Sleepware G3 is a software application used for analysis (automatic and manual scoring), display, retrieval, summarization, report generation and networking of data received from monitoring devices used to categorize sleep related events that help aid in the diagnosis of sleep related disorders. It is indicated for use with infant or adult patients in a clinical environment by or on the order of a physician.

The optional Somnolyzer Inside scoring package has the same intended use as Sleepware G3, but is indicated for use with adult patients only.

Device Description

The Sleepware G3 software is a diagnostic tool, used by trained clinical professionals, for managing Respironics polysomnography recorders using a personal computer. The Sleepware G3 software uses data that is stored in the recorder device memory, and then processes this data to display a graphical and statistical analysis for use by the trained clinical professional. It also allows the trained clinical professional to evaluate (score) the recorded respiratory, sleep staging and/or oximetry waveforms to ensure that the patient being monitored is properly diagnosed. The clinician can create unique patient reports for the patient being evaluated, and configure device parameters in the software. Sleepware G3 was formally known as the Alice Sleepware Software cleared in K040595.

Somnolyzer 24x7 is a similar standalone, polysomnography scoring application that provides automated analysis of respiratory, sleep staging and/or oximetry waveforms recorded during sleep studies. Like Sleepware G3, it processes information recorded during sleep with electrodes and sensors attached to the body according to worldwide accepted scoring standards. It then generates results that include quantitative sleep, breathing, and motion parameters, used to evaluate sleep and respiratoryrelated disorders. Somnolyzer is located on a remote server and is considered to be a software service, unlike Sleepware G3 which is located on a personal computer.

Sleepware G3 is being updated to add the scoring algorithms from the Somnolyzer 24x7 software service as an optional software package. The scoring algorithms from the cleared Somnolyzer 24x7 software were modified to operate in real time, as a sleep study is occurring, and be displayed on the Sleepware G3 user interface.

AI/ML Overview

The provided document does not contain detailed acceptance criteria or a specific study proving the device meets these criteria in the format requested. It primarily focuses on the regulatory submission for the Sleepware G3 device, comparing it to predicate devices.

However, based on the information provided, particularly in Section VII "Performance Data: Software Verification and Validation Testing" and "Non-Clinical Tests," we can infer some aspects of the device's performance assessment.

Here's an attempt to extract and frame the information, while noting what is not explicitly stated in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with numerical targets. Instead, it states that the device's performance was assessed against its predicate device. The key performance aspect mentioned is the equivalence of auto-scoring algorithms.

Acceptance Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Functional Equivalence of Somnolyzer auto-scoring algorithms to predicate Somnolyzer 24x7 (K131994) (for adult patients)	Testing confirmed that the Somnolyzer auto-scoring algorithms perform equivalently to the device predicate algorithms in the Somnolyzer 24x7 software (K131994).
Overall integration and meeting of product requirements for Sleepware G3 with Somnolyzer Inside package	Overall testing of Sleepware G3 with Somnolyzer Inside package showed that the plug-in has been successfully integrated and all product requirements have been met.
Functional Equivalence of Sleepware G3 to predicate Alice Sleepware Software (K040595) (for infant or adult patients)	Testing confirmed that the Sleepware G3 performs equivalently to the device predicate Alice Sleepware Software (K040595). All tests had passing results.
Safety and Effectiveness (not explicitly quantified, but a general regulatory requirement)	The verification and validation testing demonstrated that safety and effectiveness has not been inadvertently affected by modifications to the system. Non-clinical tests were deemed adequate to assess safety and effectiveness.
Software Level of Concern (internal classification)	The software for this device was considered to have a "moderate" level of concern, since a failure or latent flaw in the software could result in minor harm to the patient. (This is not a performance metric itself but indicates the criticality of the software and, indirectly, the rigor of testing expected).

Note: The document does not provide specific metrics like sensitivity, specificity, accuracy, or agreement rates that would typically be associated with performance criteria for medical devices, particularly those involving algorithmic analysis. Instead, it uses qualitative statements of "equivalence" and "passing results."

