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The intended use of the OptaBlate Radiofrequency (RF) Generator System is as follows:

• Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
• Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standards therapy.
• Ablation of benign bone tumors such as osteoid osteoma.

The device description of the OptaBlate Radiofrequency (RF) Generator System remains consistent with that of the previously cleared K221074, with no modifications other than the incorporation of the OptaBlate Curve 10mm, 15mm, and 20mm Probe Single Kits.

The OptaBlate Curve Probe Kits provide flexible probes with microinfusers that are used with OmniCurve 10G Fracture Kits, the OptaBlate RF Generator and the Splitter Cable. Together they enable a unipedicular approach for bone tumor ablation. The access tools from the OmniCurve Kits create a curved, unipedicular pathway to the bone tumor. Based on tumor size, a flexible probe size is selected and inserted into the curved pathway. Then with the microinfuser (which reduces impedance events), the OptaBlate RF Generator and the Splitter Cable, the bone tumor is ablated.

This document is a 510(k) clearance letter for the OptaBlate Radiofrequency (RF) Generator System. It's a medical device, not an AI/ML product. Therefore, the information requested to describe the acceptance criteria and study proving the device meets them, particularly regarding AI-specific criteria, is not present in this document.

The document discusses the substantial equivalence of the new device (including OptaBlate Curve 10mm, 15mm, and 20mm Probe Single Kits) to a previously cleared predicate device. The testing described focuses on non-clinical aspects typical for electrosurgical devices, rather than AI/ML performance.

Here's how the provided information relates to your request:

• No AI-specific acceptance criteria or performance study is described. This is a clearance for an RF generator and associated probes, not an AI/ML-driven diagnostic or treatment planning system.
• The "Performance Testing" section refers to design verification testing to confirm performance as intended and safety/effectiveness in accordance with FDA Guidance for Electrosurgical Devices, not a clinical study to demonstrate performance against a specific clinical endpoint using AI.
• "Summary of Clinical Testing: Clinical testing was not required for this Special 510(k)." This explicitly states that no clinical trial data was submitted to support this particular 510(k) given its "Special 510(k)" nature, indicating minor modifications to an already cleared device.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance validation based on the provided text. The document focuses on regulatory compliance through substantial equivalence to a predicate device for an electrosurgical system, not on proving AI efficacy.

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