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This solution is indicated for use as a tracheal lavage, nasal irrigation solution or as an irrigation solution for flushing a body cavity.

Automatic Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. These products have not experienced or been associated with toxic or undesirable effects that relate to the ingredients used in their production. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers.

The irrigation bottle is manufactured of 100% virgin low density polyethylene (LDPE) and contains no regrind, color or chemical additives.

The two solutions are sterile, aseptically filled, and are hermetically sealed for Single Use Only.

The provided text is a 510(k) summary for a medical device called "Sterile Water and Saline Bottle for Irrigation." This document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a study with specific acceptance criteria and detailed performance data on a new, unproven device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in this document. The 510(k) process for this type of device typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring novel clinical studies with extensive performance metrics.

Here's an analysis based on the provided text, highlighting what can be inferred or what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. For a product like a sterile saline solution and bottle for irrigation, acceptance criteria would typically revolve around sterility, purity of ingredients, container integrity, and potentially biological safety (e.g., non-pyrogenic). However, the specific quantitative criteria and detailed performance results against those criteria are not detailed in this 510(k) summary.

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

This information is not provided. The document does not describe a clinical study or a specific test set. The focus is on the long-standing use and known properties of the product.

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

This information is not provided. No expert review or ground truth establishment process for a test set is described.

4. Adjudication Method for the Test Set

This information is not provided. No test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not conducted or reported in this document. This type of study is more common for diagnostic imaging devices where human interpretation is crucial, not for a sterile irrigation solution and bottle.

6. Standalone Performance Study

A standalone performance study (algorithm only without human-in-the-loop) was not conducted or reported. This concept is not applicable to this type of medical device (a sterile solution and bottle).

7. Type of Ground Truth Used

The "ground truth" for this type of device is inherent in its composition and long history of use. The document states: "Automatic Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. These products have not experienced or been associated with toxic or undesirable effects that relate to the ingredients used in their production."

Therefore, the "ground truth" or basis for safety and effectiveness relies on:

• Historical clinical use/Outcomes data: The long-standing safe use of such products.
• Chemical and material properties: The known safety and inertness of the ingredients (sterile water, sodium chloride) and the container material (100% virgin low density polyethylene).
• Manufacturing processes: Aseptic filling and hermetic sealing ensure sterility.

8. Sample Size for the Training Set

This information is not provided. There is no "training set" in the context of this device's approval process. The device is not a learning algorithm or AI.

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

This information is not provided. As no training set exists, no ground truth needed to be established for it.

In summary, the provided 510(k) summary is for a relatively simple, well-understood medical device (sterile irrigation solution and bottle). Its approval hinges on demonstrating substantial equivalence to a predicate device, relying on the known safety of its components and manufacturing processes, rather than on detailed clinical studies with the kind of metrics requested for devices like AI algorithms or complex diagnostic tools.

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