(66 days)
The Merit Medical 20 ml Syringe is used to inject fluids into, or withdraw fluids from, the body.
The Merit Medical 20 ml Syringe is a device consisting of a calibrated hollow barrel into which is inserted a closely fitting movable plunger and seal. The barrel contains a male Luer Lock connector which is compatible for attaching devices with standard female Luer hubs.
The provided text describes the acceptance criteria and the study conducted for the Merit Medical 20 ml Syringe. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document lists numerous safety and performance tests that were successfully completed. It states: "The results of the testing demonstrated that the subject Merit Medical 20 ml Syringe met the pre-determined acceptance criteria applicable to the safety and efficacy of the device." However, the specific acceptance criteria values for each test and the quantified reported performance against those criteria are not provided in this summary. The summary only lists the types of tests performed.
Table of Acceptance Criteria and Reported Device Performance (as much as can be extracted):
| Acceptance Criteria Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Material/Construction | Cleanliness, Limits for acidity and alkalinity, Limits for extractable metals, Inspection for lubricant contaminants | Met pre-determined criteria |
| Dimensional/Functionality | Tolerance on graduation capacity, Graduated scale, Numbering of scale, Overall length of scale to nominal capacity, Position of scale, Barrel - finger grips, Piston/plunger assembly - design, Piston/plunger assembly - fit of piston in barrel, Piston/plunger assembly - fiducial line, Gauging, Position of nozzle on end of barrel, Nozzle lumen, Dead space | Met pre-determined criteria |
| Physical/Mechanical | Separation force, Unscrewing torque, Freedom from air leakage, Freedom from liquid leakage, Freedom from liquid leakage with side force, Adhesion of ink, Burst pressure testing, Ease of assembly, Resistance to overriding, Resistance to cracking | Met pre-determined criteria |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Hemocompatibility | Met pre-determined criteria |
| Packaging Integrity | Visual inspection, Dye penetration testing, Underwater leak test (bubble emission testing), Seal strength-seal peel tensile strength | Met pre-determined criteria |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the various tests. It also does not provide information regarding the provenance of the data (e.g., country of origin, retrospective or prospective study design).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable and therefore not provided in the document. The device is a medical syringe, and the testing described focuses on physical, mechanical, material, and biocompatibility properties rather than clinical interpretations requiring expert radiologists or similar professionals for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided in the document, as the tests are for device performance characteristics, not for diagnostic accuracy or human interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not performed as this device is a medical syringe and not an AI-assisted diagnostic tool. Therefore, information on effect size related to human reader improvement with AI is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not performed for this device, as it is a physical medical device (syringe) and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the tests described are the specified international standards and FDA guidance documents, which define acceptable ranges and criteria for the physical, chemical, and biological properties of syringes. The device's performance was compared against these established technical specifications.
8. The sample size for the training set
This information is not applicable as the device is a physical product and not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as the device is a physical product and not an AI/machine learning model.
§ 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).