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Over-the-Counter Use: For moistening absorbent wound dreaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin. Prescription Use: For moistening absorbent wound dressing and for moistening, debriding, and cleaning acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second-degree burns, cuts, abrasions, and minor skin irritations and for device irrigation.

The subject device Sterile Water USP, and Sterile 0.9% Normal Saline USP is a colorless, transparent solution with no preservatives or antimicrobial agents added. It is used only for external irrigation, and not for injection purposes and it is a single use device. The subject device is packaged in clear, polypropylene (PP) bottles capped with PP Screw cap and filled with a sterile, preservative-free, clear, colorless aqueous solution and sealed with a PP/PET aluminum induction seal. The aqueous solution composition is either sterile 0.9% normal saline, both which meet their respective USP monograph criteria and contain no additives. The container and closure system for the 250mL, and 1000mL sizes include PP bottles with a PP screw cap with a PP/PET aluminum induction seal and a tamper evident plastic shrink wrap. The container and closure system for the 100mL size includes a PP bottle with a PP screw cap and a PP/PET aluminum induction seal. These single-use devices are labeled for device irrigation and wound debridement and are not intended for injection. The subject device will function by the mechanical action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.

The provided text is a 510(k) summary for a medical device clearance, specifically for "Sterile Water USP and Sterile 0.9% Normal Saline USP" for use as sterile irrigation solutions. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/software device.

Therefore, the information required to answer your prompt, which is tailored for an AI/software medical device's performance evaluation (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details), is not present in the provided document.

The document discusses performance testing, but these are primarily bench tests, biocompatibility tests, and packaging tests for the physical product (sterile water/saline solution and its container), not performance metrics for an AI/software algorithm.

Here's a breakdown of why each point in your prompt cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not define "acceptance criteria" in the context of an AI/software's performance (e.g., accuracy, sensitivity, specificity). It lists various tests (biocompatibility, packaging, non-clinical bench tests for chemical properties and sterility) and reports that the device "complies with the criteria" or "successfully withstood" them. These are not performance metrics for a diagnostic or AI device.

2. Sample sized used for the test set and the data provenance: Not applicable. There is no AI/software test set. The tests mentioned are for physical product characteristics (e.g., "no bottles exhibited leakage," "containers remained undamaged").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for an AI/software test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set in the context of AI/software performance.

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 sterile water/saline, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the AI/software sense is not relevant here. The "truth" for this product is its chemical composition, sterility, and physical integrity, which are verified through standard laboratory tests.

8. The sample size for the training set: Not applicable. There is no training set for an AI/software.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) summary pertains to a physical medical device (sterile water/saline solution) and its substantial equivalence to a predicate device. It does not contain information about the development, validation, or performance of an AI/software medical device, which would typically involve the type of acceptance criteria and study details you have requested.

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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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