(115 days)
The BCI® model WW1020 pulse oximeter is intended for spot-checking applications (non-continuous use). It monitors and displays a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home users. The intended patient population ranges from neonatal to adult. It can be used on patients with low perfusion or during patient motion. The WW1020 may be used in the hospital or clinical environment, during emergency land transport, and in the home.
The BC10 model WW1020 pulse oximeter is intended for spot-check applications. The WW1020 monitors and displays patient functional oxygen saturation (%SpO2), pulse rate, pulse amplitude index, and pulse signal strength information. It does not have audible or visual patient alarms. The user interface includes a blue LED display and an ON/OFF button. The WW1020 comes with disposable AA batteries, the 3044S reusable pulse oximetry sensor and relevant manuals. Optional accessories include other oximetry sensors, docking station, thermal printer (attaches to dock), rechargeable battery pack, universal mains AC charger, patient isolated USB cable, universal mounting bracket and protective glove. The WW1020 is compatible with BCT® oximetry sensors, Nellcor DS100A oximetry sensor, and extension cables.
Here's a breakdown of the acceptance criteria and the study information for the BCI® Model WW1020 Pulse Oximeter, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria for SpO2 accuracy that the device needed to meet. Instead, it refers to "Accuracy Testing (Section 11)" as a mitigation measure for "Inadequate Device Performance" and describes the purpose of the clinical studies. However, the standard expectation for pulse oximeter accuracy (often RMS difference) in such submissions for the 70-100% SpO2 range is typically around 2-3% or less. Without specific numerical acceptance criteria, we can only infer the performance based on the general description of the studies.
| Acceptance Criterion (Inferred from Study Design) | Reported Device Performance (from "Clinical Testing" section) |
|---|---|
| Accuracy of SpO2 over the range 70-100% SaO2 | Clinical data obtained to determine SpO2 accuracy over the range 70-100% SaO2 as determined by a reference CO-oximeter. |
| Accuracy of SpO2 during controlled motion | Clinical data obtained to determine SpO2 accuracy over the range 70-100% SaO2 as determined by a reference CO-oximeter under controlled motion conditions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Studies (Test Set): Not explicitly stated in terms of number of patients or readings. The document mentions "three separate desaturation clinical studies: Desat 37, Desat 38, and Desat 39."
- Data Provenance: The document does not specify the country of origin. The studies appear to be prospective clinical studies ("undergone three separate desaturation clinical studies").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not explicitly stated. For pulse oximeter studies, ground truth for SpO2 is typically established by a reference instrument (CO-Oximeter) during induced hypoxemia in human subjects, not by human experts.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for SpO2 is established by a reference instrument (CO-oximeter), not through expert consensus or adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is common for image-based diagnostic devices where multiple human readers interpret cases. For a pulse oximeter, the primary performance measure is the accuracy of the device's numerical readings against a reference standard.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the clinical studies (Desat 37, 38, 39) evaluated the standalone performance of the pulse oximeter board (Digital Micro Power OEM oximeter board (31402B2)), which is the core component of the BCI WW1020. The studies aimed to determine the SpO2 accuracy of the device itself against a reference standard.
7. The Type of Ground Truth Used
The ground truth used was reference CO-oximeter measurements ("reference CO-oximeter") for arterial oxygen saturation (SaO2), obtained from human subjects during induced desaturation.
8. The Sample Size for the Training Set
No training set information is provided in this document. Algorithms in pulse oximeters are typically designed based on physiological principles and calibrated using known signals, rather than being "trained" on a large, labeled dataset in the same way modern machine learning models are. The clinical studies described are for validation/testing the device's accuracy.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is described for this device in the provided text.
§ 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).