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AEx Generator:
The AEx Generator is a radio frequency (RF) electrosurgical generator capable of simultaneously powering specified monopolar and bipolar electrosurgical instruments. It is intended to be used for delivery of RF energy to instruments indicated for cutting and coagulation of soft tissue and for delivery of RF encrgy concurrent with saline to instruments indicated for hemostatic sealing and coagulation of soft tissue and bone. It is intended for, but not limited to. General. Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gyneologic, Orthopaedic. Arthroscopic, Spinal and Neurological, Thoracic, and Open Abdominal Surgery procedures. The device is not intended for contraceptive tubal coagulation (Permanent Female Sterilization).

PlasmaBlade T:
The PlasmaBlade T is a monopolar, single use, sterile, disposable device intended for use with the AEX Generator. The device delivers RF energy concurrent with saling and coagulation of soft tissue and bone and RF energy for cutting and coagulation of soft tissue. It is intended for, but not limited to, General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal, Thoracic, and Open abdominal surgery procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Currently included as part of the system in this 510(k) submission are the AEX Generator, and the PlasmaBlade T Handpiece which is a one hand-held disposable, sterile, single use disposable electrosurgical device that is compatible only with the AEX Generator.

The AEX Generator is a line powered, electrosurgical generator with monopolar and bipolar RF that is intended for use only with specific compatible Medtronic electrosurgical Handpieces. The AEX Generator is a shelf-top unit consisting of a plastic, metal housing and a front LCD control panel. The Generator has a peristaltic pump outside the generator's 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 a touchscreen and serves as the user interface for power and saline settings. The AEX Generator has three-pin and seven-pin receptacles in its front panel that provides for the monopolar PlasmaBlade and bipolar Aquamantys disposable Handpieces connection to the Generator's RF power.

The proposed PlasmaBlade T Handpiece connection to the AEX Generator pump is configured to interface with the AEX Generator peristaltic pump. The AEX Generator accepts designated, commercially available, split-pad and single foil patient return electrode pads (neutral electrodes), non-REM neutral electrodes for monopolar applications

Here's an analysis of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a structured table or numerical values for performance metrics. Instead, it relies on a comparison of the proposed device's performance to that of predicate devices, stating it is "comparable" or shows "no clinically significant difference."

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document mentions "in-vivo, ex-vivo animal (porcine) studies" for thermal effects on tissue. However, it does not specify the number of animals or specific samples used in these studies.
• Data Provenance: The studies were animal (porcine) studies and were conducted as non-clinical testing. The document does not specify the country of origin.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for the animal studies in the context of human diagnosis or interpretation. The "ground truth" for the thermal effects appears to be directly measured or observed in the porcine tissue. For compliance with standards, the "ground truth" is adherence to the standard's requirements, which would typically be assessed by qualified engineers/testers, but no specific number or qualifications are provided.

4. Adjudication Method for the Test Set

Not applicable. The non-clinical testing and comparison against predicate devices do not involve an adjudication method in the context of human interpretation or diagnosis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document describes non-clinical testing (animal studies, software verification, EMC, electrical safety, bench-top performance) that compares the proposed device to predicate devices. It does not mention any clinical studies involving human readers or cases, nor a multi-reader multi-case (MRMC) comparative effectiveness study to assess human reader improvement with or without AI assistance. The device in question is an electrosurgical generator and handpiece, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical electrosurgical system, not an algorithm or AI. The performance studies focus on the hardware's functional capabilities.

7. Type of Ground Truth Used

For the "Thermal Effects on Tissue" studies, the ground truth appears to be direct measurement or observation of thermal damage in porcine tissue. For the other tests (Software, EMC, Electrical Safety, Bench-top), the ground truth is compliance with recognized consensus standards and verification of output characteristics.

8. Sample Size for the Training Set

Not applicable. The device is an electrosurgical generator and handpiece, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is used for this type of device.

