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The eFlow® is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.

The PARI eFlow® Electronic Nebulizer is a small, single-patient use, reusable electronic nebulizer for the inhalation treatment of aerosol medications. It is a hand-held device, containing a capped medication cup that can be filled by the user. Power input is provided by either four AA batteries or a DC or AC adapter. Alternate power cords/plugs/adapters allow its use in any country.

Here's a breakdown of the acceptance criteria and study information for the eFlow® Electronic Nebulizer, based on the provided text:

Based on the provided text, the device in question is a modified eFlow® Electronic Nebulizer, specifically the addition of a new control unit with an LCD. The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical trials with specific acceptance criteria in the same way a new drug or high-risk medical device might.

The "acceptance criteria" here are implicitly tied to demonstrating that the modifications do not adversely affect safety or performance and that the modified device remains substantially equivalent to the predicate. The study described focuses on technical verification and validation, not on clinical performance metrics like sensitivity, specificity, or reader agreement.

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 60601-1-2
• CAN/CSA C22.2 NO 601.1-M90
• UL 1431 |
  | Stress Testing
  (Compliance with specified standards for intended operational environment) | Testing performed to the applicable requirements of:
• IEC/EN/DIN 60068-2-3
• 60068-2-6
• 60068-2-14
• 60068-2-29
• 60068-2-64
• 60068-2-78 |
  | Overall Impact on Performance, Safety, or Effectiveness
  (No new issues or adverse effects) | "Testing demonstrated that the modifications to the new, optional control unit do not affect the performance of the eFlow Electronic Nebulizer, and raise no new issues of safety or effectiveness."
  "The addition of the modified unit does not affect the intended use, or alter the fundamental scientific technology of the legally-marketed PARI eFlow."
  "Additionally, there is no change to the legally-marketed device's: (1) materials; (2) performance specifications; (3) dimensional specifications: (4) environmental specifications: (5) energy sources; or; (6) packaging." |
  | Substantial Equivalence to Predicate Device
  (Based on 21 CFR 807.87 and New 510(k) Paradigm) | The manufacturer believes the modifications are substantially equivalent to the eFlow® Electronic Nebulizer (K033833), cleared on May 5, 2004.
  (The FDA's letter concurs with this finding of substantial equivalence). |

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

The provided text does not contain information about a "test set" in the context of patient data. The testing described is primarily engineering and software verification/validation on the device itself. Therefore, concepts like country of origin or retrospective/prospective data are not applicable to the reported studies.

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

This information is not applicable to the type of testing described. The studies focus on technical compliance with standards and the functionality of the device's new components, not on medical diagnoses or interpretations by experts for a clinical "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable as there is no mention of a "test set" requiring adjudication by experts in the context of medical diagnoses.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or at least not described in this document. This submission focuses on the technical aspects of a device modification, not on clinical performance comparisons of human readers with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

This is not applicable. The device is an electronic nebulizer, which is a physical medical device for drug delivery, not an AI algorithm. Its performance is inherent in its electromechanical function and software control, not in an "algorithm only" sense like a diagnostic AI.

7. The Type of Ground Truth Used

The "ground truth" for the reported studies is primarily the technical specifications and requirements defined by the referenced industry standards (e.g., IEC, CAN/CSA, UL, DIN) and the manufacturer's own SOPs. For software, it's the expected functional behavior as defined in specifications. For electrical safety and EMC, it's compliance with the limits and conditions of the standards.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical electronic nebulizer, and the testing described is not related to training an AI algorithm.

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

This information is not applicable for the same reason as above – no AI algorithm training is described.

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The eFlow is a handheld nebulizer that will be used with patients for whom doctors have prescribed medication for nebulization. The eFlow is intended for adult and pediatric patients.

The PARI eFlow™ is a small, single patient use, reusable electronic nebulizer for the inhalation treatment of aerosol medications. It is a hand-held device containing a capped medication cup that can be filled by the user. Power input is provided by cither 4 AA batteries, a DC adapter or an AC adapter. Alternate power cords/plugs/adapters allow use in any country.

This 510(k) submission for the eFlow™ Electronic Nebulizer does not contain a study proving the device meets specific acceptance criteria in the way described in your request.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing. It explicitly states that clinical testing was not completed/is not required to show substantial equivalence.

Therefore, I cannot fill out the requested table for acceptance criteria and reported device performance, nor can I provide information on sample sizes for test sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance. These types of studies are not part of this 510(k) submission for this particular device.

Here's a breakdown of what is provided, addressing your points where possible, and clearly indicating when information is absent based on the provided text:

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

• Not applicable. The submission does not define specific acceptance criteria (e.g., a "target accuracy of 90%") or report performance against such criteria. It makes comparative statements against predicate devices.

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. No clinical test set details are provided as no clinical testing was performed for substantial equivalence demonstration. The "test set" described relates to non-clinical engineering performance.

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 expert ground truth establishment method is described for this submission's non-clinical testing.

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

• Not applicable. No adjudication method is described for this submission's non-clinical testing.

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), not an AI-powered diagnostic or decision support system. Therefore, an MRMC study related to human reader improvement with AI assistance is irrelevant and not mentioned.

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

• Not applicable. This is a medical device, not an algorithm.

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

• Not applicable. For the non-clinical tests (MMAD, RF, TOR), the "ground truth" would be the measured physical properties of the aerosol generated by the device, as determined by standard laboratory methods. There is no mention of expert consensus, pathology, or outcomes data.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is relevant or provided.

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

• Not applicable. No training set for an algorithm is relevant or provided.

Summary of Non-Clinical Test Findings (as provided):

The submission states: "EFlow was tested to compare performance to the predicate devices, including:"

• MMAD (Mass Median Aerodynamic Diameter): "eFlow MMAD is comparable to or lower than prodicate devices."
• RF (Respirable Fraction): "eFlow RF is comparable to or greater than predicate devices."
• TOR (Total Output Rate): "eFlow TOR is comparable to or greater than predicate devices."
• Safety/EMC (Electromagnetic Compatibility): "eFlow meets the requirements of EN/IEC 60601-1, DIN EN 60601-2 and UL 1431."

The conclusion from these tests is: "eFlow meets performance requirements and raises no new issues of safety or effectiveness." This demonstrates "substantial equivalence" as required for a 510(k) submission, rather than meeting acceptance criteria for a specific clinical performance claim.

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