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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 Informed Vital Core Application (IVC App) is intended for non-invasive spot measurement of pulse and respiration rate of adult patients in home use, hospitals, clinics, and long-term care settings.

The Informed Vital Core Application is indicated for use on adults 22 years of age or older who do not require critical care or continuous vital signs monitoring.

Informed Vital Core is not intended to independently direct therapy.

The IVC App is a Software as a Medical Device (SaMD) progressive web application that utilizes existing optical camera technology embedded in a smart-phone, tablet, laptop, or desktop computer to estimate an individual's vital signs including pulse rate (PR) and respiration rate (RR) developed by Mindset Medical. The IVC App software algorithms will provide spot checks for PR and RR of the individual. The IVC App software uses proprietary software algorithms to extract a raw video signal through remote plethysmography (rPPG) by detecting subtle color variations in the microvasculature around a patient's face that occur with each cardiac cycle due to changes in blood volume to measure PR. Additionally, this system utilizes software for optical camera-based measurement of respiration rate. The non-contact, periodic, spot measurement of respiration rate is taken when the subject is at rest based on shoulder movement.

Here's a breakdown of the acceptance criteria and the study proving the Informed Vital Core Application (IVC App) meets them, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance for Informed Vital Core Application (IVC App)

The IVC App (v2.0.0.2.0.0) is intended for non-invasive spot measurement of pulse and respiration rate in adult patients. The performance claims for the device are presented in the following table.

1. Table of Acceptance Criteria and Reported Device Performance

Note: While acceptance criteria for Pulse Rate are stated in the comparative table, the clinical study summary specifically focuses on the respiration rate's performance. It is implied that the pulse rate performance was either established through other means (e.g., non-clinical testing, equivalence to predicate) or not the primary focus of this specific clinical study summary.

2. Sample Size and Data Provenance

• Test Set Sample Size: The clinical study enrolled 65 subjects (35 healthy patients and 29 patients with comorbidities).
• Data Provenance: The study was conducted at six study sites located in the United States. The data origin is prospective, as described by the "clinical study was conducted" and "study recruited subjects" phrasing.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: The text states, "The clinicians counting the raw EtCO2 waveform were blinded to the results from the test device." It does not specify the exact number of clinicians used, but explicitly refers to them as "clinicians."
• Qualifications of Experts: The specific qualifications (e.g., "radiologist with 10 years of experience") are not explicitly stated in the provided text. However, they are described as "clinicians," implying medical professionals capable of accurately counting end-tidal CO2 waveforms.

4. Adjudication Method for the Test Set

• Adjudication Method: The ground truth for respiration rate was established by "blinded, manually-counted end-tidal CO2 (EtCO2) with an FDA-cleared capnography device." The term "blinded" implies efforts to prevent bias, and "manually-counted" suggests human assessment. However, there is no explicit mention of an adjudication process like 2+1 or 3+1 if there were multiple clinicians involved in counting the waveforms for a single case. It only states they were "clinicians counting," not how disagreements (if any) were resolved or if multiple clinicians independently counted each waveform.

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

• MRMC Study Done?: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted to assess how human readers improve with AI vs. without AI assistance. The study described is a single-arm cohort study evaluating the device's accuracy against a gold standard for respiration rate measurement, not a human-in-the-loop performance study.

6. Standalone (Algorithm Only) Performance

• Standalone Performance Done?: Yes, the clinical study primarily assesses the standalone performance of the IVC App's algorithms for measuring respiration rate. It compares the device's output directly to the gold standard (blinded, manually-counted EtCO2). The device is a "Software as a Medical Device (SaMD)" that outputs vital signs measurements.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for respiration rate was established using expert consensus/measurement from an objective, FDA-cleared device. Specifically, it was "blinded, manually-counted end-tidal CO2 (EtCO2) with an FDA-cleared capnography device." This combination leverages both objective physiological signals (EtCO2 waveform) and expert interpretation/counting of those signals.

8. Sample Size for the Training Set

• Training Set Sample Size: The provided document does not specify the sample size or details about the training set used for the IVC App's algorithm development. The "Summary of Clinical Testing" section pertains to the validation/test study.

