The VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air delivered from a ResMed compatible CPAP therapy device. The VPAP ST and HumidAire 4i are intended for use in the hospital and home.

Device Description

The VPAP ST is similar to the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171). The VPAP ST provides CPAP, Bilevel and VAuto therapy modes to adult patients with OSA. This is achieved through the use of a micro-processor controlled blower system that generates airway pressures as required to maintain an "air splint" for effective treatment of OSA.

The system comprises the Flow Generator, HumidAire 4i, patient tubing, mask (patient interface), Smart Card and USB Adapter.

The performance and functional characteristics of the VPAP ST includes all the clinician and user friendly features of the predicate devices, VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171).

AI/ML Overview

It appears there has been a misunderstanding. The provided document is a 510(k) Premarket Notification for the ResMed VPAP ST, a medical device used for treating Obstructive Sleep Apnea (OSA).

This type of document is a regulatory submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study report detailing acceptance criteria for performance and experimental results.

Therefore, the requested information regarding a study proving acceptance criteria for device performance metrics (like sensitivity, specificity, accuracy, etc., which are common for AI/diagnostic devices) is not present in this document. The document confirms that design and verification activities were performed and that the VPAP ST met pre-determined acceptance criteria, but it does not provide the specifics of those criteria or the detailed results of a performance study in the format typically associated with AI or diagnostic device evaluation.

The key statement is: "Design and Verification activities were performed on the VPAP ST as a result of the risk analysis and product requirements. All tests confirmed the VPAP ST met the predetermined acceptance criteria." This refers to engineering and functional testing, not a clinical performance study with human readers, AI, FPs, FNs, etc.

Below is a breakdown of why I cannot fulfill your request based on the provided text, and what information is available:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states that the device met "predetermined acceptance criteria" resulting from risk analysis and product requirements, but it doesn't list them or specific performance metrics from a clinical study.
2. Sample size used for the test set and the data provenance: Not provided, as this is not a study report.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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 device is a ventilator, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not present.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a piece of hardware, a ventilator. The concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used: Not applicable in the context of this device's regulatory submission.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

Information that is available from the document:

Device Name: VPAP ST
Intended Use: For the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air. Intended for use in the hospital and home.
Regulatory Basis: Substantial equivalence to predicate devices (VPAP Malibu, S8 Pioneer, Sullivan VPAP II ST, VPAP Auto).
Key Design Aspects: Provides CPAP, Bilevel, and VAuto therapy modes through a micro-processor controlled blower system.
Regulatory Clearance: K080131, cleared on April 1, 2008.

To reiterate, this document is focused on regulatory clearance for a physical medical device (a ventilator) based on substantial equivalence, not on the performance evaluation of a diagnostic or AI-driven system against specific acceptance criteria like sensitivity or specificity.

Summary

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RESMED

VPAP ST Traditional 510(k) Premarket Notification

510(k) Summary - VPAP ST

Date Prepared	14th Jan, 2008
	APR - 1 2008
Official Contact	Dr Lionel King
	V.P., Quality Assurance & Regulatory Affairs
	ResMed Ltd
	1 Elizabeth Macarthur Drive
	Bella Vista, NSW 2153
	Australia
Tel:	+61 (2) 8884 1000
Fax:	+61 (2) 8884 2004
Classification Reference	21 CFR 868.5905
Product Code	73 BZD
Common/Usual Name	Noncontinuous ventilator (IPPB).
Proprietary Name	VPAP ST
Predicate Device(s)	VPAP Malibu (K062291) - Primary
	S8 Pioneer (K041209) - Secondary
	Sullivan VPAP II ST (K961783) - Secondary
	VPAP Auto (K071171) - Secondary
Reason for submission	New Device

Intended for Use

The VPAP ST is indicated for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing more than 66 lb (30 kg). The optional integrated HumidAire 4i is indicated for humidification of the air than oo ib (oo hg). "The optional megrated Prairial in device. The VPAP ST and HumidAire 4i are intended for use in the hospital and home.

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Substantial Equivalence

The new device has the following similarities to the previously cleared predicate device.

ﺣﺮ ﺍ Similar intended use
公 Similar operating principle
Same technologies
公 Same manufacturing process

Design and Verification activities were performed on the VPAP ST as a result of the risk analysis and product requirements. All tests confirmed the VPAP ST met the predetermined acceptance criteria. ResMed has determined that the new device is Substantially Equivalent to the predicate devices. The new device complies with the applicable standards and requirements referenced in the FDA guidance documents:

A FDA Draft Reviewer Guidance for Ventilators (July 1995)
FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical A Devices (May 11, 2005)
FDA Off-the-Shelf Software Use in Medical Devices (September 9,1999) 公

Intended Use

Device Description

The system comprises the Flow Generator, HumidAire 4i, patient tubing, mask (patient interface), Smart Card and USB Adapter.

Conclusion

The VPAP ST is substantially equivalent to the VPAP Malibu (K062291), S8 Pioneer (K041209), Sullivan VPAP II ST (K961783), and VPAP Auto (K071171).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, clean design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 1 2008

ResMed Limited C/O Mr. David D' Cruz Vice President, Clinical & Regulatory Affairs ResMed Corporation 14040 Danielson Street Poway, California 92064-6857

Re: K080131

Trade/Device Name: VPAP ST Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: BZD, BTT Dated: January 14, 2008 Received: January 18, 2008

Dear Mr. D' Cruz:

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. D' Cruz

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 (240) 276-0115. 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,

Senate Y. Michie, M.D.

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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Indication for Use

510(k) Number (if known):

Device Name:

VPAP ST

Indication for Use

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/OR

Over-The-Counter Use_

(Part 21 CFR 801 Subpart D)

(Part 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)
(Division Sign-Off)	Page 1 of 1
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number:	K040131

14" Jan, 2008

Page 15

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).