(161 days)
The 1ml DuoPross Insulin Syringe is intended for the injection of insulin into the body.
The DuoPross Syringes device is used to inject fluids into, or withdraw fluids from, the body.
The DuoProSS Syringes device is a sterile, single use, standard piston syringe, designed for manual use. The device is available in 1, 1 (insulin), 2, 5, 10, 20 and 60 cc/ml volumes with luer slip or luer lock configurations. Each syringe consists of a calibrated hollow barrel and movable plunger. At the distal end of the syringe is a male connector nozzle for fitting the female connector hub of a single lumen needle. Configurations are supplied with and without the needle already attached to the syringe. The DuoProSS Syringes device consists of 3 parts: a barrel, a plunger, a piston and a needle. The barrel is made from polypropylene and is designed with clear graduations and figures for easy use. The piston is made from Kraton IR, a highly inert isoprene rubber.
The provided text does not contain any information about acceptance criteria or a study that proves the device meets those criteria.
The document is a 510(k) summary for the DuoProSS Syringes, which is a submission to the FDA to demonstrate substantial equivalence to previously marketed devices. This type of submission generally relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device. It typically does not involve new clinical studies with defined acceptance criteria for performance, especially for a well-established device like a piston syringe.
Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a different type of document, such as a study report or clinical trial results.
Here's how I would answer your request if the information were present:
If the text contained the requested information, I would provide a table like this:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| [Specific criterion, e.g., "Syringe leakage rate ≤ X%"] | [Reported performance, e.g., "0.5% leakage rate"] |
| [Another criterion] | [Another reported performance] |
And then I would address the other points, if the data were available in the text:
- Sample size used for the test set and the data provenance: [e.g., "100 syringes, prospective study, conducted in the USA."]
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: [e.g., "3 experts, all board-certified mechanical engineers with 15+ years of experience in medical device manufacturing."]
- Adjudication method for the test set: [e.g., "All 3 experts independently evaluated the performance, and any discrepancies were resolved by consensus."]
- 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: [Likely "N/A" for a syringe, as this type of study is for AI-assisted diagnostic devices.]
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: [Likely "N/A" for a syringe.]
- The type of ground truth used: [e.g., "Direct measurement of fluid volume and pressure, visual inspection for integrity."]
- The sample size for the training set: [Likely "N/A" as this is not an AI/ML device.]
- How the ground truth for the training set was established: [Likely "N/A" as this is not an AI/ML device.]
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).