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

The MicroSurgeon Microwave Tissue Ablation device model MTAD-200 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-200 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-200 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 an RF 2.45GHz signal which is delivered to the Disposable Patient Probe DPP via related controlled electronics, and provides for required patient galvanic isolation. The MWGS component of the MTAD-200 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 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.

The provided text describes the MicroSurgeon Microwave Tissue Ablation Device (MTAD-200) and its 510(k) submission. However, it does not contain specific acceptance criteria or a detailed study outlining performance metrics for the device itself beyond safety standards and comparison to a predicate device. The document focuses on regulatory approval based on demonstrating substantial equivalence.

Here's an analysis of what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a clinical "test set" in the sense of patient data. The "testing" mentioned is bench testing and compliance with non-clinical standards. Therefore, there is no information on:

• Sample size used for a test set.
• Data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The document is for a medical device's 510(k) submission based on non-clinical testing and substantial equivalence, not a study evaluating performance against an expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with human assessment is described.

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

No. The document makes no mention of an MRMC study or any comparison of human readers with or without AI assistance. This device is a microwave tissue ablation device, not an AI diagnostic tool.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No. This is a medical device for physical intervention (tissue ablation), not an algorithm for diagnosis or image analysis. The "system algorithm" mentioned refers to pre-set values determining lesion sizes, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's approval is based on:

• Bench Testing Results: Demonstrating the device's ability to create ablations and meet performance specifications.
• Compliance with Recognized Standards: Meeting IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 for safety and electromagnetic compatibility.
• Comparison to a Legally Marketed Predicate Device (K070023): Demonstrating "nearly identical data" in ablation performance and ensuring no new safety or efficacy concerns.

8. The Sample Size for the Training Set

Not applicable. The document does not describe a machine learning model with a training set.

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

Not applicable, as no training set for a machine learning model is described.

Summary of Missing Information:

The provided 510(k) summary focuses entirely on the regulatory approval process for a physical medical device (microwave tissue ablation device) by demonstrating substantial equivalence to a predicate device and compliance with safety standards through non-clinical bench testing. It does not contain any information related to clinical studies, human reader performance, AI algorithms, or "ground truth" derived from expert consensus, pathology, or outcomes data as would be relevant for diagnostic devices or AI-powered systems. The "study" referenced is the collection of non-clinical bench test results and compliance documentation, not a clinical trial or performance evaluation against specific clinical endpoints or expert reads.

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