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The MED2000 SpA Nebulizer Compressors, Models P3, P4 and P5, with Nebulizer, are ACpowered air compressors intended to provide a source of compressed air for medical purposes for use in home health care. These devices are provided with the Model A1/C (AndyFlow) pneumatic nebulizer and should only be used with this nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for inhalation by a patient for treatment of respiratory disorders such as allergies, asthma, cystic fibrosis, COPD, etc. It can be used with adult or pediatric patients.

These line powered piston compressors are housed in a plastic cabinet (case). The plastic cabinet is the only distinctive component between the three devices, that are identical for all other components, material and characteristics. Dimensions are 4.7 in. x 9.1 x 7.5 in. and weight 3.3 lbs. P3, P4 and P5 units contain no microprocessors or other electronic components. They operate from 115 VAC, 60 Hz. Each unit is supplied with an instruction manual and an accessory kit containing a nebulizer pediatric mask, a mouthpiece.

The provided document describes a 510(k) premarket notification for MED2000 SpA Nebulizer Compressors, Models P3, P4, and P5. This submission focuses on establishing substantial equivalence to a predicate device (Med2000 SpA Nebulizer Compressor, Models P1 and P2). The testing performed is primarily non-clinical, demonstrating safety and effectiveness in accordance with FDA guidance, rather than a study proving specific acceptance criteria related to disease diagnosis or treatment efficacy.

Therefore, many of the requested elements are not applicable to this type of regulatory submission. The document explicitly states "Discussion of Clinical Tests Performed: Not Applicable."

Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Specific Tests Performed (acting as implicit acceptance criteria for safety and performance):

• EPA PM 2.5 Testing
• EMC testing
• Dielectric Withstand
• Current Dispersion Test or Leakage Current Test
• Surface Temperature Test
• Air Temperature Test
• Storage conditions Operating environment extremes
• Sinusoidal Vibration Test
• Impact Resistance - Drop Test
• Fluid Spill Resistance Test

2. Sample size used for the test set and the data provenance
The document does not specify a "sample size" in the context of a test set for clinical performance, as it primarily relies on non-clinical engineering and performance testing. The "device sample(s) tested" is mentioned, but the exact number isn't quantified. The data provenance is internal testing performed by the manufacturer, MED2000 SpA, or its contracted labs, for regulatory submission purposes, and is inherently "prospective" for the purpose of demonstrating equivalence. The country of origin of the manufacturer is Italy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a nebulizer compressor, and its performance is evaluated through engineering and safety tests rather than clinical outcomes requiring expert-established ground truth.

4. Adjudication method for the test set
Not applicable. The tests performed are objective engineering and safety measurements, not subjective evaluations requiring adjudication.

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 a medical device (nebulizer compressor), not an AI-powered diagnostic tool. There are no "human readers" or "AI assistance" in the context of its function.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this type of submission is defined by established engineering standards, regulatory guidance (e.g., FDA November 1993 Draft "Reviewer Guidance for Premarket Notification Submissions", DCRND), and comparison to the predicate device's known performance for safety and basic operational characteristics. There is no clinical "ground truth" like pathology or outcomes data needed for this 510(k) submission.

8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established
Not applicable. See point 8.

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