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This product is a nebulizer used to generate aerosols that are delivered directly to the patient for breathing. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer. This product is a single patient use, non-sterile prescription device and is designed to be used in either a hospital or homecare environment.

The Salter Labs Modified Nebulizer is a modification to the existing Salter Labs Nebutech Nebulizer (K961476). The Cone assembly has been changed to incorporate the lens deflector that was originally contained in the Lid assembly of the Nebutech Nebulizer and a horizontal baffle has been added. All materials used in the Modified Nebutech are identical to the original Nebutech product. The cone assembly fits against a molded stop so that it sits firmly on the base of the jar. There are no other modifications to this product. This product is designed to be a single patient use device.

Here's an analysis of the provided text, focusing on acceptance criteria and a hypothetical study, as the provided document is a 510(k) summary for a medical device and not a study report. The document describes a "Modified Nebutech Nebulizer" and its substantial equivalence to a predicate device.

Key takeaway: The provided document is a 510(k) summary demonstrating substantial equivalence to a predicate device. It does not contain a detailed study report with specific acceptance criteria directly tied to performance metrics or individual device performance other than stating "Test results demonstrated that the Modified Nebulizer was equivalent to the Pari LC Plus Nebulizer." Therefore, the information below is reconstructed based on the typical requirements for nebulizer performance and the limited data provided.

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

Since specific acceptance criteria are not explicitly listed with numerical targets in the provided 510(k) summary, the table below infers typical performance parameters for nebulizers based on general regulatory guidance and the statement of equivalence. The "Reported Device Performance" is derived from the summary's qualitative statement.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Product performance testing was performed according to the 'Reviewer Guidance for Nebulizers Metered Dose Inhalers (10-01-93),' and Salter Labs testing requirements." It also notes that "all testing was performed in the Salter Labs R&D test laboratory" and that the "testing was performed on the Pari LC Plus Nebulizer" for comparison. This implies a comparative in-vitro study was conducted using a sample of the Modified Nebutech Nebulizer and the predicate Pari LC Plus Nebulizer. The specific number of units tested for each, however, is not provided.
• Data Provenance: The data was generated in an "in-vitro" setting within the "Salter Labs R&D test laboratory." This is a controlled, laboratory-based study. The country of origin for the data is the USA (Salter Labs, Arvin, CA). The study is prospective in the sense that data was collected specifically for this 510(k) submission, but it is an in-vitro study, not a clinical trial involving patients.

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

This section is not applicable as the study described is an in-vitro performance test, not a study requiring human expert evaluation to establish ground truth (e.g., image interpretation, disease diagnosis). The "ground truth" for this type of study would be the scientifically established physical performance characteristics of the comparator device and regulatory requirements for nebulized particle dispersion.

4. Adjudication Method for the Test Set

This section is not applicable as the reported study is an in-vitro performance test, not a study requiring human expert evaluation or adjudication. The measurements would be objective, machine-derived data points.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed on this product."

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

This section is not applicable as the device is a physical medical device (nebulizer), not a software algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the in-vitro performance testing was based on:

• Predicate Device Performance: The established, regulated performance characteristics of the "Pari LC Plus Nebulizer," which served as the benchmark for equivalence.
• Regulatory Guidance: The "Reviewer Guidance for Nebulizers Metered Dose Inhalers (10-01-93)," which outlines acceptable performance parameters for nebulizers.
• Salter Labs Testing Requirements: Internal company standards aligned with regulatory expectations and predicate device performance.

8. The sample size for the training set

This section is not applicable as this is a physical medical device. There is no "training set" in the context of machine learning or AI algorithms for this product.

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

This section is not applicable for the same reason as point 8.

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