9. How Ground Truth for Training Set Was Established

• Ground Truth for Training Set Established: The document does not specify how the ground truth for the training set was established. This information is typically part of the device's development and validation process but is not included in the provided 510(k) summary for this clearance.

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The PanopticAl Vital Signs device is intended for noninvasive spot measurement of pulse rate when the subject is still. It is software for assessing facial video stream captured from a specified smartphone or tablet camera.

The PanopticAl Vital Signs device is intended for use by healthcare professionals. The device is only intended to be used in healthy subjects.

The PanopticAl Vital Signs device is indicated for use on humans 18 to 60 years of age who do not require critical care or continuous monitoring.

The PanopticAl Vital Signs device is not intended to be the sole method to assess a subject's physical health condition. The pulse rate measurements it provides should complement, not replace, professional medical care and/or medication.

PanopticAl Vital Signs is a medical software device that uses remote photoplethysmography (rPPG) to measure a person's pulse rate. The app utilizes the surrounding light as the light source and works by capturing and measuring the subtle color changes on the skin caused by light absorption and reflection by the blood vessels beneath the skin. The app uses the front camera of an iPhone or iPad to capture videos of the subject. Then, the algorithm in the app detects and tracks the subject's face to capture the subtle light changes reflected in the changes in RGB pixel values. This information is sent to PanopticAl's cloud server for further processing to calculate the pulse rate. The pulse rate value is then returned to the PanopticAl Vital Signs app, and the result is displayed on the app.

Here's a breakdown of the acceptance criteria and study details for the PanopticAI Vital Signs device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Clinical Validation Study): N=107
• Data Provenance: The document does not explicitly state the country of origin. It describes participants based on gender, age, BMI, facial shape, history of hypertension, race/ethnicity (Asian, Black, Hispanic, White), and Fitzpatrick Skin Type Scale. The study appears to be prospective since it's a clinical validation study aiming to assess agreement between the device and a "standard pulse rate measurement by a clinician."

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

The document mentions "standard pulse rate measurement by a clinician" as the ground truth. It does not specify the number of clinicians or their specific qualifications (e.g., years of experience).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth. The ground truth was based on "standard pulse rate measurement by a clinician."

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

No. The document describes a clinical validation study comparing the device's performance to a clinician's standard measurement. It does not mention an MRMC study or the effect size of human readers improving with AI assistance. The device is a standalone measurement tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The clinical validation study directly assesses the PanopticAI Vital Signs app's accuracy against a clinical standard, demonstrating its performance without human interpretation of its outputs beyond what is displayed by the app itself. The device is intended for "non-invasive spot measurement of pulse rate," implying a direct output from the algorithm.

7. Type of Ground Truth Used

The ground truth used was expert consensus / clinical measurement from a "clinician" performing "standard pulse rate measurement."

8. Sample Size for the Training Set

The document does not provide information regarding the sample size for the training set. It focuses solely on the clinical validation (test) set.

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

Since the training set sample size is not provided, how its ground truth was established is also not described in this document.

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The Informed Vital Core Application (IVC App) is intended for non-invasive spot measurement of pulse rate of adult patients in home use, hospitals, clinics, and long-term care settings.

The Informed Vital Core Application is indicated for use on adults 22 years of age or older who do not require critical care or continuous vital signs monitoring.

Informed Vital Core is not intended to independently direct therapy.

The IVC App is a Software as a Medical Device (SaMD) progressive web application that utilizes existing optical camera technology embedded in a smart-phone, tablet, laptop, or desktop computer to estimate an individual's vital signs including pulse rate (PR) developed by Mindset Medical. The IVC App software algorithms will provide spot checks for PR of the individual. The IVC App software uses proprietary software algorithms to extract a raw video signal through remote plethysmography (rPPG) by detecting subtle color variations in the microvasculature around a patient's face that occur with each cardiac cycle due to changes in blood volume to measure PR.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion for the device's accuracy is clearly stated: pulse rates measured with the IVC App must be accurate to within ±3 beats per minute (BPM) Average Root Mean Square (ARMS) of heart rates (HR) measured with a reference ECG device.

