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The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of medications or fluids. The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as intravenous (IV), subcutaneous, or epidural.

The addition of the PCA/Monitoring Protocol provides an optional and hospitalconfigurable feature that is intended to align with healthcare facilities' current protocols that require monitoring of patients while on PCA therapy. All device programming, data entry and validation of PCA/Monitoring Protocol parameters is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order.

The Medley PCA Module with PCA/Monitoring Protocol is intended for use with patients that are prescribed PCA pain management therapy with opioid medications, specifically: Fentanyl, Demerol, Morphine, and Hydromorphone. The Medley PCA Module with PCA/Monitoring Protocol is intended for use by healthcare professionals in clinical environments. The Protocol does not replace clinician assessment or therapy decision making, but adds an additional safety net for the clinician at the point of care. All device programming, data entry and validation of the Medley PCA Module with PCA/Monitoring Protocol is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order.

Due to the potential for opioid-induced respiratory depression, hospitals require regular monitoring and assessment of patients prescribed opioid medications. By allowing for the combination of a PCA Module and monitoring module (EtCO2 Module and/or SpO2 module) on the same platform, the Medley System provides a readily available way for the clinician to continuously monitor the patient's respiratory response while receiving opioid infusion therapy.

This submission will utilize the current system modularity to add a new hospitalconfigured Guardrails parameter (PCA/ Monitoring Protocol) to the Medley PCA Module. This Protocol is designed to help ensure patient safety when administering opioid medications. This Protocol will be available for use when a PCA Module and monitoring module(s) are attached to the same Medley Point of Care Unit (PCU). The PCA/Monitoring Protocol will be part of the Guardrails data set and will consist of a specified list of opioid medications and hospital-specified pre-configured monitoring limits. The Protocol will activate only when hospital-specified protocol indicates an unsafe state of respiratory depression is detected.

The provided document discusses the Medley™ PCA Module with PCA/Monitoring Protocol and its substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance data in the typical sense for a diagnostic or AI-powered device.

This clearance is for a medical device (an infusion pump with a specific protocol feature), which undergoes different types of validation than, for example, an AI diagnostic tool. The "performance data" mentioned in the document refers to engineering and functional testing to ensure the device operates as intended and is safe, rather than clinical performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of the requested categories (like sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance with metrics like AUC/sensitivity/specificity) are not applicable or not detailed in this type of 510(k) summary for an infusion pump.

However, I can extract what is available from the document regarding the "acceptance criteria" (implied functional requirements) and what the document states about "performance data".

Here's an attempt to answer based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

• Ability to deliver continuous or intermittent medications/fluids.
• Compatibility with various routes of administration (IV, subcutaneous, epidural).
• Integration of a PCA Module and monitoring module (EtCO2 Module and/or SpO2 module) on the Medley System platform.
• Activation of PCA/Monitoring Protocol based on hospital-specified parameters and detection of an "unsafe state of respiratory depression."
• All device programming, data entry, and validation of parameters performed by trained healthcare professionals according to protocol/physician's order.
• The Protocol acts as an "additional safety net" for clinicians without replacing assessment or decision-making.
• The device must meet specified requirements for safety and effectiveness. | The document states:
  "The Medley PCA Module is intended for use... for continuous or intermittent delivery through clinically acceptable routes of administration; such as intravenous (IV), subcutaneous, or epidural."

"By allowing for the combination of a PCA Module and monitoring module (EtCO2 Module and/or SpO2 module) on the same platform, the Medley System provides a readily available way for the clinician to continuously monitor the patient's respiratory response..."

"This Protocol is designed to help ensure patient safety when administering opioid medications... The Protocol will activate only when hospital-specified protocol indicates an unsafe state of respiratory depression is detected."

"All device programming, data entry and validation of PCA/Monitoring Protocol parameters is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order."

"The Protocol does not replace clinician assessment or therapy decision making, but adds an additional safety net for the clinician at the point of care."

