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510(k) Data Aggregation
(279 days)
MIROXI
The MIROxi pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test oximetry in people of all ages.
It can be used in any setting.
MIROxi is a pulse oximeter, designed for use by specialist who require a simple, portable and compact device, yet at the same time being capable of calculating more than 30 statistical parameters derived from the SpO2 and pulse rate.
Its connectivity capability (USB, Bluetooth, internal modem for acoustic coupling to telephone, RS232) makes it suitable also for telemedicine applications.
Here's a breakdown of the acceptance criteria and the study details for the MIROxi device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance |
|---|---|---|
| Safety | EN 60601-1:1990 (Medical electrical equipment - Part 1: General requirements for safety) | "The results demonstrates that the device is in compliance with the standards referenced and that it performs within its specifications." |
| Environmental | EN 60601-1-2:1993 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests) | "The results demonstrates that the device is in compliance with the standards referenced and that it performs within its specifications." |
| Electromagnetic Compatibility (EMC) | Included under EN 60601-1-2:1993 | "Testing was conducted in accordance with... EN 60601-1-2:1993. The results demonstrates that the device is in compliance..." |
| Electrical Durability | Not explicitly stated as a separate standard, but implied by EN 60601-1:1990 and general safety testing. | "electrical... testing have been completed. The results demonstrates that the device is in compliance with the standards referenced and that it performs within its specifications." |
| Mechanical Durability | Not explicitly stated as a separate standard, but implied by EN 60601-1:1990 and general safety testing. | "mechanical durability... testing have been completed. The results demonstrates that the device is in compliance with the standards referenced and that it performs within its specifications." |
| Safety (Operator and Patient) | Included under EN 60601-1:1990 | "safety (operator and patient)... testing have been completed. The results demonstrates that the device is in compliance with the standards referenced and that it performs within its specifications." |
| Temperature/Humidity | Not explicitly stated as a separate standard, but implied by general environmental testing. | "temperature/humidity testing have been completed. The results demonstrates that the device is in compliance with the standards referenced and that it performs within its specifications." |
| SpO2 Accuracy | Not explicitly stated as a numerical criterion, but evaluated by "in vitro testing using an optical simulator, under normal conditions." | "The results obtained were within the specification." |
| Pulse Rate Accuracy | Not explicitly stated as a numerical criterion, but evaluated by "in vitro testing using an optical simulator, under normal conditions." | "The results obtained were within the specification." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The accuracy validation mentions "in vitro testing using an optical simulator," which means the testing was conducted in a laboratory setting, not on human subjects or clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Given that the accuracy validation was "in vitro testing using an optical simulator," there were no human experts used to establish ground truth for the SpO2 and pulse rate measurements. The optical simulator itself served as the "ground truth" by providing known, precise optical signals corresponding to specific SpO2 and pulse rate values.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth for accuracy was established by an optical simulator, not human assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study typically involves human readers assessing medical images or data with and without AI assistance to measure the AI's impact on human performance. The MIROxi device is a pulse oximeter, not an imaging device, and the testing described is focused on the device's standalone accuracy, not on its assistance to human interpretations.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance
Yes, a standalone performance evaluation was conducted. The accuracy of SpO2 and pulse rate was "validated by in vitro testing using an optical simulator, under normal conditions." This testing assessed the device's ability to accurately measure these parameters independently, without human interaction influencing the measurement process (beyond operating the device and simulator).
7. Type of Ground Truth Used
For the SpO2 and pulse rate accuracy measurements, the ground truth used was established by an optical simulator. This is a calibrated instrument that can generate precise optical signals corresponding to known physiological parameters.
8. Sample Size for the Training Set
The provided text does not mention or specify any training set sample size. Given the nature of a pulse oximeter (which relies on established physiological principles and optical absorbance), it's highly probable that a "training set" in the machine learning sense was not applicable or explicitly documented for this type of device. The device likely relies on a fixed algorithm embedded based on known physics and physiological models, rather than a machine learning model trained on a dataset.
9. How Ground Truth for the Training Set Was Established
As no training set is mentioned or implies to be used in the machine learning sense, this question is not applicable. The device's underlying principles are based on established scientific understanding of light absorption by oxygenated and deoxygenated hemoglobin.
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