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The Aquamantys3 BSC 9.1S is a monopolar/bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Pump Generator. The device delivers bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone and monopolar RF energy for cutting of soft tissue. 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 proposed Aquamantys3 BSC 9.1S is a sterile, single-use hemostatic sealing and cutting device. The device employs bipolar radiofrequency (RF) energy and saline for hemostatic sealing and coagulation, and monopolar radio-frequency (RF) energy for cutting. The device is equipped with a dual electrode tip with saline orifices on both sides of the inner electrode at its distal end. Saline and RF energy are supplied to the device from lines on the proximal end of the hand piece. The cassette provides the electrical connection and saline fluid delivery from the Aquamantys3 Generator. The hand piece is equipped with an on-off Transcollation® Sealing Saline button that simultaneously activates both bioolar RF and saline flow for hemostatic sealing using both electrodes. The hand piece is equipped with an on-off Cut button that activates the monopolar RF energy for cutting on a single electrode.

The provided text describes a medical device, the Aquamantys3 BSC 9.1S, and its substantial equivalence determination based on nonclinical data. Clinical data was not required for this determination. Therefore, several of the requested sections regarding the study design and ground truth establishment (items 2, 3, 4, 5, 6, 7, 8, 9) are not applicable as no clinical study was performed.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission notes that the device underwent "bench performance testing to verify and validate the performance features and specifications." While specific quantitative acceptance criteria are not explicitly detailed in the provided text, the list below represents the types of tests performed to ensure the device met its intended performance characteristics. The reported device performance is that it successfully met the requirements of these tests, leading to a substantial equivalence determination.

Summary of the Study Proving Acceptance Criteria:

The study that proved the device met its acceptance criteria was a series of nonclinical bench performance tests. These tests were conducted to "verify and validate the performance features and specifications" of the Aquamantys3 BSC 9.1S. The purpose of these tests was to demonstrate the device's substantial equivalence to a legally marketed predicate device (Aquamantys3 8.2L Bipolar Sealer with Cutting K111285) rather than to establish clinical efficacy or safety from human clinical trials.

The specific tests performed included: visual inspections, static and dynamic cable pulls, static saline tube pulls, air leak and flow tests, hipot testing, saline flow testing, cassette separation, shaft deflection/pull, electrode pull, continuity tests, biocompatibility assessment, animal tissue testing, and electrical safety tests. The conclusion drawn from these tests was that the Aquamantys3 BSC 9.1S is substantially equivalent to the predicate device based on its design, test results, and fundamental scientific technology.

Detailed Information (as requested by enumeration, with N/A where not applicable from the given text):

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

• Test Set Sample Size: Not specified in the provided text for each individual bench test. Bench tests typically involve a relevant number of device units to ensure consistency and reliability of results, but specific numbers are not given.
• Data Provenance: The tests were "bench performance testing," implying they were conducted in a laboratory or engineering environment by the manufacturer (Medtronic Advanced Energy). There is no mention of country of origin of the data in a geographical sense, or if it was retrospective or prospective, as these terms typically apply to clinical studies.

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

• Number of Experts: Not applicable. For bench performance testing of this nature, "experts" in the context of clinical ground truth (e.g., radiologists) are not typically involved in establishing the "ground truth" of mechanical, electrical, or functional performance. Engineering and quality control personnel within the manufacturer's R&D are responsible for conducting and evaluating these tests against predefined specifications.
• Qualifications of Experts: Not applicable for establishing clinical ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic imaging, to resolve discrepancies among expert readers. For bench testing, test results are typically compared against predefined engineering specifications and criteria (e.g., pass/fail), often with established quality control and review processes rather than expert adjudication in the clinical sense.

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:

• MRMC Study: No. The provided text explicitly states, "Clinical testing was not required to establish substantial equivalence between the proposed and predicate devices." Therefore, no MRMC study, or any clinical study involving human readers or AI assistance, was performed according to this submission.
• Effect Size with AI: Not applicable.

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

• Standalone Performance: No. The device is a physical electrosurgical device, not an algorithm or AI system. Therefore, the concept of "standalone algorithm only" performance does not apply.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Type of Ground Truth: For the nonclinical bench testing, the "ground truth" was established based on engineering specifications, design requirements, and performance standards for the device's mechanical, electrical, and functional characteristics. For animal tissue testing, the "ground truth" would be the observed physical effects (hemostatic sealing, coagulation, cutting) consistent with the device's intended mechanism of action.

8. The sample size for the training set:

• Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is relevant for machine learning models, not for traditional medical devices like this electrosurgical accessory.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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