"The performance data indicate that the Medley™ PCA Module with PCA/Monitoring Protocol meets specified requirements, and is substantially equivalent to the predicate device." |

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

• Not explicitly stated in the document. The "performance data" mentioned would typically refer to engineering and functional testing of the device's hardware and software, rather than clinical trials with patient data. This is common for a 510(k) medical device clearance where substantial equivalence to a legally marketed predicate is established.

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

• Not applicable/not explicitly stated. For a medical device like an infusion pump, "ground truth" in the diagnostic sense is not typically established by experts reviewing cases. Performance is usually assessed against engineering specifications and functional output.

4. Adjudication method for the test set

• Not applicable/not explicitly stated. Clinical adjudication, as seen in diagnostic studies, is not typically part of the clearance for an infusion pump's functional performance.

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 with a safety protocol (not an AI diagnostic tool for image or data interpretation by human readers). Therefore, MRMC studies are not relevant.

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

• Partially applicable, but for device function, not diagnostic performance. The "algorithm" here refers to the PCA/Monitoring Protocol. Its standalone functionality (i.e., whether it correctly detects 'unsafe states' based on its programming and triggers alerts) would have been tested as part of the "performance data." However, its "performance" is not measured in terms of diagnostic metrics like AUC, sensitivity, or specificity against a clinical ground truth, but rather its adherence to design specifications and safety requirements. The document states it is "intended to align with healthcare facilities' current protocols."

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

• Not explicitly stated/not applicable in the traditional sense. For this device, the "ground truth" for validation would be its adherence to engineering specifications, safety standards, and its ability to correctly implement the defined "PCA/Monitoring Protocol" logic (e.g., detecting specified physiological parameters (EtCO2, SpO2) and acting in accordance with pre-configured monitoring limits). These are validated through functional and performance testing, not against clinical outcomes or expert consensus on patient cases.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model that requires a training set in the conventional sense. Its "protocol" is programmed logic, not learned from data.

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

• Not applicable. See point 8.

Summary of the Study (as described in the 510(k) submission):

The document describes the Medley™ PCA Module with PCA/Monitoring Protocol and references a "performance data" section, which is typical for 510(k) submissions. This "performance data" is designed to demonstrate that the device meets its specified requirements and is substantially equivalent to its predicate device (Medley PCA Module, K032233).

The study that proves the device meets the acceptance criteria (i.e., functional requirements and safety) is implicitly described as the "Performance Data" section of the 510(k) submission. This data would have involved:

• Bench testing: Verifying the accuracy of fluid delivery, the functionality of the monitoring module integration (EtCO2, SpO2), and the correct execution of the PCA/Monitoring Protocol logic (e.g., proper activation in response to simulated "unsafe states" and adherence to pre-configured monitoring limits).
• Software validation: Ensuring the software correctly implements the protocol and user interface.
• Electrical safety and EMC testing: Adherence to relevant standards.

The primary goal of this submission was to demonstrate Substantial Equivalence to a previously cleared device (Medley PCA Module, K032233) due to the addition of a new hospital-configurable Guardrails parameter (the PCA/Monitoring Protocol). The document states, "The results of this comparison demonstrate that the Medley™ PCA Module with PCA/Monitoring Protocol is equivalent to the marketed predicate device in technological characteristics." and "The performance data indicate that the Medley™ PCA Module with PCA/Monitoring Protocol meets specified requirements, and is substantially equivalent to the predicate device."

This means the "study" involved comparing the new device's functional and safety performance against the established requirements and the predicate device's performance, ensuring the added protocol feature did not introduce new safety concerns or compromise existing functionality.

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The Medley System with Bar Code Module 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 Bar Code Module 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 Bar Code Module functions as part of the Medley System and can operate as a fifth module (when all four infusion and/or monitoring positions are in use). The Medley Bar Code Module attaches to and receives its power from the Medley System consistent with the modular design. The Bar Code Module does not directly interface with the Medley System; all communications are routed using a separate and dedicated communications interface channel resident in the Medley System.

