The Respironics BiPAP® Pro Bi-level System is a microprocessor controlled blower based bi-level positive pressure system that delivers two different positive pressure levels (IPAP/EPAP). The dual pressure levels provide a more natural means of delivering pressure support therapy to the patient resulting in improved patient comfort. Respironics is adding an additional therapy feature to the existing BiPAP Pro Bi-level System Software. This feature will ease the transition from the end of inspiration to the beginning of exhalation. The BiPAP® Pro Bi-level System is intended for use with a patient circuit that is used to connect the device to the patient interface device (mask). A typical patient circuit consists of a six-foot disposable or reusable smooth lumen 22mm tubing, an exhalation device, and a patient interface device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Respironics BiPAP® Pro Bi-level System, structured according to your request.

Please note: The provided document is a 510(k) summary and FDA approval letter for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific, quantitative acceptance criteria and a comprehensive "study" report in the way one might expect for a novel AI/software product. Therefore, much of the requested information (like specific performance metrics, sample sizes for test/training sets, expert qualifications, etc.) is not explicitly present in the given text. The device described here is a hardware-based ventilator with a software enhancement, not a standalone AI diagnostic tool.

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

Based on the provided text, specific, quantitative acceptance criteria and their corresponding reported performance values are not detailed. The submission states that "All tests were verified to meet the required acceptance criteria," but these criteria themselves are not listed. The focus is on demonstrating substantial equivalence.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit)
Intended Use Equivalence: Same intended use as predicate device.	"Same intended use."
Operating Principle Equivalence: Same operating principle as predicate device.	"Same operating principle."
Technology Equivalence: Same technology as predicate device.	"Same technology."
Manufacturing Process Equivalence: Same manufacturing process as predicate device.	"Same manufacturing process."
Safety and Effectiveness: Modifications have no impact on safety and effectiveness.	"Respironics has determined that the modifications have no impact on the safety and effectiveness of the device."
Compliance with Standards: Complies with applicable standards for software in medical devices.	"The modified device complies with the applicable standards referenced in the Guidance for FDA Reviewers and Industry 'Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices', May 1998."
Design Verification: All design verification tests meet required acceptance criteria (tests not specified).	"Design verification tests were performed... All tests were verified to meet the required acceptance criteria."

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

This information is not provided in the given text. The document refers to "design verification tests" but does not specify the sample size of patients or data used, nor its provenance. Given the nature of a software enhancement to a CPAP machine, these tests likely involved bench testing and potentially limited human usability testing rather than a large-scale clinical trial with patient data sets.

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)

This information is not provided in the given text. The "ground truth" for a device like this would typically be established by engineering specifications and functional testing, not expert consensus on diagnostic images or clinical outcomes in the same way an AI diagnostic tool would.

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

This information is not provided in the given text.

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 comparative effectiveness study was not done, or at least not reported in this 510(k) summary. This type of study is relevant for AI-assisted diagnostic tools that impact human interpretation, which is not the primary function of this device. The device is a CPAP system with a software enhancement designed to "ease the transition from the end of inspiration to the beginning of exhalation," implying a focus on patient comfort and device function, not human diagnostic accuracy.

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

The device itself is a "blower based bi-level positive pressure system" with a microprocessor-controlled software component. While the software operates "standalone" in its functional execution, it's an embedded system controlling a physical device, not a diagnostic algorithm evaluated for its "standalone" performance against a human reader in an interpretative task. The "design verification tests" would assess the software's performance in controlling the device's pressure delivery characteristics.

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

For this type of device and software enhancement, the "ground truth" for design verification would primarily be engineering specifications and established physiological principles for pressure delivery in respiratory therapy. For example, testing would verify that the device delivers the specified IPAP/EPAP levels within acceptable tolerances, and that the new feature accurately manages the inspiratory-expiratory transition according to its design. It would not be expert consensus on diagnoses, pathology reports, or long-term clinical outcomes data in the way an AI diagnostic system would use it.

8. The sample size for the training set

This information is not provided in the given text. The software enhancement is likely based on established control algorithms and engineering principles rather than a large machine learning training set derived from patient data.

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

This information is not provided in the given text. Similar to point 7, if a "training set" (in the machine learning sense) was used, its ground truth would likely be based on engineering models, physiological data, or simulated inputs rather than expert annotation of clinical cases. However, it's more probable that this software enhancement involved traditional control system design and verification rather than an AI/ML training paradigm.

Summary

{0}------------------------------------------------

、ある、最新は、この意義をする。

的意思,在一切的影音

K011714

Premarket Notification - Special 510(k)

上海电子 -

ATTACHMENT 3 CHART 3 CHARREN CHARMER COMMENT COMMENT COMMENT COLORAL

510(K) SUMMARY OF SAFETY & EFFECTIVENESS

Official Contact	David J. VanellaManager, Regulatory Affairs/Product AssuranceRespironics, Inc.1001 Murry Ridge LaneMurrysville, PA 15668
Classification Reference	21 CFR 868.5905
Product Code	BZD - Non-Continuous ventilator
Common/Usual Name	CPAP System
Proprietary Name	Respironics BiPAP® Pro Bi-level System
Predicate Device(s)	Respironics BiPAP® Duet® LX Bi-level System (K000994)
Reason for submission	Modified design, enhanced mode

{1}------------------------------------------------

Substantial Equivalence

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

Same intended use.
Same operating principle. 0
Same technology. 0
Same manufacturing process. o

Design verification tests were performed on the Respironics BiPAP® Pro Bi-level System as a result of the risk analysis and product requirements. All tests were verified to meet the required acceptance criteria. Respironics has determined that the modifications have no impact on the safety and effectiveness of the device. In summary, the device described in this submission is substantially equivalent to the predicate device.

The modified device complies with the applicable standards referenced in the Guidance for FDA Reviewers and Industry "Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices", May 1998.

Intended Use

The Respironics BiPAP® Pro Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only for use in the home or hospital/institutional environment on adult patients.

Device Description

{2}------------------------------------------------

JUN 2 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. David J. Vanella Respironics, Inc. 1001 Murry Ridge Lane Murrysville, PA 15668-8550

Re: K011714

Respironics BiPAP® Pro Bi-level System Regulation Number: 868.5905 Regulatory Class: II (two) Product Code: BZD Dated: May 23, 2001 Received: June 4, 2001

Dear Mr. Vanella:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish

{3}------------------------------------------------

Page 2 - Mr. David J. Vanella

further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Donk Tell

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page 1 of_1

510(k) Number (if known): _Koll 711 | 11 |

Device Name: Respironics BiPAP® Pro Bi-level System

Intended Use/Indications for Use

The Respironics BiPAP® Pro Bi-level System delivers positive airway pressure therapy for the treatment of Obstructive Sleep Apnea only.

Environment of Use/Patient Population

For use in the home or hospital/institutional environment on adult patients.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	✓
------------------------------------------	-----------------------------------------------------

Over-The-Counter Use(Optional Format 1-2-96)
--------------------------------------------------	---------------------------------------------------

Division of Cardiovascular & Respiratory Devices
510(k) Number K011747

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).