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Merit Medical 1-mL Syringes are used to inject fluids into, or withdraw fluids from, the body.

Merit Medical Systems 1-mL Syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer.

This 510(k) summary (K024052) for the Merit Medical 1-mL Syringe does not contain a study that proves the device meets acceptance criteria as typically found in AI/ML device submissions. Instead, it relies on a conformity statement to an established international standard and comparison to a predicate device.

Here's an analysis of the provided text in relation to your questions:

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

The document does not provide a table of quantitative acceptance criteria or reported device performance metrics in the way one would expect for an AI/ML device.

Instead, the acceptance criteria are implicitly tied to conformance with the ISO 7886-1:1993 Standard for sterile hypodermic syringes for manual use. The document states:

• Acceptance Criteria (Implicit via ISO Standard): Conformance to the requirements of ISO 7886-1:1993, which governs various aspects of syringe performance (e.g., dimensions, force to operate plunger, leakage, sterility, breaking force, etc.).
• Reported Device Performance: The document states, "MMS has provided a statement that its syringes will conform to the requirements of ISO 7886-1:1993, an FDA- recognized consensus standard, before marketing the devices. This statement and the data that will be collected to support conformance will be used to demonstrate safety and performance in lieu of demonstrating substantial equivalence with the predicate device."
  • This indicates that test data will be collected to support conformance, but the results are not presented in this K024052 summary. The summary is a declaration of intent to conform.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified, as the data collection was stated to be "before marketing the device" and not yet submitted with this 510(k) summary.

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)

• Not applicable. This is a medical device (syringe), not an AI/ML diagnostic or prognostic tool that requires expert ground truth for image or data interpretation. Performance is assessed against physical and functional standards.

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

• Not applicable. See point 3.

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 physical medical device (syringe), not an AI/ML system.

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

• Not applicable. This is a physical medical device (syringe), not an AI/ML system.

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

• Not applicable in the context of expert ground truth. The "ground truth" for a syringe's performance would be objective measurements against the specified physical and functional requirements of the ISO 7886-1:1993 standard (e.g., volume accuracy, plunger force, leak tightness, material integrity, sterility, etc.).

8. The sample size for the training set

• Not applicable. This is a physical medical device, not an AI/ML system that requires a training set.

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

• Not applicable. See point 8.

Summary of the Study (or lack thereof, for AI/ML context):

The K024052 submission for the Merit Medical 1-mL Syringe is a premarket notification for a Class II medical device. It relies heavily on predicate device comparison for intended use, materials, design, operational principles, and technology, and on a commitment to conform to an FDA-recognized consensus standard (ISO 7886-1:1993) for demonstrating safety and performance.

The document explicitly states: "MMS has provided a statement that its syringes will conform to the requirements of ISO 7886-1:1993, an FDA- recognized consensus standard, before marketing the devices. This statement and the data that will be collected to support conformance will be used to demonstrate safety and performance in lieu of demonstrating substantial equivalence with the predicate device."

This means that at the time of this 510(k) summary, the detailed test data collected to prove conformance to ISO 7886-1:1993 was not yet submitted. The 510(k) approval is based on the promise to conform and the substantial equivalence to a predicate device for other aspects. This is a typical approach for many conventional medical devices that align with established performance standards. This document does not describe an AI/ML study, but rather a traditional device clearance pathway.

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