Through the dedicated communications channel, the Medley Bar Code Module exchanges information between itself and other sources, such as the patient wristband, medication or device packaging, Medley, or MMS System components such as the ALARIS Server and Hospital Information Management Systems. As with the Medley System with MMS, there is an information protocol for proprietary data exchange and a method to verify the integrity of the information sent or received prior to programming a Medley System infusion module. The software incorporates error checking to ensure the correct acquisition, exchange, and integrity of acquired bar coded data.

All data entry and verification of infusion parameters using the Medley System with Bar Code Module is performed by trained healthcare professionals prior to administration of medication(s). The Medley Bar Code Module does not affect the operation of the Medlev System. All Medley System functionality and performance specifications remain unchanged.

An attachable/detachable handheld scanner will be provided as an accessory to the Medley System with Bar Code Modulc as alternative way to acquire bar code data.

The provided text is a 510(k) premarket notification for a medical device (ALARIS Medical Systems® Medley™ System with Bar Code Module) from 2004. This type of document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting detailed acceptance criteria and performance studies in the way you've outlined for AI/ML-based devices.

Therefore, many of the specific details you requested (like effect size of AI assistance, sample size for AI training sets, expert compensation, etc.) are not available in this type of regulatory submission for this device. The regulatory pathway for this device predates the widespread use of sophisticated AI/ML in medical devices, and the focus is on hardware and software functionality for automating infusion parameter entry.

However, I can extract the available information and indicate where details are not provided.

Here's a summary based on the provided text:

Acceptance Criteria and Study Information (ALARIS Medical Systems® Medley™ System with Bar Code Module)

This 510(k) submission primarily focuses on demonstrating substantial equivalence to predicate devices for the Medley™ System with Bar Code Module. The performance data presented indicates that the device meets specified requirements to establish this equivalence, rather than providing detailed clinical study results with explicit numerical acceptance criteria and a detailed study protocol for AI/ML performance.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified in the provided document. The document refers to "Performance Data" but does not detail the nature or size of any test sets used.
• Data Provenance: Not specified. This type of submission generally doesn't detail the origin of data beyond internal testing in this context.

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

• This concept of "ground truth" and expert adjudication is typically relevant for interpretative AI/ML devices. For this infusion pump module, the "ground truth" would likely be based on engineering specifications and direct comparison of barcoded data to expected values.
• The document mentions "trained healthcare professionals" for data entry and validation during use, but not for establishing ground truth in a formal test set for the device's bar code module performance.

4. Adjudication method for the test set:

• Not applicable/addressed in this document. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretation or complex clinical assessments, which is not the primary function of this device.

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

• Not applicable. This device is an infusion pump module with a bar code reader, designed to automate data entry. It does not employ AI in the manner that would necessitate an MRMC study comparing human readers with and without AI assistance for interpretation. Its function is to reduce manual steps for entering infusion data, not to assist in diagnostic interpretation.

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

• The device's core function is to acquire and process barcoded data. The performance of the bar code module itself (reading accuracy, error checking) would inherently be a standalone test. However, the overall intended use always involves a "trained healthcare professional" for validation. The document states: "All data entry and verification of infusion parameters using the Medley System with Bar Code Module is performed by trained healthcare professionals prior to administration of medication(s)." Therefore, while the component can be tested standalone for its technical performance, its clinical use is human-in-the-loop.

7. The type of ground truth used:

• For the bar code module, the ground truth would typically be the known, correct data encoded in the bar codes being scanned. The "error checking" software would verify that the acquired data matches this known correct information.

8. The sample size for the training set:

• Not applicable/specified. This device is not described as using machine learning that requires a "training set" in the modern sense. Its software likely relies on programmed logic and error checking rather than learned patterns.

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

• Not applicable. As no training set is indicated, this question is not relevant to the information provided for this device.

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The Medley™ EtCO2 Module is a capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The monitor is intended for use by professional healthcare providers where continuous, non-invasive monitoring of these parameters is desired. The Medley™ EtCO2 Module is indicated for use on adults, pediatrics and infant/neonates for both intubated and non-intubated patients.

