(28 days)
The Medical Data Electronics ESCORT II+ 400 Series Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult, pediatric and neonatal patients in the hospital environment.
The modified ESCORT II+ 400 Series (ESCORT Prism) monitor is identical to the currently marketed device with the exception of the functionality of the Pulse Oximeter (SpO2) options available. The predicate device, incorporating Nellcor MP204 technology, does not predicate de id signal processing techniques to compensate for patient motion. The modified device, incorporating Nellcor MP405 technology, incorporates features to compensate for patient motion.
This K014294 submission describes the ESCORT II+ 400 Series (ESCORT Prism) Monitor, a patient monitor for vital signs. The primary change from the predicate device is an updated Pulse Oximeter (SpO2) option incorporating Nellcor MP405 technology, which includes signal processing techniques for patient motion compensation.
The provided documentation does not include a detailed study that defines specific acceptance criteria for the device's performance (e.g., accuracy, precision) and then presents test results to demonstrate compliance with these criteria. Instead, the submission states that "Testing of the modified ESCORT II+ 400 Series (ESCORT Prism) monitors was conducted by MDE to ensure mitigation of hazards. V&V conducted on the modified device to safety standards are the same as those conducted on the predicate device." This indicates a verification and validation approach focused on safety standards and equivalence to the predicate, rather than a clinical performance study with specific acceptance criteria as typically defined for algorithm-driven devices.
Therefore, I cannot populate the table and answer all the questions as requested, because the provided text does not contain the necessary information regarding detailed acceptance criteria or a specific performance study.
However, based on the available information, I can address some points:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the provided document. The submission implies that the acceptance criteria are met by demonstrating substantial equivalence to the predicate device and by ensuring the device meets safety standards ("mitigation of hazards").
- Reported Device Performance: Not explicitly reported in terms of specific metrics (e.g., accuracy, sensitivity, specificity, or specific SpO2 accuracy values) in the provided document. The primary "performance" reported is that the modified device "incorporates features to compensate for patient motion" in its Pulse Oximeter function, improving upon the predicate's lack of such compensation.
2. Sample size used for the test set and the data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-expert-validated test set is described.
4. Adjudication method for the test set: Not applicable.
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 a vital signs monitor, not an AI-assisted diagnostic imaging system that would typically undergo MRMC studies with human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document describes the device, which includes an algorithm (for motion compensation in SpO2). The statement that "Testing... ensures mitigation of hazards" and V&V "to safety standards are the same as those conducted on the predicate device" implies testing of the device's functionality, including its algorithms, though specific "standalone" performance metrics are not given.
7. The type of ground truth used: Not explicitly stated. For a vital signs monitor, ground truth typically comes from highly accurate reference instruments or invasive measurements, but this is not detailed in the provided text.
8. The sample size for the training set: Not applicable, as this is a medical device submission, not a specific AI algorithm training submission with a distinct training set described. Nellcor MP405 technology is mentioned as being incorporated, which likely involves proprietary algorithms developed by Nellcor, but details of their training data are not part of this 510(k) submission.
9. How the ground truth for the training set was established: Not applicable. (See point 8)
§ 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).