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The BB-613 Watch Oximeter is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate. It is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.

The BB-613 device is a wrist-worn device consisting of a light source (LEDs) and sensor array on the backside of the device, with a user interface on the front side of the device. The LEDs transmit light into the subject's skin at their wrist, and part of this light is reflected from the tissue and detected by a photo-diode. The integrated display is used to display the blood saturation and pulse rate results. It also displays symbols that show if there was no signal or a weak signal. The device is powered by a rechargeable battery.

Here's an analysis of the acceptance criteria and study data for the BB-613 Watch Oximeter, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Oximeter Clinical Validation: 10 patients
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study involved "patients with varying Fitzpatrick skin types (I – V)" and their ages ranged from 18 to 40, with 6 males and 4 females. It is a prospective clinical validation.
• Sample Size for Pulse Rate Validation: Not explicitly stated beyond "a custom built simulator." This implies it was a laboratory-based validation rather than human subjects for this specific test.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical validation. It only states that the clinical validation showed "equivalence to simultaneous measurements from the predicate oximeter." This implies the predicate oximeter itself served as the reference for ground truth in this comparison, rather than independent expert adjudicated measurements.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the traditional sense of multiple human readers or experts reviewing data for ground truth establishment. For the clinical validation, the BB-613's readings were compared to a "predicate oximeter" simultaneously. For pulse rate, a "custom built simulator" was used.

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, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed or described in this document. This device is an oximeter, which provides direct physiological measurements, not interpretations that would typically involve human readers or AI assistance in the way a diagnostic imaging device might.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the studies described are essentially standalone performance evaluations of the device. The clinical validation compares the device's output to a predicate, and the pulse rate validation uses a simulator. These tests assess the algorithm and hardware's ability to accurately measure and display SpO2 and pulse rate without user interpretation or interaction being a variable in the performance metric. However, it's important to note that the device's intended use is "spot-checking," implying a user still reads the display.

7. The Type of Ground Truth Used

• For SpO2 Clinical Validation: The "simultaneous measurements from the predicate oximeter" served as the reference or ground truth.
• For Pulse Rate Validation: A "custom built simulator" provided the reference for pulse rate.
• Other tests (biocompatibility, software, electrical safety, home use) relied on adherence to specified international standards and guidances, where the ground truth is defined by the criteria within those standards.

8. The Sample Size for the Training Set

The document does not explicitly reference or provide details for a "training set" in the context of the device's algorithms. If there was machine learning involved in developing the device's algorithms, the training data used is not disclosed here. The performance data focuses on validation/testing.

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

Since a training set is not described, the method for establishing its ground truth is also not provided.

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