(122 days)
The RemLogic software is intended for Polysomnography studies and allows recording, displaying, and storage of physiological signals to assist in the diagnosis of various sleep related respiratory disorders. The RemLogic software allows:
Automated analysis of physiological signals that is intended for use only in adults;
An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;
The RemLogic software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.
The RemLogic Application is a software product that runs on a desktop or laptop computer and requires no specialized hardware. It is a Windows based application used by trained medical professionals to investigate sleep disorders. The RemLogic application collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and analyzers to analyze the signals, which aid in the interpretation of a sleep study. The software consists of three main functional areas: Acquisition, Scoring & Review, and Reports. It also contains a number of computer-assisted scoring analyzers for various sleep events.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the PPA and FD/h metrics in a clear pass/fail format with specific numerical thresholds. Instead, it frames the conclusion as the device showing "performance levels comparable to the manual markings of expert reviewers" and being "clinically equivalent to the Reference standard."
However, we can infer the reported device performance from the "PPA and False Detection Rate Per Hour of RemLogic Event Detection Assisted Scoring Analyzers" table:
| Event | Mean PPA | 95% CI PPA | Mean FD/h | 95% CI FD/h |
|---|---|---|---|---|
| Central Apnea | 98% | 96% to 99% | 2.1 | 1.2 to 4.1 |
| Mixed Apnea | 98% | 96% to 99% | 2.4 | 1.3 to 5.1 |
| Obstructive Apnea | 94% | 91% to 95% | 7.8 | 5.6 to 10.9 |
| Hypopnea | 86% | 83% to 87% | 17.4 | 15.0 to 20.0 |
| Arousal | 83% | 81% to 85% | 20.2 | 17.8 to 22.6 |
| Limb Movement | 86% | 84% to 88% | 16.8 | 14.0 to 19.9 |
| Snore | 85% | 83% to 88% | 17.8 | 14.9 to 20.9 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 51 diagnostic PSG sleep studies (one study per subject) were used. This means 51 subjects were evaluated.
- Data Provenance: The document states that the data were collected from "diagnostic PSG sleep studies" and that "All subjects involved in this study were adult (>18 years old) subjects with a clinical indication for a sleep study." It does not explicitly state the country of origin, but the company (Embla Systems) is based in Canada. The study design is described as "clinical validation," implying these were existing or collected for the study, and they were de-identified and randomized for the review process. It appears to be retrospective analysis of collected physiological data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Three experienced and certified PSG specialists.
- Qualifications of Experts: The experts included "one board certified sleep specialist" and two other "experienced and certified PSG specialists" who independently marked events.
4. Adjudication Method for the Test Set
- Adjudication Method: "Reference standard" was defined using "majority rule, that is, at least two out of three expert scorings (medical professionals certified on PSG recording and analysis) agree on the presence of an event within an epoch." This is a form of 2-out-of-3 (2+1) adjudication.
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, a multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance was not performed. The study aimed to establish the standalone performance of the RemLogic automated analysis against a consensus "Reference standard" derived from expert human scoring.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance evaluation of the RemLogic computer-assisted scoring analyzers was done. The results in the table ("RemLogic PPA and FD/h") represent the algorithm's performance compared to the established ground truth.
7. The Type of Ground Truth Used
- The ground truth used was expert consensus. Specifically, a "majority rule" (2 out of 3 experts agreeing) on the presence of an event within an epoch was used to define the "Reference standard." The criteria applied for scoring various events (Apnea, Hypopnea, Limb Movement, Snore, Arousals) were based on established clinical guidelines.
8. The Sample Size for the Training Set
- The document does not provide information regarding the sample size of any training set used for the RemLogic software's automated analysis algorithms. The study described is a validation study, focusing on the performance of the already-developed algorithms.
9. How the Ground Truth for the Training Set Was Established
- Since information on a training set is not provided, details on how its ground truth was established are also not available in this document. The document focuses solely on the clinical validation of the completed software.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2016
Embla Systems Shane T. Sawall Regulatory Affairs Manager 1 Hines Road Suite 202 Kanata, Ontario Canada K2K 3C7
Re: K162140
Trade/Device Name: RemLogic Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: November 1, 2016 Received: November 2, 2016
Dear Shane T. Sawall:
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
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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 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.
