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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 <71> for Sterility, USP <85> for Bacterial Endotoxins, USP <191> for Identification, USP <755> for Minimum Fill, USP <785> for Osmolality, USP <789> for Particulate Matter, USP <790> for Foreign Matter, USP <791> for pH, USP <905> for Uniformity of Dosage Unit, USP <1207> 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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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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