(76 days)
The AMSURE® Disposable Syringe with/without Needle is intended for the injection of fluids into, or the withdrawal of fluids from parts of the body below the skin. Needles are intended to mote with mace nozzles of piston syringes or administration sets.
The AMSure® Disposable Syringe is a sterile, single-use hypodermic syringe with or without an attachable hypodermic needle. It consists of a syringe barrel, a plunger rod, a piston, a nozzle cap and/or a single lumen hypodermic needle. The AMSure® Needle is comprised of a metal tube sharpened at one end and joined to a female connector (hub) at the other end.
The provided document is a 510(k) summary for the AMSure® Disposable Syringe with/without Needle. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. While it states that "Performance and biocompatibility testing has demonstrated that the AMSure® Disposable Syringe with/without Needle is safe and effective for its intended use," it does not provide specific details about the acceptance criteria or the study results that prove the device meets those criteria in the format requested.
Therefore, many of the requested details cannot be extracted from this document alone.
Here's an attempt to answer based on the available information, with clear indications where information is not provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | "Performance and biocompatibility testing has demonstrated that the AMSure® Disposable Syringe with/without Needle is safe and effective for its intended use." (Specific quantitative performance data is not provided.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not specified in the document.
- Data provenance: Not specified in the document. This would typically be from the manufacturer's testing, but details like country of origin or whether it was retrospective/prospective are not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable / Not specified. This type of information is usually relevant for studies involving human interpretation (e.g., medical imaging AI). For a device like a syringe, the "ground truth" would be established by predefined engineering and performance standards, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. Adjudication methods are typically used in clinical or imaging studies where there's a need to resolve discrepancies in human readings. For a mechanical device, performance is typically assessed against objective thresholds, not through adjudication of expert opinions.
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
- No. An MRMC study is not mentioned, nor would it be relevant for a disposable syringe. This type of study focuses on the impact of AI systems on human performance in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm or AI system. Its performance is inherent to its physical properties and function, not an algorithm running independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for a disposable syringe would be based on established engineering standards and design requirements (e.g., ISO standards for syringes, biocompatibility standards). The document states "Performance and biocompatibility testing," implying adherence to such standards, but specific "ground truth" types like pathology or outcomes data are not relevant or mentioned.
8. The sample size for the training set
- Not applicable / Not specified. This device is not an AI/ML model that requires a "training set." Performance is evaluated through physical and material testing.
9. How the ground truth for the training set was established
- Not applicable. As the device is not an AI/ML model, there is no "training set" or ground truth for it in that context.
§ 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).