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The BD Hypoint™ Needle is intended for use with syringes and injection devices for general purpose fluid injection / aspiration.

The BD Hypoint™ Needle is a hypodermic single lumen needle, designed for use with syringes and injection devices for general purpose fluid injection / aspiration. The BD Hypoint™ Needles are offered in various gauge sizes and needle lengths. The BD Hypoint™ Needle is sterilized by gamma irradiation (Cobalt-60). The BD Hypoint™ Needle is Non-Toxic, Non-Pyrogenic, Disposable and intended for Single Use.

This document describes the BD Hypoint™ Hypodermic Needle, a physical medical device, not an AI/ML software. Therefore, many of the requested categories (such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop performance)," "sample size for the training set," and "how the ground truth for the training set was established") are not applicable.

Here's the information that can be extracted from the provided text for this medical device:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format for the BD Hypoint™ Needle against its predicate device. However, it indicates that "Bench testing was performed to confirm the BD Hypoint™ Needle equivalence to the predicate device." The overall acceptance criterion is substantial equivalence to the predicate device (BD PrecisionGlide™ Needle, K021475).

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

• Sample Size: Not specified in the provided text. The phrase "Bench testing was performed" is used, but the number of needles tested is not disclosed.
• Data Provenance: The document does not specify country of origin for the bench testing data. It mentions "extensive market history of this device outside of the United States," but this refers to prior use and not specifically the provenance of data for this particular submission's bench tests. The bench testing itself is for the US submission.
• Retrospective or Prospective: Not explicitly stated, but bench testing on a new device would typically be considered prospective for the purpose of demonstrating equivalence.

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

This concept is not applicable to a physical medical device like a hypodermic needle undergoing bench testing for substantial equivalence. "Ground truth" in this context would refer to objective measurements of physical properties and performance characteristics, not expert interpretation of data. The "Medical Affairs Department" assessed the need for clinical analysis, but this is a different role than establishing ground truth for individual test results.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretation of qualitative data, often in clinical studies or image analysis. Bench testing for a physical device involves objective measurement, not expert adjudication in this sense.

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, as this is a physical medical device and not an AI/ML software.

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

Not applicable, as this is a physical medical device and not an AI/ML software.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on objective physical and performance measurements obtained during bench testing. These tests would evaluate characteristics such as needle sharpness, glide force, hub strength, needle integrity, sterility, etc., and compare them against the predicate device or established standards.

8. The Sample Size for the Training Set:

Not applicable, as this is a physical medical device and not an AI/ML software that requires a "training set."

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

Not applicable, as this is a physical medical device and not an AI/ML software.

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