(183 days)
to inject fluids into or withdraw fluids from the body
The NIPRO Syringe is a piston syringe consisting of graduated barrel, plunger rod, and gasket. It is provided in luer slip, luer lock and eccentric luer slip tips, with and without attached hypodermic needles are available in ranges of 20-25G, and 3/8 to 1 ½" in length. Gauges are color coded for easy differentiation. Its function is mechanical. The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by Ebeam radiation. The shelf-life has been determined to be 5 years. This device is not intended for patients less than 2 years of age.
The Nipro Syringe is a medical device and thus the provided document is a 510(k) summary, which outlines its substantial equivalence to a predicate device rather than a study proving unmet acceptance criteria in the context of AI/ML performance. Therefore, most of the requested information regarding AI/ML clinical study specifics (such as expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for training and test sets) is not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria related to the device's physical and performance characteristics, and how the device's performance was evaluated against these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical tests performed to ensure the Nipro Syringe meets established standards. The acceptance criteria are implicit in the "specifications of the standards listed," and the reported device performance is that these tests were "performed within the specifications" and that the device "performs equivalent to the predicate device."
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| Visual Inspection (ISO 7886-1, ISO 7864-1) | Performed within specifications of the standards; no significant differences. |
| Dimensional Specifications (ISO 7886-1) | Performed within specifications of the standards; slight dimensional changes from predicate, but both devices remain in compliance with all aspects of ISO 7886-1. |
| Gauging (ISO 594-1) | Performed within specifications of the standards. |
| Mechanical and Performance Characteristic (ISO 7886-1, ISO 7864-1, ISO 594-1, ISO 594-2) | Performed within specifications of the standards; results demonstrate equivalent performance to the predicate device. |
| Chemical and Biological Characteristic (ISO 7886-1, ISO 11137-1, and specific biological tests) | Performed within specifications of the standards. Includes: Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, Pyrogen testing (Material Mediated & LAL), Hemolysis, Particulate Analysis. |
| Sterilization Validation (ISO 11137-1, ISO 11137-2, ISO 11137-3) | Performed within specifications of the standards; Ebeam sterilization validated. |
| Transportation Tests (ASTM-D4169-09) | Performed within specifications of the standards. |
| Biocompatibility (ISO 10993) | Performed within specifications; tests conducted: MEM Elution (Cytotoxicity), Kligman Maximization (Sensitization), Intracutaneous Irritation, ISO Systemic Toxicity Study in Mice, USP Rabbit Pyrogen Study, ASTM Hemolysis Study, USP Limulus Amebocyte Lysate (LAL) testing, Particulate Analysis Device fluid pathway. |
| Pyrogen Testing (ISO 10993-11, USP 39-NF34: 2016, ) | Performed within specifications of the standards. |
| Shelf-life Testing (ASTM F1980-07) | Performed within specifications of the standards; 5-year shelf-life determined. |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not explicitly provided in the document. The document refers to non-clinical tests performed to specific standards, but it doesn't detail the sample sizes used for each test or the provenance of any data (e.g., country of origin, retrospective/prospective). As this is a physical medical device, not an AI/ML system, "test set" in the context of data for model evaluation is not directly applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a physical syringe, not an AI/ML system requiring expert consensus for ground truth establishment. The "ground truth" for this device's performance is determined by meeting the specifications of established engineering and biological standards.
4. Adjudication Method for the Test Set:
Not applicable for a physical device. The compliance with standards and their specifications serves as the evaluation basis, not human adjudication of AI output.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic or treatment device, so there is no human-in-the-loop performance improvement with or without AI to measure.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and manufacturing, evaluated through non-clinical testing against established standards.
7. Type of Ground Truth Used:
The "ground truth" for the Nipro Syringe is compliance with internationally recognized and industry-accepted standards (ISO, ASTM, USP) for medical devices, specifically for piston syringes and needles. This includes performance benchmarks for:
- Physical dimensions and integrity
- Mechanical function
- Sterility
- Biocompatibility
- Chemical characteristics
- Shelf-life
8. Sample Size for the Training Set:
Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant in this context.
§ 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).