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For respiratory therapy and tracheal lavage

The subject device is 3 mL Steri-Neb Saline, 0.9% "/v Sodium Chioride Inhalation Solution USP. Steri-Neb Saline is used for respiratory therapy and tracheal lavage. For respiratory therapy, Steri-Neb Saline is used for dilution of solutions used in nebulizers. Steri-Neb Saline is a unit dose low density polyethylene vial containing sterile, preservative-free, clear, colourless, aqueous solution. The Steri-Neb Saline product contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.

The provided document is a 510(k) summary for a medical device called "3mL Steri-Neb Saline, 0.9% w/v Sodium Chloride Inhalation Solution USP." It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria for device performance as would be expected for a novel device or software.

Therefore, many of the requested elements regarding acceptance criteria and study design (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not typically included in a 510(k) summary for a product of this nature. This document primarily emphasizes the technological characteristics and intended use comparison to an already cleared predicate device.

However, I can extract information related to the comparison to the predicate, which serves as the "study" for establishing substantial equivalence.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of 510(k), acceptance criteria are not in the form of performance metrics (like sensitivity/specificity for an AI model) but rather revolve around demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness.

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

• Sample Size for Test Set: Not applicable in the context of this 510(k). This is a comparison of product specifications and intended use, not a clinical trial or performance evaluation with a "test set" of patients or data.
• Data Provenance: The data is based on the description and specifications of the subject device and the predicate device. No specific "country of origin" for data or "retrospective/prospective" study design is mentioned, as it's not a data-driven performance study.

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

• Number of Experts: Not applicable. Ground truth for device performance in a clinical or AI context is not established for this type of submission. The judgment of substantial equivalence is made by the FDA based on the provided technical documentation and comparison to the predicate.
• Qualifications of Experts: The submission was prepared by Steripak Limited, with John William Holloway B.Sc. CChem MRSC MBIRA, Head of Product Development and Regulatory Affairs, signing the document. The FDA, specifically the Division of Cardiovascular, Respiratory, and Neurological Devices, evaluates the submission.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" requiring adjudication. The process is a regulatory review by the FDA.

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

• MRMC Study: No. This is a saline solution, not an AI device or diagnostic imaging tool.

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

• Standalone Performance Study: No. This is not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device, as accepted by the FDA. The subject device is deemed "substantially equivalent" to this established predicate. The parameters for comparison are the device's intended use, technological characteristics (physical form, chemical composition), and labeling.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no algorithm or AI model involved that would require a training set.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set.

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20mL Normal Saline Topical Solution is usled for moistening and lubricating absorbent wound dressing prior to removal from the wound area.

The subiect device is a 20 mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride. It is used for moistening and lubricating absorbent wound dressings prior to removal from the wound area. Normal Saline Topical Solution 0.9% w/v is a unit-dose low density polyethylene vial containing a. clear, colourless, aqueous solution. Normal Saline Topical Solution contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.

The provided text describes a 510(k) summary for a medical device called "20 mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride". This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics. Therefore, most of the requested information regarding acceptance criteria, study details, and performance statistics is not available in the provided text.

Here's a breakdown of what can and cannot be extracted from the document:

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

• Not applicable/Not provided. The document does not define explicit acceptance criteria or report performance metrics in the way one would for a clinical or analytical study. The primary acceptance criterion for a 510(k) submission is demonstrating "substantial equivalence" to a legally marketed predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided. No test set or associated sample size is mentioned, as this is not a study reporting new performance data. The submission relies on a comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. No ground truth establishment is described, as there is no test set or study being conducted in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. No test set or adjudication method is described.

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/Not provided. No MRMC study or AI assistance is mentioned. This device is a topical solution, not an AI-assisted diagnostic tool.

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

• Not applicable/Not provided. This is not an algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided. No ground truth is established or used in the context of a performance study for this submission. The "ground truth" for the 510(k) equivalence claim is the performance and safety profile of the predicate device.

8. The sample size for the training set

• Not applicable/Not provided. No machine learning model or training set is mentioned.

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

• Not applicable/Not provided. No machine learning model or training set is mentioned.

Summary of what is available from the document:

The document is a 510(k) summary for a medical device. The "study" (or rather, the basis for clearance) is a comparison of the subject device to a predicate device to demonstrate substantial equivalence.

• Device Name: 20 mL Normal Saline Topical Solution, 0.9% w/v Sodium Chloride
• Intended Use: For moistening and lubricating absorbent wound dressings prior to removal from the wound area.
• Predicate Device: Brennen Medical, Incorporated's Sterile Saline Solution (510(k) K935060, cleared on January 10, 1994).
• Basis for Equivalence: The subject device is a topical sterile saline solution classified as a "liquid bandage" with the same intended use as the predicate device.
• Claimed Equivalence: "Although there are technological differences between the subject device and the predicate device, these technological differences do not raise new questions of safety and effectiveness."

The provided text simply states that a comparison was made to support substantial equivalence, but it does not detail the specific data or tests performed for that comparison, nor does it provide performance acceptance criteria beyond the general requirement of not raising new safety or effectiveness concerns.

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