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The CADD-Sentry Pro"" Medication Safety Software – Administrator allows you to establish a therapy-based protocol library that will be used by the CADD-Sentry Pro Medication Safety Software - Point of Care to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The CADD-Sentry Pro" Medication Safety Software – Point of Care allows use of a personal computer to send CADD-Sentry Pro "Medication Safety Software --Administrator established therapy-based protocols to the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The Smiths Medical MD, Inc. CADD-Sentry Pro™ Medication Safety Software, a software program that operates on commercially available personal computers or similar hardware platforms such as tablets, is designed for pump programming of the CADD-Prizm" PCS II Ambulatory Infusion Pump (software revision H or higher) through a therapy-based protocol database defined by the user. The CADD-Sentry Pro™ Medication Safety Software consists of an Administrator and a Point-of-Care (POC) software module that employs serial communications to send and receive pump information. Both modules are compatible with barcode scanners (or similar input devices) through various PC connections. Barcode format is determined by the user; but is limited to 20 alphanumerical characters. The CADD-Sentry Pro™ Medication Safety Software does not allow duplicative Drug, Protocol or User identification entries.

The CADD-Sentry Pro™ Medication Safety Software - Administrator module allows the user to create and save therapy-based protocols, including pump settings. The Administrator module allows therapy-based protocols to be stored and edited within user-defined protocol libraries. The Administrator user determines POC user access and editing capabilities of these libraries. Other Administrator module features include barcode printing, reports, and sending and receiving pump identification.

The CADD-Sentry Pro™ Medication Safety Software - Point-of-Care module allows the user to send and receive pump settings via serial communication sourced from protocol libraries established using the Administrator module. Additional features include storing and printing pump programs and reports, verifying pump settings to established protocols and viewing history logs in the easier view of the PC monitor.

The provided text describes the CADD-Sentry Pro™ Medication Safety Software. However, it does not contain specific acceptance criteria, a detailed study proving performance against those criteria, or the typical elements of a performance study for AI/machine learning medical devices.

Instead, the document focuses on:

• Device Description: What the software does (Administrator module for creating protocols, Point-of-Care module for sending protocols to a pump).
• Intended Use: How the software is meant to be used.
• Device Comparison: Stating equivalence to a predicate device (itself, indicating a modification or re-submission).
• Summary of Studies: A very brief mention of "Functional Testing" related to software validation and "verification of software controlled programming functions," and a statement that "Human clinical studies were deemed not necessary."
• Conclusion: The software is "safe, effective and performs to established specifications."

Given the information, I can only provide a general response based on the limited details regarding testing.

Acceptance Criteria and Device Performance

The document does not explicitly state numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or measurable device performance metrics in the typical sense of a diagnostic or an AI-driven device. The "acceptance criteria" appear to be met through successful completion of "Functional Testing" and "verification of software controlled programming functions."

Study Details

1. Sample size used for the test set and data provenance:

   • Test Set Sample Size: Not specified. The document only mentions "Test plans associated with software validation, verification of software controlled programming functions, and software related to proper software and pump operation were performed." This implies internal software testing rather than a dataset of patient cases.
   • Data Provenance: Not applicable, as no external data set (e.g., patient data, images, clinical records) was used in the described testing suitable for AI/ML performance evaluation. The testing would have involved the software interacting with the infusion pump.

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

   • Not applicable. The "ground truth" in this context would likely be the expected correct behavior of the software and pump based on engineering specifications and design, rather than expert interpretation of clinical data.

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

   • Not applicable. This type of adjudication method is used for clinical data where human expert disagreement needs resolution. The testing described is functional software testing.

4. 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:

   • No. The document explicitly states, "Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD-Sentry Pro™ Medication Safety Software." This software is a pump communication and programming system, not an AI diagnostic or decision support tool for human readers/clinicians, so an MRMC study is not relevant here.

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

   • The "functional testing" performed would be considered standalone in the sense that it evaluated the software's ability to perform its programmed functions (sending/receiving data, managing protocols) without a human interpreting outputs for diagnostic purposes. However, it's not "standalone" in the typical AI sense of providing a clinical assessment without human oversight. The software's function is to facilitate human programming of a pump.

