Search Results

The MD300W wrist oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital ( including clinical use in internist/ surgery, Anesthesia, intensive care and etc). Not for continuously monitoring.

The applicant device of Wrist Pulse Oximeter MD300W is a wrist-worn device, which can display %SpO2, pulse rate value and vertical bar graph pulse amplitude,

The applicant device consists of sensor, signal amplify unit, CPU, data display unit, data transmit unit, storage and power unit.

The wrist oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 940 nm, which is ultra red light.

Skin, bone, tissue, and venous vessels normally absorb a constant amount of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The applicant device has low battery voltage alarm function and automatically power of function. The power source of the applicant device is 1 AAA alkaline batteries.

The applicant device is not for life-supporting or life-sustaining, not for implant. The device or sensor are not sterile and the sensor does not need sterilization and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Wrist Pulse Oximeter MD300W:

Please note: The provided text is a 510(k) Summary for a medical device. These summaries typically contain a high-level overview and refer to more detailed reports (like clinical test reports) in their appendices. Therefore, some detailed information might not be explicitly stated in this summary but would be found in the referenced documents.

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: Not explicitly stated for the clinical test. The summary mentions "adult and pediatric patient," but the number of subjects is not provided.
   • Data Provenance: Clinical tests were "conducted in Wulanchabu City Center Hospital" and "Laboratory of Beijing Friendship Hospital." This suggests the data is prospective clinical trial data from China.

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

   • This information is not explicitly provided in the 510(k) summary. For pulse oximetry clinical studies, ground truth is typically established using a co-oximeter measuring arterial blood gas samples, not expert consensus in the traditional sense of image interpretation.

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

   • This information is not applicable to a pulse oximetry accuracy study where ground truth is established through instrumental measurement (co-oximetry) rather than expert review. There's no "adjudication" necessary for the primary outcome.

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, an MRMC comparative effectiveness study was not done. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool that involves human readers interpreting results.

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

   • Yes, a standalone performance assessment was done. The clinical test assesses the accuracy of the device itself (algorithm and hardware) against a reference standard without human interpretation. The summary states: "The Clinical Test reports following ISO 9919:2005... are conducted in Wulanchabu City Center Hospital provided in Attachment IV Clinical Test Reports."

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

   • The ground truth for pulse oximeter accuracy studies is typically established by arterial blood gas analysis using a co-oximeter. While not explicitly named in the summary, conformance to ISO 9919:2005 (which specifies requirements for in vivo clinical testing) implies this method. ISO 9919:2005 requires comparing the device's SpO2 readings to simultaneously drawn arterial blood samples analyzed by a laboratory co-oximeter.

7. The sample size for the training set:

   • This information is not applicable/not provided. Pulse oximeters of this type, especially from this era (2008), typically rely on established physiological models and calibration rather than machine learning "training sets" in the modern AI sense. While internal calibration data would be used, it's not a "training set" for an algorithm that learns from data.

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

   • As noted above, the concept of a "training set" and associated ground truth is not directly applicable in the context of this device's type and the information presented. The device's underlying principles are based on the Beer-Lambert law and physiological light absorption, not a learned AI model.

Ask a specific question about this device