The EtCO2 Module is the newest module to the currently marketed Medley™ Medication Safety System (Medley™ System). ALARIS Medical will incorporate currently marketed Oridion capnograph technology and accessories into the Medley™ EtCO2 Module. The Medley™ EtCO2 Module will be used to measure inspired and expired carbon dioxide (FiCO2 and EtCO2 respectively) and Respiration Rate (RR) on patients in the operating room, ICU, NICU, transport and emergency treatment. This capnograph technology originates from the MediCap/NPB-75 (K964239).

The provided text describes the Alaris Medical Systems Medley EtCO2 Module, a capnograph designed to continuously monitor end-tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR). The document is a 510(k) premarket notification summary.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) summary, does not explicitly state specific numerical acceptance criteria or performance metrics (like accuracy, precision, or bias) for EtCO2, FiCO2, or RR measurements. Instead, it makes a general statement:

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide details about a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The evaluation appears to be based on demonstrating "substantial equivalence" to a predicate device and relies on the predicate's established performance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not available in the provided text. No ground truth establishment by experts for a test set is described.

4. Adjudication Method for the Test Set

This is not applicable/not provided as no test set requiring expert adjudication for ground truth is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study is not mentioned in the document. The device is a monitor, not an AI diagnostic tool requiring human reader interpretation or assistance.

6. Standalone Performance Study (Algorithm Only)

The document does not describe a standalone performance study in the context of an algorithm's performance. The Medley EtCO2 Module is a hardware device that incorporates "currently marketed Oridion capnograph technology." Its performance is evaluated against (or shown to be equivalent to) an existing predicate device rather than undergoing a separate standalone algorithm performance study. The statement "The performance data included in this submission indicate that the Medley" EtCO2 Module meets specified requirements" suggests internal testing was done, but no details of such a study are provided.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any performance evaluation. Given it's a capnograph, ground truth would typically come from a gold-standard CO2 measurement method, but this is not detailed. The primary basis for approval appears to be substantial equivalence to a predicate device.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. As a hardware medical device based on existing technology, the concept of a training set for an algorithm is not directly applicable in the information provided.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as no training set is described.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Oridion MicroCap/NPB-75, K964239) rather than detailing specific standalone performance studies with quantitative acceptance criteria, test sets, or ground truth establishment relevant to AI/algorithm performance. The approval hinges on the assertion that the "technological characteristics" and "performance data" show the device is "substantially equivalent" to the predicate.

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The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of medications or fluids.

The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), subcutaneous, or epidural.

The Medley PCA Module functions as part of the Medley™ Medication Safety System. In combination with the Medley" Programming Module (PM), the PCA Module will deliver fluids in a manner similar to current PCA pumps on the market. The Medley" PCA Module uses standard non-dedicated, single-use, administration sets and syringes with luer-lock connectors, of type designed for use on syringe-type PCA pumps.

The provided document is a 510(k) summary for the ALARIS Medical Systems® Medley™ PCA Module. It states that the device is substantially equivalent to predicate devices and meets specified performance requirements. However, it does not provide specific acceptance criteria or detailed results from a study proving these criteria are met.

Therefore, I cannot populate the table or answer most of the questions using the information given. The document explicitly states: "The performance data indicate that the Medley PCA Module meets specified requirements, and is substantially equivalent to the predicate devices," but it does not detail those requirements or the specific performance data.

Here's what can be inferred or stated based on the provided text:

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 for test set: Not specified.
• Data provenance: Not specified (country of origin or retrospective/prospective nature of any studies).

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 specified, as no detailed study or ground truth establishment is described.

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

• Not applicable/Not specified.

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 mention of an MRMC study, AI, or human reader improvement. This device is a PCA infusion pump, not an AI-assisted diagnostic tool.

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

• Not applicable/Not specified. This is a medical device (infusion pump), not an algorithm.

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

• Not applicable/Not specified, as no detailed study or ground truth establishment is described. The performance data would likely relate to engineering specifications for pump accuracy, safety features, etc.

8. The sample size for the training set

• Not applicable/Not specified, as no machine learning or AI training is described.

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

• Not applicable/Not specified.

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The Signature Edition Infusion System (infusion pumps and administration sets) is intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products.

The Signature Edition Infusion System is indicated for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.