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

   • The "ground truth" for this device's functional testing would be the pre-defined functional specifications and expected behavior of the software and the CADD-Prizm pump as determined by its design and engineering requirements.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set of data. The software's logic is explicitly programmed.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of software.

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The CADD-Sentry Pro" Medication Safety Software – Administrator allows you to establish a therapy-based protocol library that will be used by the CADD-Sentry Pro Medication Safety Software - Point of Care to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The CADD-Sentry Pro" Medication Safety Software – Point of Care allows use of a personal computer to send CADD-Sentry Pro " Medication Safety Software -Administrator established therapy-based protocols to the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The Smiths Medical MD, Inc. CADD-Sentry Pro™ Medication Safety Software, a software program that operates on commercially available personal computers or similar hardware platforms such as tablets, is designed for pump programming of the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher) through a therapy-based protocol database defined by the user. The CADD-Sentry Pro™ Medication Safety Software consists of an Administrator and a Point-of-Care (POC) software module that employs serial communications to send and receive pump information. Both modules are compatible with barcode scanners (or similar input devices) through various PC connections. Barcode format is determined by the user; but is limited to 20 alphanumerical characters. The CADD-Sentry Pro™ Medication Safety Software does not allow duplicative Drug, Protocol or User identification entries.

The CADD-Sentry Pro™ Medication Safety Software - Administrator module allows the user to create and save therapy-based protocols, including pump settings. The Administrator module allows therapy-based protocols to be stored and edited within userdefined protocol libraries. The Administrator user determines POC user access and editing capabilities of these libraries. Other Administrator module features include barcode printing, reports, and sending and receiving pump identification.

The CADD-Sentry Pro™ Medication Safety Software – Point-of-Care module allows the user to send and receive pump settings via serial communication sourced from protocol libraries established using the Administrator module. Additional features include storing and printing pump programs and reports, verifying pump settings to established protocols and viewing history logs in the easier view of the PC monitor.

The provided 510(k) summary for the CADD-Sentry Pro™ Medication Safety Software does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving device performance in the manner typically expected for AI/ML-based medical devices.

This document describes a software-only device used for programming infusion pumps, and its validation appears to be centered on functional and software verification testing rather than performance metrics against a medical condition or diagnostic task. Therefore, many of the requested fields, particularly those related to clinical performance, ground truth, experts, and comparative effectiveness, are not applicable in this context.

Here's an analysis of the available information:

1. Table of acceptance criteria and the reported device performance:

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

The document only states that "Test plans" were performed for "software validation, verification of software controlled programming functions, and software related to proper software and pump operation." It does not specify a "test set" in the sense of patient data or clinical samples that would have a sample size or provenance. These appear to be internal functional tests of the software.

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. Ground truth, in the context of medical image analysis or diagnostic AI, refers to a definitive correct answer for a medical condition. This device is a software utility for programming an infusion pump, not a diagnostic tool requiring expert interpretation of medical data to establish ground truth.

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

Not applicable. Adjudication methods are typically used in studies where multiple human readers or algorithms interpret data, and their findings need to be reconciled. This is a functional software validation, not a reader study.

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:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD-Sentry Pro™ Medication Safety Software." This type of study is focused on the impact of the software on human performance or diagnostic accuracy, which is not relevant for this device.

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

The device itself is essentially a "standalone algorithm" in the sense that it performs its function of programming the pump automatically based on user input. The "functional testing" performed would be considered the standalone evaluation of the software's performance, ensuring it correctly implements the defined protocols and communicates with the pump. Performance is assessed against its functional specifications.

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

The "ground truth" for this device would be its own functional specifications and the correct operation of the infusion pump. For example, if the software is designed to program the pump with a specific flow rate and volume, the ground truth would be that the pump is indeed programmed with that exact flow rate and volume after the software transmits the data. This would be verified through system testing rather than clinical ground truth like pathology.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML system that learns from a training set of data. It is a deterministic software program that performs predefined functions.

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

Not applicable, as there is no training set for this type of software.

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