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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 <788> 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.

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