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The Delta Fly F20μ Micro Bore Winged Safety Needles and the Delta Fly Micro Bore Winged Safety Needles are intended for short term use to access the peripheral vascular system for intravenous administration of fluids using a syringe or other compatible / appropriate devices.

The Delta Med Delta Fly Winged Safety Needles are available in four versions, as follows:

• o Delta Fly F20μ Micro Bore Winged Safety Needle 25G x 35 cm
• . Delta Fly F20μ Micro Bore Winged Safety Needle 23G x 35 cm
• Delta Fly Micro Bore Winged Safety Needle 25G x 35 cm ●
• Delta Fly Micro Bore Winged Safety Needle 23G x 35 cm

The devices consist of a stainless steel needle encased in a body of plastic material, attached to a micro bore tube, ending proximally with a female Luer lock fitting closed by a final male Luer lock cap. The female Luer lock fitting includes a 20μ woven mesh filter in the F20μ versions of the device. The devices are equipped with a passive needle stick safety system for covering the tip of the needle upon needle withdrawal, in order to protect the operator from accidental needle stick injury.

To help identification between the two types (with and without filter), the male Luer lock proximal end cap is colored white on the versions with the filter and is transparent on the versions without the filter. To identify the needle size of each version, the winged body of the devices are color-coded blue for the 23G versions and orange for the 25G versions.

The distal end of the device is a stainless steel needle point has a triple bevel design. At the proximal end is a Luer lock fitting. Both device versions (with and without the mesh filter) have a final female connection in compliance with the requirements of ISO 594-2.

Delta Fly Micro Bore Winged Safety Needles are supplied for short term use only, sterile for single use, sterilized with ethylene oxide (EO) gas, and meet the biocompatibility requirements of ISO 10993-1:2009.

The provided document describes the Delta Fly F20u Micro Bore Winged Safety Needles and Delta Fly Micro Bore Winged Safety Needles. Here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by adherence to established international standards and specific performance tests. The reported device performance indicates that these criteria were met.

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

• Sample Size for Test Set: The document explicitly states that the Simulated Clinical Usage test was conducted at "four different hospitals to allow a sufficient number of healthcare professional who routinely use Winged Needles". However, the exact number of devices or uses tested is not specified within the provided text.
• Data Provenance: The manufacturer, Delta Med SpA, is located in Viadana (Mantova), Italy. Given the context, the tests were likely conducted in Italy or within Europe under the manufacturer's supervision, but the specific country of origin for the data (other than the manufacturer's location) for all tests is not detailed. The Simulated Clinical Usage test was performed at "four different hospitals," implying a prospective collection of data.

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

• Number of Experts: The Simulated Clinical Usage test involved "healthcare professional who routinely use Winged Needles." The exact number of individual healthcare professionals is not specified.
• Qualifications of Experts: They are described as "healthcare professional who routinely use Winged Needles," indicating practical experience with the device type. Specific qualifications (e.g., nurse, physician, years of experience) are not provided.

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1). The "Simulated Clinical Usage test" results state that "100% of the safety mechanism of the devices activated correctly" and "No tests failures occurred," suggesting observation and recording of outcomes without mentioning a specific adjudication process for discrepancies, if any. Given the nature of the test (device activation and failure), it might have been a direct observation without requiring expert adjudication in the traditional sense of diagnostic interpretation.

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

No. The document describes performance testing and a simulated clinical usage test to demonstrate the device's functionality and safety, and substantial equivalence to predicate devices. It does not describe a multi-reader multi-case comparative effectiveness study comparing human readers with and without AI assistance. This device is a medical needle, not an AI diagnostic tool.

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

This question is not applicable as the device is a physical medical needle, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance tests (e.g., surface testing, corrosion, gauging, leakage, tensile strength, flow rate), the ground truth is established by compliance with specified international standards (ISO 594-2, ISO 9626, ISO 23908). This is a form of empirical and objective measurement against defined benchmarks.

For the "Simulated Clinical Usage test," the ground truth for "correct activation of the safety mechanism" and "test failures" would be based on direct observation and operational assessment by the participating healthcare professionals against the device's intended functionality and safety design.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical medical needle and does not involve AI or machine learning models that require a training set.

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

This question is not applicable as the device is a physical medical needle and does not involve AI or machine learning models that require a training set.

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