The F&P Pilairo Nasal Pillows Mask is intended to be used by individuals who have been diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The F&P Pilairo Nasal Pillows Mask is intended for single-patient adult use in the home and multiplepatient adult use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.

Device Description

The Pilairo™ is a CPAP nasal pillows mask which has an external connector attached to a frame and face seal that encloses the nasal airway entrance, held in place by a single head strap. The external connector allows connection to a CPAP device. The device conveys pressurised air to the nares. The air may also be humidified and/or oxygen enriched. An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring.

AI/ML Overview

The provided text is a 510(k) summary for a medical device, the Pilairo™ Nasal Pillows Mask. It details the device's description, intended use, and comparison to predicate devices, focusing on demonstrating substantial equivalence for regulatory approval.

However, the document does not contain the kind of information typically found in a study demonstrating performance based on acceptance criteria for AI/ML-based medical devices. Specifically, it does not include:

Quantitative acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy thresholds).
Study design details like sample size for test sets, data provenance, ground truth establishment methods (expert consensus, pathology, etc.).
Information about human expert involvement (number of experts, qualifications, adjudication methods).
Details on AI/ML specific studies such as MRMC studies, standalone AI performance, or training set specifics.

The document describes non-clinical tests that were performed to compare the Pilairo™ Nasal Pillows Mask to predicate devices for performance and biocompatibility, stating that these tests demonstrate "substantial equivalence." However, it does not provide the specific results or the acceptance criteria used for these non-clinical tests in a format that would allow for the table requested. The "performance" mentioned refers to engineering performance of the mask (e.g., sealing, pressure delivery), not AI/ML model performance.

Therefore, many of the requested fields cannot be filled from the provided text as they pertain to a different type of device evaluation (AI/ML performance studies) than what is described for this medical mask.

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred/Stated)	Reported Device Performance (Inferred/Stated)
Performance (Functional)	Substantial equivalence to predicate device (Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask) in delivering CPAP/Bi-Level therapy. Includes aspects of seal, pressure conveyance.	Substantial equivalence demonstrated through non-clinical tests. "Safe and effective for CPAP and Bi-Level ventilation therapy."
Biocompatibility	Substantial equivalence to predicate device (Zest™ Nasal Mask) for materials.	Substantial equivalence demonstrated through non-clinical tests.
Intended Use	To be used by individuals requiring CPAP or Bi-Level Ventilator treatment (single-patient adult use in home, multi-patient adult use in clinical setting with disinfection).	Deemed suitable for the stated intended use.
Safety	No adverse events or safety concerns outweighing benefits.	"Demonstrated to be safe and effective."
Dead Space	Implicitly, dead space must be within acceptable limits for a CPAP mask, even if larger than predicate.	Acknowledged to have "larger dead space due to the way it achieves a seal around the nose." Implies it's still acceptable.
Fit/Sizing	Ability to fit a large proportion of the patient population with one size.	Designed to "fit a large proportion of the patient population with only one size."

Note: The document states "Copies of test reports are included in Appendix B," but Appendix B is not provided in the input text. Thus, the specific numerical results of these non-clinical tests and the precise quantitative acceptance criteria are not available.

Information Not Found in the Provided Text:

Any form of AI/ML or algorithm performance metrics (e.g., accuracy, sensitivity, specificity, AUC).
Quantitative thresholds for these metrics.

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

Sample Size for Test Set: Not specified. The document mentions "non-clinical tests" but does not detail the sample sizes (e.g., number of masks tested, number of simulated breathing cycles, or simulated patients). This is expected for a physical device rather than an algorithm.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable in the context of AI/ML studies. For this physical device, testing would likely be performed in a lab setting, presumably by Fisher & Paykel Healthcare in New Zealand, as indicated by their address. The nature of testing would be prospective (performing tests on new masks).

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

Number of Experts: Not specified. This type of human expert ground truth establishment is not typically performed for the evaluation of physical medical masks (like a CPAP mask), as their performance (e.g., seal, pressure delivery) is evaluated through engineering tests and clinical use validation rather than via human expert "reading" of data.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. As there are no human "readers" or interpretations that would require adjudication for this physical device. Performance is measured through engineering parameters.

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

MRMC Study: No. This type of study is relevant for AI/ML diagnostic or assistive devices where human readers interpret medical images or data. It is not applicable to a CPAP nasal mask.