Michael J. Hoffmann -A
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) K162140
Device Name RemLogic
Indications for Use (Describe)
The RemLogic software is intended for Polysomnography studies and allows recording, displaying, and storage of physiological signals to assist in the diagnosis of various sleep related respiratory disorders. The RemLogic software allows:
Automated analysis of physiological signals that is intended for use only in adults;
An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;
The RemLogic software does not provide any diagnostic conclusion about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.
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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Image /page/3/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a small registered trademark symbol to the right of the "s". Below "natus" is the word "neurology" in a smaller, black, italicized sans-serif font. The logo is simple and modern, and the colors are clean and professional.
510(K) Summary
Submitted by: Embla Systems 1 Hines Road Suite 202 Kanata, Ontario Canada K2K 3C7
Contact Person: Shane Sawall Regulatory Affairs Manager Tel.: (800) 356-0007 x8673 E-mail: shane.sawall@natus.com
Date Prepared: Oct. 31, 2016
Proprietary Name: RemLogic
Common Name: Polysomnograph software
Classification Name: Automatic Event Detection Software for Polysomnograph with Electroencephalograph
Product code: OLZ
Device Class: II
Requlation Number: 21 CFR 882.1400
Predicate Device: Embla (K971813); Natus SleepWorks (K090277) - primary
Description:
1. Overview RemLogic Software
The RemLogic Application is a software product that runs on a desktop or laptop computer and requires no specialized hardware. It is a Windows based application used by trained medical professionals to investigate sleep disorders.
2. Main Functional Areas
The RemLogic application collects and digitizes the electrical voltages of patient physiological signals. After collecting and saving the signals, it provides tools and analyzers to analyze the signals, which aid in the interpretation of a sleep study. The software consists of three main functional areas:
- Acquisition Real time collection of EEG and other physiological . parameters.
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- . Scoring & Review - Includes functions providing the user with tools to quickly review PSG studies, either during real time collection of data or after the recordings are complete
- . Reports - Once the digital polysomnography data has been acquired scored and reviewed by both a polysomnographic technologist and a sleep physician the RemLogic software is used to generate a summary report of the sleep study which includes summary statistics of sleep staging describing the patients sleep architecture, summary of sleep events including maximum, minimum counts, indexes, duration, and range based data as well as graphical representations of each (trends). The generated sleep reports are part of the digital polysomnography and the RemLogic software also includes tools to customize report templates to conform to individual sleep center standards/policies and graphic norms.
3. Typical work flow using the RemLogic Application software
During the Acquisition phase, the software collects data based on user selected sampling rates, amplifier set-up, and amplifier calibrations. These three factors define how the software collects and displays the data in real-time. The recording is saved on the hard disk of the user's computer in a raw data format. The user can customize displays, observations, event markers, and tags.
4. Computer-assisted scoring analyzers
The RemLogic application software contains a number of computer-assisted scoring analyzers. All computer assisted-scoring analyzers are provided to assist trained medical practitioners in the review and analysis of vast amounts of polysomnography data. The computer assisted-scoring analyzers are for analysis of adult patient data only. Each computer-assisted scoring analyzer runs a specific type of event scoring on the patient file. The scoring rule parameters used in the computer-assisted scoring analyzers depend on the montage type associated with the study.
The eight computer-assisted scoring analyzers are:
- Arousal Analyzer
- Respiratory Analyzer
- Limb Movement Analyzer
- Snoring Analyzer
- Desaturation Analyzer
- Heart Rate Analyzer
- · Associations Analyzer
- XactTrace module
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5. Diagnosis
The RemLogic application software is intended for use by qualified and trained medical practitioners in research and clinical environments, who evaluate the software output with their clinical experience and judgement to provide diagnostic conclusions about the patient's condition. The RemLogic software does not control the delivery of energy, the administration of drugs, or any form of life sustaining function to the patient.
Indications for Use:
The RemLogic software is intended for Polysomnography studies, and allows recording, displaying, analysis, printing and storage of physiological signals to assist in the diagnosis of various sleep disorders and sleep related respiratory disorders. The RemLogic software also allows:
- Automated analysis of physiological signals that is intended for use only in ● adults:
- An optional audio/visual alert for user defined threshold on calibrated DC input. These alerts are not intended for use as life support such as vital signs monitoring or continuous medical surveillance in intensive care units.
