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The lonicRF™ Generator, in combination with approved compatible electrodes and cannulae, is an aid in the management of pain in the nervous system. Examples include, facet denervation, trigeminal rhizotomy, and related functional neurosurgical procedures.

The Abbott IonicRF™ Generator is a desktop radiofrequency (RF) lesioning generator, which is intended for lesioning of neural tissue in the peripheral nervous system as an aid in the management of pain.

The generator is portable and can be placed on a level surface using the countertop stand or mounted to a compatible roll stand using the optional pole mount.

The IonicRF™ Generator is a multi-lesioning, 4 channel portable generator that can provide continuous or pulsed RF output at 460 KHz, monopolar or dual electrode modes, and a Simplicity™ mode for large lesion creation. The generator includes sensory and motor stimulation functions to fine-tune electrode placement before procedures are performed. The generator is also designed to be compatible with all existing Abbott electrodes and cannulas.

Device features include a touch screen monitor incorporating microprocessor and graphics display for user interface, and recordkeeping functions. The user interface controls all functions of the generator. The generator incudes a dial on the front for control of stimulation level during stimulation and motor testing. The IonicRF™ Generator can be set on a flat surface or mounted on a pole with the accessory pole mount bracket.

The IonicRF™ Generator can be used with previously cleared Abbott RF Electrodes (K011387, K111576), and Cannula/Introducers (K042375, K000073) used with the predicate device.

The IonicRF™ Generator is a device intended for radiofrequency lesioning of neural tissue as an aid in pain management. The provided document does not contain acceptance criteria or study details in the typical sense of a clinical performance study for an AI/ML medical device. Instead, it demonstrates substantial equivalence to a predicate device (NeuroTherm NT2000 Lesioning Generator (K111576)) through non-clinical testing.

Here's the breakdown of the information available in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison of technological characteristics between the IonicRF™ Generator and its predicate device, and a summary of non-clinical testing. These serve as the performance evaluation for substantial equivalence.

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

This document describes a medical device (radiofrequency generator), not an AI/ML software. Therefore, there isn't a "test set" in the context of image data or patient data for an algorithm. The "testing" refers to non-clinical verification and validation activities of the hardware and software. No specific sample sizes for these tests (e.g., number of devices tested, number of lesion creations) or data provenance (as it pertains to human-derived data) are detailed in this summary.

3. 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. As this is a hardware device undergoing non-clinical testing for substantial equivalence, there is no "ground truth" establishment by medical experts in the way an AI/ML diagnostic algorithm would require.

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

Not applicable. There is no test set of patient cases requiring adjudication by experts.

5. 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

Not applicable. This device is a radiofrequency generator, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a radiofrequency generator, not an algorithm.

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

For the non-clinical testing, the "ground truth" is defined by the technical specifications, performance requirements, and established standards (e.g., IEC 60601-1, IEC 60601-1-2). For instance, for comparative lesion testing, the "ground truth" would be the expected characteristics of a lesion created by a radiofrequency generator, likely determined through validated experimental methods and comparison to the predicate.

8. The sample size for the training set

Not applicable. This device is a radiofrequency generator, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. There is no training set for an AI/ML algorithm.

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