This device is essentially the same as the originally submitted devices (the predicate devices), filed as Models EZ 1 and EZ 2 Infusion Pumps (K931549) and EZ Administration Set Series (K931550). The electrical volumetric pumps and administration sets are used to control the rate or monitor the flow of solution or medication for delivery of drugs, fluids, and blood products. In general, infusion systems are used when the solution to be administered needs to be delivered with greater accuracy or at a higher flow than can be provided through a manually adjusted gravity administration set. Because they allow more accurate fluid delivery, infusion systems have been proven to be useful in applications such as continuous epidural anesthesia, administration of IV cardiovascular drugs, chemotherapy, and blood transfusions.

This document (K032147) is a 510(k) premarket notification for the "Signature Edition Infusion System," which is essentially the same as predicate devices (EZ 1 and EZ 2 Infusion Pumps and EZ Administration Sets) with minor changes. The submission primarily focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than presenting a study of its own performance against pre-defined acceptance criteria.

Therefore, the requested information regarding acceptance criteria and performance data for a new study validating the device's performance is not available within this document. The document explicitly states: "The changes as described in this Special 510(k) pose no new issues of safety or efficacy." This implies that extensive new performance studies (especially those with detailed acceptance criteria, expert adjudication, MRMC studies, or standalone performance data) were not deemed necessary because the device is substantially equivalent to already approved devices.

Here's an explanation based on the provided text, acknowledging the lack of specific performance study details:

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

This information is not provided in the document. The document asserts that the "Signature Edition Infusion System is essentially the same as the predicate devices," (EZ 1 and EZ 2 Infusion Pumps, K931549, and EZ Administration Sets, K931550). The implication is that the performance of the Signature Edition Infusion System would meet the same performance metrics and acceptance criteria as its predicate devices, but these specific metrics are not detailed in this 510(k) summary. The document states: "The results of this comparison demonstrate that the Signature Edition Infusion System is equivalent in technological characteristics and the fundamental scientific technology of the predicate devices has not been altered." This suggests that previous studies for the predicate devices established their performance, and this current submission relies on that equivalence.

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

This information is not provided in the document. Since this is a 510(k) for substantial equivalence to predicate devices with "no new issues of safety or efficacy," extensive new performance testing with specific sample sizes might not have been required or documented here.

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

This information is not provided in the document.

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

This information is not provided in the document.

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:

This is not applicable as the device is an infusion system, not an AI-assisted diagnostic tool. No MRMC study was mentioned or implied.

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

This is not applicable as the device is an infusion system, not an algorithm. Standalone performance for its intended function (fluid and medication delivery) would be evaluated based on flow rate accuracy, pressure limits, safety features, etc., but specific studies demonstrating this are not detailed in this summary. The fundamental scientific technology has not been altered, implying prior validation.

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

This information is not provided in the document for new testing of this specific device. For the predicate devices, "ground truth" would likely refer to established engineering and physiological standards for infusion accuracy, safety alarms, material compatibility, and reliable fluid delivery, as demonstrated in their original submissions.

8. The sample size for the training set:

This information is not provided in the document. This is not an AI/algorithm-based device that would typically have a "training set."

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

This information is not provided in the document. As stated above, this is not an AI/algorithm-based device.

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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™ Syringe Pump is intended for use in today's growing professional healthcare environment for facilities that utilize syringe pumps for the delivery of fluids, medications, blood and blood products.

The MEDLEY™ Syringe Pump is indicated for use on adults, pediatrics and neonates for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural, enteral, or irrigation of fluid spaces.

The MEDLEY Syringe Pump Module functions as part of the MEDLEY™ Medication Safety System. In combination with the MEDLEY™ Programming Module (PM), the Syringe Module will deliver fluids in a manner similar to current syringe pumps on the market. Up to four Syringe Modules may be connected to each PM.

The MEDLEY™ Syringe Pump uses standard, single-use, administration sets (with and without pressure disc) and syringes with luer-lock connectors, of type designed for use on syringe pumps. The MEDLEY™ Syringe Pump may be used with administration sets that contain a pressure disc. If the pressure disc is used, the following features are available:

• Back-off .
• . Fast Start
• Customizable Pressure Alarm Settings ●
• Pressure Tracking Display ●
• Auto Pressure .

