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The BC1® Model WW1030 pulse oximeter is intended to be used for continuous monitoring of a patient's functional oxygen saturation (%SpO2), pulse rate, pulse signal strength, and pulse amplitude index readings. It is equipped with audible and visual alarms. It may be used by physicians, respiratory therapists, nurses, certified nurse assistants, emergency medical technicians, sleep technicians, clinicians and home use. The intended patient population ranges from neonatal to adult. It can be used on patients with low perfusion or during patient motion. The WW 1030 may be used in the hospital or clinical environment, during emergency land transport, and the home.

The BCI model WW1030 is a handheld pulse oximeter intended for continuous monitoring. The WW1030 monitors and displays patient functional oxygen saturation %SpO2, pulse rate, perfusion index, and pulse signal strength information. It is equipped with audible and visual patient alarms. The user interface includes a blue LED display, speaker, a 5-button keypad control, and an ON/OFF button. The WW1030 comes with disposable batteries, a reusable pulse oximetry sensor with extension cable 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, nurse call cables, universal mounting bracket and protective glove. The WW1030 is compatible with BCI oximetry sensors, Nellcor DS100A oximetry sensor and extension cables.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state numerical acceptance criteria for the SpO2 accuracy tests. However, it implicitly suggests that the device passed these tests. For pulse oximeters, the FDA typically requires accuracy within a certain range (e.g., ±2-3% SpO2) compared to a co-oximeter. Given that the device received 510(k) clearance, it implies that the device met the established accuracy requirements, even if the specific numerical criteria for passing are not detailed in this summary.

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

The exact sample sizes for the "Desat 37, Desat 38, and Desat 39" studies are not explicitly stated in the provided text.
The data provenance is clinical testing, presumably conducted in a controlled environment as indicated by "desaturation clinical studies." The country of origin is not specified but it relates to FDA submission, so likely US or through an international standard applicable to FDA. The studies appear to be prospective as they were designed specifically to determine the SpO2 accuracy of the device.

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

The text states that the SpO2 accuracy was determined "as determined by the reference CO-oximeter." This implies that the ground truth for oxygen saturation levels was established by a co-oximeter, which is a laboratory device, not by human experts. Therefore, the concept of "number of experts" and "qualifications of those experts" for establishing ground truth in this context is not applicable as scientific instrumentation provided the reference.

4. Adjudication Method for the Test Set

Since the ground truth was established by a reference co-oximeter, there was no human adjudication method required for the primary physiological parameter (SpO2). The co-oximeter directly provided the reference values for comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided text. This type of study is more common for diagnostic imaging AI algorithms where human interpretation is a primary component. The device in question is a pulse oximeter, and its performance is evaluated against a gold standard (co-oximeter), not against human readers. Therefore, there's no mention of how much human readers improve with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the performance studies described are essentially standalone (algorithm only) performance assessments. The device (specifically, its internal Digital Micro Power OEM oximeter board) was directly evaluated against a reference co-oximeter to determine its SpO2 accuracy. The accuracy determined was of the device itself, providing objective measurements, not an assessment of human-in-the-loop performance.

7. The Type of Ground Truth Used

The type of ground truth used for SpO2 accuracy was established by a reference CO-oximeter. This is akin to a "laboratory gold standard" or "scientific instrumentation gold standard" rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

The provided text does not mention a training set or its sample size. This is common for devices that are not "AI" in the modern sense of machine learning algorithms requiring explicit training data. The BCI model WW1030 pulse oximeter relies on established physiological principles and signal processing, and while its internal algorithms are likely sophisticated, they are not described as being "trained" in the typical machine learning paradigm. The studies aim to validate the device's accuracy after its design and development are complete.

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

Since there is no mention of a training set, the establishment of ground truth for a training set is not applicable.

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