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The intended use of the MedSystem III Infusion Pump is to deliver a wide variety of drugs and fluids (e.g., bloods, lipids, saline, dextrose) over a broad range of infusion rates, at high levels of accuracy. IVAC's policy is to not indicate specific drugs and/or fluids. Specific intended uses include enteral, intravenous, and epidural deliveries.

The Drug Editing Software Kit (DESK) allows the user to customize the resident drug list for the Dose Rate Calculator (DRC) feature that is available in the legally marketed MedSystem III Infusion Pump. The current system allows custom changes on a one by one basis. The DESK system allows users to make permanent custom changes to the resident drug list.

The DESK is a PC-based software tool operated under Microsoft Windows. This software tool will be used to customize the drug list for the Dose Rate Calculator (DRC) feature that is already available in the legally marketed MedSystem III Infusion Pump. The DESK allows the user to access the factory default druq list in the infusion pump via the Field Maintenance Software (FMS). After access the user can add, modify, or delete drug names and dosing parameters. The modified list can then be downloaded into the MedSystem III Infusion Pump via the FMS. The FMS is already available as a legally marketed accessory to the MedSystem III Infusion Pump.

The provided text is related to a 510(k) submission for the IVAC MedSystem III™ Infusion Pump with Drug Editing Software Kit (DESK). However, it is a regulatory document and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

The document primarily focuses on:

• Device Description: The DESK is PC-based software to customize the drug list for the Dose Rate Calculator (DRC) feature of the MedSystem III Infusion Pump.
• Intended Use: To allow users to add, modify, or delete drug names and dosing parameters. The pump itself delivers fluids at high accuracy.
• Technological Characteristics: States that the MedSystem III Infusion Pump has not changed and the DESK has the same technological characteristics as an existing software accessory (FMS). It highlights that a similar feature allowing single drug list customization already exists, and DESK enables permanent customization. Crucially, it states: "The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness."
• Substantial Equivalence: The primary conclusion is that the device is substantially equivalent to existing legally marketed devices, and no new questions of safety and effectiveness are raised.

Because the submission claims substantial equivalence and states no new questions of safety and effectiveness are raised by the DESK software, no new performance studies are presented or required within this document. Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details.

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The intended use for the SmartSite Access Pin is to allow access to IV administration sets, medication vials, blood tubes, and solution bags with one convenient device without the use of needles or blunt cannulas.

The SmartSite Access Pin is a stand alone accessory and is the same device as the currently marketed /VAC Needle Free Valve (K960280) with the exception of a modified housing. The housing for the SmartSite Access Pin has been modified to accommodate the needs of an access pin by adding a protected spike and finger grips. Functionally, the SmartSite Access Pin is the same as the currently marketed /VAC Needle Free Valve in that it allows access to IV administration sets. As an access pin device, the SmartSite Access Pin also allows access to medication vials, blood tubes, and solution bags without the use of needles or blunt cannulas.

This is a medical device 510(k) premarket notification, not a study evaluating an AI algorithm or diagnostic device. Therefore, most of the requested information regarding acceptance criteria for device performance in a study setting, sample sizes for test/training sets, expert involvement, and ground truth establishment, is not applicable.

Instead, this document describes a conventional medical device (SmartSite™ Access Pin) and its substantial equivalence to previously cleared devices. The "acceptance criteria" here would refer to the regulatory requirements for substantial equivalence, rather than statistical performance metrics of a diagnostic algorithm.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and 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)

Not applicable. This is a 510(k) premarket notification for a traditional medical device, not a study involving a test set of data for an algorithm. The "testing" involved would be engineering and functional testing to ensure the device meets its specifications and is safe, but not in the context of diagnostic performance on patient data.

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 and expert adjudication are not relevant for this type of medical device submission.

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

Not applicable.

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 not an AI algorithm and does not involve human readers for diagnostic interpretation.

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

Not applicable. This is a physical medical device, not an algorithm.

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

Not applicable.

8. The sample size for the training set

Not applicable.

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

Not applicable.

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