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The ambIT™ Intermittent Ambulatory Infusion Pump is intended for the Intermittent volumetric delivery of intravenous medicines and/or fluids into patients at a preset rates and volumes for prescriptive treatment by a physician.

Sorenson Medical's amblT™ Intermittent Ambulatory Infusion Pump is compact, lightweight, microcomputer-controlled pumps that use rotary peristaltic pumping technology. The modified device differs only slightly from the Palm Pumps (K002434) already marketed. Changes have been made to that pump to incorporate three roller gears instead of two, a modified PCB, a change to color and name, and a software revision to provide for intermittent fluid delivery to specified output requirements.

The provided text describes a 510(k) submission for the ambIT™ Intermittent Ambulatory Infusion Pump. It focuses on demonstrating substantial equivalence to a predicate device and details non-clinical tests conducted to verify its performance and safety. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies (MRMC) with human readers.

Here's a breakdown of what can be extracted and what is missing:

Information Extracted from the Document:

• Study Type: Non-clinical verification and validation testing.
• Ground Truth for the Test Set: "Documented performance and safety requirements specified for the new device." These requirements form the ground truth against which the device's performance was compared.
• Sample Size for the Training Set: Not applicable, as this is pre-market non-clinical testing, not an AI/ML device training.
• How the ground truth for the training set was established: Not applicable for the same reason.

Missing Information (and why it's missing based on the document):

1. Table of acceptance criteria and the reported device performance: The document states that "requirements and results of documented verification and validation testing were defined and were conducted," but it does not provide the actual acceptance criteria or the specific performance results in a table format. It only states that the device "met documented performance and safety requirements."
2. Sample size used for the test set and the data provenance: The document mentions "All tests were conducted according to written test protocol," but it does not specify the sample size (e.g., number of devices tested, number of hours of operation, number of cycles). Data provenance (country of origin, retrospective/prospective) is also not applicable as these are non-clinical hardware/software tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. The "ground truth" here refers to pre-defined engineering and safety specifications for the pump's performance rather than expert-labeled data.
4. Adjudication method for the test set: Not applicable. Tests were against engineering specifications, not expert consensus requiring adjudication.
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. This device is an infusion pump, which does not involve human "readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes "non-clinical tests" conducted on the device, which inherently means standalone performance testing against pre-defined specifications. The entire submission focuses on the device's inherent performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): As mentioned, the ground truth was "documented performance and safety requirements specified for the new device" (i.e., engineering and functional specifications for proper fluid delivery).

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence for an infusion pump through standard engineering verification and validation testing. It is not an AI/ML-driven diagnostic device, which is why much of the requested information (like expert input, MRMC studies, training sets, etc.) is not present or applicable. The document confirms that non-clinical tests were performed and that the device "met" its specified performance and safety requirements, but the specific details of these criteria and results are not included in this summary.

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