(289 days)
Unknown
The document mentions "autoscoring" which could potentially utilize AI/ML, but it does not explicitly state that AI or ML is used for this function. The description of the Cerebra Analytics Suite mentions "signal processing" and "generating scoring results, which encompasses autoscoring," but doesn't specify the underlying technology.
No.
The device is described as an integrated diagnostic platform intended to support the evaluation and diagnosis of sleep disorders, not to provide therapy.
Yes
The device is explicitly stated as an "integrated diagnostic platform" and its intended use is "to aid in the evaluation and diagnosis of sleep disorders."
No
The device description explicitly states that the Cerebra Sleep System is comprised of three main areas, one of which is "Prodigy," a PSG recorder that includes hardware components like the Head Mounted Unit (HMU), Chest Mounted Unit (CMU), Table Top Unit (TTU), and third-party accessories including an oximeter. This indicates the system is not solely software.
Based on the provided information, the Cerebra Sleep System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in order to provide information for diagnostic purposes. This typically involves testing substances like blood, urine, or tissue samples outside of the body.
- Cerebra Sleep System Function: The Cerebra Sleep System acquires, transmits, analyzes, and displays physiological signals directly from the patient's body (EEG, EOG, ECG, EMG, etc.). It does not analyze specimens derived from the body.
- Intended Use: The intended use is to aid in the evaluation and diagnosis of sleep disorders by recording and analyzing physiological signals. This is a form of in vivo (within the living body) diagnostic testing, not in vitro.
Therefore, the Cerebra Sleep System falls under the category of a physiological signal acquisition and analysis system, not an IVD.
N/A
Intended Use / Indications for Use
The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate, and oxyhemoglobin saturation, depending on the sleep study configuration. The Cerebra Sleep System is for prescription use in a home or healthcare facility.
The Cerebra Sleep System is intended to be used as a support tool by physicians and PSG technologists to aid in the evaluation and diagnosis of sleep disorders. It is intended to provide sleep-related information that is interpreted by a qualified physician to render findings and/or diagnosis, but it does not directly generate a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
OMC, OLV, OLZ
Device Description
The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. It is for prescription use in a home or healthcare facility and is used by physicians and polysomnographic (PSG) technologists as a support tool to aid in the evaluation and diagnosis of sleep disorders. A PSG tecnologist must edit, score, and review the data before sleep reports are generated.
The Cerebra Sleep System is capable of collecting data required for Level 2 PSG and Level 3 HSAT studies. A Level 3 HSAT study is a home sleep apnea test with a minimum of 4 channels that include oxygen saturation, electrocardiogram (ECG) or heart rate, airflow (e.g., nasal flow), and respiratory effort (e.g., chest band). A Level 2 PSG study is an unattended sleep test with a minimum of 7 channels that include electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG) or heart rate, chin electromyogram (EMG), and all signals from Level 3.
The Cerebra Sleep System (CSS) is comprised of three main areas:
- Prodigy: This is a PSG recorder capable of performing Level 2 and Level 3 sleep studies. It includes the Head Mounted Unit (HMU), which is worn on the patient's head, the Chest Mounted Unit (CMU), which is affixed to a chest effort belt, the Table Top Unit (TTU), which receives data wirelessly, and third party accessories including an oximeter.
- Cerebra Analytics Suite (CAS): The CAS has 4 components Web Processing (for signal processing of data), Web Scoring (for generating scoring results, which encompasses autoscoring), Cerebra Viewer (for viewing and editing PSG studies and scoring results) and Web Reporting (for generating reports). A PSG technician must edit, score, and review the data before reports are generated. These components utilize well-defined file formats to enable communication; communication with each component is done through the internet, via the Cerebra Portal.
- Cerebra Portal: All areas of the CSS product are managed by the Portal software. The Portal is used to configure a study on the TTU and allows sleep analysis service providers to manage inventory, patients, and sleep studies. It also configures Prodigy system hardware for an individual sleep study to be performed by a patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Forehead, Head, Chest, Abdomen, Chin, Legs and Finger
Indicated Patient Age Range
adult patients
Intended User / Care Setting
physicians and PSG technologists, home or healthcare facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
For the autoscoring module of the Cerebra Sleep System, a validation study was performed to demonstrate the safety and effectiveness of the software and to support substantial equivalence to the predicate Michele Sleep System. The testing consisted of comparing the autoscoring software with the current gold standard (manual scoring) for key sleep variables. The sleep dataset consisted of 138 randomly selected pre-existing sleep studies from both sleep laboratory (Level 1 sleep test) and in-home (Level 2 or 3 sleep test) use environments.
Sleep recordings were manually scored by three board-certified registered polysomnographic technologists (RPSGT) who had a minimum of 13 years of experience scoring sleep studies. The technicians followed the rules outlined in the American Academy of Sleep Medicine manual for the scoring of sleep and associated events.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software Verification and Validation Testing - Autoscoring:
The autoscoring software compared to consensus manual scoring showed moderate to substantial agreement. The sleep dataset consisted of 138 randomly selected pre-existing sleep studies.
Results:
- SLEEP STAGING: Overall % Agreement 79.90, Kappa 0.72. Specifically for Awake (82.32% Avg. Positive, 97.15% Avg. Negative), N1 (56.80% Avg. Positive, 91.64% Avg. Negative), N2 (82.95% Avg. Positive, 88.05% Avg. Negative), N3 (84.51% Avg. Positive, 97.16% Avg. Negative), REM (79.41% Avg. Positive, 98.84% Avg. Negative).
