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G1B Pulse Oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatic patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring,

The G1B is a flexible, portable, battery powered Pulse Oximeter. The G1B Pulse Oximeter acquires the physiological signals - oxygen saturation (SpO2) and pulse rate (PR). The signals are converted into digital data and processed, and the SpO2 and pulse rate values are calculated and displayed on LED screen.

G1B uses a two-wavelength pulsatile system - red and infrared light - to obtain SpO2 based on the different light absorption of oxygenated and reduced hemoglobin. The light source in the finger sensor emits red and infrared light, which are partially absorbed and modulated by the arterial blood pulsation at the sensor site. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The electronic signals are sent to the oximeter and processed by the oximeter's circuitry. Thereafter, the SpO2 and pulse rate are obtained and indicated on the LED screen.

The provided text is a 510(k) summary for the G1B Pulse Oximeter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria or a study that rigorously proves the device meets those criteria with statistical significance.

The section titled "4. Testing" states: "Laboratory and Clinical testing was conducted to validate and verify that M700 Handheld Pulse Oximeter met all design specifications, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of all consensus standards."

This is a very general statement and does not provide the detailed information requested in the prompt.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a breakdown of what can and cannot be answered:

1. A table of acceptance criteria and the reported device performance:

• Cannot be provided. The document states that "Laboratory and Clinical testing was conducted to validate and verify that M700 Handheld Pulse Oximeter met all design specifications," but it does not specify what those "design specifications" (acceptance criteria) are, nor does it present any reported device performance metrics against them.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot be provided. The document generally mentions "Clinical testing" but provides no details on sample size, data provenance, or study design (retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• Cannot be provided. There is no information about how ground truth was established or if any experts were involved in a test set evaluation. For a pulse oximeter, ground truth for SpO2 is typically established against an arterial blood gas co-oximeter, not by expert consensus on visual interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Cannot be provided. No information on adjudication is given.

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:

• Not applicable/Cannot be provided. Pulse oximeters are standalone diagnostic devices and do not typically involve human "readers" or AI assistance in the way a medical imaging device might. Therefore, an MRMC study comparing human performance with and without AI assistance is not relevant or described. The device's performance is measured directly against a reference standard.

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

• Yes, implicitly. A pulse oximeter is inherently a standalone device. Its "performance" refers to how accurately its readings (SpO2 and pulse rate) match a reference standard. The document mentions "clinical testing" which implies this standalone performance was assessed, but without details.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Cannot be directly stated from the text. While not explicitly mentioned, for pulse oximeters, the ground truth for SpO2 accuracy is conventionally established by comparing the device's readings to those from an arterial blood gas co-oximeter. The text makes no explicit mention of this.

8. The sample size for the training set:

• Not applicable/Cannot be provided. As a traditional sensor-based device, a pulse oximeter does not typically have a "training set" in the machine learning sense. Its design involves established physiological principles and signal processing, not data-driven algorithm training.

9. How the ground truth for the training set was established:

• Not applicable/Cannot be provided. As above, there is no "training set" for this type of device.

In summary, the provided 510(k) summary is very high-level regarding performance testing and does not include the detailed scientific study information requested. It primarily focuses on the device description, indications for use, and its substantial equivalence to a predicate device, as typically required for a 510(k) submission that doesn't involve complex AI algorithms or novel clinical pathways.

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