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510(k) Data Aggregation
(32 days)
Oxehealth Vital Signs
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
| Parameter | Acceptance Criteria (from predicate's performance) | Reported Device Performance (as the modified device is stated to have "no change" in performance) |
|---|---|---|
| Pulse rate measurement | 50 to 130 ± 3 beats per minute* (9-second measurement window) | 50 to 130 ± 3 beats per minute* (9-second measurement window) |
| Estimated breathing rate (chest wall movements) measurement | 8 to 31 ± 2 breaths per minute* (30-second measurement window) | 8 to 31 ± 2 breaths per minute* (30-second measurement window) |
| Note on Accuracy | * Accuracy uses the RMSE criterion. Pulse rate accuracy may be reduced when the subject has a pulse rate greater than 110 beats per minute. | * Accuracy uses the RMSE criterion. Pulse rate accuracy may be reduced when the subject has a pulse rate greater than 110 beats per minute. |
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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(364 days)
Oxehealth Vital Signs
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
| Vital Sign | Acceptance Criteria (Study Objective) | Reported Device Performance (RMSD) | One-sided 97.5% Confidence Interval |
|---|---|---|---|
| Pulse Rate |
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