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The BD Vacutainer® One Use Holder is a single-use, non-sterile device used by healthcare professionals to attach and hold a BD Vacutainer® brand venous access device such as a blood collection needle, a blood collection set, or a luer adapter during venipuncture connected to a BD Vacutainer® blood collection tube(s). This device may also be used with a BD Vacutainer® blood collection set with a luer adapter to obtain blood samples into a BD BACTEC™ blood culture bottle.

The BD Vacutainer® One Use Holder is a non-sterile, single-use plastic device used during the blood collection process. It consists of a one piece plastic barrel with a female threaded connector at one end into which the non-patient end of the hub of a BD Vacutainer® blood collection device is screwed. The other end is open for the insertion of a BD Vacutainer® evacuated blood collection tube or BD BACTECTM Blood Culture Bottle This end also has flanges, which are intended to assist tube insertion. BD Vacutainer® One Use Holder is used to attach and hold a BD Vacutainer® Brand venous access device such as a blood collection needle, blood collection set or Multiple Sample Luer Adapter during venipuncture and to connect the subject device to a BD Vacutainer® blood collection tube or BD BACTEC™ blood culture bottle.

The provided document is a 510(k) Summary for the BD Vacutainer® One Use Holder, a blood specimen collection device. It describes the device, its intended use, and compares it to a predicate device (Greiner Vacuette® Blood Culture Holder).

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

This document does not contain information about acceptance criteria and studies that prove a device meets those criteria in the context of an AI/ML medical device. This is a 510(k) Premarket Notification for a non-AI/ML medical device, specifically a blood specimen collection holder.

Here's why the requested information cannot be extracted from the provided text:

• Type of Device: The BD Vacutainer® One Use Holder is a physical, non-sterile, single-use plastic device. It is not an AI/ML-powered software device.
• Study Focus: The "Non-clinical Performance Summary" states that tests were conducted to "verify that the proposed devices met all design specifications and performance standards." This typically refers to mechanical, material, and functional testing for a physical device, not the evaluation of an AI algorithm's performance on a dataset.
• "Clinical Data - Not Applicable": This explicitly indicates that no clinical studies (which would be the source of test sets, ground truth establishment, expert adjudication, etc., for AI/ML devices) were required or performed for this device.
• Absence of AI/ML Specific Terminology: There is no mention of algorithms, machine learning, deep learning, models, training sets, test sets, inference, sensitivity, specificity, AUC, or any other terminology associated with AI/ML device evaluation.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence based on indications for use, design, materials, and non-clinical performance characteristics relevant to a conventional medical device.

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