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

Standalone Performance: Not applicable. This device is a physical medical mask, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For a physical medical device like a CPAP mask, "ground truth" typically refers to:
- Engineering Specifications/Standards: Performance is validated against established industry standards or internal engineering specifications for parameters like pressure drop, dead space, leak rates, and material properties.
- Comparison to Predicate Device: The primary method stated is comparison to the "Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance" and "Zest™ Nasal Mask for biocompatibility" to demonstrate substantial equivalence. These predicate devices are the "ground truth" standard.
- Biocompatibility Testing: Adherence to material safety standards.
- Clinical Use Performance: Implicitly, the mask must function effectively without causing harm during use in patients requiring CPAP/Bi-Level therapy.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This device is a physical product, not an AI/ML algorithm that requires training data.

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

Ground Truth Establishment for Training Set: Not applicable. As there is no AI/ML algorithm, there is no "training set." The "ground truth" for the device's design and manufacture would be based on human engineering and medical knowledge, design specifications, and successful performance of predicate devices.

Summary

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Section 5 - 510(k) Summary

FEB 2 3 2012

Fisher & Paykel HEALTHCARE

15 Maurice Paykel Place, East Tamaki P O Box 14 348, Panmure Auckland, New Zealand Telephone: +64 9 574 0100 Facsimile: +64 9 574 0148 Website: www.fphcare.com

K120027

Contact Person	Tina Mason
Date Prepared	19 December 2011
Trade Name	Pilairo™ Nasal Pillows Mask
Common Name	Nasal Pillows Mask
Classification Name	Non continuous ventilator IPPB(21 CFR § 868.5905, product code BZD)
Predicate Devices	K063036 Fisher & Paykel Healthcare Opus HC482 Direct NasalMask
	K083832 Fisher & Paykel Healthcare Zest Nasal Mask(predicate for material biocompatibility)

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5.1 Description

An oxygen pressure port accessory is available to be used with the device for oxygen therapy and/or gas monitoring.

5.2 Intended Use

5.3 Technological Characteristics Comparison

The Pilairo™ Nasal Pillows Mask is very similar to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask. Both masks are intended for non-continuous ventilation via CPAP and Bi-Level therapy, and deliver CPAP gasses through the nose.

The main difference is the way the seal is achieved; the Pilairo™ Nasal Pillows Mask has a soft and thin seal which inflates and seals on the entrance of the nostrils and around the nose whereas the Opus HC482 seals only on the entrance of the nostrils. Other differences are that the Opus HC482 has a larger head gear with four adjustment points as opposed to the Pilairo™ Nasal Pillows Mask which has a single stretchable strap. The Pilairo™ Nasal Pillows Mask has only one size, whereas the Opus HC482 has 3 sizes (the Pilairo™ Nasal Pillows Mask is designed to fit a large proportion of the patient population with only one size). The Pilairo™ Nasal Pillows Mask has a larger dead space due to the way it achieves a seal around the nose.

5.4 Non-Clinical Tests

Testing of the Pilairo™ Nasal Pillows Mask was compared to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance and the Zest™ Nasal Mask for biocompatibility. These tests demonstrate substantial equivalence of the Pilairo™ Nasal Pillows Mask to the predicate mask. Copies of test reports are included in Appendix B.

5.5 Conclusion

The comparison of features, performance, and intended use demonstrate that the Pilairo™ Nasal Pillows Mask is substantially equivalent to the predicate Fisher & Paykel Healthcare Opus HC482 Direct Nasal Mask for performance and materials in the Zest™ Nasal Mask for biocompatibility. The Pilairo™ Nasal Pillows Mask has been demonstrated to be safe and effective for CPAP and Bi-Level ventilation therapy.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is oriented horizontally. The text is likely part of a document or sign.

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

FEB 2.3 2012

Ms. Tina Mason Regulatory Affairs Engineer Fisher & Paykel Healthcare Limited 15 Maurice Paykel Place East Tamaki Auckland 1701 New Zealand

Re: K120027

Trade/Device Name: Pilairo™ Nasal Pillows Mask Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator Regulatory Class: II Product Code: BZD Dated: January 3, 2012 Received: January 3, 2012

Dear Ms. Mason:

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 approvisions 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 – Ms. Mason

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 incall that I DA mas made a atutes and regulations administered by other Federal agencies. of the Act of ally I edelar statules and squirements, including, but not limited to: registration Tournast comply whill an the Hel brequirements, and 01); medical device reporting and ilsung (21 CF R F at 607); latesting (21 CFR 803); good manufacturing (reporting of medical device retail in the quality systems (QS) regulation (21 CFR Part 820); practice requirements as bet return in were manation 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), 11 you aceste spoolite au .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 Compilance: "Thiso; preace net 807.97). For questions regarding the reporting of promation networks under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/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 Tourinay 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,

hr for

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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Section 4 - Indications For Use Statement

K/20027 510(k) Number:

Device Name:

Pilairo™ Nasal Pillows Mask

Indications for Use:

Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Schulthe

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

510(k) Number: k 120027

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).