(142 days)
Not Found
Yes
The summary explicitly mentions "AAMI BS 34971:2022 Application of risk management to Artificial ● Intelligence and Machine Learning Devices", indicating the device incorporates AI/ML.
No.
The "Intended Use / Indications for Use" states that the device is "intended for documenting physical movements associated with applications in physiological monitoring" and to "analyze subject activity, movement and physiological sign data associated with movement during sleep and to extract information about certain sleep parameters from these movements and physiological sign data." It focuses on monitoring and assessment, not on treating or mitigating a condition.
Yes
The device "extracts information about certain sleep parameters from these movements and physiological sign data" and performs "sleep/wake classification measured against polysomnographic reference standard," indicating it provides information used for diagnosis of sleep disorders.
Yes
The device description explicitly states "Oxevision Sleep is a software-only medical device (SaMD)". While it utilizes video from off-the-shelf cameras, the device itself is the software that analyzes this video data.
Based on the provided information, the Oxevision Sleep Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Oxevision Sleep Device analyzes video data of a subject's physical movements and physiological signs directly from a camera, without requiring any biological samples (like blood, urine, or tissue).
- The intended use and device description clearly state it's a noncontact sleep assessment device based on video analysis. It focuses on analyzing external physical and physiological indicators captured through video.
Therefore, the Oxevision Sleep Device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
No
The letter does not explicitly state that the FDA has reviewed and cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Oxevision Sleep Device is an activity monitor designed and intended for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze subject activity, movement and physiological sign data associated with movement during sleep and to extract information about certain sleep parameters from these movements and physiological sign data.
The device provides a timeline of periods when a bed space is occupied, and periods when a subject is asleep when the bed space is occupied.
The Oxevision Sleep Device is software assessing video from a fixed-installation device for use within single occupancy bed spaces within hospitals, general care and secured environments.
The Oxevision Sleep Device is indicated for use on subjects 18 years of age or older.
Product codes
LEL
Device Description
Oxevision Sleep is a software-only medical device (SaMD) that provides noncontact sleep assessment in the inpatient setting based on the analysis of patient movement, activity and physiological sign data derived from video, without the need for contact devices to be attached to the patient or bed.
The device consists of custom-designed software assessing video footage collected using off-the-shelf cameras installed within single occupancy bed spaces within hospitals, general care and secured environments. Proprietary software-controlled algorithms are used to derive patient movement, activity and physiological sign data and then to obtain information on bed occupancy and sleep state from the analysis of this data.
The device software automates recognition of sleep periods, generation of sleep reports, and their presentation in a graphical display for use by a healthcare professional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
AAMI BS 34971:2022 Application of risk management to Artificial ● Intelligence and Machine Learning Devices
Input Imaging Modality
video
Anatomical Site
Not Found
Indicated Patient Age Range
18 years of age or older.
Intended User / Care Setting
single occupancy bed spaces within hospitals, general care and secured environments.
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
The clinical data used to determine the clinical performance of the device was obtained in a sample of 60 individuals (a total of 772.65 hours of data).
Reference measurements (physiological signals and video polysomnography data) were collected using an FDA-cleared polysomnography (PSG) device (SOMNOscreen™ plus device, Somnomedics, Germany). Video data was collected concurrently from a standard off-the-shelf camera and hardware installed in two rooms according to the Oxehealth Installation Instructions for use with the Oxevision Sleep Device software.
Reference PSG measurements were assessed and scored (in accordance with the American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated Events version 2.6 of January 2020) by three trained sleep physiologists, blinded to the video data collected by the standard off-the-shelf camera.
Oxevision video data was reviewed and annotated (to obtain a reference standard) for periods of bed occupancy by two reviewers, blinded to the algorithm development details.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical performance (validation) testing of the Oxevision Sleep software device was designed to assess the performance of the Oxevision Sleep Device algorithm against reference standards on two tasks:
A. The accuracy of periods of bed occupancy detected using Oxevision Sleep Device algorithms measured against periods of human-labeled bed occupancy is not inferior to 95%;
B. The agreement between Oxevision Sleep Device algorithms in sleep/wake classification measured against polysomnographic reference standard during periods of bed occupancy detected using Oxevision Sleep Device algorithms is not inferior to Agreement = 82%, Positive agreement = 88%, and Negative Agreement = 55%.
