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The ALARIS Medical Systems, Inc., Medley" System with Medication Management System (MMS) is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of fluids, medications, blood and blood products.

The Medley™ System with MMS is intended to provide trained healthcare caregivers a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by the trained healthcare professional according to a physician's order.

The Medley *** System (K950419) is a currently marketed modular infusion and monitoring system that consists of a Programming Module (PM) and attachable/detachable modules. Current infusion modules available are a Pump Module (K950419) and a Syringe Module (K023264). Monitoring modules currently include Pulse Oximetry (SpO2) using Nellcor (K022677) and Masimo (K010966) technology.

This traditional 510(k) Premarket Notification is being submitted to assist our customers in reducing the number of manual steps needed to program an infusion by allowing wireless communication capability to the currently marketed device, the Medley" Medication Safety System (Medley System) K950419. This Medication Management System (MMS) adds communication capability to the Medley" System thereby providing our customers with a "safety net" at the bedside to help reduce the number of programming errors at the point of care. This product will be called the Medley System with MMS.

As with the predicate device (B. Braun Medical Inc., Horizon™ Outlook with DoseCom™) this submission adds wireless communication to a server and to an existing infusion device. The Medley System was originally cleared with the capability of wired or wireless communication to include receiving infusion protocol information, uploading/downloading system configuration information and reporting infusion or system status. However, this capability was not well defined and did not include communication with a Server. It was also not clear about the local retrieval of data using optical laser scanning (bar-coding) or RF detection of information contained in documents, labels, RF ID Chips, etc. Adding MMS to the Medley System is simply an expansion of the original 510(k) indications for use for the Medley System. This submission will allow the Medley System to transmit and receive messages with the ALARIS® Server which in turn allows communication capability with external devices, including personal computers, Personal Digital Assistants (PDA's), hospital monitoring systems and Hospital Information Management Systems (HIMS).

The provided text is a 510(k) Premarket Notification for the ALARIS Medical Systems, Inc. Medley System with MMS. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria, especially in the context of typical AI/ML device evaluations.

Here's a breakdown based on the information provided and what is missing:

1. A 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)

• Sample Size: Not specified. The document states "performance data" was used but doesn't detail the nature or size of the dataset.
• Data Provenance: Not specified.

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)

• Number of Experts: Not applicable. This device is an infusion pump system with communication capabilities, not an AI/ML diagnostic or prognostic device that typically requires expert-established ground truth for performance evaluation.
• Qualifications of Experts: Not applicable. The "ground truth" for this type of device would likely involve functional testing against specifications and comparison to the predicate device's operational characteristics, rather than expert interpretation of medical images or patient data.

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

• Adjudication Method: Not applicable. As noted above, this is not an AI/ML diagnostic device requiring expert 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

• MRMC Study: No. An MRMC study is typically for evaluating the impact of AI assistance on human reader performance in diagnostic tasks. This device is an infusion pump system, which does not involve "human readers" in this context.

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

• Standalone Performance: The performance data assessed the device's ability to "meet specified requirements" and be "substantially equivalent to the predicate device." This implies an evaluation of the system's functionalities, including its communication capabilities and automation features, as a standalone entity in relation to its intended purpose. However, the exact methodology is not detailed. The automation of programming infusion parameters is a key function described.

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

• Type of Ground Truth: Not explicitly stated as "ground truth" in the AI/ML sense. For this device, the "ground truth" would likely be based on:
  • Functional specifications: Whether the device performs as designed (e.g., transmits and receives data correctly, automates programming accurately).
  • Comparison to predicate device: Demonstrating that its technological characteristics and performance are equivalent to the legally marketed predicate device (B. Braun Medical Inc., Horizon™ Outlook with DoseCom™).
  • Safety standards: Adherence to relevant safety and performance standards for infusion pumps.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is a hardware/software system for infusion and communication, not an AI/ML model that undergoes a "training" phase with a dataset in the typical sense.

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

• Ground Truth for Training Set: Not applicable, as this is not an AI/ML device that requires a training set with associated ground truth for model development.

