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The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringes are intended to be used only for the flushing of indwelling vascular access devices.

0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Saline Flush Syringe is a polypropylene syringe intended to flush indwelling vascular access devices. It is a sterile, single use syringe prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The device is packaged in a film-on-film blister pack and sterilized by gamma irradiation. External sterility of the device enables it to be used in the sterile field. The subject device is available only in 10mL syringe configuration.

This document pertains to the 510(k) premarket notification for the "0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe," a medical device, not an AI/ML-driven device or an imaging system. Therefore, the questions regarding AI/ML performance metrics, expert consensus for ground truth, MRMC studies, or training/test set details are not applicable to this submission.

This submission focuses on demonstrating substantial equivalence to a predicate device (K153481) through bench performance testing, packaging integrity, and biocompatibility tests. The "acceptance criteria" here refer to the specifications for these non-clinical tests, rather than diagnostic performance metrics of an AI model.

Here's the information extracted that aligns with the request, re-interpreting "acceptance criteria" and "study" in the context of this device's submission:

1. Table of Acceptance Criteria and Reported Device Performance

Note 1: Result is a qualitative statement, not a numerical pass/fail against a specific threshold listed in the table.

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

The document does not specify numerical sample sizes for each of the performance, packaging, or biocompatibility tests. It only states that "appropriate performance tests and biocompatibility tests were performed" and the gamma sterilized test samples were evaluated. The data provenance (country of origin, retrospective/prospective) is also not specified, as these are bench and lab-based tests, not clinical studies involving patient data.

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

Not applicable. This submission is for a physical medical device, not an AI/ML imaging device. Ground truth, in this context, refers to the established standards, monograph requirements (e.g., USP, ISO), and validated internal specifications to which the device performance is measured against. Experts here would be the laboratory personnel and engineers performing the tests and
interpreting results against these defined criteria, but their specific number or detailed qualifications are not provided in the summary.

4. Adjudication Method for the Test Set:

Not applicable. Since this is not an AI/ML diagnostic device, there is no "adjudication" of expert opinions on image interpretation. The tests performed are laboratory or bench-based, with results measured against predetermined quantitative or qualitative acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/ML device, and no MRMC study was performed. The device's safety and effectiveness are demonstrated through non-clinical performance, packaging, and biocompatibility testing.

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

Not applicable. This device is a physical product (saline syringe), not an algorithm or software. No standalone algorithm performance was assessed.

7. The Type of Ground Truth Used:

The "ground truth" for this device's evaluation is primarily based on:

• Established Standards: e.g., ISO 10993 series for biocompatibility, ASTM F2096-11 for vacuum bubble leak, ANSI AAMI ST72:2019 for Bacterial Endotoxins.
• Pharmacopoeia Monographs: e.g., USP43-NF38 for NaCl Injection, pH, Iron, Heavy Metals, Particulate Matter, Bacterial Endotoxin.
• Validated Internal Specifications: "BD validated force" or "BD validated internal value" for mechanical/physical properties like tip cap removal torque, reflux, breakout force, sustaining force, retaining ring force, and seal strength.
• Qualitative Observations: e.g., "No evidence of Tip Cap leakage," "No leakage of solution past the stopper ribs," "Solution and components are clear," "No defects in packaging seals when visually inspected."

Essentially, the ground truth is defined by recognized industry standards, pharmacopoeial requirements, and the manufacturer's own validated specifications for product performance and safety.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device; 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 an AI/ML model, this question does not apply.

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