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PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Concentrations of 0.9%, 3%, 3.5%, 6%, 7%, and 10% with a pH of 7.4

The proposed inhaled saline solutions are in 0.9%, 3%, 3.5%, 6%, 7%, and 10% concentrations with a pH of 7.4. They are packaged sterile in 4 ml vials for use as indicated.

This document describes a 510(k) submission for an inhaled saline solution device, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance and testing are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the device as being "substantially equivalent" to predicate devices, focusing on meeting established standards rather than setting new performance "acceptance criteria" in the sense of a novel device's performance metrics. The "performance" assessment is based on compliance with USP specifications and similarity to the predicate device.

2. Sample size used for the test set and the data provenance:
Not applicable. This is a saline solution, and the testing described is non-clinical (lot release, in-process, and finished product testing) focused on chemical properties and sterility, not clinical efficacy or diagnostic performance. There is no "test set" of patient data in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth for a diagnostic test set is established in this submission.

4. Adjudication method for the test set:
Not applicable.

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 is not an AI/ML diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML diagnostic device.

7. The type of ground truth used:
The "ground truth" for this device is based on United States Pharmacopeia (USP) specifications for saline solutions and analytical testing results (e.g., salinity, pH, identification of sodium, sodium chloride assay, sterility). The comparison to predicate devices also serves as a "ground truth" for substantial equivalence.

8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no training set in that context. The "training" for this device is the established pharmaceutical manufacturing processes and USP standards.

9. How the ground truth for the training set was established:
Not applicable. The manufacturing processes are established by pharmaceutical standards and quality control protocols.

Summary of the Study/Testing:

The study proving the device meets the acceptance criteria is a non-clinical testing summary that demonstrates the product's physicochemical properties and sterility align with relevant standards (USP) and are substantially equivalent to predicate devices. This involves:

• Lot Release Testing by Asept Pak: This ensures each lot meets specifications.
• In Process Testing: Includes incoming resin certification, water testing, pH measurement, appearance checks, salinity, environmental monitoring, container fill weight monitoring, and visual inspection.
• Finished Product Tests: Includes salinity, identification of sodium (USP 191), sodium chloride assay (USP Monograph), and sterility (USP <71>).

The conclusion is based on this performance testing, design features, and comparison to predicate devices, leading to a finding of substantial equivalence. The "study" here is essentially a comprehensive quality control and analytical chemistry assessment, rather than a clinical trial or AI/ML performance study.

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The NESSI OTC Spacer is intended to be used to administer aerosolized medication from pressurized Metered-Dose Inhalers, which are over-the-counter (OTC), e.g., bronchodilator / epinephrine.

The NESSI is a spacer intended for use in the inhalations which are provided by OTC MDIs. The device consists of a translucent housing a back piece and mouth piece or face mask. It is a single patient, multi-use device.

This 510(k) summary describes the NESSI OTC Spacer, intended for use with over-the-counter (OTC) Metered-Dose Inhalers (MDIs) like bronchodilators/epinephrine. The device is being compared to a predicate PharmaCaribe NESSI Rx Spacer (K091862) and a Primatene Mist OTC MDI.

Here's a breakdown of the requested information based on the provided text:

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

The provided document doesn't explicitly state numerical "acceptance criteria" for the NESSI OTC Spacer in terms of specific performance metrics like particle size distribution targets or usability scores. Instead, it frames the performance evaluation as demonstrating "equivalence" to predicate devices and appropriateness for OTC use.

Therefore, the table below will summarize the types of performance testing conducted and their general reported findings, rather than specific numerical criteria and results.

2. Sample size used for the test set and the data provenance

• Particle Characterization (Test Set): The document does not specify the sample size used for the Anderson Cascade Impactor testing. It also doesn't provide information about the data provenance (e.g., country of origin, retrospective/prospective).
• Usability Study (Test Set): The document does not specify the sample size used for the Usability study or the data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document describes technical and usability testing, but not a process that would involve medical experts establishing a "ground truth" in the way it might for a diagnostic imaging device.

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

This information is not applicable/provided. The performance tests described (particle characterization, usability) are not typically assessed using adjudication methods like 2+1 or 3+1, which are common in clinical trial settings for expert review of images or data.

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

This information is not applicable. The NESSI OTC Spacer is a medical device (spacer/holding chamber) designed to aid in the delivery of aerosolized medication, not an AI-powered diagnostic tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers with and without AI assistance would not be relevant to this device.

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

This information is not applicable. The NESSI OTC Spacer is a physical medical device, not an algorithm, and does not operate in a "standalone" algorithmic capacity.

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

• For Particle Characterization: The "ground truth" implicitly refers to established scientific methods for measuring particle size distribution (Anderson Cascade Impactor) and comparative data from predicate devices or MDIs. It's based on physical measurements and engineering principles.
• For Usability Study: The "ground truth" for usability would be derived from structured observations and feedback from users interacting with the device and its instructions, assessing their ability to correctly and effectively use the product as instructed. This doesn't typically involve expert medical consensus or pathology in the same way as a diagnostic tool.

8. The sample size for the training set

This information is not applicable/provided. This device is not an AI/machine learning device that would require a "training set."

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

This information is not applicable. As it's not an AI/machine learning device, there is no training set or associated ground truth establishment process in that context.

