(238 days)
The Nellcor® OxiMax® NeoMAX adhesive forchead reflectance sensor is indicated for single patient use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for neonatal and pediatric patients (≤ 40 kg).
The OxiMax NeoMAX is a sterile, latex-free, single patient use forehead sensor, sized appropriately to fit the forehead of a neonatal or pediatric patient.
The OxiMax NeoMAX sensor contains a memory chip carrying information about the sensor which the oximeter needs for correct operation, including in-sensor data. Advanced Signal Evaluation, lot code and data set revision, and sensor model. The OxiMax NeoMAX sensor is compatible with OxiMAX monitors.
The provided text describes the OxiMax NeoMAX Adhesive Forehead Reflectance Oximetry Sensor, but it does not contain a table of acceptance criteria or detailed results from a study proving the device meets specific criteria. The document states that "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," but it does not present these specifications or the results in detail.
Therefore, many of the requested items cannot be answered directly from the provided text.
Here is what can be extracted based on the input:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text. The text mentions "accuracy and precision specifications" were confirmed, but the specific values for these specifications are not given.
- Reported Device Performance: Not explicitly stated in the provided text. The document indicates that testing was performed and concluded that "The technological characteristics of the OxiMax NeoMAX sensor and the results of testing do not raise new questions of safety or effectiveness when compared to the legally marketed predicate device." However, the actual performance metrics (e.g., accuracy, bias, standard deviation of SaO2 readings) are not provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document only states "Human oxygenation evaluations were conducted."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. This device is an oximeter sensor, and ground truth for oxygen saturation measurements is typically established through arterial blood gas analysis, not expert consensus on images. The document does not describe how ground truth was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in studies involving expert interpretation of data (e.g., images), which is not the primary form of evaluation for an oximeter sensor.
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
- Not applicable. This device is an oximeter sensor, not an AI-assisted diagnostic tool that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a sensor. Its "performance" inherently refers to its ability to accurately measure oxygen saturation and pulse rate. The evaluation would be of the sensor's direct measurement capabilities, which is analogous to a standalone performance evaluation in the context of a medical device's fundamental function. The document states "Human oxygenation evaluations were conducted to confirm conformance to accuracy and precision specifications," implying a direct measurement efficacy study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated, but for oxygen saturation measurements, the common gold standard (ground truth) is arterial blood gas analysis. It is highly probable this method was used, though not specified in the text.
8. The sample size for the training set
- Not applicable/Not specified. This device is a sensor; it does not involve a "training set" in the context of machine learning algorithms.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a training set.
In summary, the provided 510(k) summary focuses on establishing substantial equivalence to a predicate device and mentions that human and bench tests were performed to confirm accuracy and precision. However, it lacks the detailed quantitative data, sample sizes, and ground truth methodologies that would be necessary to fully answer many of the questions regarding acceptance criteria and study particulars.
§ 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).