(90 days)
The Merit Syringe is used to inject fluids into, or withdraw fluids from, the body.
The Merit Syringe contains a calibrated hollow barrel into which is inserted a closely fitted, ratcheted plunger, and tip or seal. The barrel contains an ISO 594-2 compliant fixed male luer connector, which is compatible with ISO 594-2 compliant female luer hubs.
The provided text describes the performance testing of the Merit Syringe, a medical device. Here's a breakdown of the requested information based on the text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ISO 7886-1) | Reported Device Performance |
|---|---|
| Cleanliness | Complies with ISO 7886-1 |
| Limits for acidity or alkalinity | Complies with ISO 7886-1 |
| Limits for extractable metals | Complies with ISO 7886-1 |
| Lubricant | Complies with ISO 7886-1 |
| Tolerance on Graduated Capacity (based on graduation scale) | Complies with ISO 7886-1 |
| Tolerance on Graduated Capacity (based on audible/tactile use) | Complies with ISO 7886-1 |
| Graduated Scale | Complies with ISO 7886-1 |
| Barrel | Complies with ISO 7886-1 |
| Piston/Plunger Assembly | Complies with ISO 7886-1 |
| Nozzle | Complies with ISO 7886-1 |
| Performance – Freedom from air and liquid leakage past piston | Complies with ISO 7886-1 |
| Acceptance Criteria (from ISO 594-2) | Reported Device Performance |
| Gauging | Complies with ISO 594-2 |
| Liquid leakage | Complies with ISO 594-2 |
| Air leakage | Complies with ISO 594-2 |
| Separation force | Complies with ISO 594-2 |
| Unscrewing torque | Complies with ISO 594-2 |
| Ease of assembly | Complies with ISO 594-2 |
| Resistance to overriding | Complies with ISO 594-2 |
| Stress cracking | Complies with ISO 594-2 |
| Biocompatibility (from ISO 10993 series and other standards) | Reported Device Performance |
| Cytotoxicity | Complies with ISO 10993 series |
| Sensitization | Complies with ISO 10993 series |
| Irritation | Complies with ISO 10993 series |
| Acute Systemic Toxicity | Complies with ISO 10993 series |
| Pyrogenicity | Complies with USP 39, NF 34, |
| Hemolysis | Complies with ASTM F756-08:2013 |
| Sterilization (Ethylene Oxide) | Complies with ISO 11135:2014, ISO 10993-7:2008, AAMI TIR 28:2009 |
| Packaging (Terminally Sterilized Medical Devices) | Complies with ISO 11607-1:2006, ASTM D4169-14: 2014, ASTM F1980-07:2007, ISO 2233:2000 |
Reported Device Performance Summary: The device "met the standards' established acceptance criteria for the device". The text explicitly states, "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use."
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 size used for the test set for performance or biocompatibility testing. It only refers to a "battery of tests" being performed. Data provenance (country of origin, retrospective/prospective) is also not specified.
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 to this type of device and study. The testing described involves objective, standardized measurements against recognized consensus standards for physical, chemical, and biological properties of a piston syringe, not subjective interpretation by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often in clinical trials or diagnostic studies. The performance testing of the Merit Syringe involves objective measurements against predefined criteria.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study relates to the evaluation of diagnostic algorithms or AI tools, often in imaging, which is not relevant to the Merit Syringe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done, but it refers to the performance of the syringe itself, not an algorithm. The testing described (bench testing, biocompatibility, sterilization, packaging) assesses the device's inherent properties and adherence to standards without human intervention influencing the device's function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing of the Merit Syringe was established by FDA recognized consensus standards (e.g., ISO 7886-1, ISO 594-2, ISO 10993 series, ASTM standards, USP). These standards define objective, measurable criteria for the various aspects of the syringe's function and safety.
8. The sample size for the training set
This information is not applicable. The Merit Syringe is a physical medical device, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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).