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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 device is in a color-coded unit blow-fill-sealed container with liquid contents as labeled for inhalation therapy. The device contains no preservative and is sterile and pyrogen-free. The single-use containers are embossed with identifying product text and level markings. The finished device product configuration characteristics of these inhalation devices are similar to those of the predicate devices.

The provided document is a 510(k) summary for a medical device: "0.9% Sodium Chloride Inhalation Solution, USP". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving novel performance or efficacy through extensive clinical studies like those for new drug applications or high-risk devices.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or details about ground truth establishment for a test set.
• Information on expert adjudication methods or multi-reader multi-case studies.
• Results of standalone algorithm performance.
• Sample sizes for a training set or ground truth establishment for a training set.

Instead, the document focuses on demonstrating substantial equivalence to existing devices through:

• Comparison of intended use: The intended use of the device ("as accessory to medicinal nonventilatory nebulizers; in respiratory therapy; for tracheal irrigation or lavage") is stated to be identical to the predicate devices.
• Technological characteristics: The device's container materials, solution components (0.9% USP Sodium Chloride), and manufacturing process (blow-fill-seal technology) are described and compared to predicate devices. It emphasizes compliance with USP monograph requirements for the solution.
• Non-Clinical and Clinical Testing: 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 various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence."

Key Takeaways from the Document Regarding "Acceptance Criteria" (Implicit for 510(k) Submission):

The acceptance criteria are implicitly tied to demonstrating that the device is as safe and effective as its predicate devices, primarily through meeting established standards and specifications for its components and manufacturing.

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

   • Acceptance Criteria (Implicit from text):
     • Compliance with USP monograph requirements for 0.9% Sodium Chloride Inhalation Solution.
     • Container materials meet criteria for direct food and drug contact and USP container testing.
     • Finished devices undergo testing to meet stated USP monograph and container criteria (e.g., assay, fill uniformity, sterility, container integrity, solution properties, unit configuration).
     • Sterile and pyrogen-free.
     • No preservative.
     • Manufactured under current Good Manufacturing Practices (cGMP).
     • Technological characteristics are "identical or better" than predicate devices.
   • Reported Device Performance: The document states that the device "meets the current USP specifications" and "Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use." No specific performance metrics or values are provided; rather, it refers to compliance with established standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable. The document explicitly states that clinical testing (which would typically involve test sets) was not necessary. The evaluation relied on in vitro analytical methods and physical-chemical characteristics.

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):

   • Not Applicable. No ground truth established through expert review for a test set was mentioned, as clinical testing was not performed.

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

   • Not Applicable. No test set or expert adjudication was performed.

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 a medical solution (0.9% Sodium Chloride) used with nebulizers, not an AI or imaging diagnostic device. MRMC studies are not relevant.

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

   • Not Applicable. This is not an algorithm or AI device.

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

   • The "ground truth" here is the established USP (United States Pharmacopeia) monograph criteria and other regulatory standards for Sodium Chloride Inhalation Solution and its container components. This is verified through "in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration)."

8. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device that requires a training set.

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

   • Not Applicable. No training set exists for this type of device submission.

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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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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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