The REMstar Pro with C-Flex CPAP System is intended to provide CPAP (Continuous Positive Airway Pressure) for the treatment of adult Obstructive Sleep Apnea (OSA) only. The REMstar Pro may be used in the home or hospital/institutional environment.

Device Description

The Respironics REMstar Pro with C-Flex CPAP System is a microprocessor controlled blower based continuous positive pressure system. Respironics is adding an additional therapy feature to provide pressure relief during exhalation. The REMstar Pro with C-Flex CPAP 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, a method of venting exhaled gases, and a patient interface device.

AI/ML Overview

The provided text describes a 510(k) submission for a modified CPAP system, the "Respironics REMstar Pro with C-Flex CPAP System". However, it does not contain specific acceptance criteria for performance metrics, nor details of a study proving the device meets distinct acceptance criteria beyond general design verification tests.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that the modified device is as safe and effective as a previously cleared device. The key elements of the provided text that relate to your request are:

Design verification tests were performed... All tests were verified to meet the required acceptance criteria. This statement confirms that an internal testing process occurred, but it doesn't specify what those acceptance criteria were, what constituted "design verification tests," or the results of those tests in detail.

Given the information provided, many of your requested points cannot be answered as they pertain to specific performance metrics and study details that are not present in this document.

Here's an attempt to answer your questions based only on the provided text, indicating where information is missing:

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

Acceptance Criteria (Generic Statement)	Reported Device Performance (Generic Statement)
Required acceptance criteria	All tests were verified to meet the required acceptance criteria.

Specifics Missing: The document does not provide any specific quantitative or qualitative acceptance criteria (e.g., pressure accuracy within X mmHg, flow rate within Y L/min, noise level below Z dB). It only states that such criteria existed and were met.

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

Information Missing: The document does not specify the sample size for any test set or the provenance of any data used for testing. The verification tests performed would likely involve bench testing of the device itself (hardware and software), rather than patient data in the context of substantial equivalence for a CPAP device.

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)

Information Missing: This concept (experts establishing ground truth for a test set) is not relevant to the type of design verification described for this CPAP device. Ground truth is typically established for diagnostic or image-based AI devices. For a CPAP machine, "ground truth" would be related to its physical performance characteristics (e.g., actual pressure output) compared to its intended output, measured by calibrated instruments.

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

Information Missing: Adjudication methods are typically relevant for complex clinical endpoints or subjective interpretations (e.g., image reading). This is not applicable to the design verification of a CPAP device's functional performance.

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

Information Missing: An MRMC comparative effectiveness study is not mentioned because this device is a therapeutic (CPAP) device, not a diagnostic device heavily reliant on human interpretation of data where AI assistance would be a factor. The "C-Flex" feature is an enhanced therapy mode, not an AI diagnostic assistant.

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

Information Missing: This question is not applicable. The device is a physical CPAP machine with an "enhanced therapy feature" (C-Flex). There is no "algorithm only" component that would perform a standalone diagnostic function separate from the human-in-the-loop operation of the CPAP machine by the patient. The C-Flex feature is integrated into the device's operation.

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

Information Missing: As explained in point 3, the concept of "ground truth" in this context refers to the device's physical performance. For design verification tests, the ground truth would be established by reference to engineering specifications, calibrated measurement instruments, and potentially adherence to recognized standards (e.g., for pressure accuracy, flow, noise). The document does not elaborate on these specifics.

8. The sample size for the training set

Information Missing: There is no mention of a "training set" because this device pre-dates the widespread application of machine learning/AI models that require such sets for their development. The "C-Flex" is described as an "additional therapy feature," implying a designed function rather than a learned algorithm based on a training set.

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

Information Missing: As above, the concept of a "training set" is not relevant to the information provided for this device.

Summary of what the document does provide:

Device: Respironics REMstar Pro with C-Flex CPAP System.
Intended Use: Treatment of adult Obstructive Sleep Apnea (OSA) only, in home or hospital/institutional environment.
Modification: Addition of "an additional therapy feature to provide pressure relief during exhalation" (C-Flex).
Study/Verification Type: Design verification tests were performed to ensure the modified device (including the C-Flex feature) met "required acceptance criteria."
Conclusion: The manufacturer determined the modifications had no impact on safety and effectiveness, and the device is substantially equivalent to predicate devices. This implies that the design verification tests confirmed that the device, with its new feature, still operates within the safety and efficacy parameters of its predecessors.

Summary

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Usual Name CPAP System Respironics REMstar Pro with C-Flex CPAP System Proprietary Name

Respironics REMstar Auto CPAP System (K012554) Predicate Device(s)

Respironics BiPAP Pro Bi-level System (K011714)

Reason for submission Modified design, enhanced mode.

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Substantial Equivalence

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

□ Same intended use.
D Same operating principle.
Q Same technology.
O Same manufacturing process.

Design verification tests were performed on the Respironics REMstar Pro with C-Flex CPAP 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

Device Description

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2002

Respironics, Inc. c/o Ms. Zita A. Yurko 1001 Murry Ridge Lane Murrysville, PA 15668-8550

Re: K021861

Respironics REMstar Pro with C-Flex CPAP System Regulation Number: 868.5905 Regulation Name: Ventilator, Non-continuous Regulatory Class: II (two) Product Code: 73 BZD Dated: June 4, 2002 Received: June 6, 2002

Dear Ms. Yurko:

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 - Ms. Zita A. Yurko

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 (OS) 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 and additionally 21 CFR Part 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 vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.

Della Tech

Donna-Bea Tillman. Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Respironics REMstar Pro with C-Flex CPAP System

Intended Use/Indications for Use

The REMstar Pro with C-Flex CPAP System is a CPAP (Continuous Positive Airway Presure) device designed for the treatment of adult Obstructive Sleep Apnea (OSA) only.

Environment of Use/Patient Population

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use(Optional Format 1-2-96)
✓
Division of Cardiovascular & Respiratory Devices510(k) Number	K021861

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).