(29 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 to the currently marketed device with the exception of the functionality of the Pulse Oximeter (SpO2) Options available. The predicate device, incorporating Nellcor technology, requires user action to invoke special signal processing ('C-Lock') in order to better handle limited patient perfusion. The modified device, incorporating Masimo technology, requires no user action and no 'C-Lock' key to select special signal processing to cope with limited patient perfusion.
The provided text does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the way typically found for AI/ML devices. Instead, it is a 510(k) summary for a patient monitoring device (ESCORT II+ 400 Series Monitor) seeking clearance based on substantial equivalence to a predicate device.
The document focuses on:
- Device Description: The device is a patient monitor with various options like cardiac monitor, pulse oximetry, NIBP, etc.
- Modification: The key change in the modified device from the predicate is the use of Masimo technology for pulse oximetry, which "requires no user action and no 'C-Lock' key to select special signal processing to cope with limited patient perfusion," unlike the predicate which used Nellcor technology requiring user action for 'C-Lock' for limited patient perfusion.
- Substantial Equivalence: The submission claims substantial equivalence to the predicate device because the modified device has the same intended use and similar technological characteristics, with the exception of the pulse oximeter's signal processing.
- Testing: It states that "Testing of the modified ESCORT II+ 400 Series (ESCORT Prism) monitors was conducted by MDE to ensure mitigation of hazards. V&V testing and testing of the modified device to safety standards are exactly the same as those conducted on the predicate device." However, no specific performance metrics, acceptance criteria, or study results are detailed.
Therefore, I cannot provide the requested table and study information because the provided text does not include:
- A table of acceptance criteria and reported device performance: There are no quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy, or specific thresholds for physiological parameters) mentioned, nor are there any reported performance metrics from a study against such criteria.
- Sample size, data provenance, ground truth details, or adjudication methods for a test set: The document mentions "V&V testing" but provides no details about the methodology, data used, or how ground truth was established for any performance evaluation.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is relevant for AI/ML diagnostic tools where human readers interpret results. The ESCORT II+ is a patient monitor, and its clearance is based on technological equivalence for vital sign monitoring, not on enhancing human interpretation of images or complex data.
- Standalone (algorithm-only) performance: While the device uses new signal processing for pulse oximetry, the document does not present it as an "algorithm only" performance study in the context of typical AI/ML submissions. The device itself is a standalone monitor.
- Ground truth type for performance evaluation: No specific ground truth type (e.g., pathology, outcomes) is mentioned, as no detailed performance study results are provided.
- Training set details: Since no AI/ML model training is described, there's no mention of a training set or how its ground truth was established.
In summary, the provided document is a 510(k) summary focused on establishing substantial equivalence for a physical patient monitoring device, not a detailed performance study for an AI/ML algorithm with specific acceptance criteria.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).