The provided text is for a 510(k) premarket notification for a medical device, specifically the ALARIS Medical Systems® MEDLEY™ Syringe Pump Module. This document does not contain the detailed information required to fill out the requested table and answer the specific questions about acceptance criteria and study particulars for a software-based AI device.

Here's why and what information can be extracted:

Information NOT Found in the Document:

• Acceptance Criteria Table: The document states "The performance data indicate that the MEDLEY™ System Syringe Pump meets specified requirements, and is substantially equivalent to the predicate devices." however, it does not list the specific performance acceptance criteria (e.g., accuracy percentages, specific error rates) or detailed reported device performance against those criteria.
• Sample Size for Test Set and Data Provenance: This information is not provided. The document focuses on regulatory equivalence, not detailed testing methodologies.
• Number of Experts/Qualifications for Ground Truth: Not applicable and not mentioned for this type of device.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is a hardware device (syringe pump), not an AI/software device. Therefore, an MRMC study is not relevant or described.
• Standalone Performance (AI context): Not relevant as this is not an AI device.
• Type of Ground Truth: Not relevant in the AI sense. This refers to the accuracy of the pump's mechanical operation, not image interpretation or diagnostic performance validated against a ground truth.
• Sample Size for Training Set: Not applicable, as this is a hardware device lacking a "training set" in the AI/machine learning sense.
• How Ground Truth for Training Set Was Established: Not applicable.

Information That Can Be Extracted (Pertaining to the Device Type):

The document describes the device, its intended use, and its substantial equivalence to predicate devices. For a hardware device like this, "performance data" would typically refer to engineering tests demonstrating accuracy of fluid delivery, pressure settings, alarm function, and safety features.

Summary based on the provided text (and noting what's not there for your specific request):

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

   • Acceptance Criteria: Not explicitly listed as specific quantitative metrics in this document. The general criterion is that "The MEDLEY™ System Syringe Pump meets specified requirements."
   • Reported Device Performance: Not detailed in this document. It broadly states that "performance data indicate that [it] meets specified requirements, and is substantially equivalent to the predicate devices."

2. Sample sized used for the test set and the data provenance: Not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of hardware device. Performance is determined through engineering tests and calibration.

4. Adjudication method for the test set: Not applicable for this type of hardware device.

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 is a hardware syringe pump, not an AI diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a hardware syringe pump.

7. The type of ground truth used: For a syringe pump, 'ground truth' would generally refer to established engineering standards for fluid delivery accuracy, pressure measurement, and alarm functionality. The document doesn't detail the specific methods (e.g., flow rate measurements, pressure sensor calibration).

8. The sample size for the training set: Not applicable. This is a hardware device, not an AI/ML system.

9. How the ground truth for the training set was established: Not applicable.

Conclusion:

The provided document is a 510(k) summary for a hardware medical device (syringe pump) seeking substantial equivalence. The questions you've asked are largely tailored for the evaluation of AI/software devices, which involve very different types of studies, metrics, and "ground truth" establishment. Therefore, most of the requested information is not present or applicable in this source text.

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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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The following ALARIS Medical Infusion Systems are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products:

• IVAC® Signature Edition® Infusion Pumps and Administration Sets. ●
• IVAC® MedSystem III® Multi-Channel Infusion Pump and IVAC MedSystem III® Multi-. Channel Infusion Pump with DLE and Administration Sets.
• IMED® Gemini Infusion Pumps/Controllers and Administration Sets. .
• ALARIS Medical Medication Safety System and Administration Sets. ●
• IVAC®, IMED®, and ALARIS® Gravity, Extension, Components, and Secondary . Administration Sets.

