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The Douglas Medical Products Maxcess™ NeedleFree Y-Site is intended for single patient use and intended for placement between the male Luer connection of a primary solution source and the patient's vascular access device. In this position, the y-site body provides unobstructed flow between the fluid source and the patient. The needlefree side port of the y-site can be swabbed and then accessed multiple times within the limits of CDC guidelines and/or institutional guidelines. The closure system has been tested and has been found to maintain line patency throughout the labeled duration of use.

The Douglas Medical Products Maxcess™ NeedleFree Y-Site is a sterile, nonpyrogenic component packaged in a tyvek/polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess™ NeedleFree Y-Site have been tested per tripartite guidelines and is safe for it's intended use.

I am sorry, but the provided text from "Ka70800" does not contain information about acceptance criteria, device performance, study design, or any of the other specific points requested in your prompt. The document is a "Summary of Safety and Effectiveness" for a medical device (Maxcess™ NeedleFree Y-Site) and primarily focuses on its intended use, materials, sterilization, and equivalence to a predicate device for 510(k) submission.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

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The SoloPak Medical Products, Paragon Infusion Pump and Administration Sets are intended to be used as a system for the purpose of delivering drugs and solutions through an in-dwelling catheter.

The pump is made of two cylindrical high impact plastic shells with a pressure plate assembly in the top shell. It is packaged individually and can be cleaned after each use and reused. The Administration Sets that function with the pump consists of a 110mL PVC drug container, PVC tubing, a fill valve, PVC tubing, an onloff clamp, a 1.2 Micron Filter, a male Luer lock adapter with an integrated flow restrictor and tip protectors. The administration Sets are individually packaged as single use devices in tyvek and mylar pouches. They are EtO stenlized per AAMI guidelines and meet the requirements of the Federal Register Vol. 43, No. 122, June 23,1978, pp 27482-3 for ethylene oxide residuals.

This document is a 510(k) summary for the SoloPak Medical Products Paragon Infusion Pump and Administration Sets. It does not contain the detailed information required to answer your specific questions regarding acceptance criteria and study design for a device's AI performance.

The document discusses the device's technical specifications, intended use, and claims of substantial equivalence to a predicate device based on manufacturing processes and design, not AI performance. It mentions a performance claim related to flow rate accuracy but this is a traditional medical device performance metric, not an AI-related one.

Therefore, an answer fulfilling your request cannot be generated from the provided text.

To answer your questions, I would need a document that describes the development, testing, and validation of an AI-powered medical device, including information on its performance against specific acceptance criteria, details on training and test datasets, ground truth establishment, and if applicable, MRMC studies.

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The SoloPak® Sidekick Infusion Pump and Administration Set is intended to be used for the general use infusion of small volumes (50 - 100 ml) .

The SoloPak® Sidekick Infusion Pump is individually packaged and can be cleaned and reused for multiple infusions. The Administration Set is sterile, non-pyrogenic, and packaged in a tyvek/polyethylene pouch. It is a single use set. The materials used to manufacture the SoloPak Sidekick Infusion Pump and Administration Set are the same as those used in currently legally marketed products with the same intended uses.

This document pertains to the SoloPak® Sidekick Infusion Pump and Administration Set, a medical device for infusing small volumes (50-100 ml). The information provided is a 510(k) summary submitted in 1996, focusing on demonstrating substantial equivalence to a predicate device for safety and effectiveness.

Here's an analysis based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for performance testing (e.g., infusion accuracy). It mentions "the infusion sets have been tested," but no numerical sample size is provided.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. Given the nature of a 510(k) submission, the data would likely be from laboratory testing and potentially some internal verification tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided. The document describes laboratory testing and comparisons to established guidelines (AAMI, USP) and a predicate device, rather than a process involving expert consensus on "ground truth" as might be seen for diagnostic algorithms.

4. Adjudication Method for the Test Set

Not applicable. The "adjudication method" is typically relevant for studies involving human interpretation or subjective assessment where multiple experts' opinions need to be reconciled. This document describes performance testing against objective criteria (e.g., ±15% accuracy, sterility level).

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 and administration set, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not relevant to this submission.

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

Not applicable. The SoloPak® Sidekick is a mechanical/electronic medical device, not an algorithm. Standalone performance for an algorithm is not relevant. The closest equivalent would be the "standalone" performance of the pump itself in delivering fluid accurately, which is addressed by the ±15% accuracy criterion.

7. The Type of Ground Truth Used

For the infusion accuracy, the "ground truth" would be the actual volume or rate of fluid delivered compared to the intended volume or rate. This would be established through precise measurement using calibrated equipment in a laboratory setting.

For sterility, the ground truth is established by the AAMI 10⁻⁶ sterility assurance level and USP guidelines for LAL testing, which are objective, scientifically defined standards.

For material, design, and manufacturing process equivalence, the ground truth is the documented specifications and processes of the predicate device and other legally marketed products.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set" in that context.

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

Not applicable, for the same reason as point 8.

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The Douglas Medical Products Maxcess Needlefree Connector is intended to be used as a needleless injection port that can be attached to a Luer Lock connector. It is intended for single patient use and can be swabbed and then accessed multiple times within the limits of CDC guidelines and or institutional guidelines. The closure system has been found to maintain line patency throughout the labeled duration of use.

The Douglas Medical Products Maxcess Needlefree Connector is a one piece design, Luer interfacing injection port. It is sterile, non-pyrogenic and packaged in a tyvek\polyethylene form, fill, and seal package. The materials used to manufacture the Douglas Medical Products Maxcess Needlefree Connector have been tested per tripartite guidelines and are safe for their intended use. The Douglas Medical Products Maxcess Connector utilizes similar and equivalent designs, and materials, as currently legally marketed products.

This document is a 510(k) summary for a medical device (Maxcess Needlefree Connector). It is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of regulatory submission does not typically include a study with acceptance criteria and device performance as would be expected for an AI/ML medical device.

Therefore, I cannot extract the requested information from the provided text because it describes a traditional hardware medical device and not a software/AI medical device. The information requested (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is specific to the development and validation of AI/ML algorithms, which are not relevant to this type of device submission.

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