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The CADD-PCA pump is indicated for intravenous, subcutaneous, epidural space or subarachnoid space infusions.
The CADD-Micro pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space microinfusions.
The CADD-Prizm pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, epidural space or subarachnoid space infusions.

The subject devices are microcomputer controlled ambulatory infusion pumps intended for the delivery of medication via various parenteral routes, i.e., intravenous, intra-arterial, subcutaneous, intraperitoneal, or epidural space infusion. The purpose of this 510(k) Notification is to add subarachnoid space infusion to the labeling and thereby expanding the intended use of each pump. The subject devices, as a matter of course, will be used for the delivery of medication through catheters that have this indication.

The provided document is a 510(k) summary for infusion pumps, specifically requesting to add "subarachnoid space infusion" to their labeling. It does not contain information about acceptance criteria or a study proving the device meets them in the way a diagnostic AI device summary would. This document focuses on demonstrating substantial equivalence to a predicate device (a catheter kit already indicated for subarachnoid space infusion) to expand the intended use of the infusion pumps.

Therefore, many of the requested details are not applicable or cannot be extracted from this specific document.

Here's an analysis based on the provided text, indicating where information is not available:

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

• Not Applicable/Not Found: This document does not describe specific numerical acceptance criteria or performance metrics for the infusion pump's functionality related to the new indication. The approval is based on substantial equivalence to a predicate device for the intended use (administering medication via subarachnoid space), not on new performance data for the pump itself.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable/Not Found: No test set or associated data provenance is mentioned as no functional or clinical studies were deemed necessary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable/Not Found: No test set or ground truth establishment process is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable/Not Found: No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable/Not Found: This is an infusion pump, not an AI diagnostic device, so MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable/Not Found: Not an AI diagnostic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not Applicable/Not Found: No ground truth is described. The basis for equivalence is the existing indication of the predicate device (IPI AlgoLine™ Catheter Kits) for subarachnoid space infusion.

8. The sample size for the training set

• Not Applicable/Not Found: No training set is mentioned as no new functional or clinical studies were performed.

9. How the ground truth for the training set was established

• Not Applicable/Not Found: No training set or ground truth establishment process is described.

Summary of the Document's Approach:

The core of this 510(k) notification is an "equivalence device comparison" (Section III and V) and a statement that "No software and/or functional modifications were required" and "no functional testing was deemed necessary" (Section VI). The justification for the new indication relies on the fact that these pumps already deliver medication via various parenteral routes, and the catheters used for subarachnoid space infusion are already commercially available and indicated for that purpose (e.g., IPI AlgoLine™ Catheter Kits). Therefore, the substantial equivalence argument is that the pumps, without modification, can be used for this route when paired with appropriately indicated catheters.

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