Search Results

The Disposable Sterile Syringe with Needle is intended for use in the aspiration of fluids for medical purpose.

The Disposable Sterile Syringe is a sterile luer lock syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.

The proposed devices are provided in two types of configurations:

• i. a disposable sterile syringe with sterile hypodermic needle contained in a blister packaging made of PP/PE composite film and coated paper sealed by hot sealing
• ii. a disposable sterile syringe contained in a blister packaging made of PP/PE composite film and coated paper sealed by hot sealing

The disposable sterile syringe with needle is manually operated and intended for single use only, which consists of a needle and a luer lock syringe. The disposable sterile syringe consists of barrel, plunger and piston. The proposed device is available in various combination of syringe volume and needle size.

The provided text describes the 510(k) summary for a Disposable Sterile Syringe and Disposable Sterile Syringe with Needle. It details the comparison of the proposed device to a predicate device (K072739) to demonstrate substantial equivalence.

However, the request asks for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/imaging device, including details like sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, and training set information.

The provided document does not contain information about an AI/imaging device. Instead, it's a submission for a Disposable Sterile Syringe and Needle, which is a physical medical device, not a software or AI-based diagnostic tool. The "performance tests" described are non-clinical, related to physical characteristics, biocompatibility, sterilization, and packaging integrity, and are tested against established ISO and ASTM standards, not against AI model performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot fulfill the request using the provided text because it describes a different type of medical device and the requested metrics (related to AI/imaging studies) are not applicable to the content.

There is no information on:

1. A table of acceptance criteria and reported device performance specific to AI/imaging metrics like accuracy, sensitivity, specificity, etc. The performance criteria provided are for physical characteristics, biocompatibility, and sterilization.
2. Sample size for a test set, data provenance, experts, adjudication methods, MRMC studies, standalone performance, or ground truth establishment related to an AI/imaging model. The "test set" here refers to samples of syringes and needles used for physical and biological testing.
3. Training set sample size or ground truth establishment for an AI model.

The document focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and conformance to relevant device-specific and biological safety standards for syringes and needles.

Ask a specific question about this device