- AROUSALS: Overall % Agreement 86.36, Kappa 0.48. Yes (64.79% Avg. Positive, 89.74% Avg. Negative).
- PLMs (periodic limb movements): Overall % Agreement 95.99, Kappa 0.69. Yes (64.96% Avg. Positive, 98.59% Avg. Negative).
- RESPIRATORY EVENTS: Overall % Agreement 89.18, Kappa 0.54. Overall Apneas (62.60% Avg. Positive, 93.03% Avg. Negative), Hypopneas & RERAs (66.52% Avg. Positive, 98.65% Avg. Negative).
- Cerebra Sleep System was also accurate for classifying sleep scoring stages of wake (82.3%), N1 (56.8%), N2 (83.0%), N3 (84.5%), and REM (79.4%).
Clinical Performance Testing: prospectively conducted.
Sample Size: Eighty-four participants.
Key Results: The aim was to demonstrate that the signals obtained by the Cerebra Sleep System are comparable to those obtained with in-laboratory Level 1 PSG signal acquisition systems (Philips Respironics Alice 6, K040595; Nihon Kohden PSG-1100, K120888) from three different sites. All objectives were fulfilled. There were no statistically significant differences of the measured sleep variables in the overall sample or in two out of the three sites. The validation showed that the signals generated by the Cerebra Sleep System are comparable to those generated by the commercial in-laboratory Level 1 data acquisition systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- SLEEP STAGING: Overall % Agreement 79.90, Kappa 0.72.
- Awake: Averaged Positive Percent Agreement (APPA) 82.32, Averaged Negative Percent Agreement (ANPA) 97.15
- N1: APPA 56.80, ANPA 91.64
- N2: APPA 82.95, ANPA 88.05
- N3: APPA 84.51, ANPA 97.16
- REM: APPA 79.41, ANPA 98.84
- AROUSALS: Overall % Agreement 86.36, Kappa 0.48. Yes: APPA 64.79, ANPA 89.74
- PLMs: Overall % Agreement 95.99, Kappa 0.69. Yes: APPA 64.96, ANPA 98.59
- RESPIRATORY EVENTS: Overall % Agreement 89.18, Kappa 0.54. Overall Apneas: APPA 62.60, ANPA 93.03. Hypopneas & RERAs: APPA 66.52, ANPA 98.65
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
July 6, 2022
Cerebra Medical Ltd. % Mary Vater Associate Regulatory Consultant Medical Device Academy Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738
Re: K213007
Trade/Device Name: Cerebra Sleep System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, OLV, OLZ Dated: June 3, 2022 Received: June 6, 2022
Dear Mary Vater:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Cerebra Sleep System
Indications for Use (Describe)
The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EBG), electroculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate, and oxyhemoglobin saturation, depending on the sleep study configuration. The Creebra Sleep System is for prescription use in a home or healthcare facility.
The Cerebra Sleep System is intended to be used as a support tool by physicians and PSG technologists to aid in the evaluation and diagnosis of sleep disorders. It is intended to provide sleep-related information that is interpreted by a qualified physician to render findings and/or diagnosis, but it does not directly generate a diagnosis.
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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SUBMITTER
l.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:
| Cerebra Medical Ltd. |
|---|
| 1470 Willson Place, Unit B |
| Winnipeg, Manitoba, CA R3T 3N9 |
| +1.431.801.0332 |
| Contact Person: | Mary Vater |
|---|---|
| Date Prepared: | July 6, 2022 |
II. DEVICE
| Name of Device: | Cerebra Sleep System |
|---|---|
| Classification Name: | Reduced-Montage Standard Electroencephalograph |
| Regulation: | 21 CFR §882.1400 |
| Regulatory Class: | Class II |
| Product Classification Code: | OMC, OLV, OLZ |
III. PREDICATE DEVICE
| Primary Predicate Manufacturer: | Advanced Brain Monitoring, Inc. |
|---|---|
| Primary Predicate Trade Name: | X8 System - Sleep Profiler (SP40), X8 System – Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) |
| Primary Predicate 510(k): | K152040 |
| Secondary Predicate Manufacturer: | Younes Sleep Technologies |
| Secondary Predicate Trade Name: | Michele Sleep Scoring Systems |
| Secondary Predicate 510(k): | K112102 |
No reference devices were used in this submission.
IV. DEVICE DESCRIPTION
The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. It is for prescription use in a home or healthcare facility and is used by physicians and polysomnographic (PSG) technologists as a support tool to aid in the evaluation and diagnosis of sleep disorders. A PSG tecnologist must edit, score, and review the data before sleep reports are generated.
The Cerebra Sleep System is capable of collecting data required for Level 2 PSG and Level 3 HSAT studies. A Level 3 HSAT study is a home sleep apnea test with a minimum of 4 channels that include oxygen saturation, electrocardiogram (ECG) or heart rate, airflow (e.g., nasal flow), and respiratory effort (e.g., chest band). A Level 2 PSG study is an unattended sleep test with a minimum of 7 channels that include electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG) or heart rate, chin electromyogram (EMG), and all signals from Level 3.
