(186 days)
Fingertip Pulse Oximeter MD300C 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 Fingertip Pulse Oximeter MD300C is a fingertip device, which can display % SpO2, pulse rate value. 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 diastele 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 2 AAA alkaline or rechargeable batteries. The applicant device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer does not need sterilization and the transducer is reusable but does not need re-sterilization since it is not sterile. The device is not for prescription. The device does contain drug or biological products.
Here's an analysis of the acceptance criteria and study information for the Fingertip Pulse Oximeter MD300C, based on the provided text:
Acceptance Criteria and Device Performance
The submission states that the device's accuracy is in compliance with the requirements of ISO 9919:2005. While specific numerical acceptance criteria (e.g., accuracy percentages or ranges for SpO2 and pulse rate) are not explicitly enumerated in the provided text, the overall statement of compliance implies that the device met the performance standards outlined in ISO 9919:2005.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ISO 9919:2005 for effectiveness and safety of pulse oximeter equipment. | "The accuracy of MD300C pulse oximeter equipment is compliance to the requirement, and the product is safe during the used in the clinical environment." |
| Safety mechanism preventing excess current leading to burning injury. | "Safety mechanism preventing the excess current from leading to burning injury to user is effective." |
| Low-Voltage Alarm System functionality. | "And low voltage alarm system meet the function requirement of the design input." |
| Biocompatibility of skin-contacting materials. | "The Biological Evaluation Tests are in compliance with the standards of ISO 10993, 'Biological Evaluation of Medical Devices'. The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility." |
| Electrical Safety (IEC 60601-1) | "The applicant device is compliance with IEC60601-1, Medical electrical equipment - Part 1: General requirements for safety" |
| Electromagnetic Compatibility (IEC 60601-1-2) | "The applicant device is compliance with... IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility -. Requirements and tests" |
| Software Validation (FDA Guidance) | "The Software Validation is in compliance with FDA Guidance to Compliance with FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices." |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of patients or data points included in the "Clinical Test reports."
- Data Provenance: The clinical tests were "conducted in Beijing Friendship Hospital and Wulanchabu City Center Hospital." This indicates the data is prospective and originated from China.
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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 given text. For pulse oximeters, ground truth is typically established using a co-oximeter in a controlled desaturation study, not by human experts adjudicating readings.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided. Given the nature of pulse oximetry accuracy studies, a human adjudication method like 2+1 or 3+1 would not be applicable for establishing the ground truth of SpO2 and pulse rate. The ground truth (reference SpO2) comes from a reference device (co-oximeter).
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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. The device is a standalone medical device (pulse oximeter) that provides direct measurements of SpO2 and pulse rate. It does not involve "human readers" interpreting input or an "AI" component assisting interpretation in the way a diagnostic imaging AI might.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone study was done. The "Clinical Test reports following ISO 9919:2005" represent the standalone performance of the device without human interpretation or intervention in the measurement process itself, other than proper device application. The device directly outputs SpO2 and pulse rate.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- While not explicitly stated in the provided text, for pulse oximeters, the ground truth for accuracy studies (like those following ISO 9919:2005) is typically established by simultaneously measuring arterial blood oxygen saturation using a co-oximeter from an arterial blood sample, taken during controlled desaturation studies. This is the standard reference method.
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The sample size for the training set:
- Not applicable / Not provided. The device described is a pulse oximeter which uses established physiological principles and signal processing to derive SpO2 and pulse rate. It is not an AI/machine learning model that typically requires a distinct training set in the conventional sense. Its "algorithm" is based on the Beer-Lambert law and signal analysis of light absorption.
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How the ground truth for the training set was established:
- Not applicable / Not provided. As mentioned above, this device does not appear to utilize a machine learning model requiring a training set with established ground truth.
§ 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).