The clinical data used to determine the clinical performance of the device was obtained in a sample of 60 individuals (a total of 772.65 hours of data).
The results show overall agreement (>82%), positive agreement (>88%) and negative agreement (>55%) between Oxevision Sleep Device outputs and the gold-standard PSG reference. A bed state accuracy of >95% against reviewer annotations was also reported.
This testing demonstrated device performance was superior to that produced for the predicate device [K111514] in their pre-market submission. All performance endpoints have therefore been met, which substantiate the claim of substantial equivalence to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: 99% (Bed State outputs)
Overall Agreement: 90% (Sleep State outputs)
Positive Agreement: 94% (Sleep State outputs)
Negative Agreement: 80% (Sleep State outputs)
95% Confidence intervals:
Bed State outputs Accuracy: (99.0%; 99.7%)
Sleep State outputs Overall Agreement: (89.0%; 91.8%)
Sleep State outputs Positive Agreement: (92.3%; 95.6%)
Sleep State outputs Negative Agreement: (74.3%; 83.5%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
0
April 3, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Oxehealth Limited Joao Jorge, PhD Sleep Analysis Lead Magdalen Centre North Oxford Science Park Oxford, OX4 4GA United Kingdom
Re: K233618
Trade/Device Name: Oxevision Sleep Device Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback device Regulatory Class: Class II Product Code: LEL Dated: March 4, 2024 Received: March 4, 2024
Dear Joao Jorge:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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.
Patrick
Antkowiak -S
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional
2
and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Oxevision Sleep Device
Indications for Use (Describe)
The Oxevision Sleep Device is an activity monitor designed and intended for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze subject activity, movement and physiological sign data associated with movement during sleep and to extract information about certain sleep parameters from these movements and physiological sign data.
The device provides a timeline of periods when a bed space is occupied, and periods when a subject is asleep when the bed space is occupied.
The Oxevision Sleep Device is software assessing video from a fixed-installation device for use within single occupancy bed spaces within hospitals, general care and secured environments.
The Oxevision Sleep Device is indicated for use on subjects 18 years of age or older.
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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4
oxehealth®
510(k) Summary
Oxevision Sleep Device K233618
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
General information
| Submitter's Name: | Dr. Joao Jorge |
|---|---|
| Address: | Oxehealth Limited |
| Magdalen Centre North, | |
| Oxford Science Park, | |
| Oxford, OX4 4GA | |
| UK | |
| Phone: | +44 (0) 1865 900 599 |
| Contact Person: | Dr. Joao Jorge |
| Email: | joao.jorge@oxehealth.com |
| Date Prepared: | 4 March 2024 |
| Trade name: | Oxevision Sleep Device |
| Common Name: | Sleep Assessment System |
| Address of Sponsor: | Oxehealth Limited |
| Magdalen Centre North, | |
| Oxford Science Park, | |
| Oxford, OX4 4GA | |
| UK | |
| Classification Name: | LEL, Biofeedback device, 21 CFR 882.5050 |
5
Indication for Use: The Oxevision Sleep Device is an activity monitor designed and intended for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze subject activity, movement and physiological sign data associated with movement during sleep and to extract information about certain sleep parameters from these movements and physiological sign data.
The device provides a timeline of periods when a bed space is occupied, and periods when a subject is asleep when the bed space is occupied.
The Oxevision Sleep Device is software assessing video footage from a fixedinstallation device for use within single occupancy bed spaces within hospitals, general care and secured environments.
The Oxevision Sleep Device is indicated for use on subjects 18 years of age or older.
Device Description: Oxevision Sleep is a software-only medical device (SaMD) that provides noncontact sleep assessment in the inpatient setting based on the analysis of patient movement, activity and physiological sign data derived from video, without the need for contact devices to be attached to the patient or bed.
The device consists of custom-designed software assessing video footage collected using off-the-shelf cameras installed within single occupancy bed spaces within hospitals, general care and secured environments. Proprietary software-controlled algorithms are used to derive patient movement, activity and physiological sign data and then to obtain information on bed occupancy and sleep state from the analysis of this data.
The device software automates recognition of sleep periods, generation of sleep reports, and their presentation in a graphical display for use by a healthcare professional.
