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The OWL Radiofrequency System, Model URF-3AP, intended use is for:

1. Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
2. radiofrequency heat lesion procedures for the relief of pain

The OWL radiofrequency generator URF-3AP is used by qualified medical personnel to make heat ablative lesions in central or peripheral nerve tissue for the treatment of movement disorders or for the relief of pain. The lesions are ablative in order to be therapeutic; i.e. the destruction of a small portion of the thalamus within the brain interferes with the motor pathway causing the tremor of Parkinson's disease, thereby relieving the tremor, or the destruction of the facet joint nerves in the lumbar vertebrae to block pain transmission by these nerves and thereby relieve certain types of low back pain.

The URF-3AP supplies up to 50 Watts of Radio Frequency energy at 481kHz in bipolar or monopolar modes under power or temperature control while continuously monitoring and displaying actual power delivered, measured probe temperature, time of power duration, and measured impedance.

When used with monopolar probes, the system also delivers low-frequency stimulus pulses in either voltage or current controlled modes.

The provided document describes a 510(k) submission for the DIROS TECHNOLOGY INC. OWL™ RF LESION GENERATOR MODEL OWL URF-3AP. This is a medical device, and the document focuses on demonstrating its substantial equivalence to predicate devices, rather than presenting a clinical study with detailed acceptance criteria and performance metrics typically seen for completely novel devices or AI/software algorithms.

Therefore, much of the requested information regarding acceptance criteria, specific performance statistics, sample sizes, expert involvement, and ground truth for a study is not applicable in the context of this 510(k) submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Formal acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, lesion size accuracy) are not explicitly stated in this 510(k) summary as they would be for a diagnostic or AI device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices and compliance with safety and electrical standards.

2. Sample size used for the test set and the data provenance:

• Not applicable for a clinical study in this 510(k) context. The "testing" mentioned is primarily engineering and bench testing to demonstrate compliance with standards and functional specifications, not a clinical trial with patient "test sets." The document does not specify a sample size for any clinical test set or data provenance in terms of country of origin or retrospective/prospective nature, as such a study was not the basis for this 510(k).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical "test set" with ground truth established by experts is described for this type of device submission. Performance is assessed against engineering specifications and compliance with standards.

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

• Not applicable. No clinical test set requiring adjudication is described.

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 an RF lesion generator, not an AI or imaging diagnostic device. No human reader performance, AI assistance, or MRMC study is relevant or mentioned.

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

• Not applicable. This is a hardware medical device, not an algorithm.

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

• Not applicable in a clinical sense. The "ground truth" for this engineering-focused submission would be objective technical standards (e.g., a power meter measuring output wattage, a thermometer measuring temperature control accuracy, electrical safety testing results, and functional tests against design specifications).

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI that would require a "training set."

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

• Not applicable. As there is no training set, this question is not relevant.

In summary:

This 510(k) submission for the OWL URF-3AP RF Lesion Generator is a regulatory filing focused on demonstrating substantial equivalence to existing legally marketed predicate devices and compliance with relevant performance, safety, and electrical standards. It is not a clinical study involving the detailed metrics (sensitivity, specificity, clinical outcome data, etc.) that would typically be described for diagnostic devices or AI algorithms. The "study" mentioned is primarily bench testing, engineering validation, and regulatory compliance checks against established standards and the specifications of predicate devices.

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