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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 PlasmaBlade T should not be used on small appendages or body parts, as in circumcision. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

The proposed single-use disposable accessory device, the PlasmaBlade T monopolar handpiece, provides the hemostatic capabilities of the Aquamantys SBS 5.0 Handpiece (Cleared under K111732, K132974) and the cutting and coagulative capabilities of the PEAK PlasmaBlade 3.0S (Previously cleared under K093695).

The proposed PlasmaBlade T Handpiece device is a monopolar, single use, disposable device and is provided sterile. The devices are not intended for reuse or resterilization. The PlasmaBlade T handpiece consists of an enamel coated insulated blade electrode with an uncoated circular 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 AEx Generator (Cleared under K143175).

The proposed PlasmaBlade T Handpiece is a disposable device, that when connected to the AEX Generator (K143175), uses monopolar RF energy for the resection and coagulation of soft tissue and bone. The proposed PlasmaBlade T Handpiece device provides similar resection and coagulative effect to the predicate device, the PlasmaBlade 3.0S Monopolar Handpiece (Cleared under K093695).

In addition to the monopolar cutting and coagulation capabilities the proposed 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 (Cleared under K111732, K132974), 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.

This document describes a 510(k) premarket notification for the PlasmaBlade T device, an electrosurgical cutting and coagulation device. The information provided focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

Key Takeaway: The provided document is a 510(k) submission, which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving a novel device meets specific (and often more stringent) acceptance criteria through exhaustive clinical trials typically associated with a "new" device. For 510(k)s, "acceptance criteria" are generally tied to showing that the new device performs as safely and effectively as the predicate, often through a combination of bench testing and, sometimes, animal studies. Clinical trials (human studies) are usually not required for 510(k)s unless there are significant differences in technology or indications from the predicate that raise new questions of safety or effectiveness.

Based on the information, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a formal table of quantitative acceptance criteria with corresponding performance metrics like one might see for an AI-driven diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate devices through various non-clinical tests.

• "hemostatic capabilities of the Aquamantys SBS 5.0 Handpiece" (Predicate K111732, K132974)
• "cutting and coagulative capabilities of the PEAK PlasmaBlade 3.0S" (Predicate K093695).
  "The proposed PlasmaBlade T Handpiece device provides similar resection and coagulative effect to the predicate device, the PlasmaBlade 3.0S Monopolar Handpiece."
  "The proposed 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." |
  | Similar Tissue Effect (Safety): The thermal damage profile imparted on tissue is comparable to predicate devices. | "The in-vivo testing determined the zone of thermal damage imparted on the tissue by the proposed devices was comparable to the predicates." |
  | Biocompatibility: Device materials are suitable for contact with tissue. | "Biocompatibility" testing was conducted and passed. (No specific performance data given, but implied acceptance by passing this test). |
  | Sterilization Efficacy: The device can be effectively sterilized. | "Sterilization" testing was conducted and passed. |
  | Electrical Safety/Electromagnetic Compatibility (EMC): The device meets electrical safety and EMC standards. | "Electrical Safety/EMC" testing was conducted and passed. |
  | Mechanical Integrity/Durability: The device maintains its mechanical integrity through transit, shelf life, and during use. | "Transit," "Shelf Life," "Mechanical Testing," and "Activation Testing" were conducted and passed. |

Study Type: Non-Clinical Performance Testing (Bench and Animal) to demonstrate substantial equivalence.

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

• Sample Size: The document does not specify exact sample sizes for each type of bench testing (e.g., number of devices tested for sterilization, number of cycles for activation testing). For the in-vivo animal model, it states that testing was "completed" but does not give the number of animals or trials.
• Data Provenance: Not explicitly stated, but typically, these tests are conducted in a laboratory setting (e.g., Medtronic's R&D facilities or contracted labs) within the country of manufacture or testing. The document implies these were conducted specifically for this submission, making them prospective data for the purpose of this regulatory filing. There is no mention of country of origin for the data specifically.

3. Number of Experts and Qualifications for Ground Truth Establishment:

This question is largely not applicable to this type of device and study.

• This is not an AI/diagnostic device where human expert labels establish ground truth on patient data.
• Ground truth for functional performance (e.g., cutting, coagulation, thermal spread) in bench and animal studies is established through direct physical/physiological measurement and observation, not through expert consensus on interpretation. For instance, the "zone of thermal damage" is a measurable characteristic of tissue effect.
• The FDA guidance document mentioned ("Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff") served as the standard against which the tests were designed and evaluated by the manufacturer's engineers and scientists.

4. Adjudication Method for the Test Set:

Not applicable in the context of expert adjudication for diagnostic labeling. Performance testing involves direct measurement and comparison to predefined criteria or predicate device performance. Engineer/scientist review of test results would be the "adjudication" (verification) method for non-clinical studies.

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

• No, an MRMC study was NOT done.
• The device is an electrosurgical instrument, not an imaging or diagnostic AI device where human readers interpret cases. The human "user" is a surgeon performing a procedure, not "reading" data.
• The study focuses on the device's physical and functional performance, not on improving human reader interpretation.

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

• Technically, all the studies described (bench and animal) are "standalone" in the sense that they are evaluating the device's intrinsic performance characteristics without a human user's interpretive decision-making being part of the primary endpoint.
• The "human-in-the-loop" for this device is the surgeon using it during a procedure for its intended purpose (cutting, coagulating, sealing), not interpreting data generated by the device. The non-clinical studies assess the device's ability to perform these actions comparably to predicates.

7. Type of Ground Truth Used:

The ground truth for the performance claims in this submission is established through:

• Physical/Chemical Measurements: For sterilization, electrical safety, mechanical integrity, shelf-life.
• Direct Observation/Measurement on Animal Tissue: For functional performance related to cutting, coagulation, and critically, the "zone of thermal damage imparted on the tissue." This is akin to a pathological/physiological ground truth as it directly measures the device's effect on biological tissue.
• Comparison to Predicate Device Performance: The primary "ground truth" for substantial equivalence is the established safe and effective performance of the predicate devices. The new device must demonstrate comparable performance across the relevant tests.

8. Sample Size for the Training Set:

Not applicable. This device is hardware (an electrosurgical instrument), not an algorithm that requires a "training set" of data in the machine learning sense.

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

Not applicable. (See point 8).

In summary, the 510(k) submission for the PlasmaBlade T device relies on comprehensive non-clinical testing (bench and animal studies) to demonstrate substantial equivalence to its predicate devices. The "acceptance criteria" are implicitly met by showing that the new device performs comparably to the predicates in terms of safety and effectiveness across various functional and physical tests, including the critical aspect of tissue effect (thermal damage). Clinical human studies were not required for this type of device and submission pathway.

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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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