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The CADD -Solis ambulatory infusion pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both (such as patientcontrolled analgesia).

The CADD®-Solis Medication Safety Software consists of the Administrator and the Point of Care software applications. This software allows you to create a set of standard pump Protocols to be used with the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump. The Point of Care software application is used for the CADD-Prizm® PCS II Ambulatory Infusion pump (with software revision H or higher) only.

The CADD® -Solis ambulatory infusion pump ("Solis Pump") provides measured drug therapy to patients in the hospital setting. The pump can be programmed to deliver medication at a continuous rate, patient controlled analgesia (PCA), clinician bolus, continuous rate plus PCA, and continuous rate plus clinician bolus.

The Smiths Medical MD, Inc. CADD® -Solis Medication Safety Software -Administrator ("Solis Safety Software - Administrator"), a server based software program that operates on commercially available computers, is designed to establish user defined therapy based protocols for use by the Solis Pump or for use by use CADD®-Solis Medication Safety Software – Point of Care (POC) to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). The Solis Safety Software - Administrator does not allow duplicative Drug, Protocol or User identification entries.

The provided text describes two devices: the CADD®-Solis Ambulatory Infusion Pump and the CADD®-Solis Medication Safety Software – Administrator. The information primarily focuses on the regulatory submission (510(k) summary) and does not contain detailed acceptance criteria and a study that proves the device meets those criteria in the typical format of clinical performance evaluation studies (e.g., with metrics like sensitivity, specificity, or accuracy).

Instead, the submission indicates that:

• For both devices: "The Solis Pump and Solis Safety Software – Administrator were subjected to verification and validation testing. The verification and validation testing performed demonstrate the devices function as intended and perform to specification."
• For the Medication Safety Software: "Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD-Sentry Pro™ Medication Safety Software." (Note: The document inconsistently refers to "CADD-Sentry Pro™ Medication Safety Software" here, but the 510(k) is for "CADD®-Solis Medication Safety Software - Administrator").
• Conclusion: "Based upon the information provided, the CADD-Sentry Pro™ Medication Safety Software is safe, effective and performs to established specifications."

Given this, I cannot provide a table of acceptance criteria and reported device performance with quantitative metrics, nor can I answer many of the specific questions about clinical study design (sample size, ground truth, expert qualifications, etc.) because such a clinical study, as typically understood for AI/diagnostic devices, was explicitly deemed "not necessary."

However, I can extract the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• No specific sample size for a test set is mentioned.
• Data provenance is not specified. The studies mentioned are "verification and validation testing," which typically involves engineering and functional testing rather than clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable/Not provided. The document states clinical studies were "deemed not necessary."

4. Adjudication method for the test set

• Not applicable/Not provided. Clinical studies with adjudication methods were not conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. A multi-reader multi-case study was not conducted as clinical studies were "deemed not necessary."

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

• The "verification and validation testing" performed for the CADD®-Solis Medication Safety Software – Administrator can be considered a form of standalone testing, as it evaluates the software's functional performance against its specifications. However, this is not a standalone clinical performance study.

7. The type of ground truth used

• For the "verification and validation testing," the ground truth would be based on the established engineering specifications and intended functional behavior of the infusion pump and the software. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

• Not applicable/Not provided. As no AI/ML algorithm requiring a training set is explicitly discussed in the clinical study context, this information is not relevant to the described studies. The software is described as a "server based software program" designed to "establish user defined therapy based protocols."

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

• Not applicable/Not provided. No training set is mentioned.

Summary: The provided document is a 510(k) summary for medical devices (an infusion pump and its associated medication safety software). It describes "verification and validation testing" to show that the devices function as intended and perform to specification. Crucially, it states that "Human clinical studies were deemed not necessary" for the medication safety software. Therefore, the questions related to clinical study design, patient data, expert evaluation, and AI algorithm training sets are not addressed in this document. The "acceptance criteria" appear to be met through these internal functional and validation tests, rather than through a comparative clinical performance study.

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