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The Vital Signs device is intended for noninvasive spot measurement of pulse rate and breathing rate when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.

The system is intended for use by appropriately trained staff and should not be used by untrained users.

The Vital Signs device is indicated for use on subjects 12 years of age or older who do not require critical care or continuous vital signs monitoring.

The device is not intended to be the sole method of checking the physical health of a subject.

The subject device is the next generation device of the predicate (K211906).

Vital Signs is a software-only medical device (SaMD) that provides retrospective monitoring of non-contact pulse rate and respiratory rate 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 rooms within hospitals, general care and secured environments. Proprietary software-controlled algorithms are used to derive patient spot heart rate and respiratory rate data from the analysis of this video data, once the user has followed a workflow to initiate the system's data analysis.

Improvements to the device compared to the predicate are as follows:
• 24 hour trends
• Expansion of intended population from 18 years and older → 12 years and older
• Widened respiratory rate range from 8-31 bpm → 8-39 bpm

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) Clearance Letter for the Oxehealth Vital Signs Device:

1. Table of Acceptance Criteria and Reported Device Performance

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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.

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.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Oxevision Sleep Device

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

• Sample Size: 60 individuals, resulting in a total of 772.65 hours of data.
• Data Provenance: The text does not explicitly state the country of origin. It mentions "a sample of 60 individuals" and "validation data collected from the 60 adults." The study appears to be prospective as it involved collecting "Reference measurements (physiological signals and video polysomnography data) ... concurrently from a standard off-the-shelf camera and hardware installed in two rooms."

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Polysomnography (PSG) Scoring:
  • Number of Experts: Three trained sleep physiologists.
  • Qualifications: "trained sleep physiologists, blinded to the video data collected by the standard off-the-shelf camera." They 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.
• Bed Occupancy Annotation:
  • Number of Experts: Two reviewers.
  • Qualifications: "blinded to the algorithm development details."

4. Adjudication Method for Test Set

• Sleep State (PSG): The ground truth for sleep state was established using "triple-scored PSG data" with an "epoch-by-epoch majority vote." Epochs where no majority label was available (e.g., due to artifact) were excluded from the analysis.
• Bed Occupancy (Video Annotation): The ground truth for bed occupancy was established by "two reviewers, blinded to the algorithm development details" who "reviewed and annotated" the video data. The specific adjudication method beyond "annotated" by two reviewers is not explicitly detailed (e.g., if discrepancies were resolved by a third reviewer).

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

• The document does not indicate that an MRMC comparative effectiveness study was done to evaluate the effect size of human readers improving with AI vs. without AI assistance. The study focuses on the standalone performance of the algorithm against reference standards.

6. Standalone Performance

• Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The entire clinical performance section describes the algorithm's performance against established reference standards for bed occupancy detection and sleep/wake classification.

7. Type of Ground Truth Used

• Bed Occupancy: Expert annotation of video data.
• Sleep/Wake Classification: Expert consensus from "triple-scored PSG data" by trained sleep physiologists, adhering to AASM guidelines. This can be categorized as a type of expert consensus based on a gold-standard diagnostic tool (PSG).

8. Sample Size for Training Set

• The document does not explicitly state the sample size for the training set. The "Clinical Performance" section specifically focuses on the "validation data collected from the 60 adults."

9. How Ground Truth for Training Set Was Established

• The document does not explicitly state how the ground truth for the training set (if distinct from the validation set) was established. It only describes the ground truth establishment for the clinical validation test set.

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The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.

The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained users.

The Oxehealth Vital Signs device is indicated for use on humans 18 years of age or older who do not require critical care or continuous vital signs monitoring.

The device is not intended to be the sole method of checking the physical health of a subject.

The modified Oxehealth Vital Signs device uses custom-designed software to read data collected using off-the-shelf cameras. Data collected in this manner can be used to act as a non-contact monitor of pulse and breathing rates for individuals aged 18 and older in single-subject room environments. Video is collected through video cameras installed in each room. When run through proprietary software- controlled algorithms, the software will allow a user to make spot checks for pulse and breathing rates of the individual in the room. Validation testing has demonstrated that the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates.

