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Sodium Chloride Inhalation Solution, USP 3% and 7%
The Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated.

Sodium Chloride Inhalation Solution, USP 0.9%
The intended use of this sterile device is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy and for tracheal irrigation or lavage.

The proposed device is a sterile, preservative-free Sodium Chloride Inhalation Solution, USP, provided in concentrations of 0.9%, 3% and 7% with a nominal fill volume of 3 mL & 5 mL (0.9%), 4 mL (3%) and 4 mL (7%) and supplied in single-use low density polyethylene (LDPE) vials.

The provided FDA 510(k) summary (K232523) describes a Sodium Chloride Inhalation Solution. This is a medical device (a drug-device combination product, specifically an accessory to a nebulizer) and not an AI/ML-powered medical device.

Therefore, the requested information regarding acceptance criteria, study design for AI model performance (including sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.) is not applicable to this submission.

The document focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics, design verification testing, biocompatibility, and meeting USP (United States Pharmacopeia) standards for pharmaceutical solutions and manufacturing. The "Performance Data" section describes validation of the physical and chemical properties of the solution and its container, not the performance of an algorithm or AI model.

However, to answer your request based on the provided document, I will extract the relevant information regarding the device's performance acceptance criteria and study proving it meets those criteria, as described for this specific non-AI medical device.

Acceptance Criteria and Study for Sodium Chloride Inhalation Solution (K232523)

This device is not an AI/ML device, and therefore the traditional metrics and study designs associated with AI performance are not relevant. Instead, the "acceptance criteria" here refer to the product specifications and quality control parameters for a pharmaceutical solution and its container, and the "study" refers to the testing performed to demonstrate compliance with these specifications and established standards.

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "All results met the predetermined acceptance criteria." Specific numerical criteria and their exact corresponding reported values are not fully detailed in this summary document, as is typical for 510(k) summaries which provide a high-level overview. However, the types of criteria and the confirmation of meeting them are listed.

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

• Sample Size: The document does not specify exact numerical sample sizes for each test (e.g., "n=X vials tested for fill weight"). It generally states that "Design verification testing was conducted..." and "The Sodium Chloride Inhalation Solution... are manufactured and tested in an identical manner to the Predicate Device." This implies that standard pharmaceutical quality control and validation sample sizes were used, which are typically defined by internal QMS procedures, relevant ISO standards, and USP monographs.
• Data Provenance: The testing was conducted by the manufacturer, Mankind Pharma Limited, based in New Delhi, India, or its affiliates/contract laboratories. The data provenance is effectively the internal testing records of the manufacturer. This is retrospective in the sense that the testing has already been completed and compiled for the submission.

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

This is not applicable. For this type of device (a sterile saline solution), "ground truth" is established by laboratory analytical methods that measure chemical composition, sterility, pH, etc., against predefined specifications (e.g., USP monographs). Human experts are involved in reviewing and validating the test methods and results, but not in establishing a "ground truth" through consensus reading of images or clinical assessments comparable to an AI/ML study.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication is relevant for subjective assessments (e.g., agreement between multiple readers on image findings). For objective chemical/physical tests, the results are quantitative and either meet or do not meet the specification; there is no "adjudication" in the sense of resolving inter-rater disagreement.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human performance in diagnostic tasks. This device is a solution used with a nebulizer, not a diagnostic AI tool.

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

This is not applicable. There is no algorithm or AI component in this device. The "performance" refers to the intrinsic properties of the sodium chloride solution and its sterile container.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Compendial Standards: Primarily the United States Pharmacopeia (USP) monographs for Sodium Chloride Inhalation Solution and general chapters for various tests (e.g., USP for Sterility, USP for Bacterial Endotoxins, USP for Identification, USP for Minimum Fill, USP for Osmolality, USP for Particulate Matter, USP for Foreign Matter, USP for pH, USP for Uniformity of Dosage Unit, USP for Container Closure Integrity).
• Internal Specifications: Derived from the device design and quality system, often based on these compendial standards and engineering requirements for the vial and its functionality.
• International Standards: e.g., ISO 10993 series for biocompatibility.

8. The Sample Size for the Training Set

This is not applicable. There is no AI model to train for this device. The "training" in manufacturing refers to process validation and optimization, not data feeding for a machine learning algorithm.

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

This is not applicable, as there is no AI training set.

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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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The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage. The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices for inhalation therapy is well-established.

The single-use device is in a color-coded unit blow-fill-sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen-free. The single-use containers are embossed with identifying product text and level markings. The finished device product configuration characteristics of these inhalation devices are similar to those of the predicate devices.

