(30 days)
The Merit 10mL Syringe is used to inject fluids into, or withdraw fluids from, the body.
The Merit 10mL Syringe is a device consisting of a calibrated hollow barrel into which is inserted a closely fitted movable plunger and seal. The barrel contains a male Luer lock connector (which conforms to ISO 594-1 & 2 standards) which is compatible for attaching devices with standard female Luer hubs.
This document is a 510(k) Premarket Notification for the Merit 10mL Syringe. It focuses on demonstrating substantial equivalence to a predicate device, the Merit 20mL Syringe (K111091), rather than a comparative effectiveness study involving AI or human readers. Therefore, several of the requested categories related to AI performance, human reader studies, and ground truth establishment for complex datasets are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Test Standard / Criteria | Reported Device Performance |
|---|---|
| ISO 7886-1: | Met predetermined acceptance criteria for safety and efficacy. |
| - Cleanliness | Met predetermined acceptance criteria |
| - Sufficient/excessive Lubricant | Met predetermined acceptance criteria |
| - Capacity Tolerance | Met predetermined acceptance criteria |
| - Graduated Scale | Met predetermined acceptance criteria |
| - Scale Uniformity | Met predetermined acceptance criteria |
| - Scale - Evenly spaced | Met predetermined acceptance criteria |
| - Scale Vertical Alignment | Met predetermined acceptance criteria |
| - Scale - Increments | Met predetermined acceptance criteria |
| - Scale Vertical Print | Met predetermined acceptance criteria |
| - Scale Length | Met predetermined acceptance criteria |
| - Scale Position | Met predetermined acceptance criteria |
| - Capacity 10% > Nominal | Met predetermined acceptance criteria |
| - Finger Grips | Met predetermined acceptance criteria |
| - Piston/Plunger Assembly | Met predetermined acceptance criteria |
| - Piston fit in Barrel | Met predetermined acceptance criteria |
| - Fiducial line on Barrel | Met predetermined acceptance criteria |
| - Nozzle Placement | Met predetermined acceptance criteria |
| - Nozzle Lumen | Met predetermined acceptance criteria |
| - Dead Space | Met predetermined acceptance criteria |
| - Liquid Leak Test | Met predetermined acceptance criteria |
| - Air Leak Test | Met predetermined acceptance criteria |
| - Acidity / Alkalinity | Met predetermined acceptance criteria |
| - Extractable Metals | Met predetermined acceptance criteria |
| ISO 594-2: | Met predetermined acceptance criteria for safety and efficacy. |
| - Luer Gauging | Met predetermined acceptance criteria |
| - Liquid Leak Test | Met predetermined acceptance criteria |
| - Air Leak Test | Met predetermined acceptance criteria |
| - Separation Force | Met predetermined acceptance criteria |
| - Unscrewing torque | Met predetermined acceptance criteria |
| - Ease of assembly | Met predetermined acceptance criteria |
| - Resistance to overriding | Met predetermined acceptance criteria |
| - Stress Cracking | Met predetermined acceptance criteria |
| Merit's Risk Analysis: | Met predetermined acceptance criteria for safety and efficacy. |
| - Plunger Seal Detachment Test | Met predetermined acceptance criteria |
| - Ink Adhesion Test | Met predetermined acceptance criteria |
| Biocompatibility (based on ISO 10993 series, ASTM F756-08, USP 37): | Met predetermined acceptance criteria for safety and efficacy. |
| - Cytotoxicity | Met predetermined acceptance criteria |
| - Sensitization | Met predetermined acceptance criteria |
| - Irritation | Met predetermined acceptance criteria |
| - Acute Systemic Toxicity | Met predetermined acceptance criteria |
| - Pyrogenicity | Met predetermined acceptance criteria |
| - Hemocompatibility | Met predetermined acceptance criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each test, nor the specific provenance of the data (e.g., country of origin). The testing was conducted by the manufacturer, Merit Medical Systems, Inc., which is based in South Jordan, UT, USA. The nature of these tests (e.g., physical, chemical, and biological performance tests on a medical device) suggests they are prospective, conducted specifically to validate the device against established standards.
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 is not applicable as the study involves physical and biological testing of a medical device against objective standards (ISO, ASTM, USP), not interpretation of subjective data by human experts. The "ground truth" is defined by the acceptance criteria within these established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As described above, the study involves objective performance testing against predefined criteria, not subjective interpretation requiring adjudication among experts.
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
Not applicable. This is a 510(k) submission for a physical medical device (syringe), not an AI-powered diagnostic tool, and therefore no MRMC study or AI assistance was involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a 510(k) submission for a physical medical device (syringe), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the acceptance criteria defined within recognized international and national consensus standards such as:
- ISO 7886-1: Sterile hypodermic syringes for single use
- ISO 594-1 & -2: Conical fittings (Luer taper)
- ISO 11135: Sterilization
- ISO 10993 series: Biological Evaluation of Medical Devices (Biocompatibility)
- ASTM F756-08: Hemolytic Properties
- United States Pharmacopeia 37: Pyrogen Test
These standards specify measurable parameters and thresholds for acceptable performance.
8. The sample size for the training set
Not applicable. This is a 510(k) submission for a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As explained above, there is no training set. The "ground truth" for the device's acceptable performance is derived from the established consensus standards and FDA guidance.
§ 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).