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

• Test Set Sample Size: 67 subjects were enrolled in the clinical study.
• Data Provenance:
  • Country of Origin: United States (recruited from six study sites located in the United States).
  • Retrospective or Prospective: Prospective. The study is described as a "multicenter, prospective, open-label clinical study."

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

The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth was established by a legally marketed, electrocardiogram (ECG) device, which serves as the reference standard for heart rate measurement. Therefore, no human experts were involved in creating the ground truth for the clinical study's primary endpoint.

4. Adjudication Method for the Test Set

No adjudication method is mentioned or relevant, as the ground truth was established by an objective medical device (ECG), not by human readers requiring consensus or adjudication.

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

No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the IVC App compared to an ECG device. There is no mention of human readers assisting with the device or comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The "Primary endpoint" states: "The primary objective of the study was to establish that pulse rates measured with the IVC App are accurate to within ±3 beats per minute (BPM) average root mean square (ARMS) of heart rates (HR) measured with the reference ECG device." This directly assesses the algorithm's performance without human intervention in the measurement process itself, beyond initial setup.

7. Type of Ground Truth Used

The ground truth used was objective measurement from a legally marketed medical device, specifically an electrocardiogram (ECG) device. The document explicitly states: "The PR obtained by the IVC App was compared to the heart rate obtained by the ECG reference device."

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set. It provides "Bench Testing Subject Demographics" with "Subjects (Unique): 711" and "Number of Sessions: 1,413". While these subjects and sessions were used for "Non-clinical tests," it's not explicitly stated that this dataset was used for training the algorithm. It likely represents a larger dataset used for internal development, validation, and potentially training, but the text doesn't provide a distinct "training set size."

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

The document does not explicitly detail how the ground truth for the training set was established. However, given the nature of the device and the testing described, it can be inferred that ground truth for any training data would also have been established using reference medical devices (like ECG, pulse oximeters, etc.) to obtain accurate heart rate measurements, similar to how the test set ground truth was established. The "Device Description" mentions "The IVC App software uses proprietary software algorithms to extract a raw video signal through remote plethysmography (rPPG) by detecting subtle color variations in the microvasculature around a patient's face that occur with each cardiac cycle due to changes in blood volume to measure PR," implying the training would involve establishing relationships between video signals and actual pulse rates from such reference devices.

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FibriCheck is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

FibriCheck is a medical device software that can be used to determine heart rhythm conditions, with a primary focus on the detection of atrial fibrillation.

The FibriCheck Mobile Application is a smartphone application for patients intended to record, display, store and transmit photoplethysmography (PG) data. Heart rhythm measurements are performed by placing the fingertip on the camera of a smartphone device. This way, volumetric changes can be detected.

The FibriCheck Portal is a web application for healthcare providers intended to display data that was captured by the FibriCheck Mobile Application. Healthcare providers can use the issue FibriCheck prescriptions, to manage their patients and to consult measurement data.

This document is a 510(k) Pre-market Notification summary for the FibriCheck device. It outlines the device details, its intended use, comparison to a predicate device, and the non-clinical and clinical tests conducted to demonstrate safety and effectiveness.

Here’s a breakdown of the information relevant to acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical thresholds for performance metrics. Instead, it states that "The performance metrics are in line with those reported for the predicate device, and did not raise concerns regarding the safety or effectiveness of the subject device." This implies the acceptance criterion was "performance in line with the predicate device," which is K173872, also named FibriCheck.

The document reports the following general performance statement for the clinical validation study:

2. Sample Size and Data Provenance

• Sample Size for Test Set: 252 cardiology patients.
• Data Provenance: The patients were "recruited in-clinic or consulting the cardiac outpatient clinic," implying the data was collected prospectively in a clinical setting. The country of origin is not explicitly stated, but given the applicant's address in Belgium, it's highly probable the study was conducted there.