The provided document is a 510(k) summary for a medical device: "0.9% Sodium Chloride Inhalation Solution, USP". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel performance or efficacy through extensive clinical studies like those for new drug applications or high-risk devices.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about ground truth establishment for a test set.
• Information on expert adjudication methods or multi-reader multi-case studies.
• Results of standalone algorithm performance.
• Sample sizes for a training set or ground truth establishment for a training set.

Instead, the document focuses on demonstrating substantial equivalence to existing devices through:

• Comparison of intended use: The intended use of the device ("as accessory to medicinal nonventilatory nebulizers; in respiratory therapy; for tracheal irrigation or lavage") is stated to be identical to the predicate devices.
• Technological characteristics: The device's container materials, solution components (0.9% USP Sodium Chloride), and manufacturing process (blow-fill-seal technology) are described and compared to predicate devices. It emphasizes compliance with USP monograph requirements for the solution.
• Non-Clinical and Clinical Testing: The document explicitly states: "Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence."

Key Takeaways from the Document Regarding "Acceptance Criteria" (Implicit for 510(k) Submission):

The acceptance criteria are implicitly tied to demonstrating that the device is as safe and effective as its predicate devices, primarily through meeting established standards and specifications for its components and manufacturing.

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

   • Acceptance Criteria (Implicit from text):
     • Compliance with USP monograph requirements for 0.9% Sodium Chloride Inhalation Solution.
     • Container materials meet criteria for direct food and drug contact and USP container testing.
     • Finished devices undergo testing to meet stated USP monograph and container criteria (e.g., assay, fill uniformity, sterility, container integrity, solution properties, unit configuration).
     • Sterile and pyrogen-free.
     • No preservative.
     • Manufactured under current Good Manufacturing Practices (cGMP).
     • Technological characteristics are "identical or better" than predicate devices.
   • Reported Device Performance: The document states that the device "meets the current USP specifications" and "Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use." No specific performance metrics or values are provided; rather, it refers to compliance with established standards.

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

   • Not Applicable. The document explicitly states that clinical testing (which would typically involve test sets) was not necessary. The evaluation relied on in vitro analytical methods and physical-chemical characteristics.

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. No ground truth established through expert review for a test set was mentioned, as clinical testing was not performed.

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

   • Not Applicable. No test set or expert adjudication was performed.

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 device is a medical solution (0.9% Sodium Chloride) used with nebulizers, not an AI or imaging diagnostic device. MRMC studies are not relevant.

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

   • Not Applicable. This is not an algorithm or AI device.

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

   • The "ground truth" here is the established USP (United States Pharmacopeia) monograph criteria and other regulatory standards for Sodium Chloride Inhalation Solution and its container components. This is verified through "in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration)."

8. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not Applicable. No training set exists for this type of device submission.

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The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage.

The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices for inhalation therapy is well-established.

The single-use devices are color-coded unit blow-fill-sealed containers with liquid contents as labeled for inhalation therapy. The devices contain no preservative. They are sterile and pyrogen-free.

The provided document is a 510(k) Premarket Notification for Sodium Chloride Inhalation Solutions. This type of submission is for medical devices that are substantially equivalent to a predicate device already on the market. It does not typically involve clinical trials or a study to prove performance against specific acceptance criteria in the way a novel AI/software device would. Instead, substantial equivalence is demonstrated through comparative analysis of technological characteristics and non-clinical testing.

Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable to this particular submission type and product.

Here's a breakdown based on the provided text, indicating where information is not applicable:

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

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 (N/A): This submission is for a pharmaceutical/delivery device (inhalation solution), not an AI/software device that would use a "test set" in this manner. Substantial equivalence was demonstrated through non-clinical laboratory testing and adherence to USP standards. No clinical trials or patient data sets (retrospective/prospective) are mentioned.

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)

• N/A: No "ground truth" for a test set in the context of an AI/software device. The compliance is against established USP monographs and industry standards.

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

• N/A: Not applicable to this type of device and submission.

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

• N/A: This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.

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

• N/A: This is not an algorithm-based device.

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

• Standard Specifications and Monograph Requirements: The "ground truth" (or benchmark for performance) for this device is based on established USP (United States Pharmacopeia) monograph requirements for Sodium Chloride Inhalation Solution and criteria for direct food and drug contact for the container materials. It also relies on the performance characteristics of predicate devices (K884359, K870332, Travenol Laboratories pre-1976, Wyeth Laboratories pre-1976).

8. The sample size for the training set

• N/A: This is not an AI/software device that uses a "training set."

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

• N/A: Not applicable to this type of device and submission.

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