In summary: The provided 510(k) document focuses on establishing substantial equivalence for an infusion pump system with added communication capabilities. It references "performance data" indicating the device meets "specified requirements" and is "substantially equivalent" to a predicate device. However, it does not provide the detailed quantitative acceptance criteria, study design, or AI/ML-specific evaluation metrics (like sample sizes for test/training sets, expert adjudication, or MRMC studies) that would typically be found in a submission for an AI/ML-enabled diagnostic or prognostic device. The nature of this device means these AI/ML-specific questions often do not directly apply.

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The MEDLEY SpO2 Module and accessories are intended for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for adult, pediatric, and neonatal patients in hospitals and hospital-type facilities.
The MEDLEY SpO2 Module and accessories are indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. It is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions, and for patients who are either well or poorly perfused, in hospitals and hospital-type facilities.

The MEDLEY SpO2 Module, Model 8210, is essentially the same as the previously cleared device (MEDLEY SpO2 Module, Model 8220). The MEDLEY SpO2 Module (Models 8220 and 8210) and accessories is a device capable of non-invasively monitoring functional oxygen saturation of arterial hemoglobin and pulse rate. The system consists of an SpO2 Module, a Programming Module, connecting cable, and oximetry sensors.
The MEDLEY Programming Module (PM) and SpO2 Module snap together. The Nellcor board contains all of the pulse oximetry algorithms used to measure saturation and pulse rate. The patient cable and oximetry sensors, manufactured by Nellcor, work in combination with the MEDLEY SpO2 Module to utilize Nellcor's technology to measure functional oxygen saturation and pulse rate.

The provided text does not contain detailed information about specific acceptance criteria and the comprehensive study results to demonstrate that the MEDLEY SpO2 Module, Model 8210, meets these criteria. It primarily focuses on demonstrating substantial equivalence to predicate devices and states that verification testing was completed.

However, based on the general nature of the submission for a pulse oximeter, we can infer some aspects and present the available information within the requested structure.

Here's an attempt to answer the questions based on the provided text, with explicit notes where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "The performance information provided demonstrates that the MEDLEY SpO2 Module, Model 8210 and accessories perform as intended and within the required specifications to demonstrate the safety and effectiveness of the device." However, it does not provide a specific table of acceptance criteria (e.g., accuracy ranges for SpO2 or pulse rate) or detailed reported device performance values. These would typically be found in Section 8, which is only referenced.

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

• Sample size for test set: Not explicitly stated in the provided text.
• Data provenance: Not explicitly stated in the provided text. Clinical data for pulse oximeter accuracy typically involves human subject studies, but the details (e.g., country of origin, retrospective/prospective) are absent.

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

• Not explicitly stated in the provided text. For pulse oximeters, ground truth for SpO2 is usually established via co-oximetry of arterial blood samples. This does not typically involve "experts" in the sense of clinicians reviewing data, but rather laboratory analysis.

4. Adjudication method for the test set:

• Not applicable as the nature of the test set (if involved human review) is not described. For objective physiological measurements like SpO2, adjudication in the sense of multiple expert reviews is not typically used for ground truth establishment.

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 device is a pulse oximeter, which directly measures physiological parameters. It does not involve "human readers" or "AI assistance" in the interpretation of complex images or data in a diagnostic context that would warrant an MRMC study.

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

• Yes, implicitly. A pulse oximeter is a standalone device that provides direct measurements (SpO2 and pulse rate) via its internal algorithms without continuous human-in-the-loop performance influencing its primary output. The "design verification testing including software V&V" would encompass standalone algorithm performance.

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

• Inferred: For SpO2 measurements, the gold standard (ground truth) is typically co-oximetry of arterial blood samples. The document does not explicitly state this, but it's the standard for pulse oximeter validation.

8. The sample size for the training set:

• Not explicitly stated. The document refers to the device utilizing "Nellcor's technology" and its "pulse oximetry algorithms." The training of these algorithms would have occurred during the development of the Nellcor technology itself, rather than being a specific training set for this particular 510(k) submission, which is primarily focused on substantial equivalence.

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

• Not explicitly stated. For Nellcor's existing algorithms, the ground truth would have been established through extensive physiological studies using co-oximetry of arterial blood samples across a range of subjects and conditions, typically involving induced hypoxia.

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