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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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