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The Temperature Sensor Probe, used with Varian ablation systems, is intended for monitoring tissue temperature near the ablation site.

Temperature Sensor Probe is an optional accessory designed for use with compatible Varian ablation systems. Principal components of the temperature sensor probe include:

• Needle
• Handle
• Lead cable and connector

The provided text describes the regulatory clearance of a Temperature Sensor Probe (ABL-18TP20) for use with Varian ablation systems for monitoring tissue temperature. The submission focuses on demonstrating substantial equivalence to a predicate device, the Emprint™ Ablation System with Thermosphere Technology: K200796, specifically the Ablation Remote Temperature Probe (RTP20).

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Explanation of "Differences" for key criteria:

• Temperature Range (Accuracy): The subject device has a wider temperature range (10-60°C vs 37-60°C) and a slightly lower accuracy (±2°C vs ±1.5°C). The document states this is "Similar performance specifications" and notes that the compatible ablation system rounds reported temperature to the nearest integer for usability, implying this difference is acceptable.
• Needle Gauge (inserted in tissue): While both effectively result in an 18G insertion, the subject device uses a thicker-wall 18G needle directly, eliminating the need for a separate cannula and stylet, which the predicate device uses with a thinner 20.5G needle inside an 18G cannula. This is deemed "Similar" in overall gauge size.
• Probe handle with PCBA: The subject device has a PCBA in the handle for analog-to-digital signal conversion, whereas the predicate performs this in the console. This is a "Different design" but ultimately serves the same function of displaying real-time temperature.
• Lead Cable Outer Jacket: Different polymers (PVC vs TPV), but stated as "thermoplastic elastomer similar to the predicate device."
• Packaging: Different configurations (Tyvek pouch in cardboard box vs thermoform tray and Tyvek lid in SBS carton), noted as "Different packaging (less footprint)."

Study Information

1. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The document implies that testing for "accuracy of temperature monitoring" involved side-by-side testing of the subject and predicate devices. However, specific numerical sample sizes for these tests are not provided.
   • Data Provenance: The studies are described as "non-clinical testing" and "non-clinical animal testing." No country of origin is specified for these tests. The animal testing was conducted on "porcine soft tissue models." These are likely prospective studies as they involve testing the new device.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable/Not provided. The testing described is primarily focused on physical and electrical device performance, temperature accuracy, and biocompatibility, not on expert interpretation of medical images or diagnostic outcomes. Therefore, no experts were explicitly used to establish "ground truth" in the manner relevant to image-based diagnostic AI.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This concept typically applies to studies where multiple readers interpret cases and their discrepancies need to be resolved for ground truth. The studies for this device are technical performance tests, not reader studies.

4. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This device is a temperature sensor probe, an accessory for ablation systems. It does not involve AI or human interpretation of data in a diagnostic context that would warrant an MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • The device "does not contain software" that performs analytical functions. The testing focused on the physical device's performance, such as temperature accuracy. Therefore, "standalone" algorithm performance in the typical AI sense is not applicable.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the non-clinical testing of temperature monitoring, the ground truth would be established by calibrated reference standards or laboratory-controlled conditions (e.g., precise temperature baths with highly accurate reference thermometers).
   • For biocompatibility, the ISO 10993-1 standard provides the framework for establishing ground truth regarding material safety.
   • For animal testing, the ground truth would be directly measured tissue temperature in the porcine model using reference temperature measurement methods.

7. The sample size for the training set:

   • Not applicable/Not provided. This device does not use AI/machine learning algorithms that require a training set.

8. How the ground truth for the training set was established:

   • Not applicable. As the device does not use AI/machine learning, no training set or ground truth for such a set was established.

In summary, the FDA clearance for the Varian Temperature Sensor Probe is based on a demonstration of substantial equivalence through non-clinical performance testing, including accuracy of temperature monitoring, biocompatibility, electrical safety, sterilization, and packaging integrity. The nature of this device (a physical accessory for temperature measurement) means that many of the typical AI/ML study components (like expert ground truth, MRMC studies, or training sets) are not relevant or applicable.

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