Sleep
4
The Cerebra Sleep System (CSS) is comprised of three main areas:
- Prodigy: This is a PSG recorder capable of performing Level 2 and Level 3 sleep studies. It ● includes the Head Mounted Unit (HMU), which is worn on the patient's head, the Chest Mounted Unit (CMU), which is affixed to a chest effort belt, the Table Top Unit (TTU), which receives data wirelessly, and third party accessories including an oximeter.
- Cerebra Analytics Suite (CAS): The CAS has 4 components Web Processing (for signal ● processing of data), Web Scoring (for generating scoring results, which encompasses autoscoring), Cerebra Viewer (for viewing and editing PSG studies and scoring results) and Web Reporting (for generating reports). A PSG technician must edit, score, and review the data before reports are generated. These components utilize well-defined file formats to enable communication; communication with each component is done through the internet, via the Cerebra Portal.
- Cerebra Portal: All areas of the CSS product are managed by the Portal software. The Portal is used to configure a study on the TTU and allows sleep analysis service providers to manage inventory, patients, and sleep studies. It also configures Prodigy system hardware for an individual sleep study to be performed by a patient.
V. INDICATIONS FOR USE
The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes, and displays physiological signals from adult patients, and then provides for scoring (automatic and manual), editing, and generating reports. The system uses polysomnography (PSG) to record the electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate, and oxyhemoglobin saturation, depending on the sleep study configuration. The Cerebra Sleep System is for prescription use in a home or healthcare facility.
The Cerebra Sleep System is intended to be used as a support tool by physicians and PSG technologists to aid in the evaluation and diagnosis of sleep disorders. It is intended to provide sleep-related information that is interpreted by a qualified physician to render findings and/or diagnosis, but it does not directly generate a diagnosis.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
The following characteristics were compared between the subject devices in order to demonstrate substantial equivalence:
| Cerebra Sleep System | X8 System (K152040) | |
|---|---|---|
| Product Code | OMC, OLV, OLZ | OMC, OLV |
| Regulation | Same as predicate. | 21 CFR 882.1400 |
| Electroencephalograph | ||
| 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. | ||
| Indications for Use | The Cerebra Sleep System is an integrated diagnostic platform that | |
| acquires, transmits, analyzes, and displays physiological signals | ||
| from adult patients, and then provides for scoring (automatic and | ||
| manual), editing, and generating reports. The system uses | ||
| polysomnography (PSG) to record the electroencephalogram | ||
| (EEG), electrooculogram (EOG), electrocardiogram (ECG), | ||
| electromyogram (EMG), accelerometry, acoustic signals, nasal | ||
| airflow, thoracic and abdomen respiratory effort, pulse rate, and | ||
| oxyhemoglobin saturation, depending on the sleep study | ||
| configuration. The Cerebra Sleep System is for prescription use in a | ||
| home or healthcare facility. | ||
| The Cerebra Sleep System is intended to be used as a support tool | ||
| by physicians and PSG technologists to aid in the evaluation and | ||
| diagnosis of sleep disorders. It is intended to provide sleep-related | ||
| information that is interpreted by a qualified physician to render | ||
| findings and/or diagnosis, but it does not directly generate a | ||
| diagnosis. | The X8 System is intended for prescription use in the home, | |
| healthcare facility, or clinical research environment to acquire, | ||
| record, transmit, and display physiological signals from adult | ||
| patients. All X8 models (SP40, SP29, and XS29) acquire, | ||
| record, transmit, and/or display electroencephalogram (EEG), | ||
| electrooculogram (EOG), electrocardiogram (ECG), and/or | ||
| electromyogram (EMG) signals, with optional accelerometer, | ||
| acoustical, and photoplethysmographic signals. Model SP29 | ||
| additionally includes a nasal pressure transducer and cannula | ||
| (for airflow), thoracic and abdomen respiratory effort, and | ||
| pulse rate and oxyhemoglobin saturation from the finger. The | ||
| X8 system only acquires and displays physiological signals; no | ||
| claims are being made for analysis of the acquired signals with | ||
| respect to the accuracy, precision, and reliability." | ||
| Patient Population | Same as predicate. | Adults |
| Anatomical Sites | Forehead, Head, Chest, Abdomen, Chin, Legs and Finger | Forehead, Head, Chest, Abdomen, Chin and Finger |
| Environment of Use | Home (data acquisition), Healthcare facility (data acquisition, analysis and reporting) | Home (data acquisition), Healthcare facility (data acquisition, analysis and reporting), |
| Clinical Research Environment | ||
| User Control | ON/OFF – Tablet End Study | ON/OFF |
| Visual Indicator | Blue, Green, Yellow, Red Light Pipe. | Green and yellow LED |
| Audio Indicator | None | Speaker. Voice messages alert user to problems during |
| recording. | ||
| EEG Electrodes | Ambu 720 Series AM-72000S/E (K970639) | Vermed VersaTrode Sensor 40- 4305 (K781430) |
| EOG Electrodes | King Lead, Touch Proof, Single Snap, KM-S020, (HC 99983) | |
| Ambu 720 Series AM-72000S/E (K970639) | Vermed VersaTrode Sensor 40- 4305 (K781430) | |
