(147 days)
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.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).