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The MicroSurgeon Microwave Soft Tissue Ablation Device is intended to be used for the surgical ablation of soft tissue.

The MicroSurgeon Microwave Soft Tissue Ablation device model MTAD-100 is intended to be used by the physician for the ablation of soft tissue by the induction of thermal necrosis in the targeted tissue. The ablation occurs by direct application of microwave energy to the targeted tissue by use of a sterile hand held Disposable Patient Probe (DPP). Lesion sizes ablated by the system are determined by preset values within the system algorithm. The MTAD-100 allows the physician to use a minimally invasive procedure that is an alternative to surgical removal of solid tissue anomalies. It is to be used in conjunction with the clinician's knowledge of the patient as well as the results of a physical examination along with clinical findings as deemed pertinent. The MTAD-100 system is not to be used by untrained and unqualified users in a manner other than that for which it is labeled. The systems Microwave Generator Subsystem (MWGS) generates the RF 2,45GHz signal which is delivered to the DPP via related controlled electronics. It has an RF port for connecting an insulated coaxial cable from the DPP, a port for connecting a temperature measuring interface data cable from the DPP, and an RS232 port for connecting the system Control Processing Subsystem (CPS). Additionally the MWGS provides for required patient galvanic isolation, and is mounted to a Portable Transport Console with a caster base for easy transport in the hospital environment, The MWGS component of the MTAD-100 was designed for exclusive use of, and to generate microwave energy to the patient disposable probe cited above. The one time use sterile DPP Hand-piece incorporates a Tip that is inserted directly into the tissue for localized energy delivery, and acts as a microwave radiator in a bipolar mode; thus near-field radiated energy is contained within a limited field with no currents flowing into the patient (as opposed to uni-polar RF Radiators in which current flows thru the patient's body). Two independent Thermo-sensors (provided for further redundancy of the system) located at the tip of the DPP are used to provide for localized temperature measurement during the ablation process. The CPS utilizes these temperature measurements to control the delivery of energy in order to achieve the desired ablation. The CPS, running a Microsoft Windows Operating System, provides for procedure profile programming onto a patient data file; provides user interface and controls the MWGS unit based on predetermined settings. All MWGS functionality and temperature measurements are processed and displayed by this unit, and utilized to achieve a desired ablation. Additionally, it stores all relevant patient information and measured parameters for the procedure.

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroSurgeon Microwave Soft Tissue Ablation System:

Based on the provided document, the device approval is primarily based on non-clinical testing and substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria directly tied to human outcome measures or a specific device performance metric.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific performance metrics (e.g., specific ablation lesion size, success rate of ablation). Instead, it refers to:

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

The document explicitly states that the determination of substantial equivalence was primarily supported by "bench testing" and "non-clinical testing."

• Sample Size for Test Set: Not applicable in the context of human data. The "test set" would refer to the materials and conditions used in the bench and non-clinical tests, for which specific sample sizes (e.g., number of devices tested, number of in-vitro tissue samples, etc.) are not provided in this summary.
• Data Provenance: The data is primarily from non-clinical lab/bench testing. No human clinical data (retrospective or prospective, or country of origin) is mentioned.

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

This question is not applicable as there was no human-centric "test set" requiring expert ground truth for medical imaging or diagnosis. The ground truth for the non-clinical tests would have been established by engineering specifications, calibration standards, and established laboratory protocols.

4. Adjudication Method for the Test Set

Not applicable. There was no human "test set" requiring adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The approval pathway detailed in this document relies on non-clinical testing and substantial equivalence to predicate devices, not on assessing human reader improvement with or without AI assistance.

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

While the device's control system ("CPS") utilizes an algorithm to achieve desired ablation based on temperature measurements, this is an integral part of the device's operational functionality, not a standalone AI algorithm in the diagnostic or image interpretation sense. The document does not describe a standalone performance study of this algorithm detached from the physical device's operation.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" would be based on:

• Engineering specifications and design requirements: For functionality, safety, and performance parameters (e.g., power output, temperature control accuracy, lesion creation capabilities in non-biological models).
• Established test standards: Adherence to standards like IEC 60601-1, ISO 10993-1, etc., which have their own defined ground truths for testing specific device characteristics (e.g., electrical safety, biocompatibility, sterilization efficacy).
• Comparison to predicate device performance data: The "nearly identical data" claim suggests the predicate devices' established performance metrics served as a comparative "ground truth."

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI models being developed for diagnostic purposes. The device's algorithm controls energy delivery based on pre-determined settings and real-time temperature feedback; it's not a learning algorithm that would typically require a "training set."

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

Not applicable, as no machine learning "training set" is described for this device.

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