Based on the provided text, the Oxehealth Vital Signs device is a software-only medical device used for noninvasive spot measurement of pulse rate and estimated breathing rate. The document (K220899) is a Special 510(k) Notice, indicating modifications to a previously cleared device (Oxehealth Vital Signs version 1.47.0, K211906), rather than an initial submission. Therefore, the detailed clinical study data with sample sizes for test and training sets, ground truth establishment methods, expert qualifications, and detailed statistical results (like MRMC study effect sizes) are not explicitly present in this document, as it refers back to the original DEN200019 submission for clinical evidence.

However, based on the provided text, we can extract the following information regarding acceptance criteria and general study approach:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "no change" in performance for the modified device compared to the predicate, K211906, which in turn relied on clinical evidence from DEN200019. Therefore, the acceptance criteria and reported performance for the modified device are the same as its predicate.

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set Sample Size: This specific 510(k) submission (K220899) does not provide new sample sizes for a test set. It states: "Clinical evidence was supplied and reviewed in DEN200019. The proposed modifications discussed in this Special 510(k) submission do not affect any of the fundamental principles of operation or performance of the device in measuring pulse rate and estimating breathing rate (chest wall movements). ... The original clinical evidence is still considered applicable now, no new clinical evidence is required..." To find the specific sample sizes, one would need to refer to the DEN200019 submission.
• Data Provenance: Not specified in this document. It would be in the original DEN200019 submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not specified in this document. This information would be in the original DEN200019 submission.

4. Adjudication Method for the Test Set

• Not specified in this document. This information would be in the original DEN200019 submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

• This device is a standalone measurement device, not an AI-assisted diagnostic tool for human readers, so an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance is not applicable to its stated function. The primary comparison is to "conventional methods and technology" for vital sign measurement (as stated in Device Description, page 5 of 11).

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

• Yes, this is a standalone device. The "Validation testing has demonstrated that the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates." (Device Description, page 5 of 11). The performance data listed in the table (50-130 ± 3 bpm, 8-31 ± 2 bpm) refers to the algorithm's direct output compared to a reference.

7. The Type of Ground Truth Used

• The ground truth for the clinical evidence (from DEN200019) was established by comparison with "a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner." (Clinical data requirement, page 6 of 11). This implies direct physiological measurement using established medical devices.

8. The Sample Size for the Training Set

• Not specified in this document, as it refers back to the original DEN200019 submission for clinical evidence.

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

• Not specified in this document, as it refers back to the original DEN200019 submission for clinical evidence. However, given that it's a device that measures vital signs by assessing video footage, it's highly probable that the ground truth for training would have been established by simultaneously recording vital signs using "clinically accurate patient-contacting relevant comparator devices" while the video footage was collected.

Ask a specific question about this device

The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.

The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained users.

The Oxehealth Vital Signs device is indicated for use on humans 18 years of age or older who do not require critical care or continuous vital signs monitoring.

The device is not intended to be the sole method of checking the physical health of a subject.

The modified Oxehealth Vital Signs device uses custom-designed software to read data collected using off-the-shelf cameras. Data collected in this manner can be used to act as a non-contact monitor of pulse and breathing rates for individuals aged 18 and older in single-subject room environments. Video is collected through video cameras installed in each room. When run through proprietary software- controlled algorithms, the software will allow a user to make spot checks for pulse and breathing rates of the individual in the room. Validation testing has demonstrated that the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates.

The provided document is a 510(k) summary for the Oxehealth Vital Signs device, specifically for a modification to a previously cleared version. The core of the submission revolves around demonstrating substantial equivalence to the predicate device, meaning the new modification does not raise new questions of safety or effectiveness.

Therefore, the study proving the device meets acceptance criteria largely refers to the studies performed for the original predicate device (Oxehealth Vital Signs version 1.30.0, classified in DEN200019), as the modifications discussed in this 510(k) submission do not affect the fundamental principles of operation or performance in measuring pulse rate and estimated breathing rate.

Here's a breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states the performance criteria that were established for the predicate device and are considered unchanged for the modified device.