- . Sleep report templates which summarize recorded and scored sleep data using simple measures including count, average, maximum and minimum values as well as data ranges for trended values;
- ●
The RemLogic software does not provide any diagnostic conclusions about the patient's condition and is intended to be used only by qualified and trained medical practitioners, in research and clinical environments.
| Predicate | Predicate | Subject Device | |
|---|---|---|---|
| Embla K971813 | SleepWorks K090277 | RemLogic | |
| Device Class | Class II | Class II | Class II |
| Class Name | Electroencephalograph | Electroencephalograph | Electroencephalograph |
| Product Code | OLV = StandardPolysomnograph withElectroencephalograph | OLZ = Automatic EventDetection Software forPolysomnograph withElectroencephalograph | Same as SleepWorks |
| Intended User | Medical Professional | Medical Professional | Medical Professional |
| Indications for Use | Embla is a | The Sleepworks software | The RemLogic software |
| polysomnographicsystem that is intendedto record, display, andprint EEG and otherphysiologicalinformation toclinicians/physicians.The device will be usedin hospitals,institutions, sleepcenters or clinics, orother test environmentswhere patients requiredocumentation ofvarious sleep or otherphysiologic disorders. | works in conjunction withConnex, Trex or Netlinkamplifiersintended forpolysomnography studies.The software allowsrecording, displaying,analysis, printing andstorage of physiologicalsignals to assist in thediagnosis of varioussleep disorders and sleeprelated respiratorydisorders.The Sleepworks allows:Automated analysis ofphysiological signals thatis intended for use only inadults.An optional Audio /visual alert for userdefined threshold oncalibrated DC input.These alerts are notintended for use as lifesupport such as vitalsigns monitoringor continuous medicalsurveillance in intensivecare units.Sleep report templatesare provided whichsummarize recorded andscored sleepdata using simplemeasures including count,average, maximum andminimumvalues as well as dataranges for trended values;Sleep Works softwaredoes not provide anydiagnostic conclusionabout the patient'scondition and is intendedto be used only by | is intended forPolysomnographystudies and allowsrecording, displaying,analysis, printing andstorage of physiologicalsignals to assist in thediagnosis of varioussleep disorders andsleep related respiratorydisorders. TheRemLogic softwareallows:Automated analysisof physiological signalsthat is intended for useonly in adults;An optionalaudio/visual alert foruser defined thresholdon calibrated DC input.These alerts are notintended for use as lifesupport such as vitalsigns monitoring orcontinuous medicalsurveillance in intensivecare units.Sleep reporttemplates whichsummarize recordedand scored sleep datausing simple measuresincluding count,average, maximum andminimum values as wellas data ranges fortrended values;The RemLogic softwaredoes not provide anydiagnostic conclusionabout the patient'scondition and isintended to be usedonly by qualified andtrained medical | |
| qualified and trainedmedical practitioners;in research and clinicalenvironments. | practitioners, inresearch and clinicalenvironments. | ||
| User input | Mouse/keyboard | Mouse/keyboard | Mouse/keyboard |
| Acquire,display, store,and archivePSG data | Yes | Yes | Yes |
| Signal digitized | Amplifier included aspart of the system | By separate proprietaryamplifier | By separate proprietaryamplifier |
| SoftwareAnalyzers | |||
| Respiratoryevent marking | Yes (Manual &Computer Assisted forapneas only) | Yes (Manual & ComputerAssisted) | Yes (Manual &Computer Assisted) |
| Sleep staging/scoring | Yes. Manual | Yes. Manual/computerassisted | Yes. Manual |
| Arousal EventMarking | Yes (Manual) | Yes. Manual/computerassisted | Yes (Manual &Computer Assisted) |
| Limbmovementsevent marking | Yes (Manual) | Yes (Manual & ComputerAssisted) | Yes (Manual &Computer Assisted) |
| Snore eventmarking | Yes (Manual) | Yes (Manual & ComputerAssisted) | Yes (Manual &Computer Assisted) |
| OxygenDesaturationevent marking | Yes (Manual) | Yes (Manual & ComputerAssisted) | Yes (Manual &Computer Assisted) |
| Heart Rate datatrend &summary(including HeartRate Variability) | No | Yes (Manual & ComputerAssisted) | Yes (Manual &Computer Assisted) |
| CO2 data trend& summary | No | Yes | Yes |
| Associaterelated events | No | Yes (Manual & ComputerAssisted) | Yes (Manual &Computer Assisted) |
| Derivedrespiratorytraces | No | Yes, Effort Sum,difference, average, FlowVolume Loop | Yes, XactTrace moduleand Flattening Index;cleared to market viaK041724 |
| Synchronizedpatient video | No | Yes | Yes |
| Oximetry datadisplay andreporting | Yes | Yes | Yes |
