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The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring,use during motion or for patients with low perfusion.

The YUWELL® Finger Pulse Oximeter is a non-invasive, non-sterile, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring, use during motion or for patients with low perfusion. The YUWELL® Finger Pulse Oximeter features in small volume, low power consumption, convenient operation and portable. It is only necessary for patient to put one of his fingers into a fingertip photoelectric sensor for measurement, and then the screen will display the measured value of Pulse Oxygen Saturation (SpO2) and pulse rate(PR) . The device consists of electronic circuits, plastic housing. OLED/LED display(differentiated by models) and button (YX301,YX306 equipped, YX102,YX103 not equipped) which powered by two alkaline AAA batteries. The device does not include alarms.

The provided text is a 510(k) summary for the YUWELL® Finger Pulse Oximeter. Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter, K101577). The key performance acceptance criteria can be inferred from the comparison table and the clinical study results.

Table of Acceptance Criteria and Reported Device Performance (Inferred from comparison and study results):

Study Information

The document describes a clinical study to verify the device's accuracy.

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

   • Sample Size: 12 healthy adult volunteer subjects (ages 18-50yr, with light to dark pigmentation).
   • Data Provenance: The location of the study is not explicitly stated, but the company is based in China. The study was conducted to evaluate SpO2 accuracy during stationary (non-motion) conditions with induced hypoxia. This implies a prospective study design.

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

   • The document does not specify the number of experts or their qualifications for establishing the ground truth. It states that "Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison." This indicates that CO-Oximetry was the ground truth reference.

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

   • No information on an adjudication method is provided, as the ground truth was based on a reference medical device (CO-Oximetry) and not expert reader consensus.

4. 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 MRMC study was conducted or mentioned. This device is a standalone measurement device (pulse oximeter), not an AI-assisted diagnostic tool for human readers.

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

   • Yes, the clinical study conducted was a standalone performance evaluation of the pulse oximeter's accuracy in measuring SpO2 and pulse rate against a reference standard (CO-Oximetry), without human interpretation as part of the primary measurement.

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

   • The ground truth used was arterial blood CO-Oximetry. This is considered the reference standard for blood oxygen saturation measurement.

7. The sample size for the training set:

   • The document does not mention a distinct "training set" or sample size for training. This device does not appear to be an AI/machine learning product that requires separate training and test sets in the conventional sense. Its principle is based on established photoelectric oximetry technology (Lambert Beer law, Spectrum Absorption Characteristics). The comparison notes mention that an "experience formula of data process is established taking use of Lambert Beer law according to Spectrum Absorption Characteristics...verified by a large amount of data." However, the size or provenance of this data is not detailed as a "training set."

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

   • Since a formal "training set" for an AI model is not explicitly described, the method for establishing ground truth for such a set is also not provided. The phrase "verified by a large amount of data" suggests historical data or internal validation, but no specifics are given.

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