use, comparison to predicate devices, and a summary of non-clinical and clinical testing.

However, the document does not contain specific acceptance criteria or quantitative performance data in the way a clinical study report with predefined endpoints and statistical analysis would. Instead, it states that the device was found to be "substantially equivalent" to predicate devices based on non-clinical performance testing.

Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document directly. I will provide the information that is available and explicitly state when information is not present.

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating equivalence to predicate devices. The reported device performance is qualitative: "the tissue effect of the Aquamantys3 system was comparable to the predicate devices for both monopolar RF for cutting and bipolar RF concurrent with saline for haemostatic sealing and coagulation (Transcollation® technology) applications."

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample size: Not explicitly stated as a number of subjects or samples. The testing involved "in-vivo animal (porcine) studies" and "related verification bench tests."
   • Data provenance: "in-vivo animal (porcine) studies" and "related verification bench tests." Country of origin is not specified, but the applicant is Salient Surgical Technologies, Inc., based in Portsmouth, NH, USA. The studies are prospective in nature, as they were conducted to evaluate a new device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of experts: The document states that "In-vivo animal study participants included surgeons, circulating nurses and Salient Surgical Technologies' personnel." A specific number of experts or their roles in establishing "ground truth" (e.g., assessing tissue effect outcomes) is not quantified.
   • Qualifications of experts: Only general roles are given (surgeons, circulating nurses). Specific qualifications (e.g., years of experience, board certification) are not detailed.

3. Adjudication method for the test set:

   • Not specified. The document only mentions that animal study participants included surgeons, nurses, and company personnel, but how their observations or assessments were adjudicated to determine "comparability" is not described.

4. 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:

   • No, this type of study was not conducted. This document describes a medical device (electrosurgical system), not an AI-assisted diagnostic tool or system that would typically involve human "readers" or AI assistance in interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • This question is not applicable. The device is a surgical instrument and generator system, not an algorithm. Its performance inherently involves human operation.

6. The type of ground truth used:

   • The "ground truth" was implicitly established by the observed "tissue effect" and "general performance" in the in-vivo animal studies and bench tests, assessed for comparability against predicate devices. This would likely involve visual assessment by surgeons, potentially histological analysis of tissue, and objective measurements from bench tests. The document does not explicitly state a definitive "ground truth" method like pathology or specific outcome measures, but rather "comparable tissue effect."

7. The sample size for the training set:

   • Not applicable/Not provided. This device is not an AI/ML algorithm that requires a training set. The "testing" referred to is for device validation and verification.

8. How the ground truth for the training set was established:

   • Not applicable. No training set for an AI/ML algorithm was used.

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