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The BD Preset™ Syringe & BD A-Line™ Syringe are sterile, single use medical devices specifically intended to be used for the collection of whole blood specimens for the purpose of in vitro diagnostic testing which may include: pH, blood gases, electrolytes (including ionized calcium), metabolytes, co-oximetry. The device is intended to be used by trained healthcare professionals.

The BD Preset™ Syringe & BD A-Line™ Syringe is a sterile, single use device designed to collect whole blood specimens for diagnostic testing. The BD A-Line™ Syringe is specifically designed for aspiration of blood samples from arterial lines. The BD Preset™ Syringe is offered with and without a pre-attached Eclipse™ needle and is specifically designed to preset a desired volume but permits aspiration when necessary. It also includes a venting system that expels residual air through the self-venting membrane (as blood fills the syringe), which ensures rapid filling. The syringe is individually packaged, and Gamma sterilized with an SAL of 10-6.

The provided text describes a Special 510(k) premarket notification for the BD Preset™ Syringe & BD A-Line™ Syringe. This submission focuses on demonstrating substantial equivalence to a predicate device after minor modifications.

Here's a breakdown of the acceptance criteria and the study conducted, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly present a table of acceptance criteria defined as numerical thresholds alongside reported device performance for blood gas measurements or similar clinical metrics. This submission focuses on bench, biocompatibility, and sterilization testing to demonstrate that the modified device performs equivalently to the predicate, and that the changes introduce no new safety or effectiveness issues.

Instead, the "acceptance criteria" are implied to be meeting the performance of the predicate device and relevant international standards. The "reported device performance" is a general statement that the device functioned as intended and demonstrated acceptable performance.

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

• Sample Size for Test Set: The document does not specify exact sample sizes for each of the bench, biocompatibility, or sterilization tests. It only lists the types of tests conducted.
• Data Provenance: The data are internal company testing results ("BD performed the following bench, biocompatibility, and sterilization testing"). The document does not specify country of origin for the data (e.g., US, Europe, etc.) or whether it was retrospective or prospective, though performance testing of a new/modified device would generally be prospective.

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

This type of submission (510(k) for a medical device like a syringe) does not involve establishing ground truth through expert review in the way a diagnostic AI submission would. The "ground truth" for the performance tests listed (e.g., tip cap leak, heparin activity) would be established by the physical and chemical properties of the materials and the manufacturing process, verified by standard laboratory testing procedures. There's no interpretive component requiring multiple human experts.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic interpretation study. The tests performed are objective measurements.

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

No. An MRMC study is relevant for diagnostic devices where human reader performance (e.g., radiologists interpreting images) is being evaluated for improvement with or without AI assistance. This submission is for a blood collection syringe, a physical medical device, not a diagnostic interpretation system. Therefore, this type of study was not conducted.

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

Not applicable. This is not an algorithmic or AI device. The "performance data" refers to the physical and chemical performance of the syringe.

7. The Type of Ground Truth Used

The "ground truth" for the performance "studies" (which are laboratory tests rather than clinical trials with patient outcomes) is based on:

• Established physical and chemical test methods (e.g., ASTM, ISO standards).
• Functional specifications for the device (e.g., desired plunger force, leak-free operation).
• The performance of the legally marketed predicate device (demonstrating equivalence).

Essentially, the "ground truth" is that the device must function safely and effectively according to engineering and material science principles, and meet the performance standards of its predicate.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not a machine learning algorithm. Therefore, there is no "training set."

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

Not applicable, as there is no training set for this type of device.

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