The aura CPAP System provides a continuous positive airway pressure (CPAP) to support treatment of obstructive sleep apnea. During obstructive sleep apnea, the airway collapses. When interfaced with a CPAP Mask or CPAP Patient Interface the aura CPAP System provides a constant pressure of 4 to 20 cmH2O above the ambient atmospheric pressure to patient's nasal airway. This constant pressure supports retaining an open airway during sleep.

The aura CPAP System has four significant components:

1. CPAP Blower,
1. Optional Humidifier,
1. Optional Battery Pack, and
1. Patient Interface.

AI/ML Overview

The provided document describes the AEIOMed aura CPAP System, a device intended for the treatment of obstructive sleep apnea. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the way typically expected for a detailed scientific or clinical study.

Instead, the document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. The "Summary of Safety and Effectiveness" section and the FDA letter confirm this.

Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, detailed ground truth methods, training set details) are not available in this specific document, as those are generally associated with more extensive clinical trials or performance studies that were likely not required for a 510(k) submission based on substantial equivalence and laboratory testing.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in terms of numerical performance targets (e.g., specific pressure accuracy, flow rates across different conditions).	The device "provides a constant pressure of 4 to 20 cmH2O above ambient atmospheric pressure to patient's nasal airway." This is a functional description, not a performance metric against a defined criterion.
Substantial equivalence to predicate devices (BREAS PV10 CPAP System, Respironics REMstar Plus CPAP System).	Conclusion: "The aura CPAP System is substantially equivalent to the predicate devices. Laboratory and standards compliance were provided to support the aura CPAP System performance."
Compliance with relevant laboratory and safety standards.	"Laboratory and standards compliance were provided..." (details of which standards and specific compliance data are not included in this summary).

2. Sample size used for the test set and the data provenance

Not explicitly stated/Provided. The document refers to "Laboratory and standards compliance" but does not detail a clinical test set with human subjects. The evaluation for 510(k) substantial equivalence often relies on bench testing, electrical safety, and biocompatibility rather than extensive clinical studies if the technology is well-established and has predicate devices.
Data Provenance: Not specified, but given it's a US company seeking FDA clearance, any supporting data would likely adhere to US regulatory standards.

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

Not applicable/Provided. This type of detail is absent because the submission focuses on substantial equivalence and laboratory testing, not a clinical study requiring expert ground truth for interpretation of outcomes.

4. Adjudication method for the test set

Not applicable/Provided. No clinical test set with adjudicated outcomes is described.

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

No. This is not an AI-assisted device. It's a medical device (CPAP system) for delivering continuous positive airway pressure. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This question pertains to algorithmic performance, which is not relevant to a mechanical CPAP device.

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

Not applicable. For this type of device and submission, the "ground truth" would be related to engineering specifications, safety standards, and performance characteristics demonstrated through bench testing, rather than clinical outcomes or diagnoses. The device's ability to maintain a prescribed pressure and operate safely and effectively as designed would be the focus.

8. The sample size for the training set

Not applicable/Provided. There is no indication of a "training set" in the context of machine learning or AI, as this is a mechanical medical device.

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

Not applicable/Provided. As above, no training set or machine learning components are mentioned.

In summary: The document is a 510(k) clearance summary, which primarily aims to demonstrate substantial equivalence to existing devices through appropriate testing (likely bench testing and compliance with relevant standards) rather than extensive de novo clinical trials with human subjects and expert adjudication of outcomes. Therefore, much of the requested information related to clinical study design and performance metrics against specific, numerically defined acceptance criteria is not present here. The main "acceptance criterion" presented is substantial equivalence, which the FDA concurred with.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for AEIOMed. The logo is in black and white and features a stylized font. There is a curved line above the letters that adds a dynamic element to the design.

MAR 3 - 2005

1313 5" St. SE Suite 205 Minneapolis, MN 55414 Ph: 612-455-0550 Fax: 612-455-0551

Summary of Safety and Effectiveness

Company Name: AEIOMed, Inc. 1313 5th Street SE, Suite 205 Minneapolis, MN 55414

Dave Markovich, Senior Director of Operations Contact:

(612) 455-0550 Phone:

Fax: (612) 455-0551

Summary Date: January 26, 2005

aura CPAP System Trade Name:

Common Name: CPAP Device

Classification Name: 21 CFR 868.5905, Non-Continuous (Respirator) Ventilator

Predicate Devices:

510(k) Number:	K030985
Manufacture:	Vital Signs, Inc.
Trade Name:	BREAS PV10 CPAP System
510(k) Number:	K010263
Manufacture:	Respironics, Inc.
Trade Name:	REMstar Plus CPAP System

1.0 Description of Device

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The aura CPAP System is initially used under the direct supervision of a trained medical professional. The aura CPAP System function and applications may be reviewed in a clinical setting when the patient is treated for obstructive sleep apnea by the application of CPAP therapy.

Intended Use 2.0

The aura CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30kg) with Obstructive Sleep Apnea.

3.0 Technology

The aura CPAP System has four significant components:

1. CPAP Blower,
1. Optional Humidifier,
1. Optional Battery Pack, and
1. Patient Interface.

The Patient Interface or CPAP Mask is a commercially available accessory provided to the user separately. The Patient Interface or CPAP Mask is not addressed in this submission.

4.0 Conclusions

The aura CPAP System is substantially equivalent to the predicate devices. Laboratory and standards compliance were provided to support the aura CPAP System performance. No new questions of safety or effectiveness are raised.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three wavy lines extending from its head, enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 3 - 2005

AEIOMed, Incorporated C/O Mr. Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589

Re: K042945

Trade/Device Name: CPAP System Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: January 28, 2005 Received: January 31, 2005

Dear Mr. Syring:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Syring

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _K042945

Device Name: aura CPAP System

Indications for Use:

The aura CPAP System provides continuous positive airway pressure (CPAP) to support treatment of adults (over 30kg) with Obstructive Sleep Apnea.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).