(235 days)
The device's primary intended use is general purpose injection of fluids into, or withdrawal of fluids from the body, below the surface of the skin except for phlebotomy. Its secondary intended use is to retract inside the safety barrel, contain the contaminated needle and aid in the prevention of accidental needle stick injuries.
The Safety Syringe per (21 CFR § 880.5860) 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.
This 510(k) summary (K053519) describes a Safety Syringe. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor does it describe any AI/algorithm component.
The document is a standard 510(k) submission for a medical device (a syringe with a safety feature to prevent needle stick injuries). The FDA's letter states that they reviewed the premarket notification and determined the devices are substantially equivalent to legally marketed predicate devices. This determination is based on the device's design, materials, and intended use being similar to existing cleared devices, and it implies that the device meets generally accepted performance standards for syringes, but no specific performance study details are provided in this summary.
Therefore, I cannot provide the requested information from the given text.
Here's why each point cannot be addressed:
- A table of acceptance criteria and the reported device performance: This information is not present. The summary focuses on the device description, intended use, classification, and predicate device.
- Sample sized used for the test set and the data provenance: No test set or study details are provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no test set or experts are mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI/software device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/software device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there's no mention of a diagnostic study or "ground truth" in this context.
- The sample size for the training set: Not applicable. This is not an AI/software device and no training sets are mentioned.
- How the ground truth for the training set was established: Not applicable.
§ 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).