The AeroNeb™ II is a battery operated hand-held portable nebulizer using the same materials and piezoelectric vibration aerosol generator technology as the predicate device.

AI/ML Overview

The provided text describes the AeroNeb™ II Portable Nebulizer and aspects of its 510(k) premarket notification. However, it does not contain the detailed information necessary to fully answer all the questions regarding acceptance criteria and the study that proves the device meets them.

Here's a breakdown of what can be extracted and what is missing:

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

The document states: "The performance evaluations including nebulizer delivery characterization, electrical, and EMC safety, were based on those suggested in the FDA CDRH - REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS issued on: October 1, 1993." and "The successful tests demonstrated the device consistently performed within its design parameters, is as safe and effective, and performs as well as, or better than, the predicate device."

This indicates that specific performance evaluations were conducted, but the acceptance criteria values and the actual reported device performance values are not detailed in this summary. These would typically be found in the full submission, not a general 510(k) summary.

Acceptance Criteria Category	Acceptance Criteria (Value/Range)	Reported Device Performance (Value/Range)
Nebulizer Delivery Characterization	Not specified in document	Stated as "performed within its design parameters"
Electrical Safety	Not specified in document	Stated as "successful tests"
EMC Safety	Not specified in document	Stated as "successful tests"
Overall Safety and Effectiveness	As safe and effective as predicate	Stated as "as safe and effective, and performs as well as, or better than, the predicate device"

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

This information is not provided in the given text.

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)

This device is a nebulizer, not a diagnostic imaging device. Therefore, the concept of "ground truth" derived from expert consensus, as typically applied in AI/ML performance studies, is not applicable here. The performance is assessed through objective engineering and safety tests (nebulizer delivery characterization, electrical, and EMC safety).

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

As mentioned above, the concept of "adjudication" for expert consensus is not applicable for this type of device 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

This is a physical medical device (nebulizer), not an AI/ML diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable.

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

This is a physical medical device (nebulizer), not an algorithm. Therefore, "standalone" algorithm performance is not applicable.

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

For this device, the "ground truth" or standard of comparison is based on:

FDA CDRH - REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS issued on: October 1, 1993.
Comparison to the predicate device (FPT Nebulizer K970010), demonstrating it is "as safe and effective, and performs as well as, or better than" the predicate.

8. The sample size for the training set

This is a physical medical device. The concept of a "training set" as understood in machine learning is not applicable. Device development involves design, prototyping, and testing, but not a "training set" in the computational sense.

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

Again, the concept of "training set" and "ground truth for the training set" is not applicable to this type of device. Performance is validated against established physical and electrical standards, and comparison to a legally marketed predicate device.

Summary

{0}------------------------------------------------

Section 2 Page 4 of 4 JUN AeroNeb™ II Portable Nebullzer 510(K) Premarket Notification

SMDA 510(k) Summary of Safety and Effectiveness

(1) Submitter's Name / Contact Person:
AeroGan™ Inc. 1310 Orleans Drive Sunnyvala, CA 94089

Contact Person:

Traci V. A. Edwards Director, Quality Assurance & Regulatory Affairs Tel .: (408) 543-2400 Fax: (408) 543-2450 E-mall; tedwards @ aerogen.com

Date prepared:

August 23, 2000

(2) Name of device:

Trade Name: Common Name: Classification Name:

AeroNebTM II Portable Nebulizer Nebulizer Nebulizer, 21 CFF1 5868.5630

(3) Identification of predicate device:

ManufacturerI wall a manufacture to the manufacture manufacturer in the manufacturer and consistence and the contraction of the comments of the comments of the contribution of the commen	Device	510(k) Number
Fluld Propulsion Technologies	FPT Nebulizer	K970010

(4) Description of the device:

The AeroNeb™ II is a battery operated hand-held portable nebulizer using the same materials and piezoelectric vibration aerosol generator technology as the predicate device.

