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The Aquamantys™ Minimally Invasive Sealer (MIS) FLEX and Aquamantys™ Minimally Invasive Sealer (MIS) Flex Mini are sterile, single-use bipolar electrosurgical devices intended to be used in conjunction with a qualified Pump Generator for delivery of Radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. They are intended for, but not limited to orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. These devices are not intended for contraceptive tubal coagulation (permanent female sterilization).

MIS FLEX and MIS FLEX Mini are single-use, disposable, bipolar devices. The MIS FLEX and MIS FLEX Mini employ radio-frequency (RF) energy and saline irrigation (termed Transcollation Technology™) for hemostatic sealing and coagulation. The devices are equipped with dual electrode tips while 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 either of the FDA cleared AEX (K143175) or Aquamantys (K052859) Pump Generators. The MIS FLEX devices feature a fully malleable shaft, altered saline delivery and dual ports for saline delivery (two for each electrode). The distal end of the device features small, rounded electrode geometry. The MIS FLEX and MIS FLEX Mini differ by the length of the shaft. The MIS FLEX is designed for transsphenoidal and MIS Spine procedures while the MIS FLEX Mini is designed for craniotomies with application in posterial cervical and other spinal procedures.

The provided text does not contain detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the manner typically seen for performance claims like accuracy, sensitivity, or specificity. This document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel performance against acceptance criteria.

However, based on the information provided, I can infer the "acceptance criteria" were primarily related to safety, electrical performance, biocompatibility, and functional access. The "study" refers to the non-clinical testing performed to demonstrate these aspects.

Here's an interpretation based on the document's content:

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance

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

The document does not specify exact sample sizes for most tests.

• Cadaver Study (Anatomical Access): "The access study was conducted to ensure that the MIS FELX will be able to access key anatomy..." No sample size (number of cadavers) is given. Data provenance is not specified beyond being an "access study."
• In-vivo Porcine Model (Comparative Performance): "The second study was a comparative performance test, which was conducted in an in-vivo porcine model." No specific number of animals is given. Data provenance is "in-vivo porcine model."
• Ex-vivo Tissue Testing (Comparative Performance): "Ex-vivo tissue testing was also completed." No sample size (number of tissue samples) is given. Data provenance is "ex-vivo tissue."
• Biocompatibility, Sterilization, Shelf Life, Electrical Safety, EMC, Mechanical Testing: These are generally performed on device units. The specific number of units tested is not provided, which is typical for a 510(k) summary. Data provenance would be laboratory testing.

All testing described appears to be prospective, laboratory-based, or animal-based, as part of the device development and validation process. The country of origin of the data is not specified but is implicitly from the manufacturer's testing facilities or contract labs.

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

• Cadaver Study (Anatomical Access): The document mentions ensuring access to "key anatomy and meet customer needs for neurosurgical and spine procedures." This implies involvement of medical experts (e.g., neurosurgeons, spine surgeons). However, the number of experts, their qualifications, or how they established "ground truth" for access (e.g., by subjective evaluation, objective measurement of reach) is not specified.
• For other tests (biocompatibility, electrical safety, thermal effect), "ground truth" is typically defined by adherence to recognized standards and objective measurements, rather than expert consensus on a test set.

4. Adjudication Method for the Test Set

Not applicable in the conventional sense for a device of this type, especially for performance studies described. The "acceptance" was based on meeting pre-defined requirements or demonstrating substantial equivalence to a predicate, not on a human-expert adjudication of results. For the access study, evaluation criteria for "meeting needs" would have been set by the manufacturer, possibly in consultation with clinicians, but an adjudication method is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. The document describes a "comparative performance test" for thermal effect, but this was a technical comparison of the device against a predicate in animal and ex-vivo models, not a study evaluating human readers' performance with and without AI assistance. This device is an electrosurgical tool, not an AI-assisted diagnostic or interpretative system that would typically warrant an MRMC study.

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

• This question is not applicable as the device is not an algorithm or AI system. It is a physical electrosurgical device. The "standalone" performance refers to its direct functional capabilities (e.g., thermal effect, access).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Biocompatibility: Adherence to ISO standards, measured biological responses (e.g., cytotoxicity, irritation, sensitization).
• Electrical Safety & EMC: Adherence to IEC standards, objective electrical measurements.
• Performance (Thermal Effect): Objective measurements of thermal effect (e.g., temperature, tissue charring, coagulation depth) in animal and ex-vivo models, compared against the predicate and potentially against defined specifications derived from predicate performance. The "ground truth" is primarily the measured physical effect relative to established benchmarks and predicate performance.
• Performance (Anatomical Access): Likely subjective or objective assessment of the device's ability to reach target anatomical locations in cadavers, possibly based on expert opinion/feedback from surgeons.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical electrosurgical instrument, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

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

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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 <= 50 Watts, and provides monitoring of the patient return circuit for safety purposes.

The proposed single-use disposable accessory device, the PlasmaBlade T monopolar handpiece, provides the hemostatic capabilities of the Aquamantys SBS 5.0 Handpiece and the cutting and coagulative capabilities of the PEAK PlasmaBlade 4.0.

The proposed PlasmaBlade T Handpiece device is a monopolar, single use, disposable devices and is provided sterile. The devices are not intended for reuse or resterilization. The PlasmaBlade T handpieces consists of an enamel coated insulated blade electrode, an insulated telescoping shaft, handle with three integrated controls, and a co-extruded cable assembly to provide both power and saline. The seven-pin electrical connector is designed to be plugged into the proposed AEx Generator.

The proposed PlasmaBlade T Handpiece is a disposable device, that when connected to the AEX Generator, uses monopolar RF energy for the resection and coagulation of soft tissue and bone. The proposed PlasmaBlade T Handpiece device shares similar handpiece designand tip configuration as its predicate device, the PlasmaBlade 4.0 Monopolar Handpiece.

In addition to the monopolar cutting and coagulation capabilities the propsoed PlasmaBlade T Handpiece device also uses monopolar RF energy concurrent with saline delivery to provide a broader coagulative effect; similar to the predicate Aquamantys SBS 5.0 Handpiece, this result is trademarked as Transcollation® Technology by Medtronic. The proposed PlasmaBlade T Handpiece device also has a pump header tubing segment and saline bag spike tubing allowing the user to manually connect the device to saline source in the OR as well as the AEX Generator's peristaltic pump. This ensures the device is connected for saline delivery at the same time as the device is connected electrically to the proposed AEX Generator.

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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