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The Arrow StimuOuik Insulated Peripheral Nerve Block Needle permits the stimulation and location of nerves and nerve plexuses for single-shot nerve block anesthesia or analgesia techniques.

The StimuQuik peripheral nerve block needle is used to locate nerves or nerve plexuses and facilitate delivery of regional anesthesia to the desired location. The needles are constructed of a steel needle and insulated by a white, non-conductive siliconized polyester coating. A small area at the distal tip remains exposed to conduct the stimulating current to nerve tissue. The tip features a 30-degree bevel. and black centimeter markings are printed along the shaft of the needle. An electrical wire with a shrouded 2 mm female connector and an extension line with a Luer lock extend from the ergonomic plastic hub of the needle.

The StimuQuik ECHO peripheral nerve block needle is identical to the StimuQuik needle with the addition of 5 echogenic grooves on the needle tip. The five grooves are designed to help clinicians locate the tip of the StimuQuik ECHO needle under ultrasound.

The provided text describes a 510(k) premarket notification for a medical device, the StimuQuik Peripheral Nerve Block Needle, and its substantial equivalence to a predicate device. However, it does not describe a study involving an AI/Machine Learning device or a diagnostic algorithm. Therefore, I cannot extract information related to acceptance criteria or studies proving device performance in the context of an AI/ML device from this document.

The document details the following:

• Device: StimuQuik Peripheral Nerve Block Needle
• Purpose: To permit the stimulation and location of nerves and nerve plexuses for single-shot nerve block anesthesia or analgesia techniques.
• Approval type: 510(k) premarket notification, seeking substantial equivalence to a predicate device (AVID-NIT Nerve Stimulation Needles, K014246).
• Testing: Biocompatibility testing (per ISO 10993-1) and Non-clinical performance testing (e.g., needle markings, ink adherence, continuity, current density, leakage, tensile strength, kink resistance, echogenicity).

The performance testing section shows a table with "Test," "Test Objective," "Acceptance Criteria," and "Results" (all pass). However, these are engineering and material performance tests for a physical medical device, not a diagnostic algorithm or AI/ML product. The "acceptance criteria" listed are for physical properties and safety parameters of the needle itself, not for the accuracy or effectiveness of a diagnostic output.

Therefore, I cannot fulfill the request as it pertains to an AI/ML device's acceptance criteria and study design for proving its performance. The provided document is for a traditional physical medical device.

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