The VPAP ST-A is indicated to provide non-invasive ventilation for patients weighing more than 30 lbs (13kg) or more than 66 lbs (30kg) in iVAPS mode with respiratory insufficiency or obstructive sleep apnea (OSA). The VPAP ST-A is intended for use in the hospital or home.

Device Description

VPAP ST-A System (VPAP ST-A with H5) is similar to the predicate device(s), using a blower based positive pressure system with an integrated heated humidifier and heater controller. The device platform is similar to the S9 VPAP ST (K102513) and contains a Micro-processor controlled blower system that generates controlled positive airway pressure (CPAP) between 4-20 cmHzO as required to maintain an "air splint" for effective treatment of OSA and (Bilevel) pressures between 3-30 cmHzO for the treatment respiratory insufficiency. The system comprises the flow generator, patient tubing, mask (patient interface), alarm functions and integrated humidifier. Therapy modes contained in the VPAP ST-A are CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS. Therapy modes come from the S9 VPAP ST (K102513) and Stellar 150 (K103167). The functional characteristics of the VPAP ST-A system includes all the clinician and user friendly features of the predicate devices.

AI/ML Overview

The provided document is a 510(k) summary for the ResMed VPAP ST-A. It discusses the device's substantial equivalence to predicate devices and outlines non-clinical testing. However, it does not contain information about a study that used a test set with established ground truth, MRMC studies, or training sets.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from a study with a test set, nor can I answer questions related to sample sizes for test/training sets, expert involvement for ground truth, adjudication methods, or MRMC studies, as this information is not present in the document.

Based on the provided text, here's what can be inferred and what cannot:

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

Cannot be provided directly. The document states: "All bench tests confirmed the product met the predetermined acceptance criteria, this included Pressure. Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests against the predicate devices using common protocols for both devices." However, the specific acceptance criteria values and the quantitative reported device performance for these criteria are not detailed in the summary.

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

Cannot be provided. The document describes "bench tests" and "validated patient simulation models" but does not detail a "test set" in the context of patient data with a specific sample size or provenance. It explicitly states: "Clinical data for the VPAP ST-A is not required as the predicate devices have been subjected to clinical trial requirements or validated patient simulation models have been used during the bench testing phases."

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/Cannot be provided. As there is no mention of a clinical test set requiring expert ground truth establishment for patient outcomes, this information is not present.

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

Not applicable/Cannot be provided. Similar to point 3, without a clinical test set subject to human interpretation, adjudication methods are not relevant here.

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, an MRMC study was not done. The document explicitly states: "Clinical data for the VPAP ST-A is not required". The device described is a medical device (ventilator) and not an AI or imaging diagnostic tool that would typically involve human readers.

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

Yes, in essence, standalone testing was done. The "bench tests" and testing "against the predicate devices using common protocols" along with the use of "validated patient simulation models" can be considered a form of standalone performance assessment against engineering and functional specifications, rather than human-in-the-loop performance. However, this is for the device's core functions, not an 'algorithm' in the typical AI sense.

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

Objective engineering/functional specifications and predicate device performance. For the bench tests, the "ground truth" would be the pre-defined engineering design specifications for parameters like pressure, flow, trigger, cycling, and apnea/hypopnea detection, as well as the performance characteristics of the predicate devices. These are objective, measurable parameters rather than clinical outcomes or pathology.

8. The sample size for the training set

Not applicable/Cannot be provided. The device is a ventilator, not an AI model that undergoes "training" in the machine learning sense from a dataset.

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

Not applicable/Cannot be provided. As there is no training set for an AI model, this question is not relevant.

Summary of what the document does state regarding testing:

Type of Testing: Non-clinical bench tests and simulation models.
Confirmation: "All bench tests confirmed the product met the predetermined acceptance criteria."
Criteria Areas: Pressure, Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests.
Comparison Basis: Against predicate devices.
Protocols: Common protocols for both devices (new and predicate).
Clinical Data: "Clinical data for the VPAP ST-A is not required."
Standards: Tested to appropriate FDA consensus standards and other applicable requirements, including IEC 60601-1-2:2007, IEC 60601-1:2005, and IEC 60601-1-8:2006.

Summary

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ResMed

KI13288 510(k) Summary - VPAP ST-A

MAR 2 9 2012

Date Prepared 31st Oct, 2011 Submitter Greg Dockar Senior Regulatory Affairs Manager Mr David D'Cruz – V.P., US Medical & Regulatory Affairs Official Contact ResMed Corp. 9001 Spectrum Center Boulevard,

San Diego, CA 92123

Tel: (858) 836-5984

21 CFR §868.5895 Classification Reference 73 MNS Product Code Common/Usual Name Ventilator, continuous, non-life-supporting Proprietary Name VPAP ST-A Predicate Device(s) ResMed, VPAP ST with H5i (K102513) ResMed, Stellar 150 (K103167) ResMed, VPAP III ST-A (K033276) Reason for submission New Device

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Indication for Use

Substantial Equivalence

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

A Similar intended use
Same operating principle A
Similar technologies A
Same manufacturing process A

Design and Verification activities were performed on the VPAP ST-A System as a result of the risk and design requirements. All bench tests confirmed the product met the predetermined acceptance criteria, this included Pressure. Flow, Pressure Support, Trigger and Cycling, Hypopnea and Apnea tests against the predicate devices using common protocols for both devices. Clinical data for the VPAP ST-A is not required as the predicate devices have been subjected to clinical trial requirements or validated patient simulation models have been used during the bench testing phases. The new device complicable 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 Devices (May > 11, 2005)

Non-Clinical Testing:

The VPAP ST-A has been tested to apropriate FDA consensus standards and other applicable requirements passing all test protocols. The VPAP ST-A with and without the integrated heated humidifier (H5i) was designed and tested according to:

IEC 60601-1-2:2007, Medical electrical equipment Part 1-2: General requirements for basic safety and A essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements for safety Medical electrical equipment - General requirements for basic safety and essential performance
IEC 60601-1-8:2006. Medical electrical equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and quidance for alarm systems in medical electrical equipment and medical electrical systems

Device Description

Therapy modes contained in the VPAP ST-A are CPAP, Spontaneous, Spontaneous/Timed, Timed, PAC and iVAPS. Therapy modes come from the S9 VPAP ST (K102513) and Stellar 150 (K103167).

The functional characteristics of the VPAP ST-A system includes all the clinician and user friendly features of the predicate devices.

Conclusion

The VPAP ST-A is substantially equivalent to the Predicate devices.

31st Oct, 2011

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

ResMed Limited C/O Mr. David D' Cruz Vice President Clinical & Regulatory Affairs ResMed Corporation 9001 Spectrum Center Boulevard Kearny Mesa, California 92123

MAR 2 9 2012

Re: K113288

Trade/Device Name: VPAP ST-A Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous ventilator Regulatory Class: II Product Code: MNS Dated: March 24, 2012 Received: March 28, 2012

Dear Mr. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony v. Anton

Anthony D. Watson, B.S., M.S., M.B.A. 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-A

Indication for Use

AND/OR Prescription Use _____________________________________________________________________________________________________________________________________________________________

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)

Page 1 of	1
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(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K113288
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Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).