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SnapLock Catheter/Syringe Adapter is intended to be used in conjunction with 19 and 20 Ga. Arrow Pain Management Catheters to facilitate access to the catheter so that an infusion device may be used. Please refer to applicable Arrow Pain Manager Catheter IFU for complete catheter instructions for use.

The Arrow Epidural Catheter permits access to the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.

The Arrow FlexBlock Continuous Peripheral Nerve Block Kit Set permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques including upper extremity, abdominal and paravertebral locations for periods not exceeding 72 hours.

The Arrow SnapLock Catheter Adapter serves as the connecting link between the anesthesia catheter and an infusion device. The adapters facilitate delivery of the desired substance through the adapter-catheter system, into the patient.

Arrow markets two versions of the SnapLock Adapter. The non-stimulating version is used with epidural and peripheral nerve block catheters and the stimulating version includes an integral electrical connector or tab for use with stimulating Peripheral Nerve Block catheters. Both versions of the adapters are included as accessories in their respective kits. The non-stimulating version is also available separately as a replacement component.

The provided text is a 510(k) summary for the Arrow SnapLock Catheter Adapter. It describes the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. The document outlines performance testing for the new device to show it meets specific "acceptance criteria." However, it is not a study that proves a device meets acceptance criteria in the context of medical AI/imaging devices, which typically involves clinical studies with human readers, ground truth establishment, and statistical analysis of performance metrics like sensitivity, specificity, AUC, etc.

The acceptance criteria and performance data described here are for mechanical and material properties of a medical device (a catheter adapter), not for an AI/imaging diagnostic device. Therefore, many of the requested points in the prompt (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this document's content.

Here's an interpretation based on the provided document, addressing the applicable points:

Device: Arrow SnapLock Catheter Adapter (a non-AI medical device; specifically, an adapter for pain management and nerve block catheters)
Purpose of the Study (as described in the document): To demonstrate substantial equivalence to predicate devices through performance testing related to mechanical properties, material biocompatibility, and functional aspects.

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

The document provides tables for Biocompatibility Testing and Performance Testing with their respective acceptance criteria and results.

Table 1: Biocompatibility Testing Acceptance Criteria and Results

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