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The Thermedx 37~5 electrocautery probes are indicated for electrosurgical cutting and coagulation during a variety of urological, gynecological, laparoscopic and general surgical procedures.

The Thermedx 37~5 electrode probes are electrosurgical devices which enable the user to have the functions of cutting and coagulation along with suction and irrigation in a single hand held device. These probes are intended to be used in conjunction with the Trumpet valve disposable assembly (model number TV0002), The probes come in a variety of tip configurations. Monopolar electrodes include a J Hook. L Hook. Spatula and Needle tip. . All electrodes have working dimensions of 33 cm in length and 5 mm diameter. Electrodes are manufactured of biocompatible materials per ISO 10993 and are safe, effective and durable for their intended use. All electrodes have an ABS coupling to connect to the trumpet valve disposable assembly and are connected to an electrosurgical unit with a cable of PVC insulation and copper wires.

1. Table of Acceptance Criteria and Reported Device Performance

This submission does not provide specific quantitative acceptance criteria or detailed device performance metrics in the format of a table. The document focuses on demonstrating substantial equivalence to predicate devices. The "performance" assessment is qualitative, asserting that the new device has "similar technological characteristics" and "minor differences are not significant with respect to the safety or effectiveness."

The key performance claims are:

• Electrosurgical cutting and coagulation capability.
• Suction and irrigation capabilities (for the integrated hand-held device).
• Compliance with electrical safety (IEC 601-2-2) and biocompatibility (ISO 10993-1) standards.

Since no specific numerical acceptance criteria or test results are provided in the summary, a table cannot be constructed with performance values. The primary acceptance criterion for this 510(k) submission was the demonstration of substantial equivalence to predicate devices, which was achieved through:

• Same intended use.
• Similar technological characteristics.
• Compliance with relevant safety standards (IEC 601-2-2 and ISO 10993-1).

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

No specific test set or data provenance (e.g., country of origin, retrospective/prospective) is described for demonstrating the performance of the device. The submission explicitly states: "No animal or clinical test results were required to demonstrate substantial equivalence." This indicates that no human or animal test data was used for this 510(k) submission from the perspective of a "test set." The evaluation relied on technical comparisons and compliance with recognized standards.

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

Not applicable. Since no animal or clinical test results were required for substantial equivalence, there was no "ground truth" to be established by experts in the context of clinical or performance data for this submission. The ground truth for regulatory acceptance was based on a comparison to predicate devices and compliance with established standards.

4. Adjudication Method for the Test Set

Not applicable. As no test set data was presented or required for this 510(k) submission, there was no adjudication method used for such data.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No animal or clinical test results were required to demonstrate substantial equivalence." This type of study would involve human readers and clinical data, which was not part of this submission.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is an electrosurgical probe, a physical medical instrument, not an algorithm or AI software. Therefore, there is no concept of "standalone (algorithm only)" performance in this context.

7. Type of Ground Truth Used

The "ground truth" for this 510(k) submission was based on:

• Predicate Device Equivalence: The primary ground truth was the established safety and effectiveness of the identified predicate devices (Modulap Disposable Electrosurgical Probes, Genicon Re-Usable Monopolar Probes, Stryker Stiletto Electrosurgical Probe, Conmed Electrosurgical Probe). The new device was deemed substantially equivalent to these devices.
• Compliance with Standards: Compliance with recognized international standards for electrical safety (IEC 601-2-2) and biocompatibility (ISO 10993-1) served as a "ground truth" for basic safety and performance characteristics.

No clinical expert consensus, pathology, or outcomes data from the new device was used to establish ground truth for this submission, as such data was not required.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm requiring a training set. The "training" for the device's design and manufacture would involve engineering principles, materials science, and adherence to quality system regulations, rather than data-driven machine learning.

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

Not applicable. As there is no AI/ML algorithm and thus no "training set," the concept of establishing ground truth for a training set is not relevant to this device submission.

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