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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 The active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position.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 The Needle shaft is permanently attached to the active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position.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).

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