3. Number of Experts and Qualifications

The document states, "The participants were instructed to record PPG measurements using the subject device which were compared against the gold-standard reference diagnosis." It does not explicitly specify the number of experts used to establish ground truth or their qualifications. However, given the "gold-standard reference diagnosis" in cardiology and the mention of "cardiology patients," it can be inferred that diagnoses were made by qualified medical professionals, likely cardiologists.

4. Adjudication Method

The document does not describe an adjudication method for the test set. It mentions comparison against a "gold-standard reference diagnosis," suggesting a single, definitive ground truth rather than a process requiring adjudication among multiple readers.

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

The document does not mention an MRMC study or any comparative effectiveness study involving human readers with and without AI assistance. The study described focuses on the device's standalone performance against a gold standard.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance study was done. The clinical validation study directly compared the PPG measurements from the FibriCheck device (acting as the algorithm) against a "gold-standard reference diagnosis." The statement "The participants were instructed to record PPG measurements using the subject device which were compared against the gold-standard reference diagnosis" highlights the device's algorithmic performance.

7. Type of Ground Truth Used

The ground truth used was a "gold-standard reference diagnosis." While the specific nature of this diagnosis (e.g., expert consensus based on ECG, long-term monitoring data, etc.) is not detailed, in cardiology, a "gold-standard reference diagnosis" for atrial fibrillation typically involves a 12-lead electrocardiogram (ECG) or continuous ECG monitoring interpreted by a cardiologist.

8. Sample Size for Training Set

The document does not provide information on the sample size used for the training set. It only describes the clinical validation study (test set).

9. How Ground Truth for Training Set Was Established

The document does not provide information on how the ground truth for the training set was established, as it does not discuss the training process or dataset.

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The FH Vitals SDK is designed to measure the pulse rate based on the given facial video stream. It is intended for non-invasive spot measurements of pulse rate when the subject is still. This SDK is not intended for use in patients with known or suspected heart arrhythmias.

While the SDK can be used for general healthcare, it is not designed to treat patients. The pulse rate measurement results provided by the FH Vitals SDK should complement, but not replace, the user's usual professional medical care and/or medication. If abnormalities are detected during the measurement with the FH Vitals SDK, users are advised to consult a medical professional.

The FH Vitals SDK is indicated for use in humans 18 years of age or older who do not require critical care or continuous vital signs monitoring. This software should not be the primary or sole method for assessing an individual's health.

FH vitals SDK is a video-based, non-contact pulse rate measurement software with a face recognition function designed to measure and real-time display the pulse rate of adults. This system uses cameras to detect the user's face and obtains the continuous face image data, with signal processing and algorithm to compute the pulse rate. The software is intended to be installed on commercial mobile devices/laptops/computers equipped with cameras. It can be deployed on Android, iOS platform and Windows platforms.

Here's a breakdown of the acceptance criteria and the study details for the FaceHeart Vitals Software Development Kit (FH vitals SDK):

1. Table of Acceptance Criteria and Reported Device Performance:

The document notes that the predicate device had a pulse rate measurement range of 50-130 bpm and the same performance error level of ±3 bpm. The FH vitals SDK can measure a wider range of pulse rates.

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

• Sample Size: 527 participants.
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "clinical study," which implies it was prospective data collection.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method. It implies a direct comparison to the reference device.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The study compares the stand-alone performance of the FH Vitals SDK to a reference device.

6. Stand-Alone Performance (Algorithm Only without Human-in-the-Loop Performance):

Yes, a standalone performance study was done. The clinical study compares the FH Vitals SDK's pulse rate measurements against a reference device (Philips MX100 ECG) without human assistance being part of the measurement process.

7. Type of Ground Truth Used:

The ground truth used was established by a clinically accurate patient-contacting relevant comparator device, specifically the Philips MX100 ECG.

8. Sample Size for the Training Set:

The document does not provide information on the sample size used for the training set. It mentions "Software documentation included a description of algorithm training and validation data," but does not give specific numbers for the training set itself.

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

The document does not explicitly state how the ground truth for the training set was established. It generally refers to "algorithm training and validation data" but doesn't detail the method for labeling or establishing truth for that data.

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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.

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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.

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.

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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 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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