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The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.

The MiniLoad Syringe is a device intended to provide a means of fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component is available in two configurations: 1) with a male slip tip end 2) with a luer-lock end; both for the fitting of a compatible needle. The device is available in a 1ml volume.

This document is a 510(k) summary for a medical device (MiniLoad Syringe) and primarily focuses on demonstrating substantial equivalence to a predicate device. It does not describe a study involving an AI/Machine Learning device or a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it provide the detailed types of information requested in your prompt regarding AI model performance, training sets, ground truth establishment, or expert adjudication.

The document discusses acceptance criteria and device performance in the context of bench testing for a standard medical device (a syringe), not an AI-powered diagnostic or assistive technology.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document details:

• Acceptance Criteria and Device Performance (Bench Testing for a Syringe): The table on pages 4-5 compares the subject device to a predicate device regarding physical characteristics, materials, and some performance specifications. Page 6 lists general performance data categories and Biocompatibility standards used to support substantial equivalence.
• Sample Size, Data Provenance, Expert Information, Adjudication Method, MRMC Studies, Standalone Performance, Ground Truth Type, Training Set Sample Size/Ground Truth: None of this information is provided because the submission is for a physical medical device (syringe), not an AI/ML system. The "performance data" refers to standard mechanical and material tests for the syringe, not diagnostic accuracy based on human image interpretation.

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The MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.

The MiniLoad Syringe is a device intended to provide a means of general use fluid injection and aspiration. The device is comprised of a hollow barrel with gradient markings and a plunger. The barrel component has a male slip tip end for the fitting of a compatible needle. The device is available in a 1ml volume.

The provided document is a 510(k) Premarket Notification for the MiniLoad Syringe, not an AI/ML device. Therefore, the information typically requested for AI/ML device studies (such as acceptance criteria for AI model performance, sample sizes for AI test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance) is not available in this document.

The document focuses on demonstrating substantial equivalence to a predicate device (NORM-JECT Syringe) for a traditional medical device (piston syringe). The "performance data" section in the document refers to physical and biological performance characteristics of the syringe itself, not the performance of an AI/ML algorithm.

Here's why the requested information cannot be provided from this document:

• No AI/ML Component: The MiniLoad Syringe is described as a device comprised of a hollow barrel with gradient markings and a plunger, used for fluid injection and aspiration. There is no mention of any artificial intelligence or machine learning component.
• Performance Data Type: The "Performance Data" section (VII.) details testing for characteristics like freedom from extraneous matter, lubricant quantification, plunger stop detachment, leakage, piston operational force, biocompatibility, sterility, and shelf-life. These are all tests related to the physical and material properties of a syringe, not the accuracy or performance of an AI algorithm.
• Ground Truth: For a traditional device like a syringe, "ground truth" relates to physical measurements and laboratory testing results adhering to specific standards (e.g., ISO 7886-1 for syringes, ISO 10993 for biocompatibility, USP for particulate matter). There is no "expert consensus" or "pathology" ground truth as would be used for image analysis AI/ML.

Therefore, since the core premise of your request is about an AI/ML device, and the provided document is for a non-AI/ML device, I cannot fill in the table or answer the specific questions related to AI/ML device acceptance criteria and study design.

Ask a specific question about this device