(104 days)
Pulse Oximeter MD3001 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 Pulse Oximeter MD3001 is a device, which can display % SpO2, pulse rate value and vertical bar graph pulse amplitude. The applicant device consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit. The Pulse oximetry 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 over time. The photodetector in fingersensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts 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, automatically power of function and data storage function. The power source of the applicant device is 2 AAA alkaline or rechargeable batteries.
Acceptance Criteria and Device Performance for Pulse Oximeter MD300I
1. Table of Acceptance Criteria and Reported Device Performance
The provided document K072825 for the Pulse Oximeter MD300I references compliance with ISO 9919:2005 for effectiveness and safety. However, specific numerical acceptance criteria and corresponding reported device performance values (e.g., accuracy ranges for SpO2 and pulse rate) are not explicitly detailed within the provided text.
The document states:
- "The accuracy of MD300I pulse oximeter equipment is compliance to the requirement, and the product is safe during the use."
- "The Clinical Test reports following ISO 9919:2005, Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use are conducted in the lab of Beijing Military General Hospital provided in Attachment 4 Clinical Test Reports."
To fully answer this question with a table of specific numerical acceptance criteria and reported device performance, the Attachment 4 Clinical Test Reports referenced in the submission would be necessary. Without this attachment, only a generic statement of compliance can be made.
Based on the available information, the table would look like this (with placeholders for specific numerical values):
| Acceptance Criteria (from ISO 9919:2005, e.g.) | Reported Device Performance (MD300I) |
|---|---|
| SpO2 Accuracy (e.g., ±X% over Y-Z% SpO2 range) | Not specified in provided summary (Stated as compliant with ISO 9919:2005 requirements) |
| Pulse Rate Accuracy (e.g., ±W bpm) | Not specified in provided summary (Stated as compliant with ISO 9919:2005 requirements) |
| Alarm Functions (e.g., Low-Voltage Alarm System performance) | Compliant with requirements (Report No. MD300I-01-003) |
| Biocompatibility (skin-contacting materials) | Compliant with ISO 10993 (Presented in Table IV-2) |
| Electrical Safety | Compliant with IEC60601-1 |
| Electromagnetic Compatibility (EMC) | Compliant with IEC60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided summary. The document mentions "clinical test reports" but does not give the number of subjects or data points.
- Data Provenance:
- Country of Origin: China ("Beijing Military General Hospital").
- Retrospective or Prospective: Not explicitly stated, but clinical tests are typically prospective to evaluate device performance on live subjects according to a protocol.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given text. While clinical tests were conducted at a hospital, there is no mention of a ground truth established by experts for the purpose of validating the oximeter's readings against a reference standard. Pulse oximeters are typically validated against arterial blood gas (ABG) measurements or a CO-oximeter, where the ABG result itself is considered the ground truth, not an expert consensus on a reading.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments where multiple readers provide interpretations. For pulse oximetry, the ground truth is usually derived from objective measurements (e.g., CO-oximetry of arterial blood gas). Therefore, an adjudication method in the traditional sense is not applicable or mentioned in the context of this device. The device's SpO2 and pulse rate readings would be compared directly against the reference standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done or mentioned. This type of study is more common for diagnostic imaging AI systems where human readers interpret images with and without AI assistance. A pulse oximeter is a direct measurement device, not an interpretive one.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance assessment was done. The clinical tests described (compliance with ISO 9919:2005) assess the device's ability to accurately measure SpO2 and pulse rate independently. The device itself is designed to provide readings directly to the user (human-in-the-loop interpretation of the measurement, but not the algorithm itself).
7. The Type of Ground Truth Used
The type of ground truth used for pulse oximeters in clinical studies according to ISO 9919:2005 typically involves simultaneous measurements with a reference CO-oximeter on arterial blood samples. This provides a highly accurate and objective measure of arterial oxygen saturation (SaO2) against which the pulse oximeter's SpO2 readings are compared. While not explicitly stated to be CO-oximetry in the provided summary, it is the standard for such clinical performance evaluations.
8. The Sample Size for the Training Set
Not applicable/Not provided. The MD300I is a traditional hardware-based pulse oximeter, not an AI/machine learning algorithm that requires a training set in the typical sense. Its underlying physics and signal processing are deterministic.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. As explained above, this device does not utilize a training set in the way AI/ML algorithms do.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).