Note: The document explicitly states "No change" for performance regarding the modified device compared to the predicate, implying that the acceptance criteria and the performance demonstrated by the predicate are carried over.

2. Sample Size Used for the Test Set and Data Provenance

The document refers to the clinical evidence provided and reviewed in the original DEN200019 submission. It states: "As that clinical evidence is still applicable now, no new clinical evidence is required".

Therefore, the specific sample sizes and data provenance for the test set are not detailed in this 510(k) summary, but would be found in the documentation for DEN200019. The summary only confirms that such data was provided for the predicate device and is considered sufficient for the modified device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide details about the number and qualifications of experts directly for this 510(k) summary. This information would have been part of the original DEN200019 submission, where the clinical evidence was initially reviewed.

4. Adjudication Method for the Test Set

The document does not provide details about the adjudication method used for the test set. This information would have been part of the original DEN200019 submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The device's function is explained as "software assessing video footage from a fixed-installation solution for use within single occupancy rooms" to produce "spot check measurements." It's generally intended as a non-contact monitor, not as an AI-assistance tool for human interpretation in the sense of a diagnostic imaging study. The focus is on the device's ability to provide accurate measurements directly, not on enhancing human interpretation of complex data.

The validation testing demonstrated that "the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates." This implies a comparison against ground truth measurements, not a human-AI team performance study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, based on the description, the "Performance Data" section indicates that "As the modified Oxehealth Vital Signs device is solely software, performance testing is demonstrated through software validation." The prior validation (from DEN200019) compared the device's output to "clinically accurate patient-contacting relevant comparator device." This strongly suggests a standalone performance evaluation where the algorithm's output is directly compared to a reference standard, without human intervention in the measurement process.

7. The Type of Ground Truth Used

The document states: "The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner."

This indicates that the ground truth was established using measurements from "clinically accurate patient-contacting relevant comparator device(s)". This would imply standard, validated medical devices (e.g., pulse oximeters, capnographs, or other physiological monitoring equipment) used as the reference standard for pulse and breathing rates.

8. The Sample Size for the Training Set

The document does not provide details on the training set sample size. The focus of this 510(k) is on the substantial equivalence of a modified device to a predicate device, and it states that the modifications "do not affect the algorithm or the functionality of the software." This implies that the core algorithm, which would have been trained based on a training set, remains unchanged from the predicate version. Information on the training set would have been part of the initial submission for the predicate device (DEN200019).

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

Similar to point 8, the document does not provide details on how ground truth for the training set was established. This information would have been part of the original DEN200019 submission. The current submission reiterates that the original clinical evidence, which included comparison to "clinically accurate patient-contacting relevant comparator device," is still applicable.

Ask a specific question about this device

The Oxehealth Vital Signs device is intended for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still. It is software assessing video footage from a fixed-installation solution for use within single occupancy rooms within hospitals, general care and secured environments with professional healthcare oversight and where a framework exists which mandates periodic checks by a trained professional to ensure subject safety.

The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained users.

The Oxehealth Vital Signs device is indicated for use on humans 18 years of age or older who do not require critical care or continuous vital signs monitoring.

The device is not intended to be the sole method of checking the physical health of a subject.

The device is a software algorithm that reads data collected using off-the-shelf cameras collecting images in the near-infrared spectrum. These images can be used to act as a non-contact monitor of pulse and breathing rates for individuals aged 18 and older in single-subject room environments. Pulse rate is determined by monitoring pixel intensity changes for exposed skin. Breathing rate is determined with motion tracking of the patient's chest. Video is collected through video cameras installed in each room. When run through proprietary software-controlled algorithms, the software will allow a user to make spot checks for pulse and estimated breathing rates (chest wall movements) of the individual in the room. This allows vital monitoring without disturbing the patient either to allow for patient rest or to protect staff that would otherwise need to enter the room with a potentially dangerous patient.

Off-the-shelf components must meet specifications set by the sponsor in order to ensure they will provide adequate quality video capture for analysis by the medical device.

Here's a breakdown of the Oxehealth Vital Signs device's acceptance criteria and the study proving it, based on the provided text:

Oxehealth Vital Signs Device Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

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