(147 days)
The Pulse Oximeter CMS-50C is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care etc.). This device is not intended for continuous monitoring.
The pulse oxygen saturation is the percentage of HbO2 in the blood, so-called the O2 concentration in the blood. It is an important bio-parameter for the respiration. Many of the respiration disease will cause hypoxemia, even damage the patient's life. As a result, monitoring the SpO2 is indispensable in the clinical rescuing. The traditional method to measure SpO2 is to analyze the sample of the patient's blood to get the partial pressure of oxygen and calculate the SpQ2 by use the blood-gas analyzer. This method is inconvenient and discontinuous. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Pulse Oximeter. The device can measure the pulse rate simultaneously.
Pulse Oximeter is tiny, and with low power consumption, convenient to use and carry. The You just need to put the into the sensor of the device, the SpO2 value will appear on the screen immediately. In the clinical practice, the tolerance is smaller than ±2% in the range from 70% to 99%.
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.
The applicant device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does not need sterilization or re-sterilization. The device is for prescription. The device does contain drug or biological products.
The device is electrically operated and the Electrical Safety Test and Electromagnetic Compatibility Test following IEC 60601-1 and IEC60601-1-2 were conducted.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implicit from ISO 9919:2005) | Reported Device Performance (Summary) |
|---|---|
| Accuracy of SpO2 measurement | compliance to the requirement for accuracy of pulse oximeter equipment, as per ISO 9919:2005. |
| Basic safety of pulse oximeter equipment | compliance to the requirement, product is safe during the use. |
| Essential performance of pulse oximeter equipment | compliance to the requirement, product is safe during the use. |
| Electrical Safety (IEC 60601-1) | Compliance |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliance |
| Biocompatibility (ISO 10993) | Compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility. |
| Software Validation (FDA Guidance) | Compliance |
| Low-Voltage Alarm System Performance | Reported in Attachment 3 |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "The Clinical Test reports following ISO 9919:2005... are conducted in the lab of Beijing Military General Hospital". While it states a clinical test was performed, the actual sample size used for this test set is not provided in the document.
The data provenance is:
- Country of Origin: China (Beijing Military General Hospital).
- Retrospective or Prospective: Not explicitly stated, but clinical tests are typically prospective. Without further information, it's assumed to be prospective to gather specific performance data for the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The general nature of pulse oximeter testing, which typically compares device readings to a reference method (e.g., co-oximetry of arterial blood samples), implies medical expertise is involved in collecting and interpreting the reference data. However, the exact number and qualifications of experts are not detailed.
4. Adjudication Method for the Test Set:
This information is not provided in the document. For pulse oximeter accuracy, ground truth is usually established by directly comparing the device's SpO2 readings with arterial blood gas analysis (co-oximetry), rather than through expert adjudication of images or symptoms which would require methods like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study focuses on how human readers' performance changes with or without AI assistance, which is not applicable to a standalone device like a pulse oximeter that provides a direct numerical reading.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, a standalone study was done. The entire clinical test described for the Pulse Oximeter CMS-50C is inherently a standalone performance study. The device provides a direct measurement (SpO2 and pulse rate) without requiring human interpretation or intervention in the measurement process itself, beyond proper application. The device's performance was evaluated against a reference standard.
7. Type of Ground Truth Used:
The ground truth for pulse oximeter accuracy studies (as per ISO 9919:2005) typically involves comparison against arterial blood gas analysis (specifically, co-oximetry). While the document doesn't explicitly state "co-oximetry," it mentions the "traditional method to measure SpO2 is to analyze the sample of the patient's blood to get the partial pressure of oxygen and calculate the SpQ2 by use the blood-gas analyzer." This implies that a similar gold standard, likely laboratory-based blood analysis, would be used as the ground truth for the clinical tests.
8. Sample Size for the Training Set:
This information is not applicable and therefore not provided. A pulse oximeter is a sensor-based medical device that relies on physical principles (light absorption) rather than machine learning algorithms trained on a dataset. Therefore, there is no "training set" in the context of an AI/ML model for this device.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and therefore not provided. As mentioned above, there is no training set for this device.
§ 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).