Technological Characteristics and Comparison:
The Oxevision Sleep Device is substantially equivalent to the SBV2™ System (K111514) from Fatigue Science Inc. based on the technological and performance characteristics as described in Table 1.
The subject device, Oxevision Sleep Device, and the predicate SBV2™ System are both intended for the assessment of sleep and are both used to measure, record, display, transmit and analyze physiological parameters during sleep and wake. Both are intended for documenting physical movements associated with applications in physiological monitoring in patients, and derive sleep measurements from these movements. Both can be used on adult patients. Both provide a timeline of periods when a subject is in bed, and of periods when a subject is asleep for a set time period (e.g. 7 days.) in
6
reports that can be viewed and exported in electronic format. These similarities led to the conclusion that the Oxevision Sleep Device is substantially equivalent to the SBV2TM System.
Table 1: Comparison between the Oxevision Sleep Device and the previously cleared SBV2 System [K111514] (cleared by FDA under the LEL product code).
7
| Subject Device | Predicate Device | Equivalence | |
|---|---|---|---|
| Trade Name | Oxevision Sleep Device | SBV2 | |
| Reference | K233618 | K111514 | |
| Sponsor | Oxehealth Limited | Fatigue Science Inc. | |
| Intended Use | Sleep Assessment Device | Sleep Assessment Device | |
| Product Code | LEL | LEL | Same as the predicate |
| device. | |||
| Intended Use | The Oxevision Sleep Device is an | ||
| activity monitor designed and | |||
| intended for documenting physical | |||
| movements associated with | |||
| applications in physiological | |||
| monitoring. The device's intended use | |||
| is to analyze subject activity, | |||
| movement and physiological sign data | |||
| associated with movement during | |||
| sleep and to extract information | |||
| about certain sleep parameters from | |||
| these movements and physiological | |||
| sign data. | The SBV2 System is an activity | ||
| monitor designed and intended for | |||
| documenting physical movements | |||
| associated with applications in | |||
| physiological monitoring. The | |||
| device's intended use is to analyze | |||
| limb activity associated with | |||
| movement during sleep and to | |||
| extract information about certain | |||
| sleep parameters from these | |||
| movements. SBV2 can also be used | |||
| to assess activity in any instance | |||
| where quantifiable analysis of | |||
| physical motion is desirable. | Substantially equivalent | ||
| to the predicate device. | |||
| Intended Use | |||
| Population | The Oxevision Sleep Device is | ||
| indicated for use on subjects 18 years | |||
| of age or older. | The use of SBV2 is indicated for | ||
| adults 22 years of age and over. | Intended use population | ||
| is substantially | |||
| equivalent to the | |||
| predicate device. | |||
| Differences in age | |||
| groups have been | |||
| validated as part of a | |||
| US-census balanced | |||
| study cohort. | |||
| Commercial | |||
| distribution | Prescription use. | Indicated for Over the Counter (OTC) | |
| Use. Patient receives data recording | |||
| unit from a dispensing agent such as | |||
| a pharmacist. | Prescription use | ||
| represents a lower risk | |||
| posture than OTC. | |||
| Differences to predicate | |||
| do not introduce any | |||
| questions of safety or | |||
| effectiveness. | |||
| Intended use | |||
| environment | Single occupancy bed spaces within | ||
| hospitals, general care and secured | |||
| environments. | Body-worn device providing | ||
| actigraphy data to a PC processing | |||
| application/software. For use in any | |||
| sleeping location. | No change from | ||
| reference device. | |||
| Data | |||
| Collection | Data collection is from an off-the shelf | ||
| video camera, collecting continuously. | |||
| The specification of the camera and | |||
| qualification as suitable for use is | |||
| controlled by Oxehealth | Data recording unit is attached to | ||
| patient's limb or torso and worn | |||
| continuously | Differences to predicate | ||
| do not introduce any | |||
| questions of safety or | |||
| effectiveness. | |||
| Clinical performance has | |||
| been validated and | |||
| found to be as good or | |||
| better than the | |||
| predicate. | |||
| Subject Device | Predicate Device | Equivalence | |
| User | |||
| Interface | Application developed by the | ||
| manufacturer, installed on OTS | |||
| computer or mobile device. Installed | |||
| by Oxehealth with no other | |||
| applications in the operating | |||
| environment. | Application developed by the | ||
| manufacturer, installed on OTS | |||
| computer. Installed by the user on a | |||
| BYOD platform. | Differences to predicate | ||
| do not introduce any | |||
| questions of safety or | |||
| effectiveness. | |||
| Compatibility | |||
| with | |||
| Hardware | Standard, off the shelf computers and | ||
| mobile devices, specified and installed | |||
| by Oxehealth, and validated during | |||
| installation. | SleepAnalyzer application can be | ||
| used in standard, off-the-shelf | |||
| computers to retrieve collected data | |||
| from the data recording unit and | |||
| generate reports based on collected | |||
| data. | Differences to predicate | ||
| do not introduce any | |||
| questions of safety or | |||
| effectiveness. |
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Non-Clinical Performance :
Since the device is SaMD using off-the-shelf image acquisition and data processing equipment, no EMC or electrical safety testing has been performed.
