(90 days)
WW1021 is intended for use with any oximeter/device which supports the BCI® Communication Protocol 1030 (BCICP 1030), if the device is connected to the PC through the USB port. It can be used to view the data being recorded in real time; download the recorded data to the PC from the device; analyze and print the recorded data and can be used in sleep screening. It can show only visual alarms and cannot annunciate audio alarms. It is not intended to be used as a central station monitoring system or as a patient monitoring system. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, sleep technicians and other qualified health care providers. The WW1021 may be used in the hospital or clinical environment.
The BCI® WW1021 is intended for use with any device which supports the BCI® Communication Protocol (BCICP), if the device is connected to the PC through the USB port. It can be used to configure the device; view the data being recorded in real time; download the recorded data to the PC from the device; analyze and print the recorded data; view event logs and self diagnostic information from the device and can be used in sleep screening. It can show only visual alarms and cannot annunciate audio alarms. It is not intended to be used as a central station monitoring system or as a patient monitoring system. It cannot be used to configure or download data to the PC from devices that are wirelessly connected. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians and other qualified health care providers. BCI® WW1021 may be used in the hospital or clinical environment. Communication between the device and BCI® WW1021 is possible using any standard USB cable.
Here's an analysis of the acceptance criteria and the study conducted for the BCI® WW1021 PC Application Software, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance | Pass/Fail |
|---|---|---|
| False Negative ≤ 10% | 7.49% False Negative events | Pass |
| False Positive ≤ 10% | 0.17% False Positive events | Pass |
Study Details
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: 4 subjects (one subject was studied twice, making it 5 "sessions" of data for analysis).
- Data Provenance: Retrospective – the study re-analyzed clinical data previously gathered for the investigation of the BCI® 1621 Software. The country of origin of the data is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document states "comparison to clinician scoring of desaturation events." It does not specify the number of clinicians/experts, nor their specific qualifications (e.g., years of experience, specialty).
4. Adjudication method for the test set:
- The document implies that the ground truth was established by "clinician scoring," but it does not describe an adjudication method (e.g., 2+1, 3+1) if multiple clinicians were involved. It simply refers to "clinician scoring" as if it were a singular, definitive assessment.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focused on the performance of the software's desaturation detection algorithm against clinician scoring, not on human reader improvement with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was performed. The "Clinical Testing" section describes an investigation to determine the clinical accuracy and functionality of the BCI® WW1021 software's desaturation detection algorithm by comparing its output directly to clinician scoring. The reported false negative and false positive rates are for the algorithm's performance.
7. The type of ground truth used:
- Expert consensus (single clinician or unspecified number of clinicians) based on "clinician scoring of desaturation events." The definition of a desaturation event used by the BCI® WW1021 Software was also used by the clinicians for scoring.
8. The sample size for the training set:
- The document does not specify a sample size for a training set. The study described is a clinical validation with a test set. There is no mention of a separate training phase or an independent dataset used for training the algorithm. Given the nature of a "PC Application Software," it's possible the "algorithm" refers to predefined thresholds or rules rather than a machine learning model that requires a dedicated training set.
9. How the ground truth for the training set was established:
- This information is not provided. As noted above, a separate training set is not mentioned in the documentation provided.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).