Search Results

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, plunger, and O-ring 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 syringe uses a fluorocarbon based non-silicone lubricant.

This document describes the premarket notification (510(k)) for the Merit Syringe, which is a piston syringe used to inject or withdraw fluids from the body. Given the nature of this submission (a 510(k) for a Class II medical device like a syringe), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to performance bench testing against recognized consensus standards and biocompatibility testing, rather than studies involving human readers or AI algorithms.

Here's a breakdown based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't provide a direct table format for each acceptance criterion with a pass/fail. Instead, it states that the device "complies with the FDA recognized consensus standards ISO 7886-1 and ISO 594-2" and that "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use."

The general categories of acceptance criteria and the overall reported performance are:

Specific Biocompatibility Tests Performed:

• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Pyrogenicity
• Hemolysis
• Bacterial Endotoxins (AAMI/ANSI ST72:2011/(R) 2016)
• Pyrogen Test (United States Pharmacopeia 40, National Formulary 35, )

2. Sample sized used for the test set and the data provenance

The document does not specify the exact sample sizes used for each test (e.g., number of syringes tested for flow rate, number of samples for biocompatibility). The testing is described generally as "a battery of tests" and "Performance testing... was completed against FDA recognized consensus standards." For device performance (like the Merit Syringe), the "test set" would typically refer to the samples of the manufactured device subjected to the physical and chemical tests, not a dataset of patient images or clinical data.

Data provenance: Not explicitly stated, as this refers to a medical device's physical/chemical performance, not clinical data collection. It's implied the testing was performed by "Merit Medical Systems, Inc." directly or by a contracted lab.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable to a 510(k) submission for a piston syringe or the type of performance testing described. "Ground truth" and "experts" in this context typically refer to clinical validation studies, particularly for AI/imaging devices, where expert radiologists/clinicians establish diagnostic labels. For a syringe, the "ground truth" is established by the specifications of the recognized consensus standards (e.g., ISO 7886-1 defines specific dimensions, pressures, and flow rates that the device must meet).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used in clinical studies, particularly for interpreting medical images or patient outcomes, not for bench testing of a physical device. The "adjudication" in this context would be the pass/fail criteria defined by the consensus standards themselves, and the testing results are objectively measured.

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. MRMC studies are specific to evaluating the diagnostic performance of medical imaging devices or AI algorithms used in conjunction with human interpretation. This submission is for a physical medical device (syringe) and does not involve imaging or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is not an algorithm. "Standalone performance" would refer to the bench testing of the syringe against the specified standards, as described in section 1.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this type of device, the "ground truth" is defined by the technical specifications and performance requirements outlined in the referenced international consensus standards (e.g., ISO 7886-1, ISO 594-2). These standards stipulate acceptable ranges for attributes like dimensional accuracy, fluid leakage, plunger force, and luer connection integrity. Biocompatibility testing refers to established chemical and biological test methods detailed in standards like ISO 10993.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

Not applicable, for the same reasons as #8.

Ask a specific question about this device