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The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, is a pneumatic nebulizer which, when driven by a compatible air compressor, nebulizes specific inhalable drugs for inhalation by a patient. It can be used with adult or pediatric patients.

The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, may be used with compatible compressors or an air gas source providing between 4 and 8 lpm.

The Nebulizer, Model A1/C (AndyFlow), is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing.

This device operates on the Venturi principle and is refillable. It is manufactured using polypropylene plastics, injection molded and is intended for single patient use.

The Nebulizer, Model A1/C (AndyFlow), has several attachments that are used with the nebulizer during the nebulization process. The attachments include a mouthpiece, a 2 meter connecting tube (which connects to the lower part of the nebulizer opposite the mouthpiece), a pediatric breathing mask and an adult breathing mask. These are standard accessories for nebulizer devices.

The provided text describes a 510(k) submission for a medical device, the Med2000 SpA Nebulizer, AndyFlow Model A1/C with accessories. This is a premarket notification to demonstrate that the device is substantially equivalent to a legally marketed predicate device, not a study proving the device meets specific acceptance criteria in the way clinical trials or performance evaluations typically do for AI/ML devices. Therefore, a direct answer to your request in the format provided is not fully applicable.

However, I can extract information related to the "acceptance criteria" and "study" as presented within the context of a 510(k) for this specific type of medical device (a nebulizer). For medical devices like nebulizers, "acceptance criteria" are typically related to performance specifications that ensure the device delivers medication effectively, and "studies" are often bench tests demonstrating these performance characteristics.

Here's the information broken down based on your request, with an explanation of why some sections are "Not Applicable" for this type of submission:

Acceptance Criteria and Device Performance for Med2000 SpA Nebulizer, AndyFlow Model A1/C

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: In a 510(k) process for a device like a nebulizer, the "acceptance criteria" are largely based on demonstrating substantial equivalence to a predicate device. This means showing that the new device performs as intended and is as safe and effective as the predicate. The "reported device performance" demonstrates that these criteria are met, primarily through bench testing in this case.

Detailed Information as Requested:

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

• Sample Size: Not specified for the bench tests. For device performance tests like particle characterization, sample sizes typically refer to the number of devices tested or the number of particle measurements taken, but this level of detail is not provided.
• Data Provenance: Not explicitly stated, but the manufacturer is Med2000 SpA, located in Padenghe Sul Garda, Italy. The testing would likely have been conducted by or for the manufacturer. The data is prospective in the sense that the tests were performed specifically for this submission.

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

• Not Applicable. For a nebulizer's particle characterization and safety testing (bench tests), "ground truth" is established by validated measurement techniques and adherence to international standards (e.g., ISO 10993). It does not involve expert consensus on subjective observations like in image interpretation.

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

• Not Applicable. Adjudication methods are relevant for subjective evaluations typically found in clinical trials or studies involving human interpretation. Bench testing for device performance relies on objective measurements and established protocols.

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 nebulizer, not an AI/ML diagnostic or image analysis tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.

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

• Not Applicable. This device is a mechanical nebulizer; it does not contain an "algorithm" or operate in a "standalone" computational capacity.

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

• Ground Truth Type: For the performance tests (Nebulizer Particle Characterization), the "ground truth" is based on objective physical measurements and adherence to recognized standards (e.g., for particle size distribution or nebulization rate). For biocompatibility, it's compliance with ISO 10993 standards. For safety, it's compliance with EPA PM 2.5 standards (though the context here indicates it's related to the device itself and not environmental monitoring).

8. The sample size for the training set

• Not Applicable. This device relies on mechanical and physical principles, not a machine learning model. Therefore, there is no "training set."

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

• Not Applicable. As there is no training set for a machine learning model, this question is not relevant.

Summary of the "Study" (Non-Clinical Tests):

The "study" performed to demonstrate substantial equivalence consisted of non-clinical bench testing:

• Nebulizer Particle Characterization Studies: Conducted at both 4 lpm and 8 lpm flow rates. The purpose was to verify that the nebulizer effectively produces aerosols with appropriate particle characteristics for drug delivery, especially given the new broadened flow range (4-8 lpm). The submission states these tests "revealed that no other parameters were affected," indicating satisfactory performance and equivalence.
• EPA PM 2.5 Testing: This test was previously performed for the predicate device and remained unchanged, implying its continued relevance and compliance.
• ISO 10993 Biocompatibility Testing: Similar to PM 2.5 testing, this was previously done for the predicate and remained unchanged, demonstrating the materials used in the device are biocompatible.

The overall "study" conducted for this 510(k) was focused on demonstrating that the slight labeling change (flow range) did not negatively impact the performance, safety, or effectiveness of the device compared to its predicate. No clinical studies were deemed necessary ("Not Applicable" for clinical tests).

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