(64 days)
A properly placed syringe provides access to a vein or tissue for fluid sampling or infusion. The safety syringe is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a needle retraction system which is activated after the infusion procedure is completed.
The SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature to reduce the risk of accidental needlestick injuries.
Here's a summary of the acceptance criteria and study details for the SafePro* Safety Syringe, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Safety and Biocompatibility | Meets ISO 10993-1 and US FDA G-95 requirements. |
| Risk Reduction of Accidental Needlestick Injuries | 0 sharps injuries or failure of the safety mechanism observed in the simulated use study. |
| Functional and Performance Aspects (Customer Requirements) | Positive responses from Evaluators, indicating the device meets customer requirements. |
Study Details
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Sample Size used for the test set and the data provenance:
- Sample Size: 500 SafePro* Safety Syringes were evaluated by 50 participants. (Note: The document does not specify a separate "test set" from a "training set" in the context of typical AI/machine learning studies. This appears to be a performance validation study for a medical device).
- Data Provenance: Not explicitly stated, however, the study involved "participants" evaluating the syringes, implying prospective human use simulation. No country of origin for the participants is mentioned.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device study. This was a simulated use study with direct observation of safety mechanism function and user feedback, not an expert-driven ground truth establishment for a diagnostic output. The "evaluators" (50 participants) provided feedback, but weren't "experts establishing ground truth."
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Adjudication method for the test set:
- Not applicable. The study involved direct observation of safety mechanism function and collection of user feedback. There is no mention of a process requiring adjudication among multiple observers for a single outcome.
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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 physical medical device, not an AI or diagnostic imaging system. No human reader involvement in a diagnostic task is described.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The device's safety mechanism operates independently (standalone) after activation, but it's not an "algorithm only" performance evaluation.
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The type of ground truth used:
- Direct Observation of Safety Mechanism Function: The absence of sharps injuries and failure of the safety mechanism during simulated use served as direct evidence of the device's protective function.
- User Feedback/Satisfaction Surveys: Positive responses from participants regarding functional and performance aspects.
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The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI system that requires a "training set." The development process would have involved internal testing and iterative design, but not a formally defined "training set" in the machine learning sense.
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How the ground truth for the training set was established:
- Not applicable, as no "training set" in the machine learning context is described.
§ 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).