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The Normal Saline prefilled syringes are indicated solely for use in flushing intravascular catheters and maintaining the patency of indwelling intravascular catheters.

B. Braun Medical. Inc. intends to introduce into interstate commerce the Braun Prefilled Syringes. The syringes are aseptically filled with sterile 0.9% saline solutions intended solely for use in flushing intravascular catheters and maintain the patency of indwelling intravascular catheters. The syringes and solutions are not intended for use as anticoagulant therapy. The aseptic filling of these syringes with these solutions does not alter the intended use of the svringes or the solutions. The svringes have been cleared for marketing under K760392. The solutions meet the specifications of the applicable USP monograph for sodium chloride.

The provided text is a 510(k) Summary for B. Braun Prefilled Syringes (K970736), which are described as being aseptically filled with sterile 0.9% saline solutions for flushing intravascular catheters. This document primarily focuses on establishing substantial equivalence to previously cleared devices under FDA regulations.

Based on the content, there is no information regarding acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/ML medical device. This 510(k) is for a physical medical device (prefilled syringes) and relies on demonstrating substantial equivalence to predicate devices and adherence to manufacturing guidelines, rather than performance metrics from a clinical study.

Therefore, most of the requested information regarding AI/ML device performance is not applicable or cannot be extracted from this document.

Here's a breakdown of why and what information can be inferred:

1. A table of acceptance criteria and the reported device performance:

• Not Applicable in the traditional sense. The "acceptance criteria" for this device are implicitly tied to meeting the specifications of the U.S. Pharmacopeia (USP) monograph for 0.9% sodium chloride, and the substantial equivalence to predicate syringes regarding materials, manufacturing processes, intended use, design, and labeling.
• Reported Device Performance: The document states that the "solutions meet the specifications of the applicable USP monograph for sodium chloride" and that "the materials use to manufacture the syringes, as well as, the solutions used to fill the syringes have previously been reviewed by the FDA and determined to be suitable for the intended use of this product." This indicates that the performance is tied to material safety and chemical composition meeting established standards, not a specific measurable clinical outcome from a quantitative study.

2. Sample size used for the test set and the data provenance:

• Not Applicable. This is not an AI/ML device or a device that underwent a clinical performance study with a test set of data points in the customary sense. The "testing" involved demonstrating that the materials and solution meet standards, and asserting equivalence to a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. Ground truth, in the context of an AI/ML device, refers to verified labels or outcomes used to evaluate an algorithm. For this physical device, "ground truth" would be the established chemical composition standards of USP and safety profiles of the materials, which are defined by regulatory bodies and scientific consensus, not a specific set of experts for a single study.

4. Adjudication method for the test set:

• Not Applicable. As there is no test set in the AI/ML context, there's no adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This type of study is for evaluating human performance with and without an AI assistant, which is not relevant for a prefilled saline syringe.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This device does not have an "algorithm."

7. The type of ground truth used:

• Regulatory/Standard Compliance. The ground truth is the established U.S. Pharmacopeia (USP) monograph for 0.9% sodium chloride and the FDA's prior clearances and safety assessments of the syringe materials (K760392) and saline solutions. This is not "expert consensus, pathology, or outcomes data" in the AI/ML sense but rather established scientific and regulatory benchmarks.

8. The sample size for the training set:

• Not Applicable. This is not an AI/ML device that uses a "training set."

9. How the ground truth for the training set was established:

• Not Applicable.

In summary, the provided K970736 document is a regulatory submission for a physical medical device (prefilled syringes) and not for an AI/ML-driven device. Therefore, the questions related to AI/ML device performance, ground truth establishment for training/test sets, expert adjudication, and MRMC studies are not applicable to this document. The "study" referenced in the document is implicitly the demonstration that the components (syringes, saline solution) meet existing FDA clearances, USP standards, and manufacturing guidelines, leading to a finding of "substantial equivalence" to predicate devices.

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