The following ALARIS Medical Infusion Systems are included in this Special 510(k):

• . IVAC Signature Edition Infusion Pumps & Administration Sets.
• IVAC MedSystem III Multi-Channel Infusion Pump & IVAC MedSystem III Multi-Channel Infusion Pump with DLE & Administration Sets.
• . IMED Gemini Infusion Pumps/Controllers & Administration Sets.
• ALARIS Medical Medication Management System & Administration Sets.
• IVAC, IMED, and ALARIS Medical Gravity, Extension, Components, & Secondary Administration Sets.

This document is a 510(k) premarket notification for ALARIS Medical Infusion System Administration Sets, not a study proving device performance against acceptance criteria. The submission is a "Special 510(k)" which affects only the labeling of the administration sets to improve consistency and customer satisfaction. It explicitly states that "The intended use, typical applications, and fundamental scientific technology for ALARIS Medical Infusion Systems have not changed with this Special 510(k) submission".

Therefore, the provided text does not contain any information regarding:

• Acceptance criteria for device performance.
• A study that demonstrates the device meets acceptance criteria.
• Sample sizes used for test sets or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth for a training set was established.

The document is a regulatory submission for a labeling change, asserting substantial equivalence to previously marketed devices, rather than a report on new performance testing.

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The Single Dose Dispensing Pin is a stand-alone, single use, disposable access device which permits syringe access to a medication vial without the use of a needle. The device is intended for use by healthcare professionals in a wide variety of healthcare environments including hospitals, healthcare facilities, and pharmacies.

The Single Dose Dispensing Pin is indicated for use with standard medication vials and needleless syringes for withdrawal and/or injection of fluid.

The Single Dose Dispensing Pin (Dispensing Pin) is a stand-alone, single use, disposable syringe access device which permits access to a medication vial without the use of a needle. The Dispensing Pin is connected to a needleless syringe and is inserted into the rubber stopper of a medication vial. The healthcare provider uses the Dispensing Pin to inject or withdraw fluid from a vial.

The provided text describes a medical device, the "Single Dose Dispensing Pin," and its substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study proving that the device meets specific performance criteria.

The document is a 510(k) summary for premarket notification to the FDA. In this type of submission, the focus is on demonstrating that a new device is "substantially equivalent" to legally marketed predicate devices, rather than conducting new performance studies against pre-defined acceptance criteria for a novel device.

Here's how the information provided aligns with your request, with critical missing details highlighted:

Description of Acceptance Criteria and Study to Prove Device Meets Them

Missing Information: The provided text explicitly states: "The performance data supplied in this submission indicate that the Single Dose Dispensing Pin meets all specified requirements, and is substantially equivalent to the predicate devices." However, it does not explicitly list the "specified requirements" (acceptance criteria) or describe the actual "performance data" or studies conducted.

Without the actual study report or a more detailed summary of its findings, it's impossible to fill out most of the requested table and answer the specific study-related questions.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, this table cannot be completed. The document only generally states that the device "meets all specified requirements" without detailing those requirements or the specific performance metrics achieved.

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

Missing Information: The document does not describe a "test set" in the context of performance testing, nor does it provide any sample size or data provenance details. The 510(k) is about demonstrating substantial equivalence, not a new performance study with a distinct test set.

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

Missing Information: This question is not applicable to the information provided. There is no mention of "ground truth" or expert review in the context of a performance study for this device in the given text.

4. Adjudication method for the test set

Missing Information: Not applicable. 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

Missing Information: This question is not applicable. The device is a "Single Dose Dispensing Pin," which is a physical medical device, not an AI-powered diagnostic tool requiring human reader studies.

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

Missing Information: This question is not applicable. The device is a physical medical device, not an algorithm.

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

Missing Information: Not applicable. No "ground truth" is discussed in relation to a performance study for this device.

8. The sample size for the training set

Missing Information: This question is not applicable. The device is a physical medical device and does not involve AI or machine learning models that would require a "training set."

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

Missing Information: This question is not applicable. As above, there's no training set for this type of device.

In summary: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to existing predicate devices. It states that performance data was supplied and that the device meets requirements, but it does not provide the details of those performance requirements (acceptance criteria), the actual performance data, or the methodology of any studies conducted. Therefore, most of the specific questions about acceptance criteria and study details cannot be answered from the given text.

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