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The Solace Infusion System is intended for continuous infusion of medications directly into the intraoperative site for post-operative pain management. Additional routes of administration include subcutaneous and intramuscular infusion.

Apex's Solace Post-Operative Pain Relief Infusion System is a single use infusion device, which incorporates an elastomeric bladder with a permanently attached fixed flow rate administration set designed to deliver medication at a constant flow rate. The medication enters the body via a catheter, which is inserted near a surgical wound site then positioned under the skin. The pump attaches to the catheter at the distal end of the administration set. The catheter consists of four design options (same as predicate devices).

The provided text is a 510(k) Premarket Notification for the Solace Post-Operative Pain Relief Infusion System, an elastomeric infusion pump. This type of regulatory submission focuses on demonstrating substantial equivalence to already marketed devices, rather than conducting new clinical trials with acceptance criteria and studies demonstrating device performance against those criteria.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document details the device description, intended use, and technological characteristics, comparing them to predicate devices like the Baxter Infusor and I-Flow Pump to establish substantial equivalence. The key performance metric mentioned is flow accuracy:

• The Solace pump utilizes flow restrictive tubing to achieve +/-15% flow accuracy over the infusion system.
• The I-Flow pump utilizes a glass capillary and/or flow restrictive tubing to achieve +/- 15% flow accuracy over the infusion system.
• The Baxter pump utilizes a glass capillary to achieve +/- 10% flow accuracy over the infusion system.

However, this is a description of the design goal and a comparison point, not a report of a specific study demonstrating that the device meets an acceptance criterion through empirical testing described in this document. The 510(k) process typically relies on bench testing and comparisons to predicate devices for such performance claims, but the detailed study results are not present here.

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