| ECG Electrodes | King Lead, Touch Proof, Single Snap, KM-S020, (HC 99983) | |
| Ambu 720 Series AM-72000S/E (K970639) | Vermed VersaTrode Sensor 40-4305 (K781430) | |
| EMG Electrodes | King Lead, Touch Proof, Single Snap, KM-S021, (HC 99983) | |
| King Lead, Touch Proof, Single Snap, KM-S022, (HC 99983) | ||
| King Lead, Touch Proof, Single Snap, KM-S008, (HC 99983) | ||
| Ambu 720 Series AM-72000S/E, (K970639) | ||
| Natus 019-429400 (K850108) | ||
| Kendall CV-31112/E (Exempt) | Vermed NeuroPlus Sensors A10041-60 (K010638) | |
| Linked Mastoid Sensors | King Lead, Touch Proof, Single Snap, KM-S011, (HC 99983) | |
| Ambu 720 Series AM-72000S/E, (K970639) | MBS (3BF3) Disposable Ag/Cl sensors with adhesive | |
| (K842514) | ||
| Respiratory Accessory | Same as predicate. | Nasal Cannula and nasal pressure sensor |
| Chest and abdomen effort belts | ||
| Signals Acquired | Forehead/head EEG | |
| ● Infra-red (IR) and red optical signal | ||
| ● Acoustic microphone | ||
| ● 3-D Actigraphy | ||
| ● Optional channel | ||
| ● (ECG/EEG/EOG/EMG) | ||
| ● Nasal Pressure & cannula (airflow) | ||
| Respiratory Effort | Forehead/head EEG | |
| ● Infra-red (IR) optical signal | ||
| ● Acoustic microphone | ||
| ● 3-D actigraphy | ||
| ● Optional channel | ||
| ● (ECG/EEG/EOG/EMG) | ||
| ● Nasal Pressure & cannula (airflow) | ||
| ● Respiratory Effort | ||
| ● Photoplethysmography | ||
| Power Supply | TTU: Non-removable min. 3000 mAH Li-ION | |
| HMU/ CMU: Non-removable 800 mAH 3.7V Li-Po batteries | 1 x 600 mAH 3.7V Li-ION battery | |
| Battery Charging | Patients &Technicians - Via USB cable connected to USB port or | |
| USB wall charger | Patients - external battery pack Technicians - Via USB cable | |
| connected to USB port or USB wall charger | ||
| Typical Charging | ||
| Time | Same as predicate. | 0.5 - 3.0 hours |
| Acquisition modes | Record | Record or Monitor |
| Operating Time | Hours of Use: | |
| 0-4 days after charging: Record: 9 to 13 hours | Hours of Use: | |
| 0-4 days after charging: Record: 11.5 - 18.5 hours | ||
| 5-10 Days after charging: Record: 8 to 10 Hrs | 5-10 days after charging: Record: 10.0 - 16.5 | |
| Data Storage | 32 GB Tablet Storage min. | 8 GB Micro-SDHC memory card or greater capacity |
| File size per 8 hr | ||
| recording | Approx: 120MB | Standard mode – 72 MB |
| PSG2 Mode - 134 MB | ||
| Dimensions | Table Top Unit (TTU): ~21 x 12 x 0.7 cm | |
| Head-Mounted Unit (HMU): ~63 x 38 x 28 cm | ||
| Chest-Mounted Unit (CMU): ~140 x 36 x 24 cm | 2.1" long, 1.5" wide, 0.75" deep | |
| Weight | TTU: ~300 g (~10 ounces); HMU: ~56 g (~2.0 ounces) | |
| CMU: ~81 g (~3 ounces) | 2.5 ounces with battery | |
| Cleaning enclosures and | ||
| EEG Strip | Cleaned and disinfected by: Pre-clean using solution with a | |
| minimum Hydrogen Peroxide concentration 0.5% w/w or 10% | ||
| aqueous sodium hypochlorite solution and allow the device to | ||
| remain wet for minimum 3 minutes. Repeat to disinfect; place | ||
| devices in a clean dry area to prevent re-contamination. | Cleaned and disinfected by rubbing with alcohol-based hand | |
| sanitizer and isopropyl alcohol. | ||
| Cleaning enclosure strap | Same as predicate. | Cleaned and disinfected by washing with dish soap. |
| Nasal Pressure | ||
| Transducer | Pressure transducer luer incorporated on CMU device to attach | |
| Nasal cannula. | Pressure transducer incorporated into airflow adapter, Affixes | |
| to USB connector Size: 3.5 (l) x 2.5 (w) x 1.5 (d) cm Weight - | ||
| 5.5 grams | ||
| Oximeter | Same as predicate. | Bluetooth (BT) used to obtain pulse and SpO2 acquired with |
| wrist oximeter. Nonin WristOx2 Wireless Pulse Oximeter | ||
| (K102350) | ||
| Respiratory | ||
| effort belts | Uses 3rd party respiratory induced plethysmography (RIP) thorax | |
| and abdomen effort belt - SleepSense (K042253) | Uses 3rd party respiratory induced plethysmography (RIP) | |
| thorax and abdomen effort belts Philips/Pro-Tech ezRIP | ||
| Respiratory Effort Sensors (K913395), and Ambu SleepMate | ||
| RIPmate Respiratory Effort Sensor (K903300) | ||
| Data transfer | No Physical transfer | Native from SD card through USB |
| Study Setup | Devices are set up via Cerebra Portal. Devices must be connected to | |
| Wi-Fi or cellular to set up the device for a sleep study. | Devices are Setup via Device Manager. Devices must be | |
| connected to PC via USB in order to Setup the device for a | ||
| sleep study. | ||
| Device/Inventory | ||
| Management | Devices and serial numbers of devices are stored in Cerebra Portal. | |
| Technicians select the serial number from the list of devices in | ||
| inventory when setting up a study. Cerebra Portal displays devices | ||
| that are assigned to a study or that are in stock and available to be | ||
| assigned to a study | Device serial number is only displayed when the device is | |
| connected via USB. Inventory management is handled | ||
| manually, not as part of the Device Management | ||
| Portal Access | Same as predicate. | Technicians receive email invitation with a link to create their |
| password for their account. Technicians have a username and | ||
| password to login to the Portal | ||
| USB data transfer rate | Not Applicable | > 250 MB per minute |
| Wireless data transfer | Bluetooth; WiFi; Cellular | Bluetooth |
| Maximum Bluetooth | ||
| wireless transfer distance | ||
| and rate | Same as predicate. | Transfer distance 10 meters line of sight, maximum transfer |
| rate 3 Mbaud | ||
