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The VACUTAINER® Brand Pronto™ Needle Holder is a non-sterile, reusable device designed to attach and hold a VACUTAINER® Brand needle or VACUTAINER® Blood Collection Set during venipuncture.

The VACUTAINER® Brand Pronto™ Needle Holder is a non-sterile, reusable device designed to attach and hold a VACUTAINER® Brand needle or VACUTAINER® Blood Collection set during venipuncture. The holder has a quick release feature which allows the contaminated needle to be disengaged with a simple one handed push-button technique.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Becton Dickinson VACUTAINER® Brand Pronto™ Needle Holder:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "results indicating acceptable product performance" for all three attributes. However, it does not provide specific numerical thresholds for "acceptable product performance" for each attribute, nor does it provide the measured values for these attributes.

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

• Sample Size for Test Set: A total of 30 holders were tested.
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Given the context of a 510(k) submission to the FDA in the USA for a US-based manufacturer, it is highly probable the testing was conducted in the USA as part of a prospective design verification study.

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

This information is not provided in the document. The study described is a mechanical testing study of the device's physical attributes, not a study requiring expert interpretation of results or clinical outcomes. Therefore, the concept of "ground truth established by experts" as typically applied in clinical or diagnostic studies is not relevant here.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. As noted above, this was a mechanical testing study, not a study involving human interpretation of results requiring adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a mechanical testing study of the device itself, not a study involving human readers or assessment of human performance with or without AI assistance.

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

No, a standalone study was not done, and it is not applicable. This device is a mechanical medical instrument (needle holder), not an algorithm or AI-powered system.

7. The Type of Ground Truth Used

The "ground truth" for this study was established by pre-defined engineering specifications and established BDVS procedures for mechanical testing of overtorque, activation force, and spinout. The performance of the devices was measured against these internal specifications to determine "acceptable product performance."

8. The Sample Size for the Training Set

This information is not applicable/not provided. The device is a mechanical instrument, and the study described is a design verification test, not a study involving a "training set" in the context of machine learning or algorithms.

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

This information is not applicable/not provided as there was no training set for this type of device and study.

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