Since the device has no patient contacting parts, no biocompatibility or mechanical safety testing has been performed.
Oxehealth have reviewed the FDA's database of recognised consensus standards and has consequently applied the following standards to the development of the device:
- ISO 14971:2019 + A11:2021 - Application of risk management to medical devices
- AAMI BS 34971:2022 Application of risk management to Artificial ● Intelligence and Machine Learning Devices
- IEC 62304:2006 + A1:2015 - Software life cycle processes
- IEC 82304-1:2016 - Health software
- IEC 80001-1:2021 - Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
- IEC 81001-5-1:2021 - Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle
- IEC/TR 80002-1:2009 - Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
- IEC 62366-1:2015 +A1:2020 Application of risk management to ● medical devices
- ISO 15223-1:2021 - Medical devices — Symbols to be used with information to be supplied by the manufacturer
- ISO 20417:2021 Symbols to be used with information to be supplied by the manufacturer
9
510(k) Summary
The firm has also performed penetration and vulnerability testing in line with FDA's guidance on cybersecurity.
Clinical Performance: The clinical performance (validation) testing of the Oxevision Sleep software device was designed to assess the performance of the Oxevision Sleep Device algorithm against reference standards on two tasks:
A. The accuracy of periods of bed occupancy detected using Oxevision Sleep Device algorithms measured against periods of human-labeled bed occupancy is not inferior to 95%;
B. The agreement between Oxevision Sleep Device algorithms in sleep/wake classification measured against polysomnographic reference standard during periods of bed occupancy detected using Oxevision Sleep Device algorithms is not inferior to Agreement = 82%, Positive agreement = 88%, and Negative Agreement = 55%.
These endpoints were selected as they are the stated performance specifications of the predicate device.
The clinical data used to determine the clinical performance of the device was obtained in a sample of 60 individuals (a total of 772.65 hours of data). The demographic characteristics of this sample are shown in Table 2.
Table 2: Summary of demographic characteristics for the validation data collected from the 60 adults in the validation sample.
| Variable | Value |
|---|---|
| Age (mean ± std) | 48.6 ± 14.5 years |
| Weight (mean ± std) | 76.2 ± 17.7 kg |
| Height (mean ± std) | 168.7 ± 9.7 cm |
| Body mass index (mean ± std) | 26.7 ± 5.6 kg/m² |
| Sex | |
| Male | |
| Female | 30 volunteers |
| 30 volunteers | |
| Fitzpatrick skin type | I : 3, Ⅱ : 12, Ⅲ : 21, IV : 6, V : 10, VI : 8 |
Reference measurements (physiological signals and video polysomnography data) were collected using an FDA-cleared polysomnography (PSG) device (SOMNOscreen™ plus device, Somnomedics, Germany). Video data was collected concurrently from a standard off-the-shelf camera and hardware installed in two rooms according to the Oxehealth Installation Instructions for use with the Oxevision Sleep Device software.
10
Reference PSG measurements were assessed and scored (in accordance with the American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated Events version 2.6 of January 2020) by three trained sleep physiologists, blinded to the video data collected by the standard off-theshelf camera.
Oxevision video data was reviewed and annotated (to obtain a reference standard) for periods of bed occupancy by two reviewers, blinded to the algorithm development details.