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PharmaCaribe inhaled saline solutions are used in conjunction with a nebulizer. The contents of these vials are for the induction of sputum production where sputum production is indicated. Concentrations of 3%, 3.5%, 6%, 7%, and 10%

PharmaCaribe Sodium Chloride Solutions are homogeneous mixtures (complete solutions) and are composed of USP sterile water and sodium chloride only and provided in 3%, 3.5%, 6%, 7%, and 10% concentrations. They are packaged sterile in standard 5ml (4ml fill) flexible material vials. The vials have a tear-off top. They are marked NOT FOR INJECTION.

The provided document describes a 510(k) premarket notification for PharmaCaribe inhaled saline solutions. This is not a study proving device performance against acceptance criteria in the context of an AI/ML medical device. Instead, it is a submission for a medical device (saline solutions) demonstrating substantial equivalence to predicate devices already on the market.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/ML device performance, are not applicable to this document.

Summary of Device and Approval:

• Device Name: PharmaCaribe inhaled saline solutions 3%, 3.5%, 6%, 7%, and 10%
• Intended Use: For the induction of sputum production where sputum production is indicated, in conjunction with a nebulizer.
• Classification: Class II, Nebulizer (Direct Patient Interface), Product Code CAF
• Predicate Devices: DEY Laboratories - K972778 and Pari - K070498
• Approval Date: August 17, 2010
• Basis of Approval: Substantial equivalence to predicate devices. The device's manufacturing and testing processes (including pH, osmolality, appearance, sterility, identification of sodium and chloride, bacterial endotoxin, iron content, heavy metals content, sodium chloride assay, and stability testing) are identical or similar to the predicate devices and conform to USP monographs.

Non-Applicability of AI/ML Study Criteria:

The questions related to acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are specifically designed for evaluating the performance of AI/ML algorithms. Since the PharmaCaribe inhaled saline solutions are a pharmaceutical-like product (albeit regulated as a medical device) and not an AI/ML system, these criteria do not apply to this 510(k) submission. The "performance testing" referenced in the document refers to chemical and sterility testing to ensure the product meets established standards, not diagnostic or predictive performance.

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The NESSI Spacer is intended to be used by patients who are under the care of treatment of a licensed healthcare professional or physician. The device is intended to be used by these patients to administer aerosolized medication from pressurized Metered-Dose Inhalers, prescribed by a physician or healthcare professional.

The NESSI is a spacer intended for use in the inhalation of MDIs for the therapy of the upper and lower respiratory system. The device consists of a translucent housing a back piece and mouth piece.

The NESSI Spacer can be used to inhale aerosolized drugs of approved MDIs from the following groups of active substances:

• · Corticosteroids (anti-inflammatory medications)
• · Anti-cholinergics and ß2-sympathomimetics (bronchodilater medications)
• · Non-steroidal chromones (DNCG)

It is a single patient, multi-use device.

The provided document describes a 510(k) premarket notification for the NESSI Spacer, which is a medical device. 510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies to prove acceptance criteria in the same way a PMA (Premarket Approval) would. Therefore, the information requested regarding a "study that proves the device meets the acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or reader improvement, or details on training/test sets, ground truth, and expert adjudication, is largely not applicable or present in this type of document.

A 510(k) focuses on demonstrating that the new device is as safe and effective as a predicate device through comparison of indications for use, technological characteristics, materials, and other attributes.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission, "acceptance criteria" are generally based on demonstrating "substantial equivalence" of the new device's attributes to those of predicate devices. The "reported device performance" is a comparison to the predicate devices.

Note: The "acceptance criteria" here are inherently tied to satisfying the substantial equivalence requirements by closely matching or being demonstrably as safe and effective as the predicates.

Regarding items 2-9 from your request:

The provided document does not contain information typically associated with a study proving clinical performance using specific metrics, test sets, ground truth establishment, or expert adjudication, as would be expected for a device requiring higher levels of clinical evidence. This is because the NESSI Spacer is a Class II device seeking 510(k) clearance based on substantial equivalence to existing predicate devices. The review focuses on comparing the new device's characteristics to the predicates, as detailed in the table above, not on a new clinical efficacy study with performance metrics in the way your questions imply for AI/software devices.

Therefore, the following points are not applicable (NA) or not provided in this 510(k) submission:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
* NA: No clinical performance study with a test set of data is detailed. The substantial equivalence is based on device characteristics, materials, and indications, not a data-driven performance test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
* NA: No test set or ground truth established by experts is mentioned for performance evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
* NA: No test set or adjudication method mentioned.

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
* NA: This is not an AI/software device, and no MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* NA: This is a physical medical device (spacer), not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
* NA: No ground truth in the context of clinical performance evaluation is used. The "ground truth" for this submission is that the predicate devices are legally marketed and considered safe and effective for their intended use.

8. The sample size for the training set
* NA: No training set mentioned.

9. How the ground truth for the training set was established
* NA: No training set or ground truth mentioned.

Summary Rationale:

The NESSI Spacer received 510(k) clearance (K091862) based on demonstrating substantial equivalence to predicate devices (K010680 - CT Spacer and K070674 - Trudell AeroChamber Plus). This process generally involves comparing product descriptions, indications for use, technological characteristics, materials, and other non-clinical factors. For devices like this spacer, extensive new clinical performance studies with metrics, test sets, and expert adjudication (as typically required for AI/software or novel high-risk devices) are usually not part of the 510(k) submission. Therefore, the specific types of "acceptance criteria" and "study" details requested are not relevant or present in this document for this type of device and regulatory pathway.

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