| Compatibility | Personal computer with 2.4GHz (Pentium 4) processor or better, 2 | |
| GB RAM or higher (or equivalent). | ||
| Windows 10 or Mac iOS Operating System | ||
| Microsoft Edge, Google Chrome, Apple Safari or Firefox | ||
| Internet connection required | Personal computer with 2.4GHz (Pentium 4) Processor or | |
| better, 2 GB RAM or higher (or equivalent) with Windows 7, | ||
| 8, or Mac iOS Operating System | ||
| Estimated file size per | ||
| minute | Up to 355 KB/Min depending on configuration | Standard Mode: 150 KB/Min |
| PSG2 Mode: 280 KB/Min | ||
| File format type | European Data Format (EDF), converted from Cerebra Sleep Data | |
| (CSD) and Cerebra Channel Data (CCD). | European Data Format (EDF) | |
| Presents raw signals | ||
| during acquisition in | ||
| monitoring mode | N/A | Yes |
| Presents previously | ||
| acquired signals | Same as predicate. | No |
| Desktop interface min. | ||
| computer requirements | Not applicable for Prodigy or Cerebra Portal | 1. Processor : 2.4 GHz; 2. Operating System: Windows 7 or 8; |
- RAM: 2GB; 4. USB port: 1 |
| Web interface minimum
computer requirements | 1. Processor: Minimum 2.4 GHz; 2. Operating System: Windows
10, Mac iOS; 3. No Java dependency (HTML/JS only); 4. RAM:
1GB; 5. No USB port is required; 6. Internet connection: constant; - Browser: Microsoft Edge, Google Chrome, Apple Safari, or
Firefox | 1. Processor : Minimum 2.4 GHz; 2. Operating System:
Windows 7 or 8, Mac iOS; 3. Java version 6 or greater; 4.
RAM: 1GB; 5. USB port: 1; 6. Internet connection: constant; - Browser: Internet Explorer, Firefox, Opera, Chrome, or
Safari |
| Web interface server
requirements. | Virtual Server: - Processing: Google Cloud; 2. Operating system: any O/S
supporting Docker; 2. Certificates: Signed SSL; 3. Application
framework: Rails 6.0 & .NET Core 2.1; 4. Database: Google Cloud
SQL, Google Cloud Storage
Physical Server - not applicable | Virtual Server:
- Processor: > 2 GHz; 2. Operating system: WinServer 2008.
- RAM: > 2GB; 4. Certificates: Signed SSL; 5. .NET
framework: version 2.0 - web server version 3.5 – processing
server or Win Server 2008 6. Database: SQL server 2005
Physical Server: - Processor: > 2 GHz; 2. Operating system: Win Server 2008
Enterprise edition (for virtual servers); 3. RAM: > 2GB |
| Computer/portal Security | • Installation requires administrative rights to Cerebra Google
Cloud.
• User must have rights to the account to access data via the
Portal. No group access, each User access is defined according
to role & associated permissions.
• No requirement to directly manage the firewall. | 1. The person installing the Java applet must have
administrator privileges. - User must have rights to the account and group to access
data via the portal. - The firewall is not configured to prevent input or output
communication with access to the server via ports 22 and 30-
39 |
| Industry standard access management: HTTP authentication over SSL, token authentication for TTU. Portal uses Device Gem (Rails 6.0) Data in test and development environments is anonymized. Administrative access in Production is limited to required staff. Source code and database access limited to required development staff. Access to testing system (Jenkins) restricted to internal VPN. | Benchtop Performance Testing | IEC 60601-1:2005 (3rd Edition) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2014 (4th Edition) Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests IEC 60601-1-11:2010 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-2-26:2012 Particular requirements for the basic safety and essential performance of electroencephalographs IEC 62133: 2012 Secondary Cells And Batteries Containing Alkaline Or Other Non Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications ISO 14971:2007 Medical devices - Application of risk management to medical devices |
| ANSI/AAMI ES60601-1:2005 + A1:2012 + C1:2009 + A2:2010 and CAN/CSA-C22.2 No. 60601-1:14 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2014 (4th Edition) Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests IEC 60601-1-2:2020 (4.1 Edition) Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests ANSI/AAMI HA60601-1-11:2015 and CAN/CSA-C22.2 No. 60601-1-11:2015 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment IEC 60601-2-26:2012 Particular requirements for the basic safety and essential performance of electroencephalographs AAMI TIR69: 2017 Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems ANSI / IEEE C63.27-2017 American National Standard for Evaluation of Wireless Coexistence IEC 62133-2: 2017 Secondary Cells And Batteries Containing Alkaline Or Other Non Acid Electrolytes - Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications ISO 14971:2007 and 2012 Medical devices - Application of | | |
| Clinical Testing | Clinical testing compared device's results with those obtained using
commercial PSG equipment available in 3 sites | Advanced Brain Monitoring has conducted prospective studies
to compare equivalence of signals obtained with X8 System
airflow and respiratory effort signals with an FDA cleared
device, Compumedics Somte (K072201) |
| Biocompatibility | Testing on patient-contacting materials:
• ISO 10993-5: 2009 Cytotoxicity; ISO 10993-10: 2010
Sensitization; ISO 10993-10: 2010 Irritation | Not available. |
| Cleaning Validation | Reprocessing protocols. Verify reprocessing (i.e. cleaning and
disinfecting) instructions intended to be included in device labeling
does not contribute to deterioration of mechanical components.
