(319 days)
The Model 960 Series is a desktop monitor intended for use as a continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, non invasive blood pressure and temperature. The intended patient population comprises adult, and pediatric weighing more than 5Kg. The intended environment of use is hospital environment. Hospital use typically covers areas such as general care floors, operating rooms, special procedure areas, intensive and critical care areas within the hospital plus hospital-type facilities such as surgical centers, sub-acute centers, special nursing facilities and sleep labs. The Model 900 is an Pulse Oximeter only.
WARNING: The Model 900 and 960 Series is intended only as an adjunct in patient assessment. It must be used in conjunction with clinical signs and symptoms.
The Mediaid Vital Signs monitor Pulse Oximeter Model M960P provides real time monitoring and display of ox vgen saturation of arteriolar hemoglobin (SpO2), Non Invasive Blood Pressure, pulse rate and body temperature. Where as the Mediaid Pulse Oximeter Model M900 provides real time monitoring and display of oxygen saturation of arteriolar hemoglobin (SpO2) and pulse rate only.
Noninvasive arterial oxygen saturation measurement is obtained by directing red and infra red light through a pulsating vascular bed. The pulsating arterioles in the path of the light beam cause a change in the amount of light detected by a photodiode. The pulse oximeter determines the oxygen saturation of arterial blood by measuring the ratio of transmitted red to infrared light within the pulse waveform. The non-pulsatile signal is removed electronically for the purpose of calculation. Therefore, skin, bone, and other non-pulsating substances do not interfere with the measurement of arterial oxygen saturation.
Non invasive blood pressure is intended to non invasively measure systolic, diastolic and mean arterial pressures (MAP).
Temperature- Thermometer takes patient temperature in oral, axillary or rectal mode.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Mediaid M960/M900 series devices:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Component | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pulse Oximeter | "equivalent to predicate device accuracy claims" (for SpO2 accuracy) | Mediaid Pulse Oximeter Model 900 series readings were compared to arterial blood samples analyzed on a laboratory co-oximeter and found to be "equivalent to predicate device accuracy claims." Bench testing was performed to verify pulse rate accuracy. |
| NIBP Monitor | "claimed accuracy is met as per the requirement of IEC 60601-2-30 and AAMI SP10" | Clinical study was conducted by Suntech Medical Inc on their OEM module (which Mediaid uses in Model 960 series) and the results show that the claimed accuracy is met as per the requirement of IEC 60601-2-30 and AAMI SP10. |
| Clinical Thermometer | "meets the claimed accuracy as per ASTM E 1112:00 and EN 12470-4" | Clinical Tests for Clinical thermometer is conducted on an external hospital and the results show that the thermometer module of Model 960 series meets the claimed accuracy as per ASTM E 1112:00 and EN 12470-4. |
| General | Compliance with IEC60601-1-2 and other applicable standards | Applicable environmental and non-clinical testing was performed per IEC60601-1-2 as well as other applicable standards and procedures. The Mediaid Pulse Oximeter Model 960 series passed all tests as per the requirements of various applicable international standards (including Biocompatibility, electrical safety, and EMC testing). This demonstrates conformance with established industry standards. |
2. Sample Size Used for the Test Set and Data Provenance
- Pulse Oximeter (SpO2): The document states "clinical hypoxia studies conducted in an independent research lab." It does not specify the sample size for the patients involved in these studies. The data provenance is described as "independent research lab," implying a controlled clinical environment, likely prospective for the specific hypoxia challenge. No country of origin is explicitly mentioned.
- NIBP Monitor: No specific sample size is provided. The study was conducted by "Suntech Medical Inc on their OEM module." This suggests the test data was generated by the OEM, not Mediaid directly. The provenance would be wherever Suntech Medical Inc. conducted their studies.
- Clinical Thermometer: No specific sample size is provided. The clinical tests were "conducted on an external hospital." The provenance would be the location of that hospital.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not explicitly provided in the document for any of the components.
- Pulse Oximeter (SpO2): Ground truth was established by "arterial blood samples analyzed on a laboratory co-oximeter." This implies the co-oximeter is the "expert" or standard reference, not human experts.
- NIBP Monitor: Ground truth would be derived from the reference method used in compliance with IEC 60601-2-30 and AAMI SP10 (e.g., intra-arterial measurement or a highly accurate sphygmomanometer with expert oversight), but the document does not elaborate on the specific experts or their qualifications.
- Clinical Thermometer: Ground truth would be derived from a highly accurate reference thermometer in the hospital setting, but the document does not elaborate on specific experts or their qualifications for establishing this ground truth.
4. Adjudication Method for the Test Set
This information is not provided for any of the tests. The measurements are compared against reference standards rather than subject to adjudication by multiple human experts.
5. 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 involving human readers and AI assistance was not performed and is not applicable to this type of device (vital signs monitor). This document describes the performance of a medical device itself, not an AI or imaging diagnostic tool that would typically involve human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are essentially standalone performance evaluations. The devices (pulse oximeter, NIBP, thermometer) are designed to provide direct measurements, and their accuracy is assessed against reference standards without a human interpreting an image or output that then needs to be compared to a human baseline. The "human-in-the-loop" here is the clinician using the device for patient assessment, but the device's accuracy is evaluated independently of that use.
7. The Type of Ground Truth Used
- Pulse Oximeter (SpO2): "Arterial blood samples analyzed on a laboratory co-oximeter." This is a high-precision, gold-standard laboratory reference.
- NIBP Monitor: Based on compliance with IEC 60601-2-30 and AAMI SP10, the ground truth would be established through defined reference methods within those standards (e.g., invasive arterial pressure measurement or a validated oscillometric reference).
- Clinical Thermometer: Based on compliance with ASTM E 1112:00 and EN 12470-4, the ground truth would be established using a calibrated reference thermometer in a clinical setting.
8. The Sample Size for the Training Set
This information is not provided. Since these are vital signs monitors and not AI/machine learning algorithms that are "trained," the concept of a "training set" as typically understood in AI development does not directly apply here. The devices are based on established physiological principles and calibrated during manufacturing.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a training set in the AI sense is not applicable. The devices are calibrated based on physical principles and validated against reference standards.
§ 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).