The VPAP III™ is intended for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE® 2I™) is indicated for the humidification and warming of air from the VPAP III™ flow generator. The VPAP III™ flow generator and HUMIDAIRE 2I™ are for home and hospital use.

Device Description

The VPAP III is a microprocessor-controlled blower-based positive airway pressure flow generator for the treatment of OSA. The device is based on the S7 Elite with an additional therapy mode (bi-level), derived from the VPAP II ST, to provide pressure relief during exhalation. The flow generator is used in combination with patient tubing and a mask. For additional humidification, an optional integrated humidifier, the HUMIDAIRE 2i, is compatible with the flow generator.

AI/ML Overview

This 510(k) summary for the ResMed VPAP III does not contain a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/ML device.

Instead, this submission is for a modified device (a CPAP/Bi-level flow generator) and focuses on demonstrating substantial equivalence to predicate devices already on the market. Therefore, the "acceptance criteria" and "study" are not presented in the typical format you'd expect for an AI/ML diagnostic or therapeutic device.

However, I can extract information related to design validation and verification, which serves a similar purpose in demonstrating the device performs as intended and is safe/effective.

Here's an analysis based on the provided text, structured to align with your request where possible, but with important caveats due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not list specific, quantifiable acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI/ML device. Instead, the "acceptance criteria" are implied by the successful completion of "Design Verification and Validation tests" which confirmed that modifications had "no impact on the safety or effectiveness of the device."

Acceptance Criteria (Implied)	Reported Device Performance
No impact on safety of the device due to modifications	All tests confirmed no impact on safety
No impact on effectiveness of the device due to modifications	All tests confirmed no impact on effectiveness
Same intended use as predicate devices	Yes, "Same Intended Use"
Same operating principle as predicate devices	Yes, "Same Operating Principle"
Same technologies as predicate devices	Yes, "Same Technologies"
Same manufacturing line as predicate devices	Yes, "Same Manufacturing Line"
Device functions as a microprocessor-controlled blower-based positive airway pressure flow generator for OSA treatment	Device described as such
Bi-level therapy mode provides pressure relief during exhalation (new feature)	Device incorporates bi-level therapy mode for pressure relief
Compatibility with optional integrated humidifier	Yes, HUMIDAIRE 2i is compatible

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

This information is not provided in the 510(k) summary. The document states "Design Verification and Validation tests were performed," but it does not detail the specifics of these tests, including sample sizes for any test sets (e.g., number of patients, test cases, or simulated scenarios) or the provenance of any data used (e.g., country of origin, retrospective/prospective). This is typical for a device like a CPAP machine where performance is often evaluated through engineering bench testing, simulated use, and compliance with recognized standards, rather than large-scale clinical trials measuring outcomes in patients directly for equivalence claims.

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

This information is not applicable/provided in this 510(k) summary. "Ground truth" established by experts (like radiologists for imaging devices) is typically relevant to AI/ML diagnostic devices where human interpretation is being augmented or replaced. For a CPAP device, performance is evaluated against engineering specifications, physiological principles, and clinical outcomes that are not typically determined by a panel of expert "readers" establishing a "ground truth" for a test set in the same way.

4. Adjudication Method for the Test Set

This information is not applicable/provided for the reasons stated above. Adjudication methods like 2+1 or 3+1 are used when reconciling disagreements among expert readers for ground truth generation in AI/ML validation studies.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or mentioned in this 510(k) summary. Such studies are specific to AI-assisted diagnostic tools where the impact on human reader performance is being evaluated. The VPAP III is a therapeutic device (flow generator), not an AI diagnostic tool.

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

This concept is not applicable here. The VPAP III is a physical medical device (a flow generator) for therapy, not a standalone algorithm. While it contains a microprocessor and likely algorithms for pressure delivery, these are integral to the device's function as a "human-in-the-loop" isn't a relevant paradigm for its primary function. Its performance is its intrinsic output of airflow and pressure, not an interpretation or prediction.

7. The Type of Ground Truth Used

The "ground truth" for a device like the VPAP III would primarily be:

Engineering Specifications: Compliance with predefined pressure, flow, and timing specifications.
Physiological Principles: The device's ability to maintain positive airway pressure at specified levels, which is the mechanism for treating OSA.
Clinical Efficacy (established by predicates): The understanding that CPAP and bi-level therapy are effective for OSA, as demonstrated by the predicate devices and general medical knowledge.

The submission confirms that "Design Verification and Validation tests were performed... in accordance with the risk analysis and product requirements," implying that the device was tested against its intended performance specifications.

8. The Sample Size for the Training Set

This information is not applicable/provided. "Training set" refers to data used to train AI/ML algorithms. The VPAP III is a hardware device with embedded software/firmware; it does not explicitly describe a "training set" in the context of machine learning.

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

This information is not applicable/provided for the reasons stated in point 8.

Summary

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K030843	RESMED
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510(k) SUMMARY— VPAP III

Date Prepared

10" March 2003

VPAP III™

Official Contact

Dr Lionel King ResMed Ltd 97 Waterloo Road North Ryde NSW 2113 Australia

Tel: + 61 (2) 9886 5000

Fax: + 61 (2) 9878 5517

Device Trade Name	VPAP III™
Device Common Name	CPAP and Bi-level Flow Generator
Classification Name	BZD Noncontinuous Ventilator
Predicate Devices	S7 Elite CPAP System (K013909)
	VPAP II ST Nasal VPAP System (K961783)
Reason for Submission	Modified design, additional therapy mode
Indications for use	The VPAP III™ is intended for the treatment ofObstructive Sleep Apnea (OSA) in adult patients. Theoptional integrated humidifier (HUMIDAIRE® 2I™) isindicated for the humidification and warming of air fromthe VPAP III™ flow generator. The VPAP III™ flowgenerator and HUMIDAIRE 2I™ are for home and hospitaluse.

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Device Description

Substantial Equivalence

The modified device has the following similarities to the previously cleared devices:

ച Same Intended Use
J Same Operating Principle
Same Technologies
Same Manufacturing Line า

Design Verification and Validation tests were performed on the VPAP III flow generator, in accordance with the risk analysis and product requirements. All tests confirmed that the modifications have had no impact on the safety or effectiveness of the device. In summary, the device in this submission is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

AUG 1 5 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ResMed Limited Senior Director of QA/RA C/O Roger Kotter 14040 Danielson Street Poway, California, 92064-6857

Re: K030843

Trade/Device Name: VPAP III Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD Dated: June 13, 2003 Received: June 16, 2003

Dear Mr. Kotter:

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 either 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. Kotter

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 your 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 (301) 594-4646. 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/dsma/dsmamain.html

Sincerely yours,

Susan Runs

Susan Runner, DDS, MA Interim 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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RESMED

VPAP III™

510(k) Number (if known):

KD30843

Device Name:

VPAP |||"*

Indications for Use:

The VPAP III™ is intended for the treatment of Obstructive Sleep Apnea (OSA) in adult patients. The optional integrated humidifier (HUMIDAIRE® 21™) is indicated for the humidification and warming of air from the VPAP III™ flow generator. The VPAP III™ flow generator and HUMIDAIRE 21™ are for home and hospital use.

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

Concurrence of CDRH; Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:	K030 843
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Prescription Use(Per 21 CFR 801.109)	X
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Over-The-Counter Use
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(Optional Format 1-2-96)

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).