2. Sample Size and Data Provenance for the Test Set

Sample Size: The document does not specify the sample size (number of polysomnography recordings or events) used for the non-clinical tests that confirmed the algorithmic equivalence.
Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth Establishment

The document does not specify the number of experts used to establish ground truth or their qualifications. The reference to "trained clinical professionals" evaluating and scoring waveforms for diagnosis implies expert involvement in the intended use, but not necessarily in the validation test set creation.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not mentioned in the document. The study was focused on algorithmic equivalence to predicate devices, not on human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

Yes, a standalone (algorithm only) performance assessment was done. The key statement is "Testing confirmed that the Somnolyzer auto-scoring algorithms perform equivalently to the device predicate algorithms in the Somnolyzer 24x7 software (K131994)." This directly refers to the performance of the automated scoring algorithms without human-in-the-loop assistance in the context of the validation tests.

7. Type of Ground Truth Used

The type of ground truth used is not explicitly stated in terms of "expert consensus," "pathology," or "outcomes data." However, given the context of polysomnography scoring, it is highly probable that the ground truth for evaluating the auto-scoring algorithms would have been established by manual expert scoring of reference data. The document mentions "clinician can evaluate (score) the recorded respiratory, sleep staging and/or oximetry waveforms to ensure that the patient being monitored is properly diagnosed," implying expert scoring as the gold standard for clinical use. It also states the algorithms were "designed to fulfill the same scoring rules as the predicate Somnolyzer 24x7 version 2.5."

8. Sample Size for the Training Set

The document does not specify the sample size used for training the Somnolyzer scoring algorithms (or if they were "trained" in a machine learning sense, or simply rule-based). It mentions "modification #1" was "Added Somnolyzer 24x7 scoring algorithms to Sleepware G3 as an optional software package" and they were "modified to operate in real time," but doesn't detail how the original algorithms were developed or trained.

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

The document does not specify how the ground truth for any training set was established. As mentioned above, the origin and development steps of the Somnolyzer algorithms (which were integrated and adapted) are not detailed in this regulatory submission summary.

Summary

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

March 16, 2015

Respironics, Inc. Daniela Aizpitarte Regulatory Affairs Engineer 1740 Golden Mile Highway Monroeville, Pennsylvania 15146

K142988 Trade/Device Name: Sleepware G3 Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLZ, MNR, OLV Dated: February 9, 2015 Received: February 10, 2015

Dear Ms. Aizpitarte,

Re:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Felipe Aquel -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142988

Device Name Sleepware G3

Indications for Use (Describe)

Sleepware G3 is a software application used for analysis (automatic and manual scoring), display, retrieval, summarization, report generation and networking of data received from monitoring devices used to categorize sleep related events that help aid in the diagnosis of sleep related disorders. It is indicated for use with infants in a clinical environment by or on the order of a physician.

The optional Somnolyzer Inside scoring package has the same intended use as Sleepware G3, but is indicated for use with adult patients only.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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TAB 5

510(K) SUMMARY

I. Submitter

Official Contact	Daniela AizpitarteRegulatory Affairs Engineerdaniela.aizpitarte@philips.com
	Respironics Inc.1740 Golden Mile HighwayMonroeville, PA 15146
	Phone: 724-387-7954Fax: 724-387-7490
Date of Preparation	February 9, 2015

II. Device

Name of Device:	Sleepware G3
Common/Usual Name:	Electroencephalograph analysis software
Classification Name:	Automatic Event Detection Software For Polysomnograph WithElectroencephalograph (21 CFR 882.1400)
Regulatory Class:	II
Primary Product Code:Secondary Product Code:	OLZMNR, OLV

III. Predicate Devices

Alice Sleepware Software (K040595) •
. Somnolyzer 24x7 (K131994)

These predicates have not been subject to any design-related recalls.

No reference devices were used in this submission.

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Device Description IV.

Indications for Use V.

The optional Somnolyzer Inside scoring package has the same intended use as Sleepware G3, but is indicated for use with adult patients only.

