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1. The ON-Q Pump is intended for continuous and/or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites and/or close proximity to nerves for preoperative, perioperative and postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, percutaneous and epidural.
2. The ON-Q Pump is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to or around surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

The ON-Q Pump consists of an elastomeric pressure source with an integrated administration line. Fill volumes range from 50 to 770 ml. Flow rates range from 0.5 to 250 ml/hr. The administration line typically consists of fixed flow rate control tubing or orifice but may contain any of the following optional features:
• Select-A-Flow component that provides a range of flow rates that may be dialed depending on the needs of the healthcare professional.
• Bolus component (e.g. OnDemand) that provides basal and/or bolus delivery.
• Y-adapter component that may split the administration line into two or more delivery sites. The Y-adapter component may also be used to provide a combination of options (such as both the Select-A-Flow and OnDemand components) for one delivery site.
• Air and particulate eliminating filter.
The pump may be sold as a kit with additional medical devices or accessories such as the following:
• Catheter, introducer needle, Tunneler, syringe, dressing, filling extension set, carry case, E-clip, nerve block accessories, etc.

This document is a 510(k) summary for a medical device (ON-Q Pump) that describes a design change to increase its maximum fill volume. It does not provide information about acceptance criteria or a study proving that a device (specifically an AI device) meets acceptance criteria.

Therefore, I cannot answer your request based on the provided text. The questions you've asked are typically relevant for AI/ML device submissions, which involve performance metrics like sensitivity, specificity, and detailed study designs. This document is for a mechanical infusion pump and discusses substantial equivalence to a predicate device, not AI performance.

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