(29 days)
The Acacia Piston Syringe is indicated for the injection of fluids into, or withdrawal fluids from, the body. It is also used as a dispenser, a measuring device, and a fluid transfer device.
The Acacia Piston Syringe consists of a calibrated hollow cytincrical body and movable plunger. At the tip of the barrel is a tapered male connector, which can be in a luer lock, luer slip, oral lock, and oral slip configurations.
The Acacia Piston Syringe can also be used as a dispenser without the use of a plunger.
The provided document does not contain information regarding a study that proves the device meets acceptance criteria, beyond a general statement that "All necessary verification and validation testing has been performed for the Piston Syringe to assure substantial equivalence to the predicate devices."
Therefore, I cannot provide detailed information for most of the requested points.
Here's what can be inferred from the document:
- Device Name: Acacia Piston Syringe
- Purpose: A general-purpose Piston Syringe
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or detailed performance data. It broadly states that the device has "similar physical and technical characteristics to the predicate devices" and that "All necessary verification and validation testing has been performed... to assure substantial equivalence."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
2. Sample size used for the test set and the data provenance
Not specified in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as specific testing details, including ground truth establishment or expert involvement, are not provided.
4. Adjudication method for the test set
Not applicable as specific testing details are not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC study was not mentioned. The device is a physical medical device (piston syringe), not an AI-assisted diagnostic tool where human readers would be involved in interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to a physical piston syringe. Performance would be assessed through engineering and materials testing, not algorithm-only performance.
7. The type of ground truth used
Not specified. For a physical device like a piston syringe, "ground truth" would likely refer to engineering specifications, material properties, and functionality tests (e.g., fluid volume accuracy, force required for plunger movement, sterility, biocompatibility).
8. The sample size for the training set
Not applicable as this is not an AI/algorithm-based device that requires a training set in the conventional sense.
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).