(84 days)
The American Syringe Company 3cc Syringe is indicated for use in the injection of medication into a patient.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the American Syringe Company's 1cc and 3cc Syringe with Needle. It confirms that the device is substantially equivalent to legally marketed predicate devices.
This type of submission does not typically include detailed performance data, acceptance criteria, or clinical study results in the way that, for example, a submission for a new AI-powered diagnostic device would. For syringes, equivalence is often established primarily through design specifications, material conformance to ISO standards, and sometimes physical performance testing against predicate devices, rather than clinical efficacy studies with expert consensus ground truth.
Therefore, many of the requested details are not present in this document. Based on the information available, here's what can be provided:
1. A table of acceptance criteria and the reported device performance
This document does not contain a table of acceptance criteria or reported device performance for the American Syringe Company's 1cc and 3cc Syringe with Needle. For this type of device, acceptance criteria would typically relate to factors like:
- Dimensional conformity: Meeting specified lengths, diameters, and volumes.
- Material compatibility: Ensuring materials are non-toxic and compatible with intended medications.
- Sterility: Ability to maintain sterility until use.
- Functionality: Smooth plunger movement, secure needle attachment, accurate dose delivery markings, no leakage, sufficient needle sharpness and strength.
- Biocompatibility: Absence of adverse reactions.
- Packaging integrity.
2. Sample size used for the test set and the data provenance
Not applicable/Not provided in this document. The 510(k) pathway for a basic device like a syringe often relies on established standards and predicate device comparisons rather than extensive clinical testing with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not provided. Ground truth in the context of expert review for medical imaging or diagnostics is not relevant for a simple medical device like a syringe.
4. Adjudication method for the test set
Not applicable/Not provided.
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 a syringe, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used
Not applicable in the conventional sense. For a syringe, "ground truth" would relate to its physical and functional specifications as verified through engineering tests against recognized standards (e.g., ISO standards for syringes and needles), rather than expert consensus or pathology on biological samples.
8. The sample size for the training set
Not applicable. There is no machine learning model or "training set" for a syringe.
9. 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).