(30 days)
The Medical Data Electronics ESCORT 100/300 Series B Patient 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® 100/300 Series B (ESCORT II) Patient Monitor Device 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 describes a 510(k) submission for a patient monitor and focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a standalone study for a new device. Therefore, much of the requested information regarding acceptance criteria and study design is not explicitly available in the provided text.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or performance metrics for the device. Instead, the "acceptance criteria" are implied to be the successful demonstration of substantial equivalence to the predicate device, particularly regarding the functionality of the Pulse Oximeter (SpO2) option.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Modified device (with Masimo technology) is "identical to the currently marketed device" with the exception of SpO2 signal processing. It "requires no user action and no 'C-Lock' key to select special signal processing to cope with limited patient perfusion." |
| Mitigation of hazards | "Testing of the modified ESCORT® 100/300 Series B (ESCORT II) Patient Monitor was conducted by MDE to ensure mitigation of hazards." |
| Compliance with safety standards | "V&V testing and testing of the modified device to safety standards are exactly the same as those conducted on the predicate device." |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a "test set" in the context of a clinical study or a dataset for performance evaluation in the way one might expect for an AI/ML device. The testing described is more aligned with verification and validation (V&V) of a medical device's engineering specifications and safety, rather than a performance evaluation against a specific clinical dataset.
- Sample Size: Not specified.
- Data Provenance: Not specified. The testing was "conducted by MDE" (Medical Data Electronics), suggesting internal testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The concept of "ground truth" established by experts for a test set is typically relevant for diagnostic or screening devices, often involving interpretation of images or clinical data. The testing mentioned in this document appears to be focused on device functionality and safety, not on clinical diagnostic accuracy requiring expert ground truth.
4. Adjudication Method for the Test Set
Not applicable/Not specified, as there is no mention of a test set requiring expert adjudication for ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, an MRMC comparative effectiveness study was not done. The device described is a patient monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output. The change described is an improvement in signal processing for pulse oximetry, making it less reliant on user intervention.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone patient monitor, but the testing described focuses on the device's performance and safety, particularly the improved pulse oximetry technology. It's not a standalone algorithm in the modern AI/ML sense that would have separate standalone performance metrics distinct from the integrated device. The signal processing improvement in the pulse oximeter is inherent to the device's function.
7. The Type of Ground Truth Used
The document does not detail the type of "ground truth" as it relates to a clinical accuracy study. The "testing" mentioned refers to V&V to ensure "mitigation of hazards" and compliance with "safety standards." In this context, the ground truth would likely be established by engineering specifications, regulatory standards, and objective measurements of the device's functional parameters (e.g., accuracy of SpO2 readings compared to a reference standard, though this level of detail is not provided).
8. The Sample Size for the Training Set
Not applicable/Not specified. The device does not appear to be an AI/ML device that requires a "training set" in the conventional sense. The "Masimo technology" for signal processing would have been developed and validated by Masimo, likely using proprietary datasets, but this information is not part of the 510(k) submission for the ESCORT monitor.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not specified, as no training set for an AI/ML algorithm is mentioned.
§ 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).