Used FDA Guidance "Reprocessing Medical Devices in Health
Care Settings: Validation Methods and Labeling". Per Section VI of
document, device is considered a “Non-Critical Device” as it is
intended to contact only intact skin and is not intended to penetrate
it. | Not available. |
| Sterilization | N/A | N/A |
| Usability | Cerebra Medical Ltd. has conducted
usability testing, as per IEC 62366:2015 Medical Device Usability
Engineering standard, to evaluate the performance and usability of
the system. | Advanced Brain Monitoring has conducted usability testing to
demonstrate that high quality signals can be obtained when the
X8 System is self-applied with the user instructions. X8
System Model SP29 was used for both portions of the study. |
Table 1: Comparison of Cerebra Sleep System with primary predicate device (K152040).
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Table 2: Comparison of Cerebra Sleep System with secondary predicate device (K112102).
| Cerebra Sleep System | Michele Sleep Scoring System (K112102) | |
|---|---|---|
| Product Code | OMC, OLV, OLZ | MNR |
| Regulation | 21 CFR 882.1400 | |
| Electroencephalograph | ||
| 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. | 21 CFR 868.2375 | |
| Breathing frequency monitor | ||
| A breathing (ventilatory) frequency monitor is a device intended to | ||
| measure or monitor a patient's respiratory rate. The device may provide | ||
| an audible or visible alarm when the respiratory rate, averaged over | ||
| time, is outside operator settable alarm limits. This device does not | ||
| include the apnea monitor classified in § 868.2377. | ||
| Indications for Use | The Cerebra Sleep System is an integrated diagnostic platform | |
| that acquires, transmits, analyzes, and displays physiological | ||
| signals from adult patients, and then provides for scoring | ||
| (automatic and manual), editing, and generating reports. The | ||
| system uses polysomnography (PSG) to record the | ||
| electroencephalogram (EEG), electrooculogram (EOG), | ||
| electrocardiogram (ECG), electromyogram (EMG), | ||
| accelerometry, acoustic signals, nasal airflow, thoracic and | ||
| abdomen respiratory effort, pulse rate, and oxyhemoglobin | ||
| saturation, depending on the sleep study configuration. The | ||
| Cerebra Sleep System is for prescription use in a home or | ||
| healthcare facility. | ||
| The Cerebra Sleep System is intended to be used as a support | ||
| tool by physicians and PSG technologists to aid in the | ||
| evaluation and diagnosis of sleep disorders. It is intended to | ||
| provide sleep-related information that is interpreted by a | ||
| qualified physician to render findings and/or diagnosis, but it | ||
| does not directly generate a diagnosis. | The MICHELE Sleep Scoring System is a computer program | |
| (software) intended for use as an aid for the diagnosis of sleep and | ||
| respiratory related sleep disorders. | ||
| The MICHELE Sleep Scoring System is intended to be used for | ||
| analysis (automatic scoring and manual rescoring), display, redisplay | ||
| (retrieve), summarize, reports generation and networking of digital data | ||
| collected by monitoring devices typically used to evaluate sleep and | ||
| respiratory related sleep disorders. | ||
| The device is to be used under the supervision of a physician. Use is | ||
| restricted to files obtained from adult patients | ||
| Clinical condition or | ||
| purpose | Diagnosis of sleep disorders. | Diagnosis of sleep and respiratory disorders. |
| Population: Human | ||
| subjects undergoing | ||
| sleep studies | Same as predicate. | Yes |
| Five-stage Sleep | ||
| Stage Scoring (wake, | ||
| Rem, three non-Rem | ||
| stages) | Same as predicate. | Yes |
| Arousal Scoring | Same as predicate. | Yes |
| Respiratory Events | ||
| Scoring | Same as predicate. | Yes |
| Leg Movements | ||
| Scoring | Same as predicate. | Yes |
| Processing of PSG | ||
| recorded from | ||
| patients and PSG | ||
| report creation | Same as predicate. | Yes |
| Central EEG | Same as predicate. | Scoring; display; reporting |
| Left and right eye | ||
| EOG | Same as predicate. | Scoring; display; reporting |
| Chin EMG | Same as predicate. | Scoring; display; reporting |
| ECG | Same as predicate. | Scoring; display; reporting |
| Chest and abdomen | ||
| respiratory | Same as predicate. | Scoring; display; reporting |
| Oxygen saturation | Same as predicate. | Scoring; display; reporting |
| Respiratory airflow | Same as predicate. | Scoring; display; reporting |
| Thermister | Scoring | Scoring; display; reporting |
| Audio | Same as predicate. | Scoring; display; reporting |
| Head/Body position | Same as predicate. | Scoring; display; reporting |
| Airway CO2 | Scoring | Scoring; display; reporting |
| Airway pressure | Scoring | Scoring; display; reporting |
| EMG recorded from | ||
| right and left legs | Same as predicate. | Scoring; display; reporting |
| PSG records scored | ||
| per 30 second epoch | Same as predicate. | Yes |
| Cardiac artifacts | ||
| removed from EEG, | ||
| EMG and ECG | Same as predicate. | Yes |
| Support multiple | ||
| Config/Study Types | Same as predicate. | Yes |
| Desktop interface | ||
| minimum | ||
| computer | ||
| requirements | Cerebra Portal and most of Cerebra Analytics Suite: Not | |
| applicable | ||
| CAS Cerebra Viewer: |
- Processor: 2.0 GHz or faster; 2. Operating System: Windows
10 64 bit; 3. RAM: 4GB; 4. Monitor: 19 inch or greater; 1600 x
1050 resolution | 1. Processor : 1.6 GHz - Operating System: Windows 10
- RAM: 4GB
- Monitor: 19 inch or greater; 1280 x 1024 resolution |
| Usability Testing | Same as predicate. | Usability testing was conducted for the product. |
| Clinical Testing | Same as predicate. | Validation testing included comparison of autoscoring to those
obtained by manual scoring |
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VII. PERFORMANCE DATA
The following performance data were provided in support of the safety and efficacy of the subject device, as well as support of the substantial equivalence determination.
