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For the subcutaneous injection of insulin.

The Top Fine® disposable sterile insulin syringes are intended for subcutaneous injection of insulin.

Top Fine® insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle . The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. Rx only. The devices operate on the principles of common piston syringes.

The provided text describes the 510(k) summary for the "Top Fine® Insulin Syringe" (K063348), comparing it to a predicate device (BD Insulin Syringe K024112). It focuses on demonstrating substantial equivalence rather than presenting detailed acceptance criteria and a specific study proving the device meets them quantitatively in the way one might expect for a complex AI/software device.

However, based on the provided text, I can infer the "acceptance criteria" were related to safety and effectiveness, and the general "study" information is about these aspects.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "bench and clinical tests were performed," but does not specify the sample sizes for either the bench or clinical tests. The data provenance (country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. For a physical device like an insulin syringe, "ground truth" is typically established through direct measurements, laboratory assays, and user performance observations rather than expert review of data.

4. Adjudication Method for the Test Set

This information is not provided as it's not relevant for this type of device and testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or AI interpretation devices, not for a physical medical device like an insulin syringe. The "clinical testing" mentioned was likely focused on user experience and function.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable to an insulin syringe, which is a physical device, not an algorithm.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would have been established by standardized laboratory measurement methods and industry standards for biocompatibility, mechanical properties (e.g., fluid delivery accuracy, needle integrity, plunger force), and sterility.

For the clinical tests (focusing on "adequacy of instructions for use, the range of patient population, performance characteristics, and reliability"), the "ground truth" would likely be based on direct observation of use, user feedback, and comparison to predefined performance metrics.

8. The Sample Size for the Training Set

This concept is not applicable as this is a physical medical device, not an AI/software device that would have a "training set."

9. How the Ground Truth for the Training Set Was Established

This concept is not applicable for the same reason as point 8.

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