The indications for use for Sleepware G3 are a combination of the indications for uses of the two predicate devices. Alice Sleepware Software has been updated to include the Somnolyzer 24x7 product cleared in K131994. The patient populations of Somnolyzer 24x7 and Sleepware G3 remain unchanged

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in this submission. The Alice Sleepware Software (K040595) was cleared for infant or adult patients, and Somnolyzer 24x7 (K131994) was cleared for adult patients. The optional Somnolyzer 24x7 scoring algorithms being added to Sleepware G3 can only be used on adult patients.

The intended use and purpose of this device has not changed. The Sleepware G3 software with the added Somnolyzer scoring algorithms still allow clinicians to diagnose sleep disorders, and no new diagnostic functions were added. The same scoring rules are used to identify respiratory events, and no new respiratory events have been added. The addition of the algorithms from Somnolyzer 24x7 does not modify the intended use of the Sleepware G3 software package.

Comparison of Technological Characteristics with the Predicate VI. Device

Both the Alice Sleepware and Somnolyzer 24x7 predicate devices and the Sleepware G3 subject device are software products designed to detect events for polysomnography with electroencephalography. The subject and predicate devices are based on the following same technological elements:

. Same intended use as the Somnolyzer 24x7 software (K131994) and Alice Sleepware Software (K040595). The indications for use that were previously cleared for each software program have also been retained.
Same control mechanism and real-time operating principle as the Alice Sleepware Software ● (K040595).
Same technology as the Somnolyzer 24x7 software (K131994) and Alice Sleepware Software . (K040595).

The following differences exist between the subject and predicate devices:

Modification #1: Added Somnolyzer 24x7 scoring algorithms to Sleepware G3 as an optional . software package
The Somnolyzer 24x7 scoring algorithms were modified to display results in real time, as the sleep study is progressing. The algorithms were designed to fulfill the same scoring rules as the predicate Somnolyzer 24x7 version 2.5 (K131994). This modification required a change in coding lanquage.
Modification #2: Confidence Trend .

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Respiratory event detection confidence trends were added to the Somnolyzer plug-in. The information used to derive the trend data is based off the signal quality of the channels throughout the acquisition and the scored events.

The product labeling was updated to instruct the sleep scoring technicians to review sections of data marked as yellow and red. This feature allows for the sleep labs to increase scoring efficiency by reducing the amount of time it takes to score a sleep study.

Modification #3: User Interface changes to accommodate for Somnolyzer additions .
The Sleepware G3 user interface has been modified from the predicate devices to display Somnolyzer scoring in real time. The Somnolyzer scoring package has been integrated into the configuration and settings of the Sleepware G3 program to allow the user to access and launch the scoring package.

Performance Data: VII.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered to have a "moderate" level of concern, since a failure or latent flaw in the software could result in minor harm to the patient.

Non-Clinical Tests

Respironics has determined that the modifications discussed in this submission have no impact on the safety and effectiveness of the Sleepware G3 with Somnolyzer Inside software verification and validation included software code reviews, automated testing, bench verification testing and labeling review.

Testing confirmed that the Somnolyzer auto-scoring algorithms perform equivalently to the device predicate algorithms in the Somnolyzer 24x7 software (K131994). Overall testing of Sleepware G3 with Somnolyzer Inside package showed that the plug-in has been successfully integrated and all product requirements have been met. The verification and validation testing demonstrated that safety and effectiveness has not been inadvertently affected by modifications to the system.

Testing confirmed that the Sleepware G3 performs equivalently to the device predicate Alice Sleepware Software (K040595). All tests had passing results.

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Clinical Tests

Clinical tests were not required to demonstrate the safety and effectiveness of Sleepware G3. Product functionality has been adequately assessed by non-clinical tests.

VIII. Conclusion

Sleepware G3 has passed all of the aforementioned non-clinical tests and required no clinical tests in order to demonstrate safety or effectiveness. It is therefore concluded that Sleepware G3 is substantially equivalent to the predicate device.

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Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).