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The Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae Models DTR and DTRH are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.

The Diros OWL Sterile Single Use Trident™ RF Cannulae DTR and DTRH models are very similar in construction, materials, energy source and intended use to predicate devices of 466 and DHC. They are single use disposable devices to be used with the Diros OWL RF Generators.

Sterile Single Use Trident™ RF Cannulae model DTR: The DTR device consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. Needle shaft is permanently attached to the hub that is used as a handle and the fluid injection port. The active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position. The device also has a detachable stylet with cap. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.

Sterile Single Use Trident™ RF Hybrid Cannulae model DTRH: The DRTH device consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. The Needle shaft is permanently attached to the active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position. The handle also is permanently attached to the thermocouple probe, cable (with connector) and injection port. The Thermocouple probe is used to deliver the RF energy from the generator and measure the needle tip temperature. The injection port is used for fluid injection. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.

The provided document is an FDA 510(k) Premarket Notification for a medical device: Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae Models DTR and DTRH.

This document describes the device, its intended use, and a comparison to predicate devices, focusing on non-clinical testing to demonstrate substantial equivalence, rather than a clinical study with human subjects validating performance against typical AI/ML acceptance criteria.

Therefore, many of the requested points regarding acceptance criteria, human reader studies, and AI/ML model training/testing are not applicable to this 510(k) submission directly, as it pertains to a physical medical device (cannulae) and its mechanical, electrical, and biocompatibility properties, demonstrated through non-clinical performance data.

However, I can extract and present the information available that most closely aligns with your request, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence based on non-clinical testing:

Acceptance Criteria and Device Performance (Non-Clinical)

The "acceptance criteria" in this context are the standards and performance metrics that the device (Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae) needed to meet to demonstrate substantial equivalence to its predicate devices for FDA clearance. The study proves the device meets these criteria through various non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are compliance with established standards (ISO, IEC) and comparable performance to predicate devices in terms of material properties, electrical safety, mechanical integrity, and functional performance (e.g., lesion creation, temperature accuracy).

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

• Sample Size: The document does not specify a numerical sample size (e.g., N=X devices tested) for each non-clinical test. It states that "All nonclinical testing performed on new devices are identical to testing performed on Diros predicate devices." and results are generally described as "Passed" or "Compliance." For the biocompatibility section, it states "Additional testing per ISO 10993-7 is performed to evaluate the new device for EtO residuals," implying that new device samples were used for this specific test, while for other biocompatibility tests, the reports for the predicate device's materials were leveraged.
• Data Provenance: The data is from non-clinical laboratory testing performed on the devices themselves, not human patient data. There is no information about the country of origin of the test data. The tests are "in accordance with applicable standards," which are international (ISO, IEC). The testing is prospective in the sense that the tests were conducted specifically for this submission to verify the device's properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is not a study requiring human expert ground truth for interpretation of medical images or diagnoses. The "ground truth" for these tests is defined by the objective, quantitative criteria set by international standards (e.g., a specific bond strength, a maximum leakage current, a lack of cytotoxicity). The results are objective measurements/observations from laboratory tests.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation or adjudication involved in the test results. The tests yield objective measurements or pass/fail outcomes based on established quantitative and qualitative criteria defined by the relevant standards.

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 is a physical medical device (cannulae), not an AI/ML diagnostic or assistive software. No MRMC study was performed.

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

Not applicable. This is a physical medical device. There is no algorithm or standalone software component. The performance tests are on the physical device itself (e.g., how much lesion it creates, its electrical properties).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for this submission is based on established international standards and objective physical/chemical measurements. For example:

• Biocompatibility: In vitro (cell culture) and in vivo (animal, though for this device, existing predicate reports were largely leveraged for this category if materials were the same) tests against ISO 10993.
• Electrical Safety: Specific voltage, current, and electromagnetic compatibility thresholds defined by IEC 60601 series.
• Mechanical Testing: Physical properties and dimensional tolerances defined by ISO standards (e.g., tensile strength, dimensional accuracy, luer taper specifications).
• Performance Testing: Empirical measurements, such as lesion size and shape in a tissue model, impedance, and temperature accuracy, for which the established performance of the predicate device acts as a benchmark for "sameness."

8. The Sample Size for the Training Set

Not applicable. This involves a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. As above, there is no AI/ML model or training set.

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