(210 days)
JMS Syringe is intended to be used to inject fluids into or withdraw fluids out of the body.
JMS syringe is a single use standard piston syringe without hypodermic needle, which consists of a calibrated hollow barrel and a movable plunger with a male Luer lock or Luer slip connector on the tip of barrel.
The provided document is a 510(k) summary for a medical device (JMS Syringe), not a study report for an AI/ML-based device. Therefore, it does not contain the information required to answer the prompt regarding acceptance criteria and performance studies for an AI/ML device.
The document discusses the "JMS Syringe" and its predicate device, focusing on:
- Acceptance criteria: For the syringe, these are described in terms of physical, chemical, and performance requirements (e.g., cleanliness, limits for extractable metals, tolerance of nominal capacity, freedom from leakage).
- Device performance: The performance data is presented as a "Pass or Fail" for each test category, indicating that the device met the established physical and performance criteria.
- Non-clinical performance data: This section lists various tests conducted, such as cleanliness, limits for acidity/alkalinity, lubrication, tolerance of nominal capacity, piston/plunger assembly design, nozzle lumen, dead space, and freedom from air/liquid leakage. All are marked as "Pass."
- Clinical tests: The document explicitly states "Not applicable as no clinical tests were referenced in this submission," indicating that clinical studies were not required or performed for this specific 510(k) submission for the syringe.
- Ground truth: For a physical device like a syringe, "ground truth" would be established by objective measurements against engineering and material standards, not expert consensus or pathology in the way it's used for AI/ML models.
Therefore, I cannot provide the full requested information about AI/ML device acceptance criteria and study details (sample size, expert qualifications, MRMC study, training set details, etc.) based on the provided text, as it describes a traditional medical device (syringe) and not an AI/ML-driven diagnostic or therapeutic device.
§ 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).