| Data storage | Local or remote, hard disk | Local or remote, hard disk | Local or remote, hard disk |
| Audio/ VisualAlerts OnCalibratedChannels | No | Yes | Yes |
| Signalsrecorded(output) | Respiratory Effort (abdomen and chest) Airflow Pressure Snore Body Position Pulse Rate Oximeter ECG EEG EMG EOG DC Leg Movement and other signals required for sleep studies | Respiratory Effort (abdomen and chest) Airflow Pressure Snore Body Position Pulse Rate Oximeter ECG EEG EMG EOG DC Leg Movement and other signals required for sleep studies | Respiratory Effort (abdomen and chest) Airflow Pressure Snore Body Position Pulse Rate Oximeter ECG EEG EMG EOG DC Leg Movement and other signals required for sleep studies |
| Reportgenerationincluding countsindexes,max/min/average/duration,range based datasummaries.Numeric & graphicalrepresentations | Yes, customizable templates | Yes, customizable templates | Yes, customizable templates |
Comparison to Predicate Device:
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Image /page/6/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a small registered trademark symbol next to it. Below "natus" is the word "neurology" in a smaller, black, italicized sans-serif font. The logo is simple and modern.
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Image /page/7/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, with a registered trademark symbol next to it. Below that, the word "neurology" is in a smaller, black, sans-serif font.
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Image /page/8/Picture/0 description: The image shows the logo for Natus Neurology. The word "natus" is in a teal sans-serif font, and the word "neurology" is in a black sans-serif font. The logo is simple and modern, and it is likely used to represent a company that specializes in neurology products or services.
RemLogic also includes derived calculation of pulse transit time (PTT) which is a measure of time difference between the ECG R top and the peak of the pleth waveform from the pulse oximeter. The reference predicate for this feature of RemLogic is K142988 Sleepware G3.
Brief Summary of Performance Tests:
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Biocompatibility
The RemLogic is a software-only device. Biocompatibility testing is not applicable.
Electrical Safety and EMC
The RemLogic is a software-only device. Electrical safety evaluation and EMC evaluation is not applicable.
Software Verification
Testing of the RemLogic was performed in compliance with the Natus Medical incorporated design control process. It was found that the RemLogic software meets the design specification and performs as specified.
Animal Study
There were no animal studies performed for this submission.
Clinical Study Summary - Respiratory, Limb Movement and Snore Event Assistedscoring Analyzers
1.1. Participants
Fifty-one (51) diagnostic PSG sleep studies were collected (one study per subject). All subjects involved in this study were adult (>18 years old) subjects with a clinical indication for a sleep study. The subject data were de-identified and applied as subject data to this study.
1.2. Dataset description
Total Number of Subjects: 51 per event evaluated Total Number of scored Epochs (30 Sec): > 47,113 Total Number of Hours: 392:36:30 Average number of epochs per subject: 924 Minimum number of epochs per subject: 764
Data from 51 subjects were evaluated for respiratory, arousal, limb movement and snore events. All epochs from these subjects were scored.
1.3. Objective of the study
The goal of the validation study reported here is to establish that RemLogic performance is equivalent to the performance of the predicate device. For the purpose of this study "Reference standard" is defined using majority rule, that is, at least two out of three expert scorings (medical professionals certified on PSG recording and analysis) agree on the presence of an event within an epoch.
1.4. PSG acquisition protocol
For this study, the following signals were recorded from each subject:
- Six (6) Electroencephalogram ([EEG] channels: F3, F4, C3, C4, O1, and O2. .
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- Two (2) Electrooculogram (EOG) channels ●
- Submental and bilateral tibial electromyogram (EMG) ●
- Electrocardiogram (ECG) ●
- . Airflow (nasal-oral thermistor and nasal pressure sensors or PAP flow)
- Chest and abdominal movement using respiratory inductance Plethysmography. ●
- Pulse oximetry (SpO2) and pulse rate ●
- Body position ●
- Snoring .
1.5. PSG analysis protocol
All physiologic data were collected and stored on a RemLogic System. The ECG, EEG, EMG, EOG and Snoring channels were sampled at 200 Hz. The Airflow and Chest, abdominal movement channels were sampled at 25 Hz. The Pulse oximetry channel was sampled at 10 Hz. The Body Position channel was sampled at 1 Hz.