(5) A statement of the intended use of the device:

The AeroNeb™ II Portable Nebulizer is intended for breath-triggered nebulization of aerosolized medications prescribed by a physician.

(6) Predicate Device Comparison;

The AeroNeb™ II Portable Nebulizer Is a smaller portable version of the FPT Nebulizer,

The AeroNeb™ II Portable Nebullzer is substantially equivalent to similar features in the predicate device and has the same intended use and technological characteristics as the predicate device. Non-clinical performance tests were conducted comparing AeroNeb™ II to the FPT Nebulizer and are summarized in the submission.

The performance evaluations including nebulizer delivery characterization, electrical, and EMC safety, were based on those suggested in the FDA CDRH - REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS issued on: October 1, 1993.

The successful tests demonstrated the device consistently performed within its design parameters, is as safe and effective, and performs as well as, or better than, the predicate device

AeroGen Inc.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 5 2000

Ms. Traci V. A. Edwards AeroGen, Inc. 1310 Orleans Drive Sunnyvale, CA 94089

K992831 Re: AeroNeb™ II Portable Nebulizer Regulatory Class: II (two) Product Code: 73 CAF Dated: August 11, 2000 Received: August 14, 2000

Dear Ms. Edwards:

We have reviewed your Section 510(k) notification of intent to market we have reviewed your boose and we have determined the device is the device forcioned and it a the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrosure) to regarif mariese pay 28, 1976, the enactment date of the Incelstate Commerce proble of to devices that have been reclassified redical bevree famonakenos, is one of the Federal Food, Drug, and In acturation with oneous therefore, market the device, subject to the general controls provisions of the Act. The general controls the general controlo provisions quirements for annual registration, provisions of thes, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special It your device ID enemarket Approval), it may be subject to such ednerold) or crais. Existing major regulations affecting your device additionar concease - Enederal Regulations, Title 21, Parts 800 can be roa substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set with the Ouality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ocheral regaration on Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in assumptions. Italiae of Ottion, FDA may publish further announcements regaratory acouvere in the Federal Register. Please note: this concerning your as remarket notification submission does not affect any response co your have under sections 531 through 542 of the Act obrigation you major the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{2}------------------------------------------------

Page 2 - Ms. Traci V. A. Edwards

This letter will allow you to begin marketing your device as described This letter will allow you co begin mirroans from of substantial
in your 510(k) premarket notification. www.stated modicato device in your 310(K) premaired notifications and the marketed predicate device equivalence of your device of a regioned device to proceed to the market.

. If you desire specific advice for your device on our labeling If you desire specific advice for for for for for in vitro regulation (21 CM fart our and the Office of Compliance at diagnostic devices), predoc ochool on the promotion and (301) 594-4646. AdditIonally) 10- quosect the Office of Compliance at
advertising of your device, please contact later antitled (301) 594-4639. Also, please note the regulation entitled, (301) 594-4639. "AI30, premarket notification" (21 CR 807.97).
"Misbranding by reference to premarket notification" (21 CER 807.97) "Misbranding by relerence to premarked instituties under the Act may Other general information of Small Manufacturers Assistance at its internet be obtained from the Dribico. I ---------------------------------------------------------------------------------------------------------------------------------------------coll free namber (ovefda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours, ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Section 1 Page 7 of 11 A EROGEN AeroNeb™ II Portable Nebullzer 510(K) Promarket Notification

510(k) Number (if Known): ____________________________________________________________________________________________________________________________________________________

Device Name: AeroGen™ Inc. AeroNeb™ II Portable Nebullzer

Indications For Use:

The AeroNeb™ II Portable Nebulizer is intended for breath-triggered nebulization of aerosolized medications prescribed by a physician.

Division of Cardioyascular & Respiratory Devices
510(k) Number KY 1 28 3 /

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEGORD)

Concurrence of CDRH, Office of Device Evaluation (ODB)

Prescription Use (Per 21 CFR 801.109) OR

Over-The Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).