Table 3: Confusion matrix of Oxevision Sleep Device outputs against the reference standards of expert-scored PSG and annotated bed occupancy for all epochs in the validation sample A.
| No. epochs | | Reference standard
from expert-scored PSG and annotated bed occupancy | | | | |
|------------------------|-------------------|--------------------------------------------------------------------------|--------|---------------------|-------------|--------|
| | | In Bed | | | | |
| | | Sleep | Wake | No sleep
status1 | Out-of-bed1 | |
| Oxe
vision
Sleep | In
Bed | Sleep | 33,951 | 2,872 | 78 | 0 |
| | | Wake | 2,072 | 11,203 | 2 | 136 |
| | | No sleep status | 1,273 | 1692 | 0 | 213 |
| | | Out-of-bed | 0 | 102 | 1 | 25,753 |
| | State unavailable | | 5 | 844 | 0 | 955 |
The analysis of pertinent data held by Oxehealth and used for the validation of the algorithm was performed under the following protocols.
The outputs of the Oxevision Sleep Device were evaluated against the reference standard for sleep states obtained from triple-scored PSG data to obtain sleep state statistics; and against the reviewer-annotated bed occupancy states to obtain bed state statistics.
1 The sleep state reference was constructed using epoch-by-epoch majority vote (see example in Appendix D - PSG reference standard for sleep state). Per protocol for data analysis in SLP.REG.241: Validation of the Oxevision Sleep device: Protocol for clinical data analysis, epochs for which no majority label was available, which occurred as sleep physiologists may label epochs as artefact under AASM guidelines, are excluded from the analysis. The number of epochs excluded for this reason will be reported.
2 This table entry has been amended due to a code print error in the previous version of this document. The previous version read 844 instances. Primary and secondary outcomes had been computed on the correct data, so no amendments were needed.
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Table 4: Performance of Oxevision Sleep device algorithms in the validation sample A data. An asterisk (*) denotes secondary outcome measures.
| Clinical-related evaluation of Oxevision Sleep Device outputs | |||||
|---|---|---|---|---|---|
| Bed State outputs | Sleep State outputs | ||||
| *Bed State | |||||
| Unavailable | Accuracy | *Sleep | |||
| State | |||||
| Unavailable | Overall | ||||
| Agreement | Positive | ||||
| Agreement | Negative | ||||
| Agreement | |||||
| 2.3% | 99% | 2.8% | 90% | 94% | 80% |
Table 5 presents per epoch agreement statistics between the outputs of the Oxevision Sleep Device and the reference standards for bed occupancy state and sleep state.
Table 5: Performance of Oxevision Sleep Device algorithms in validation data collected from the 60 participants.
| Clinical-related evaluation of Oxevision Sleep Device outputs | |||
|---|---|---|---|
| Bed State outputs | Sleep State outputs | ||
| Accuracy | Overall | ||
| Agreement | Positive | ||
| Agreement | Negative | ||
| Agreement | |||
| >95% | >82% | >88% | >55% |
The results show overall agreement (>82%), positive agreement (>88%) and negative agreement (>55%) between Oxevision Sleep Device outputs and the gold-standard PSG reference. A bed state accuracy of >95% against reviewer annotations was also reported.
Two-sided 95% confidence intervals for the mean of each performance statistic were obtained using a bootstrap resampling approach.
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Table 6: Two-sided 95% confidence intervals for the mean of each outcome measure over the 60 study sessions in the evaluation data (including validation samples A and B). Two-sided 95% confidence intervals were obtained based on the 2.5th and 97.5th percentiles of the bootstrap distribution of resamples (10,000 resamples).
| 95% Confidence intervals for primary outcome measures | |||
|---|---|---|---|
| Bed State outputs | Sleep State outputs | ||
| Accuracy | Overall Agreement | Positive Agreement | Negative Agreement |
| (99.0%; 99.7%) | (89.0%; 91.8%) | (92.3%; 95.6%) | (74.3%; 83.5%) |
This testing demonstrated device performance was superior to that produced for the predicate device [K111514] in their pre-market submission. All performance endpoints have therefore been met, which substantiate the claim of substantial equivalence to the predicate device.
Conclusions Based on the comparison to the predicate device and performance characteristics, the Oxevision Sleep Device is substantially equivalent to the currently U.S. legally marketed device Fatigue Science, SBV2™ System (K111514) and presents no new concerns about safety or effectiveness.