Sterilization & Shelf-life Testing
Sterilization is not applicable to this device. Instead, cleaning and disinfection are applicable to the reusable components.
Shelf-life is only applicable to the rechargeable polymer lithium-ion batteries used in the system. Appropriate shelf-life testing was conducted for the battery components in the Cerebra Sleep System. The batteries passed this testing.
Biocompatibility Testing
The following biocompatibility testing was provided to demonstrate the safety and efficacy of the Cerebra Sleep System:
- ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices Part 5: Tests for in . vitro cytotoxicity
- ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices Part 10: Tests for ● irritation and skin sensitization
The device passed all biocompatibility testing per the test standards.
Electrical Safety and Electromagnetic Compatibility (EMC) Testing
The following electrical safety and EMC testing were provided to demonstrate the safety and efficacy of the subject device, as well as substantial equivalence with the predicate:
- ANSI/AAMI ES60601-1:2005 + A1:2012 + C1:2009 + A2:2010 and CAN/CSA-C22.2 . No. 60601-1:14 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- ANSI/AAMI HA60601-1-11:2015 and CAN/CSA-C22.2 No. 60601-1-11:2015 Medical ● electrical equipment - Part 1: General requirements for basic safety and essential performance – Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . IEC 60601-1-2:2014 and :2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 60601-2-26:2012 and CAN/CSA-C22.2 No. 60601-2-26:14 Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
- . IEC 60601-2-49:2011 and CAN/CSA-C22.2 No. 60601-2-49:11 Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment.
- AAMI TIR69: 2017 Technical Information Report Risk management of radio-frequency ● wireless coexistence for medical devices and systems
- ANSI / IEEE C63.27:2017 American National Standard for Evaluation of Wireless ● Coexistence
14
The device passed all electrical safety and EMC testing per the test standards.
Software Verification and Validation Testing
Software verification and validation testing in compliance with IEC 62304:2006 were provided to demonstrate the safety and efficacy of the subject device. Testing was conducted and documented as per the recommendations in FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The Cerebra Sleep System has been thoroughly tested through hundreds of test cases of various types (unit, integration, exploratory, system, regression, usability, etc.). The results of these activities demonstrate that the software meets requirements for safety, function, and intended use.
Software Verification and Validation Testing - Autoscoring
For the autoscoring module of the Cerebra Sleep System, a validation study was performed to demonstrate the safety and effectiveness of the software and to support substantial equivalence to the predicate Michele Sleep System. The testing consisted of comparing the autoscoring software with the current gold standard (manual scoring) for key sleep variables. The sleep dataset consisted of 138 randomly selected pre-existing sleep studies from both sleep laboratory (Level 1 sleep test) and in-home (Level 2 or 3 sleep test) use environments.
Sleep recordings were manually scored by three board-certified registered polysomnographic technologists (RPSGT) who had a minimum of 13 years of experience scoring sleep studies. The technicians followed the rules outlined in the American Academy of Sleep Medicine manual for the scoring of sleep and associated events.
When comparing the Cerebra Sleep System (CSS) autoscoring software to the consensus manual scoring, the results showed moderate to substantial agreement, as reported in Table 3.
