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The Dual Spike Transfer Device is intended for the direct transfer of fluid/medication from one rubber-stoppered container to another.

The Dual Spike Transfer Device is a device containing two opposing spikes. Each spike contains a second lumen (adjacent to the spike). which facilitates direct flow of fluid/medication from one container (glass or flexible comainer) to another (glass or flexible container).

The proposed device is designed for, use by healthcare professionals during medication preparation, admixture, or fluid transfer. When the Dual Spike Transfer device is attached to the additive container, only air within the vial or flexible container is released into the recipient container. Once fluid transfer is complete, the transfer device attached to the additive container is discarded. This device is intended for admixture only.

The Dual Spike Transfer Device is individually packaged with two guards placed on each spike that provide protection to the spike ends of the device and prevent touch contamination.

The provided text describes a 510(k) premarket notification for a medical device called the "Dual Spike Transfer Device." However, it does not include information about acceptance criteria or a study proving the device meets said criteria in the way typically expected for an AI or diagnostic device.

Here's why and what can be extracted from the document given its nature:

• Nature of the Device: The Dual Spike Transfer Device is a fluid transfer device, not an AI or diagnostic tool. Its performance is assessed through safety and functional testing, not statistical metrics like sensitivity, specificity, or AUC, or a clinical study with human readers.
• 510(k) Process: A 510(k) submission primarily focuses on demonstrating "substantial equivalence" to a predicate device. This often involves comparing technological characteristics, intended use, and performance testing to show that the new device is as safe and effective as the legally marketed predicate. It's not typically a full-scale clinical trial with complex statistical analysis.

Given these points, I will extract what is available regarding performance testing and interpret the "acceptance criteria" in the context of a 510(k) for a physical transfer device.

Acceptance Criteria and Study for the Dual Spike Transfer Device

Based on the provided 510(k) summary, the "acceptance criteria" for the Dual Spike Transfer Device are implicitly met by demonstrating its safety and functional performance, and by demonstrating substantial equivalence to a predicate device. The "study" in this context refers to the safety and functional testing conducted.

1. Table of Acceptance Criteria (Implied) and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample size used for the safety and functional testing. It only states "Safety and functional testing were conducted."
• Data Provenance: Not explicitly stated, but assumed to be internal testing conducted by B. Braun Medical Inc. It would be prospective testing on manufactured devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This question is not applicable to this type of device and submission. The "ground truth" for a fluid transfer device's function is its physical ability to perform the transfer without leaks, contamination, or damage. This is assessed through engineering and quality control testing, not expert consensus in a clinical setting.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (like 2+1) are used for resolving disagreements in expert opinions, typically in diagnostic imaging studies. The performance of this physical device is determined by objective functional and safety tests.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images) and AI might assist them. The Dual Spike Transfer Device is a mechanical fluid transfer device.

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

• No, this is not applicable. The device is a physical product, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is established through objective engineering and safety testing against predefined specifications for:
  • Material compatibility
  • Sterility
  • Fluid transfer efficiency and integrity (no leaks, proper flow)
  • Spike integrity and protection mechanisms
  • Biocompatibility (implied by material safety and non-pyrogenicity)
• It is not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The Sample Size for the Training Set

• Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set."

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

• Not applicable. As above, there is no training set for this type of device.

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