(27 days)
The DuoPro™ Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and nonreusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
The modified DuoPro™ Safety Syringe (DuoProSS™) is a sterile, single-use, disposable and non-reusable, manual, 3 mL or 5 mL retractable safety syringe, provided with or without needle in various product configurations.
The provided text is a 510(k) summary for a medical device called the DuoPro™ Safety Syringe (DuoProSS™). It describes the device, its intended use, and claims substantial equivalence to predicate devices based on similarities in design, technological, and operational characteristics.
However, the document does not provide specific acceptance criteria or details of a study that proves the device meets such criteria in the format requested by the prompt. The "TESTING" section briefly states:
"Verification and validation testing provided in this premarket notification includes standards conformity, testing according to FDA guidance, biocompatibility, and measurement of latex protein. Testing shows that the performance of the modified DuoProSS™ is equivalent to predicate devices."
This is a high-level statement indicating that testing was performed and concluded equivalence, but it lacks the granular details requested, such as:
- A table of acceptance criteria and reported device performance metrics.
- Sample sizes for test sets, data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone performance.
- The type of ground truth used.
- Sample sizes and ground truth establishment for training sets (which would be relevant for an AI/ML device, but this appears to be a mechanical device).
Therefore, based solely on the provided text, I cannot complete the table or answer most of the questions as the detailed information is not present. The document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for approval, rather than detailing a study against specific, quantified acceptance criteria for a new AI/ML device.
Summary of missing information based on the prompt's requirements:
The provided 510(k) summary does not contain the detailed information needed to fill out the requested table and answer the study-specific questions. The device in question appears to be a mechanical medical device (safety syringe), not an AI/ML powered device, which explains the absence of data provenance, expert adjudication, MRMC studies, or training/test set details typically associated with AI/ML device evaluations.
The document states "Verification and validation testing provided in this premarket notification includes standards conformity, testing according to FDA guidance, biocompatibility, and measurement of latex protein. Testing shows that the performance of the modified DuoProSS™ is equivalent to predicate devices," but no specific results or acceptance criteria are detailed.
§ 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).