(138 days)
The Masimo ReSposable SpO2 Series Oximetry Sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, infant and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals, hospital-type facilities, mobile, and home environments.
The Masimo ReSposable SpO2 Series Oximetry Sensors are pulse oximetry sensors. They measure tissue oxygenation non-invasively through infrared emitters and detectors. The ReSposable SpO2 Series Oximetry Sensors are fully compatible for use with instruments which include the following technologies:
- · Masimo SET technology
- · Masimo Rainbow SET technology
- · Nellcor technology
- · Philips FAST-SpO2 technology
The provided documentation is a 510(k) summary for the Masimo ReSposable SpO2 Series Oximetry Sensors. This document primarily focuses on establishing substantial equivalence to predicate devices and detailing the device's intended use and physical characteristics, along with a list of non-clinical and clinical testing performed.
However, the document does not include specific acceptance criteria or the detailed results of a study that proves the device meets those criteria. The available information states that "The following clinical and non-clinical testing was conducted to verify that the Masimo ReSposable SpO2 Series Oximetry Sensors met all design specifications," but it doesn't elaborate on the "design specifications" (acceptance criteria) or the measured performance against them.
Therefore, I cannot populate the table of acceptance criteria and reported device performance, nor can I fully answer questions about sample sizes, ground truth establishment, or specific study designs (like MRMC or standalone performance) because that detailed information is not present in the provided text.
Based on the available information, here's what can be inferred or stated:
1. Table of Acceptance Criteria and Reported Device Performance
Information Not Available: The document mentions "all design specifications" were met but does not specify what these acceptance criteria are or present a table of reported device performance against them.
2. Sample size used for the test set and the data provenance
Information Not Available: The document does not provide details on the sample size used for any clinical or non-clinical tests or the data provenance (e.g., country of origin, retrospective/prospective). It only lists the types of tests conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Information Not Available: The document does not describe any expert-based ground truth establishment as typically seen in image analysis or diagnostic studies. The tests listed are primarily related to physical performance, electrical characteristics, and overall biocompatibility and environmental robustness. For SpO2 accuracy, typically arterial blood gas measurements (Gold Standard) are used, but details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Information Not Available: Not applicable to the type of tests briefly described.
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
Information Not Available: This device is an oximetry sensor, not an AI-assisted diagnostic or imaging device used by human readers. Therefore, an MRMC study with AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Information Not Available: The document mentions "clinical and non-clinical testing" was done, but it doesn't specify if this included a standalone performance evaluation of the sensing algorithm in isolation. For SpO2 devices, standalone performance typically refers to the accuracy of the device's SpO2 readings against a "gold standard" (like arterial blood gas analysis) under various physiological conditions (motion, low perfusion, different SpO2 levels). While clinical tests were conducted, details about this specific type of assessment are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Information Not Available: For the SpO2 device, the gold standard for ground truth in clinical testing of SpO2 accuracy is typically arterial blood gas co-oximetry. However, the document does not explicitly state what ground truth method was used for its "clinical testing." For the non-clinical tests (biocompatibility, light rejection, etc.), the ground truth would be established by relevant scientific standards and measurement techniques.
8. The sample size for the training set
Information Not Available: The document does not describe any machine learning or AI component that would require a "training set." Therefore, this information is not applicable and not provided.
9. How the ground truth for the training set was established
Information Not Available: See point 8. Not applicable as no training set is mentioned.
§ 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).