(344 days)
Sure-fine Insulin Syringes are hypodermic insulin syringes for subcutaneous injection of U100 insulin.
Sure-fine Insulin syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel(U-100), a plunger rod, needle cap, protective end cap and needle permanently affixed to the tip of the syringe with expoxy.
The provided document describes a 510(k) premarket notification for "Sure-Fine Insulin Syringes." The submission is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical effectiveness study. Therefore, some of the requested information (such as effect size of human readers with/without AI assistance, standalone algorithm performance, number of experts for ground truth, and training set details) is not applicable to this type of medical device submission.
Here's the information that can be extracted from the document:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implicitly tied to various testing standards to demonstrate biocompatibility and performance. The reported performance is that the device complies with these standards, supporting its substantial equivalence.
| Acceptance Criteria (Test) | Standard Applied | Reported Device Performance |
|---|---|---|
| Cytotoxicity Test | ISO 10993-5 | Complies with standard |
| Animal Intracutaneous Reactivity Test | ISO 10993-10 | Complies with standard |
| Guinea Pig Maximization Test | ISO 10993-10 | Complies with standard |
| Acute Systemic Toxicity Test | ISO 10993-11 | Complies with standard |
| Pyrogen Test | ISO 10993-11, USP | Complies with standard |
| In-vitro Hemolysis Test | ISO 10993-4, ASTM F756-17 | Complies with standard |
| Shelf Life Performance Test | ASTM F1980, ISO 8537, ISO 7864 | Complies with standard |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes for each specific test. These are typically determined by the requirements of the individual ISO and ASTM standards cited for each test. Data provenance is not specified, but these are laboratory tests performed on the device components or final product itself, not clinical data from countries of origin. The study described is a series of laboratory and biocompatibility tests, not a clinical study involving patients or data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not a study requiring expert readers to establish ground truth. The "ground truth" for these tests comes from established scientific and engineering principles within each standard.
4. Adjudication method for the test set:
Not applicable. This is not a study requiring adjudication of expert interpretations. The results are typically quantitative measurements or qualitative assessments (e.g., presence/absence of cytotoxicity) as defined by the standard.
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 device is not an AI-assisted diagnostic tool, but a medical syringe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm.
7. The type of ground truth used:
The ground truth is based on recognized industry standards and scientific testing procedures (ISO 10993 series, ASTM F756-17, ASTM F1980, ISO 8537, ISO 7864, USP ) for biocompatibility and performance of syringes.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-driven device requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. This is not a machine learning or AI-driven 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).