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The VYVO Life Watch 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 Life Watch, Model WL is a small, wrist-worn device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate (PR). The expected measuring location of the device is the finger, which actively presses onto the sensor on the side of the watch for measurement. The Life Watch is a watch-like device with a reflectance pulse oximetry sensor located at the side of the reflectance pulse oximetry sensor includes two light emitting diodes (LEDs) of red wavelength (660 nm) and infrared wavelength (940 nm), and one photodiode light detector placed next to each other. Light beams are emitted from LEDs through the skin to the arteriolar bed of the tissue. Changes in light absorption during the pulsing cycle are measured by the photodiode light detector as scattered lights are reflected back from the pulsating arteriolar bed. The functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate are measured by the well-established non-invasive pulse oximetry technology where the red and infrared light is absorbed in different amounts depending on the oxygenation of the blood during the arterial pulsing. The maximum optical output power is less than 2 mW. The Life Watch is a single-patient use, non-sterile pulse oximeter. It is available in one configuration as a standalone device with a wrist pulse oximeter and a detachable watchband for wearing the pulse oximeter on the wrist.

The Life Watch is a compact and light weight device which consists of a reflectance pulse oximetry sensor, a color graphic OLED display, a lithium ion polymer rechargeable battery, an analog and digital unit, a microprocessor and an operating software. The functions of the life watch include the following: (1) Measurement and display of the functional oxygen saturation of arterial hemoglobin (% SpO2) and pulse rate; (2) Spot-checking of specific physiological parameters of adult patients; (3) Easy to read OLED graphic display; (4) Peripheral micro-USB connector used as the battery charging base; (5) Built-in rechargeable lithium ion polymer battery (3.8V, 250mAh) (6) Low battery power indicator in OLED graphic display.

The device consists of the watch case, band, charging case, USB cable.

The proposed device is not used for life-supporting or life-sustaining, and not for implant. The device does not contain drug or biological products.

The provided text describes the 510(k) premarket notification for the VYVO Life Watch, an oximeter, and its claim of substantial equivalence to a predicate device (Bio-Beat Technologies Ltd. BB-613 Watch Oximeter) and a reference device (Beijing Choice Electronic Technology Company, Limited Wrist Pulse Oximeter).

However, the document does not provide specific acceptance criteria or detailed results of a study proving the device meets those criteria in the format requested. It states that "nonclinical and clinical test results have demonstrated that the VYVO Life Watch is the same as safe and effective as the BB-613 Watch Oximeter," and indicates that the clinical test was "conducted in accordance with the FDA's guidance 'Pulse Oximeters - Premarket Notification Submission [510(k)s]' and the standard ISO 80601-2-61:2017."

Based on the provided information, I can extract the following:

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

The document lists performance specifications and compares them to the predicate and reference devices, but it does not explicitly state specific acceptance criteria (e.g., a mean difference of X with Y confidence interval) that the device aims to meet. Instead, it implies that the device's performance is "same" or "substantially equivalent" to the predicate.

2. Sample size used for the test set and the data provenance:

• Sample Size: 12 subjects
• Data Provenance: The document states "12 subjects with Fitzpatrick skin types. In addition, the 12 subjects include 6 healthy adult males and 6 healthy adult females, and their age range is from 19 to 42 years old." It does not specify the country of origin or whether the data was retrospective or prospective, though "clinical test has been conducted" implies prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the document. The study compares the device measurements to "simultaneous measurements from the predicate device," implying the predicate device itself served as a reference or a comparative standard, rather than explicit expert ground truth derivation.

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

• This information is not provided in the document.

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, this was not an MRMC study. The device is an oximeter, not an AI-assisted diagnostic tool that would involve human readers.

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

• Yes, the performance evaluation described (comparison to simultaneous measurements from the predicate device) appears to be a standalone assessment of the device's accuracy.

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

• The "ground truth" or reference standard for the clinical test appears to be simultaneous measurements from the predicate device. The document states, "Testing shows equivalence to simultaneous measurements from the predicate device." For pulse oximeters, the typical gold standard for SpO2 accuracy is direct arterial blood gas analysis (CO-oximetry). While the document states adherence to ISO 80601-2-61:2017, which dictates such testing, it explicitly states comparison to the predicate device in this summary.

8. The sample size for the training set:

• This information is not provided. The device is an oximeter, not an AI/ML device that typically requires a large training set in the same way. The software mentioned is likely for device operation and data processing, not a deep learning model.

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

• This information is not applicable/not provided as a "training set" in the context of an AI/ML model for diagnostic tasks is not described. The software validation is mentioned as "in compliance with the FDA's Guidance 'Content of Premarket Submissions for Device Software Functions'," indicating a robust software development lifecycle and testing, but not a data-driven training process.

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