(79 days)
The Insulin Syringes (0.3 to 1.0 cc) are intended for subcutaneous injection of U-100 insulin.
The UltiCare disposable syringes and needles (0.3 to 3.0 cc) are used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceur icul directly to the patient. As an alternative use the product will allow administration of the pharmacenty to to the patient via an intravenous port, heparin lock, or saline lock.
The UltiCare Disposable Syringes and Needles and Insulin Syringes are standard piston type syringes with permanently attached (unibody) needles. They are sterile, single-use, disposable piston syringes consisting of a syringe barrel, a plunger rod, and a hypodermic single lumen needle. The UltiCare Disposable Syringes and Insulin Syringes are non-toxic and non-pyrogenic, and are available in a variety of combinations of syringe sizes (0.3 to 3.0 cc (ml)), needle sizes (31 to 22 gauge), and needle lengths (5/16" to 1.5").
The provided text does not contain detailed information about specific acceptance criteria and a study proving a device meets these criteria in the way typically found for AI/ML-based medical devices or diagnostic tools. The document is a 510(k) summary for a traditional medical device (syringes and needles), which focuses on "substantial equivalence" to predicate devices rather than novel performance metrics and validation studies common for AI.
Therefore, I cannot populate the requested table and answer the questions related to AI/ML device performance validation. The document describes the device, its intended use, and lists predicate devices, but it does not include data on acceptance criteria, a test set, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an algorithm.
Here's why the information isn't available in the provided text:
- Device Type: The device is a traditional disposable syringe and needle, not an AI/ML-based diagnostic or imaging device. Its clearance hinges on demonstrating substantial equivalence to existing devices in terms of materials, design, and intended use, rather than demonstrating specific accuracy or performance metrics against a ground truth dataset.
- 510(k) Summary Nature: A 510(k) summary (especially for traditional devices) typically outlines the device description, intended use, predicate devices, and a comparison demonstrating substantial equivalence. It generally does not include extensive clinical study data with detailed performance metrics, especially not in the context of AI/ML validation.
- Lack of Performance Data: There are no sections discussing performance metrics like sensitivity, specificity, AUC, or a "reported device performance" that would align with acceptance criteria for a diagnostic algorithm. The "performance" for these devices would typically relate to sterility, material compatibility, and physical dimensions, which are not outlined in such a summary.
Therefore, I must state that the requested information cannot be extracted from the provided document.
§ 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).