(130 days)
The MD2000A vital sign monitor is portable device indicated for use in non-invasively measuring and displaying functional oxygen saturation of arterial haemoglobin (SpO2), and pulse rate of adult, pediatric and neonate patients via finger in hospitals, medical facilities, and subacute environments. The vital sign monitor is intended for spot-checking and/or continuous monitoring of patients, the sensor of device is reusable.
The device 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 during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The applicant device of MD2000A Vital Sign Monitor is the Desktop Pulse Oximeter Monitor, which mainly function are measurement, display, alarm, data storage.
The provided text contains information about a 510(k) submission for the "MD 2000A Vital Sign Monitor," an oximeter. However, it does not contain the specific details required to fully address all parts of your request regarding acceptance criteria and the comprehensive study that proves the device meets them.
Here's a breakdown of what can and cannot be extracted from the text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that a "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 in the Clinical Laboratory." However, it does not provide the specific acceptance criteria or the reported device performance values (e.g., accuracy, bias, or A_rms) from this clinical test.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text | Not specified in the provided text |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "The Clinical Test Report following ISO 9919:2005... are conducted in the Clinical Laboratory." This implies a prospective clinical study. However, the sample size for the test set and the geographical country of origin of the data are not specified.
- Sample Size (Test Set): Not specified.
- Data Provenance: Conducted in "the Clinical Laboratory," but the country of origin is not specified. It's likely China, given the manufacturer's location, but this is not explicitly stated for the clinical trial data itself.
- Retrospective/Prospective: Implied prospective due to "Clinical Test Report."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the document. Oximeter clinical studies typically involve assessing the device's SpO2 readings against a reference standard (e.g., co-oximetry of arterial blood samples), not against expert consensus.
4. Adjudication Method for the Test Set:
This is not applicable in the traditional sense for oximeter performance studies, as the ground truth is typically a direct physiological measurement rather than an interpretation requiring adjudication. The document does not mention any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This type of study is typically used for image-based diagnostics where human readers interpret medical images. For an oximeter, which provides a direct physiological measurement, an MRMC study is not applicable and therefore not mentioned. The device measures SpO2 and pulse rate; it does not involve human interpretation of complex data that AI would assist with.
6. Standalone (Algorithm Only) Performance:
The device itself is the algorithm, providing a direct measurement without human interpretation of the algorithm's output. Therefore, the "clinical test report" mentioned in the summary would inherently be a standalone performance study for the device's SpO2 and pulse rate measurements. The document refers to "The Clinical Test Report following ISO 9919:2005," which would assess the device's performance directly.
7. Type of Ground Truth Used:
While not explicitly detailed, for pulse oximeters following ISO 9919, the ground truth for SpO2 measurements is almost universally established by arterial co-oximetry (i.e., direct measurement of arterial blood oxygen saturation). This is the gold standard for clinical testing of oximeters. The document implies this by referencing ISO 9919.
8. Sample Size for the Training Set:
The document does not mention a training set or any details about how the algorithm within the oximeter was developed or trained. This type of information is generally not required for a conventional oximeter 510(k) summary, as it's not typically a "machine learning" device in the modern sense.
9. How Ground Truth for the Training Set Was Established:
Since a training set is not mentioned, this information is not provided and likely not applicable as per the common understanding of algorithms in pulse oximeters. The oximeter's operation is based on established biophysical principles and algorithms, not typically on a "training set" in the context of machine learning.
In summary, the provided 510(k) summary gives high-level information about the clinical testing conducted per ISO 9919 but lacks the specific performance metrics, sample sizes, and detailed methodology you requested for a comprehensive understanding of the acceptance criteria and study execution.
§ 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).