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This device is a hypodermic insulin syringe for subcutaneous injection of insulin.

Shina Insulin Syringes are designed for the subcutaneous injection of a desired dose of insulin. The syringe has a graduated barrel, a plunger rod and needle/hub assembly. The needle shield is colored orange. The Syringes are available in the following sizes:

1/2cc and 1cc 28 gauge x 1/2"
3/10cc, 1/2cc, and 1cc 29 gauge x ½"
3/10cc, 1/2cc, and 1cc 30 gauge x 1/2"
3/10cc, 1/2cc, and 1cc 30 gauge x 5/16"
3/10cc, 1/2cc, and 1cc 31 gauge x 5/16"

These devices operate on the principles of a piston syringe. The syringe fluid path is sterile (EO Gas sterilization), non-toxic, non-pyrogenic, and single use disposable.

The provided text describes a 510(k) summary for Shina Insulin Syringes, which is a submission to the FDA to demonstrate substantial equivalence to a predicate device. This document does not contain an "acceptance criteria and study" in the typical sense of a clinical or analytical performance study with specific metrics like sensitivity, specificity, or accuracy compared to a ground truth established by experts.

Instead, the "performance" section refers to bench tests conducted to demonstrate equivalence to a predicate device for the purpose of regulatory clearance.

Here's the information extracted from the document, organized to address your questions as much as possible within the given context:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "The results demonstrate that Shina Insulin Syringes perform equivalent to the predicate devices and are safe and effective when used as intended." This implies that the acceptance criteria for each test were met if the performance was equivalent to the predicate devices (BD Insulin Syringe: K941657, K955235, K024112).

2. Sample Size and Data Provenance

• Sample Size for Test Set: The document does not specify the sample size used for the bench tests.
• Data Provenance: The tests were conducted internally by Shina Corporation, whose factory is located in Kongju-City, Choong Nam, Korea. The study is retrospective in the sense that it's a submission for regulatory clearance based on testing of the manufactured product, not a prospective clinical trial.

3. Number of Experts and Qualifications for Ground Truth

• This question is not applicable to this type of regulatory submission. Bench tests for medical devices like syringes do not typically involve human experts establishing a "ground truth" for diagnostic or predictive purposes. The "ground truth" for these tests is based on objective, measurable physical properties and engineering standards (e.g., force measurements, dimensional accuracy).

4. Adjudication Method for Test Set

• Not applicable. Bench tests measure physical properties against defined engineering specifications or in comparison to a predicate device, which does not require adjudication by human experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This is a physical medical device (syringe), not an AI or diagnostic imaging device that would typically involve an MRMC study.

6. Standalone Performance Study

• Yes, in the context of bench testing. The "Performance" section describes bench tests (needle pull-out, hub pull-off, needle angularity, needle break-off testing, and dose accuracy) that evaluate the device itself. These are considered standalone performance tests for the physical properties of the syringe.

7. Type of Ground Truth Used

• For this type of device, the "ground truth" refers to established engineering specifications, physical measurement standards, and performance characteristics of legally marketed predicate devices. The aim is to demonstrate that the Shina Insulin Syringes meet these specifications and perform equivalently to the predicate.

8. Sample Size for Training Set

• Not applicable. This document is about a physical medical device and its bench testing, not an algorithm or AI model that requires a "training set."

9. How Ground Truth for Training Set Was Established

• Not applicable. As above, no training set is relevant in this context.

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