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Sterile Water for Inhalation, USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional and non-institutional care settings.

Sterile Water for Inhalation, USP is a sterile, single-dose medical device provided in durable Polypropylene (PP) bottles, which are resistant to breakage and designed for safe and easy handling. The bottles are available with two types of closures:

• A 36 mm PP screw cap with a PP/PET aluminium induction seal .
• A 28mm bromobutyl stopper with an aluminium seal .
  The bottles are available in the following volume configurations:
• . 1000mL PP bottles with either a bromobutyl stopper and aluminium seal, or a PP/PET aluminium induction seal, PP screw cap, and tamper-evident plastic shrink wrap.
• 500mL PP bottles with a PP/PET aluminium induction seal, PP screw cap, and tamper-. evident plastic shrink wrap.
  Sterile Water for Inhalation, USP is not for parenteral administration or irrigation. The product is For Inhalation Therapy Only. It is supplied sterile and intended for single use only. Discard any unused portion.

The provided text describes a 510(k) summary for a medical device called "Laboratorios Biogalenic Sterile Water for Inhalation, USP." This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

It's important to note that this document does not describe a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device performance evaluation. Instead, it's a regulatory submission demonstrating the substantial equivalence of a general medical device (sterile water for inhalation) to an existing one. The "acceptance criteria" here refer to regulatory requirements for substantial equivalence, not performance metrics like sensitivity, specificity, or AUC as seen in AI/ML device evaluations.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable to the information provided in this document as it relates to an AI/ML device.

However, I can extract information related to the "performance testing" conducted for this non-AI/ML device to demonstrate its substantial equivalence to the predicate device.

Summary of Acceptance Criteria and Device Performance (Non-AI/ML Device)

The "Laboratorios Biogalenic Sterile Water for Inhalation, USP" is a non-AI/ML medical device. Its acceptance criteria and performance are assessed through physicochemical, biological, packaging, and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify a distinct "test set" in the context of an AI/ML algorithm. The tests described are laboratory-based validation tests performed on samples of the manufactured device.
• The provenance of the data (e.g., country of origin, retrospective/prospective) is not detailed for these specific tests. These are standard validation tests for manufacturing processes and product integrity.

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

• This concept is not applicable as there is no "ground truth" derived from expert consensus for a diagnostic medical device in this context. The validity of the tests (e.g., sterility, leak resistance) is determined by established scientific methods and standards (USP, ASTM, ISO).

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

• Not applicable. The tests are laboratory-based with objective outcomes against defined standards.

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, as this is not an AI/ML device.

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

• Not applicable, as this is not an AI/ML device.

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

• The "ground truth" for this device's performance is established by scientific standards and analytical methods defined in regulations and industry standards (e.g., USP for sterility, ASTM for packaging, ISO for biocompatibility and sterilization). It's not based on expert consensus, pathology, or outcomes data in the way it would be for a diagnostic AI/ML device.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device. There is no training set for an algorithm.

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

• Not applicable, as this is not an AI/ML device.

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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.

This 510(k) premarket notification is for Sterile Water for Inhalation, USP. This product is a Class II medical device, specifically an accessory to medicinal non-ventilatory nebulizers and a nebulizer accessory.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

• "Each of the finished devices undergoes testing to meet the stated USP monograph and container criteria." (Section 7. Non-Clinical and Clinical Testing) |
  | Container Integrity: Meet container criteria and direct food and drug contact standards. | * "The component materials of the accessory device container have been substantiated to each meet criteria for direct food and drug contact or additive respectively." (Section 7. Non-Clinical and Clinical Testing)
• "Each of the finished devices undergoes testing to meet the stated USP monograph and container criteria." (Section 7. Non-Clinical and Clinical Testing) |
  | Sterility: Device is sterile. | * "The single-use devices... are sterile and pyrogen-free." (Section 4. Description of the Devices)
• One of the in vitro analytical methods used to demonstrate equivalence is "sterility." (Section 7. Non-Clinical and Clinical Testing) |
  | Pyrogen-free: Device is pyrogen-free. | * "The single-use devices... are sterile and pyrogen-free." (Section 4. Description of the Devices) |
  | Fill Uniformity: Consistent fill volume. | * One of the in vitro analytical methods used to demonstrate equivalence is "fill uniformity." (Section 7. Non-Clinical and Clinical Testing) |
  | Water Purity: Meet purity standards. | * "The water raw material source is Water for Injection, USP produced at Holopack." (Section 6. Technological Characteristics)
• One of the in vitro analytical methods used to demonstrate equivalence is "water purity." (Section 7. Non-Clinical and Clinical Testing) |
  | Physical-Chemical Characteristics: (e.g., water properties, unit configuration) | * These characteristics were used in "various in vitro analytical methods" to demonstrate equivalence. (Section 7. Non-Clinical and Clinical Testing) |

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

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 several various in vitro analytical methods (water purity, fill uniformity; sterility; container integrity) and physical-chemical characteristics (water properties; unit configuration) available which demonstrate this equivalence." (Section 7. Non-Clinical and Clinical Testing)

Therefore, there appears to be no "test set" in the traditional sense of a clinical study involving human subjects or a defined dataset for AI model evaluation. The assessment was based on analytical and physical-chemical testing of the manufactured product. The data provenance is internal to the manufacturer's quality control and testing processes.

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

Given that no clinical "test set" was used, the concept of experts establishing ground truth for such a set is not applicable here. The ground truth for the product specifications (e.g., USP monograph criteria) would have been established by the United States Pharmacopeia (USP) and other relevant regulatory bodies.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This device is a sterile solution (Sterile Water for Inhalation, USP). It is not an imaging or diagnostic device that would typically involve human readers or an AI algorithm requiring an MRMC study.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Performance:

Not applicable. This device is a physical product (sterile water), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" used for this device's acceptance was:

• USP Monograph Criteria: The legally defined specifications for Sterile Water for Inhalation, USP.
• Manufacturer's Internal Quality Control Specifications: Based on the USP and good manufacturing practices.
• Predicate Device Characteristics: The known and established characteristics of legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The manufacturing processes and quality checks are based on established scientific principles and regulatory standards, not on data-driven learning models.

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

Not applicable, as there is no training set for this type of device.

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