(65 days)
The primary indicated use for the 1cc SafePro* Safety Syringe is for general purpose use in aspirating and injecting fluid. The secondary indicated use for the 1cc SafePro * Safety Syringe is for needlestick protection; the device may aid in the reduction of needlestick injuries.
The 1cc SafePro* Safety Syringe consists of a syringe assembly and a needle assembly. The device has a built-in safety feature which may aid in the reduction of the risk of accidental needlestick injuries.
Here's an analysis of the provided text regarding the 1cc SafePro Safety Syringe, focusing on the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria for the simulated use study. Instead, it describes the outcome of the study as supporting the claim.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| No sharps injuries occurred | No sharps injuries occurred |
| No failure of the safety mechanism occurred | No failure of the safety mechanism occurred |
| Meets customer requirements (functional/performance) | Positive responses from Evaluators regarding functional and performance aspects |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Size: 500 1cc SafePro® Safety Syringes were evaluated by 50 participants. This implies a test set of 500 syringes, evaluated by users.
- Data Provenance: The study was a "Simulated Use Study." The document does not specify the country of origin of the data or if it was retrospective or prospective, but "simulated use" generally implies a prospective study conducted in a controlled environment designed to mimic real-world usage.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
No external experts are mentioned as establishing ground truth for the simulated use study results. The study directly assessed the performance of the device (occurrence of sharps injuries, safety mechanism failure, and user feedback). The "evaluators" were the participants, whose direct experience constituted the data for this specific study.
4. Adjudication Method for the Test Set
No adjudication method is mentioned for the simulated use study. The outcomes (sharps injuries, mechanism failure) appear to be direct observations, and customer requirements were assessed through "positive responses from the Evaluators." This suggests direct reporting rather than a consensus or adjudicated process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Its Effect Size
No MRMC comparative effectiveness study is mentioned. This device is a medical instrument (syringe), not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable here.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a physical medical instrument, not an algorithm. Its performance is intrinsically linked to human interaction (human-in-the-loop, in this context meaning operation by a user).
7. The Type of Ground Truth Used
For the simulated use study, the "ground truth" was established by direct observation of events (sharps injuries, safety mechanism failure) and user feedback on functional and performance aspects. This can be categorized as observed outcomes and user satisfaction data.
8. The Sample Size for the Training Set
No training set is mentioned. This device is a physical product, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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).