(57 days)
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."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Thermal Effects on Tissue | |
| Zone of thermal damage (AEx Generator vs. Predicates) | Comparable zone of thermal damage to predicate Aquamantys and Pulsar Generators. |
| Zone of thermal damage (PlasmaBlade T vs. Predicates) | Comparable zone of thermal damage to predicate Aquamantys SBS 5.0 and PlasmaBlade 4.0 Handpieces. |
| Software Verification | |
| Compliance with IEC 62304 Edition 1: 2006 | Software development and testing executed in compliance. |
| Electromagnetic Compatibility (EMC) | |
| Compliance with IEC 60601-1-2 Edition 3: 2007-03 | Tested in compliance. |
| Compliance with IEC 60601-2-2 Edition 5.0 2009-02 | Tested in compliance. |
| Electrical Safety | |
| Compliance with IEC 60601-1:2005 3rd Edition And A1:2012 | Tested in compliance. |
| Compliance with IEC 60601-2-2 Edition 5.0 2009-02 | Tested in compliance. |
| General Performance Characteristics | |
| Output characteristics | Verified. |
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.
§ 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.