| Scoring Function | Total Epochs
by Techs | CSS Autoscoring | | Overall %
Agreement | Kappa |
|------------------|--------------------------|-----------------|-------|------------------------|-------|
| SLEEP STAGING | 114017 | | | 79.90 | 0.72 |
| Awake | 28838 | 82.32 | 97.15 | | |
| N1 | 11242 | 56.80 | 91.64 | | |
| N2 | 48806 | 82.95 | 88.05 | | |
| N3 | 10442 | 84.51 | 97.16 | | |
| REM | 14689 | 79.41 | 98.84 | | |
| No Consensus | 1654 | | | | |
| AROUSALS | 81526 | | | 86.36 | 0.48 |
| Yes | 11043 | 64.79 | 89.74 | | |
| None | 70483 | | | | |
| PLMs | 81526 | | | 95.99 | 0.69 |
| Yes | 6315 | 64.96 | 98.59 | | |
Table 3 - Comparison of CSS autoscoring to consensus manual scoring in all studies
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| None | 75211 | ||||
|---|---|---|---|---|---|
| RESPIRATORY EVENTS | 81526 | 89.18 | 0.54 | ||
| Overall Apneas | 5631 | 62.60 | 93.03 | ||
| Hypopneas & RERAs | 3608 | 66.52 | 98.65 | ||
| None | 72287 | 92.38 | 73.11 | ||
| No Consensus | 833 |
Note: Numbers in sleep staging rows are number of 30-second epochs. Event rows are the number of epochs where an event began except in the "None" category where the number of epochs with no events. APPA = Averaged Positive Percent Agreement: ANPA= Averaged Negative Percent: N1, N2, and N3, REM are sleep stages; PLMs = periodic limb movements; RERAs = respiratory effort-related arousals; No Consensus = all three technologists gave different scores.
Cerebra Sleep System was also accurate for classifying sleep scoring stages of wake (82.3%), N1 (56.8%), N2 (83.0%), N3 (84.5%), and REM (79.4%), see Table 4.
Table 4 - Confusion matrix comparing the classification of sleep stages of the CSS autoscoring (Automatic Analysis) with the consensus of three manual scorers (Manual Staging).
| Automatic Analysis | |||||||
|---|---|---|---|---|---|---|---|
| Wake | N1 | N2 | N3 | REM | Epoch | ||
| Count | |||||||
| Manual Staging | |||||||
| Wake | 82.3% | 10.4% | 4.5% | 1.4% | 1.3% | 28838 | |
| N1 | 9.7% | 56.8% | 30.7% | 0.3% | 2.5% | 11242 | |
| N2 | 1.6% | 9.4% | 83.0% | 5.1% | 1.0% | 48806 | |
| N3 | 0.5% | 0.2% | 14.6% | 84.5% | 0.2% | 10442 | |
| REM | 3.3% | 7.0% | 10.3% | 0.1% | 79.4% | 14689 |
A similar performance analysis was completed for the Michele Sleep System autoscoring and the Alice 5 autoscoring, where the two autoscoring software systems were compared to consensus manual scoring. The results, as per Table 5, show that the Cerebra Sleep System autoscoring performance is similar to the Michele software performance and far exceeds the Alice 5 software performance. Although the CSS autoscoring was run on a different dataset than the Michele and Alice 5, the CSS autoscoring shows a similar and appropriate agreement with manual scoring.
| Table 5 - Comparison of CSS autoscoring performance to Michele and Alice 5 reported results | |||
|---|---|---|---|
| Latest Autoscoring | Michele | Alice 5 | ||||
|---|---|---|---|---|---|---|
| Overall % | ||||||
| Agreement | Kappa | Overall % | ||||
| Agreement | Kappa | Overall % | ||||
| Agreement | Kappa | |||||
| Scoring Function | ||||||
| Sleep Staging | 79.9 | 0.72 | 82.6 | 0.77 | 30.5 | 0.06 |
| Arousals | 86.4 | 0.48 | 89.9 | 0.54 | 57.9 | 0.10 |
| PLM Index | 96.0 | 0.69 | 95.7 | 0.69 | 88.3 | 0.38 |
| Respiratory Events | 89.2 | 0.54 | 94.0 | 0.74 | 78.0 | 0.25 |
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Benchtop Performance Testing
The following benchtop performance testing was provided to demonstrate substantial equivalence with the predicate device:
- . Human Factors / usability testing in accordance with IEC 62366-1:2015
- Cleaning Validation ●
- Hardware inspections ●
- Mechanical verification and inspection ●
- Shipping validation per ASTM D4169
The devices passed all benchtop performance testing per the testing requirements.
Animal Study
Animal performance testing was not required to demonstrate safety and effectiveness of the device.
Clinical Performance Testing
Clinical validation was prospectively conducted to demonstrate the safety and effectiveness of the device. The aim of the validation was to demonstrate that the signals obtained by the Cerebra Sleep System are comparable to those obtained with in-laboratory Level 1 PSG signal acquisition systems. Key comparisons between manually scored total sleep time (TST), the apnea hypopnea index (AHI), respiratory disturbance index (RDI), sleep onset latency, sleep stages, sleep onset latency, and the periodic limb movement index (PLMI) derived from the Cerebra Sleep System and two types of Level 1 systems (Philips Respironics Alice 6, K040595; Nihon Kohden PSG-1100, K120888) from three different sites was performed to show statistical equivalence between the measurements. Eighty-four participants were part of the validation, with sample characteristics (Age: 46.7±13.6, BMI: 34.5±9.0, Sex: 48.8% Male, Ethnicity: 75% White) that are similar to patients attending sleep disorder clinics.
All objectives for the validation were fulfilled. There were no statistically significant differences of the measured sleep variables in the overall sample or in two out of the three sites. The validation therefore showed that the signals generated by the Cerebra Sleep System are comparable to those generated by the commercial in-laboratory Level 1 data acquisition systems.
VIII. CONCLUSIONS
Cerebra Medical considers the Cerebra Sleep System to be substantially equivalent to the predicate devices in terms of indications for use, technological characteristics and testing performed.