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The SB100II Fingertip Pulse Oximeter is a non-invasive device intended for the spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). The SB100II is not intended for continuous monitoring.

The SB10011 pulse oximeter is an instrument for photoelectrically determining the oxygenation of blood in a translucent part of the body, in this case the finger. This SB1001 contains the electronics to interface to the integral sensor. This sensor consists of a light emitting diode and a photoelectric cell placed on either side of the finger. Red and infrared light are transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood. The SB10011 has the ability to determine both the percent of saturated hemoglobin and the pulse rate. It performs these functions on adult and pediatric patient populations. It is designed for spot checking both the SpO2 and Pulse rate information. To perform this, the SB100Il display digital values for both the SpO2 and Pulse. Pulse amplitude is displayed graphically by means of a vertical bar, which elevates in synch with the pulse cycle. The SB1001 is powered by two "AAA" batteries. The wavelength of red LED is 660nm and Infrared LED is 905/880nm with maximum optical output power of 4mW. The device incorporates a battery state indicator and provides a visual indication of low battery.

Here's a breakdown of the acceptance criteria and the study information for the SB100II Finger Pulse Oximeter, based on the provided documents:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Discussion of Performance vs. Criteria:

• SpO2 Accuracy: The SB100II reports an accuracy of +/-3% in the 70-99% range. The document states this is "Similar, actual Arms 2.5 Meets FDA guidance for non-motion ≤ 3.0 % Meets ISO 9919 for non-motion <4.0 %". This indicates that while it's numerically slightly less accurate than the predicate's reported +/-2%, it still meets the FDA guidance and ISO standards for non-motion pulse oximeters.
• Pulse Accuracy: The SB100II reports +/-3 bpm accuracy, which is described as "Similar" to the predicate's "±2% or 2 bpm whichever is greater". This suggests it is within acceptable limits.
• Other Parameters: SpO2 Range, SpO2 Resolution, Pulse Range, and Pulse Resolution are identical or directly comparable to the predicate devices and meet the criteria.
• Standards Compliance: The SB100II meets current revisions of the listed consensus standards (IEC 60601-1, IEC 60601-1-2, and ISO 9919), demonstrating compliance with recognized safety and performance standards.
• Ingress Protection & Electrical Safety: The SB100II reports specific compliance (IPX1, Type BF) which meets FDA guidance and suitable protection class, respectively. These were unknown for the predicate devices.

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

The document states "ISO 9919 including clinical testing" was performed (Page 5, "Performance Testing").

• There is no explicit sample size mentioned for the clinical testing in the provided text.
• There is no specific data provenance (e.g., country of origin, retrospective/prospective) mentioned within the provided text, other than the general statement of "clinical testing" as part of ISO 9919.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This information is not provided in the document. For pulse oximetry, the "ground truth" for SpO2 is typically established by arterial blood gas analysis, which is an objective measurement, not expert consensus.

4. Adjudication Method

• This information is not applicable and not provided. The "ground truth" for pulse oximetry is a direct physiological measurement, not an interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done or reported. This type of study focuses on human reader performance, which is not relevant for a standalone pulse oximeter device. The device provides a direct numerical reading.

6. Standalone Performance Study

• Yes, a standalone performance study was conducted. The "Performance Testing" section states: "The following performance tests were done and the SB100II meet all requirements. - ISO 9919 including clinical testing". The "Summary of Differences" table also directly compares the SB100II's performance attributes (SpO2 Accuracy, Pulse Accuracy, etc.) against predicate devices, indicating standalone evaluation. The device is explicitly stated as "a standalone device" (Page 2).

7. Type of Ground Truth Used for Test Set

• The ground truth for the clinical testing to establish SpO2 accuracy as per ISO 9919 (which is the relevant standard for pulse oximeters) involves comparing the device's readings against arterial blood gas analysis (functional oxygen saturation). This is considered an objective, gold-standard physiological measurement.

8. Sample Size for the Training Set

• Training set details are not provided. For this type of medical device (pulse oximeter), there typically isn't a "training set" in the sense of machine learning. The device's algorithms are based on established physiological principles and calibrated during development, rather than "trained" on a large dataset. The provided document focuses on performance verification rather than algorithm development.

9. How Ground Truth for the Training Set Was Established

• This information is not provided and generally not applicable for the type of device. The ground truth for calibration and design of pulse oximeters usually comes from extensive physiological studies and controlled desaturation studies where arterial blood gas measurements are the reference.

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