(147 days)
To inject fluids into or withdraw fluids from the body.
For Injection of Insulin U-100 only.
The FORSURE™ Disposable Syringes with Needle are Single Use, Sterile, Non-Pyrogenic devices used to inject fluids into or withdraw fluids from the body.
The provided text describes a 510(k) submission for "FORSURE™ Disposable Syringes with Needle" and "FORSURE™ Disposable Insulin Syringes". This is for a relatively simple medical device (a syringe), and the information typically required for sophisticated AI/ML devices regarding acceptance criteria and studies (like those involving image analysis or diagnostic aid) is not applicable or detailed in this type of submission.
Therefore, many of the requested fields regarding AI/ML performance metrics, ground truth establishment, expert adjudication, and large-scale clinical studies will not be found as they are not relevant to approving a disposable syringe.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present a formal table of quantitative acceptance criteria for device performance in the way one would see for an AI/ML diagnostic. Instead, the acceptance is based on meeting safety and performance standards equivalent to a predicate device.
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Mechanical Properties and Functioning | "The FORSURE™ Disposable Syringes with Needle have been subjected to performance and safety testing to verify mechanical properties and functioning, as well as biocompatibility and sterility, using FDA recognized Standards, where applicable" | The specific standards and their compliance levels are not detailed in this summary document, but it states they were met. |
| Biocompatibility | Tested and verified. | Specific test results are not provided. |
| Sterility | Tested and verified. | Specific test results are not provided. |
| Substantial Equivalence | Determined by FDA to be substantially equivalent to the Becton Dickinson® Disposable Syringe (K980580). | This is the overarching acceptance by the FDA for market clearance. |
2. Sample size used for the test set and the data provenance
Not applicable in the context of this 510(k) summary for a disposable syringe. The "test set" here refers to physical product samples subjected to laboratory testing (e.g., for sterility, structural integrity, fluid delivery accuracy), not a data set for an AI/ML model. The document does not specify the number of syringes tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of AI/ML, refers to the verified correct answer for a given input. For a syringe, "ground truth" would be inherent in the physical properties and functionality observed through standard engineering and laboratory tests, not subjective expert assessment.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human annotators or experts establishing ground truth for complex AI/ML tasks. For a physical device like a syringe, the "adjudication" would be based on objective measurement against established engineering standards.
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 is a study design specific to AI/ML devices that assist human interpretation (e.g., radiologists reading images). This device is a disposable syringe, not an AI assistant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual medical instrument, not an algorithm.
7. The type of ground truth used
For a disposable syringe, the "ground truth" refers to established engineering standards for mechanical properties, biocompatibility, and sterility. These are typically defined by recognized standards organizations (e.g., ISO, ASTM) and are measured using objective laboratory methods. The summary states that "FDA recognized Standards, where applicable" were used.
8. The sample size for the training set
Not applicable. There is no AI/ML model requiring a "training set" for a disposable syringe.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no need to establish ground truth for it.
§ 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).