(126 days)
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."
| Acceptance Criteria (Quantitative) | Reported Device Performance (Quantitative) |
|---|---|
| Not specified in the document. | Not specified in the document. |
| Qualitative Acceptance: The tissue effect and general performance of the Aquamantys3 Pump Generator with its disposable devices (Aquamantys3 6.0 Bipolar Sealer and Aquamantys3 8.2L Bipolar Sealer with Cutting) must be comparable to predicate devices for relevant applications. | Reported Performance: 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
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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.
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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.
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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.
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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.
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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.
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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."
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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.
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How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML algorithm was used.
§ 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.