(188 days)
The M-50 Series SpO2 Sensor is intended for spot checking or continuous monitoring of functional arterial oxygen saturation and pulse rate in non-invasive with oximeter equipment.
The M-50A, M-50E and M-50G SpO2 Sensor is intended for adult patients in hospitals, hospital-type facilities, and home environments.
The M-50B and M-50H SpO2 Sensor is intended for pediatric patients in hospitals, hospital-type facilities, and home environments.
The M-50C SpO2 Sensor is intended for adult, pediatric, infant and neonatal patients in hospitals, hospital-type facilities, and home environments.
The applicant sensor M-50 Series SpO2 Sensors measure, non-invasively, the arterial oxygen saturation of blood. The measurement method is based on the red and infrared light absorption of hemoglobin and oxyhemoglobin. Light of a red and infrared light source is emitted through human tissue and received by a photodiode.
The measurement is based on the absorption of light, which is emitted through human tissue (for example through the index finger). The light comes from two sources (red LED and infrared LED) with different wavelengths and is received by a photodiode. Out of the different absorption behavior of the red and infrared light a so-called ratio can be calculated. The saturation value is defined by the percentage ratio of the oxygenated hemoglobin [HbO2] to the total amount of hemoglobin [Hb].
SpO2 = [HbO2]/([Hb+[HbO2]]
Those sensors contain a red and infrared light source and a photodiode receiving the non-absorbed red and infrared light. The received signals are forwarded to a measurement device that amplifies the acquired signal and an algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value.
The model M-50A and M-50B sensors are the accessory of legally marketed device MD300I ( K072825 ).
All of the sensors included in applicant M-50 Series SpO2 sensors have the identical materials , electro-optical components and basic technical specification.
The model M-50A,M-50B and M-50E sensor use the same configuration manner as the finger clip. All the clip sensors ( M-50A, M-50E) composed by two sorts of material, the enclosure's material of the sensor is ABS, and the material of another part which contact with patient skin, we call that " silica gel cushion", is Medical Silicon
The model M-50C use a sort of configuration manner as binding manner. The M-50C just have single material as the Medical Silicon.
The model M-50G and M-50H use the same configuration manner as the fingertip. Because of the fingertip sensor just have single material as the Medical Silicon, so they are soft.
The applicant sensors are not for implant. Those sensors are not sterile and do not need sterilization or re-sterilization. The device is for prescription. The device does not contain drug or biological product.
The device is electrically operated and the electrical safety and electromagnetic compatibility following IEC 60601-1 and IEC60601-1-2 were conducted.
The device is not software-driven.
A11 the information about the device performance was according to the FDA guidance.
The Clinical Test Report 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.
- Acceptance Criteria and Reported Device Performance:
The provided document describes the M-50 Series SpO2 Sensor as being substantially equivalent to a predicate device (MD300I, K072825). The acceptance criteria for the M-50 Series SpO2 Sensor models are not explicitly described with numerical thresholds in the provided text. However, the document states:
- "The Clinical Test Report 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."
- "The result of neonate clinical trial is meet the requirements of FDA Pulse Oximeter Guidance."
This implies that the device performance was measured and found to comply with the performance standards outlined in ISO 9919:2005 and FDA Pulse Oximeter Guidance. Without direct access to these reports or the specific guidance documents, the precise numerical acceptance criteria and reported performance cannot be extracted.
Table of Acceptance Criteria and Reported Device Performance (Inferred):
| Acceptance Criteria (Inferred from ISO 9919:2005 & FDA Guidance) | Reported Device Performance (Inferred from study conclusion) |
|---|---|
| Compliance with ISO 9919:2005 for basic safety and essential performance of pulse oximeter equipment for medical use. | The clinical test report confirmed compliance. |
| Meeting requirements of FDA Pulse Oximeter Guidance for neonate use (for M-50C). | The neonate clinical trial results met requirements. |
- Sample size used for the test set and the data provenance:
The document mentions "Clinical Test Report following ISO 9919:2005" and "neonate clinical trial." However, the exact sample sizes for these test sets are not specified in the provided text.
The data provenance is also not explicitly stated beyond the mention of "Clinical Test Report" and "neonate clinical trial." It is not clear if the studies were retrospective or prospective, or the country of origin of the data.
- 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.
- Adjudication method for the test set:
This information is not provided in the given text.
- 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:
The device described is an SpO2 sensor, which non-invasively measures arterial oxygen saturation. It is a standalone medical device and not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, a standalone study was done. The document states, "AII the information about the device performance was according to the FDA guidance. The Clinical Test Report 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." This refers to performance testing of the device itself, which operates as an algorithm calculating SpO2 values without direct human intervention in the calculation process. Additionally, a "neonate clinical trial" was conducted to demonstrate safety and effectiveness for neonate use of the M-50C sensor.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For pulse oximetry, the ground truth for arterial oxygen saturation is typically established through co-oximetry of arterial blood samples. While the document doesn't explicitly state "co-oximetry," clinical trials for pulse oximeters following ISO 9919:2005 commonly use arterial blood gas analysis with co-oximetry as the reference standard to establish ground truth for SpO2 measurements. The phrase "Clinical Test Report following ISO 9919:2005" implies the use of such accepted methods for ground truth establishment.
- The sample size for the training set:
This information is not provided in the given text. The device's operation is based on a "validated calibration table" and an "algorithm that calculates the ratio and converts via a validated calibration table the ratio to a saturation value," rather than a continuously learning AI model with a distinct "training set" in the modern machine learning sense. The calibration table would have been developed using a set of data, but this is not referred to as a "training set."
- How the ground truth for the training set was established:
As mentioned above, the device uses a "validated calibration table" rather than a training set for a machine learning model. The method for establishing the ground truth for this calibration table is not explicitly detailed in the provided text, but it would typically involve
comparing the device's optical absorbance ratio measurements against arterial blood gas co-oximetry readings from various subjects with different oxygen saturation levels.
§ 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).