The raw PSG recordings were de-identified, randomized and provided to three experienced and certified PSG specialists, including one board certified sleep specialist, who independently marked events of interest in each epoch, applying the following criteria:
- Apnea is scored when both of the following criteria are met: ●
- There is a drop in the peak signal excursion by > 90% of pre-event baseline a. respiratory nasal pressure or flow sensor signal.
- The duration of the > 90% drop in sensor signal is > 10 seconds. b.
- . The apnea is Obstructive if it meets apnea criteria and is associated with continued or increased inspiratory effort throughout the entire period of absent airflow.
- . The apnea is Central if it meets apnea criteria and is associated with absent inspiratory effort throughout the entire period of absent airflow.
- . The apnea is Mixed if it meets apnea criteria and is associated with absent inspiratory effort in the initial portion of the event followed by resumption of inspiratory effort in the second portion of the event.
- Hypopnea is scored if all of the following criteria are met: ●
- The peak signal excursions drop by > 30% of pre-event baseline using a. nasal pressure, PAP device flow or alternative hypopnea sensor.
- The duration of the > 30% drop in signal excursion is > 10 seconds. ﻘ
- There is a > 3% oxygen desaturation from pre-event baseline or the event C. is associated with an arousal.
- . Limb movement is scored if the following significant leg movement (LM) events are indicated:
- a. The minimum duration of a LM event is 0.5 seconds.
- The maximum duration of a LM event is 10 seconds. ﻒ
- The minimum amplitude of a LM event is an 8 µV increase in EMG voltage C. above resting EMG.
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- . Snore: The scoring of snore events relies on clinical interpretation
- . Arousals: Score arousals during sleep stages (N1, N2, N3 or R) if there is an abrupt shift in the EEG frequency that lasts at least 3 seconds (exclude sleep spindles) with at least 10 seconds of stable sleep preceding the change. Scoring arousals in REM requires a concurrent increase in Chin EMG lasting at least 1 second.
Separate from the expert review, all PSG studies were also analyzed by RemLogic assisted-scoring analyzers at default values for:
- Central apnea .
- Mixed apnea ●
- . Obstructive apnea
- Hypopnea
- Limb movement ●
- Snoring
- . Arousals
1.6. Outcomes
Positive Percent Agreement (PPA) between RemLogic assisted-scoring analyzers compared to the Reference standard were measured on an epoch basis. The mean and 95% confidence interval (CI) of the PPA and false detection rate per hour for event detection assisted-scoring analyzers are shown in the following table.
PPA and False Detection Rate Per Hour of RemLogic Event Detection Assisted Scoring Analyzers
| RemLogic | ||||
|---|---|---|---|---|
| PPA | FD/h | |||
| Event | Mean | 95% CI | Mean | 95% CI |
| Central Apnea | 98% | 96% to 99% | 2.1 | 1.2 to 4.1 |
| Mixed Apnea | 98% | 96% to 99% | 2.4 | 1.3 to 5.1 |
| Obstructive Apnea | 94% | 91% to 95% | 7.8 | 5.6 to 10.9 |
| Hypopnea | 86% | 83% to 87% | 17.4 | 15.0 to 20.0 |
| Arousal | 83% | 81% to 85% | 20.2 | 17.8 to 22.6 |
| Limb Movement | 86% | 84% to 88% | 16.8 | 14.0 to 19.9 |
| Snore | 85% | 83% to 88% | 17.8 | 14.9 to 20.9 |
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1.7. Clinical Study Conclusion
Compared to the Reference standard. RemLogic assisted-scoring analyzers showed performance levels comparable to the manual markings of expert reviewers. The device performance is clinically equivalent to the Reference standard (majority rule) as constructed for this study, similar to results reported in the literature and to performance reported for other commercially available devices.
510(k) Summary Conclusions:
The substantial equivalence of the RemLogic with the predicate Natus SleepWorks product was demonstrated by software verification testing and clinical validation. The non-clinical data support the safety of the device. The software verification and validation demonstrate that RemLogic device should perform as intended in the specified use conditions. The clinical validation of the computer-assisted scoring analyzers demonstrates that the RemLogic device performs comparably to the predicate device that is currently marketed for the same intended use.
§ 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).