(133 days)
The MTS Option for the ESCORT II Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment.
The MTS Option for the ESCORT® II Monitor is a modular patient monitor capable of monitoring two parameters simultaneously, including dual-vector ECG and SpO2. The MTS Module is equipped with an alphanumeric LCD display that is capable of displaying vital signs providing the detail needed to aid clinical decisions.
The provided text describes a 510(k) summary for the MTS Option for the ESCORT® II Monitor. However, it does not contain the specific details required to complete your request for acceptance criteria, device performance, or study specifics as if it were a modern AI device submission.
The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria with detailed studies. It references general standards and guidance documents, but doesn't present the results of specific performance tests in the format you've requested.
Here's why the requested information cannot be fully extracted from the provided text and what general inferences can be made:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document states that the device is "designed to meet established standards" such as "ANSI/AAMI EC-13: 1992, Cardiac monitors, heart rate meters, and alarms" and "ASTM F 1415 - 92, Standard Specification for Pulse Oximeters." However, it does not explicitly list specific numerical acceptance criteria (e.g., heart rate accuracy within X bpm, SpO2 accuracy within Y%).
- Reported Device Performance: The document generally states, "The MTS Option for the ESCORT® II Monitor is shown by performance testing to be a safe, effective portable patient monitor." It does not provide specific performance metrics (e.g., sensitivity, specificity, accuracy, precision for ECG or SpO2 measurements) or a comparison of these against the (unspecified) acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Not provided. The document states "comprehensive bench testing and product verification and validation studies" were conducted but does not give any details on sample sizes, types of data (e.g., patient data, simulated data), or where the data came from (country, retrospective/prospective). This was common for 510(k) submissions of this era, which often relied on meeting established standards and substantial equivalence rather than extensive clinical efficacy studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. For a device like a patient monitor measuring ECG and SpO2, ground truth is typically established by reference measurement equipment (e.g., a calibrated ECG simulator, co-oximeter for SpO2) rather than expert consensus on diagnostic images or interpretations. The document does not describe any studies involving human experts establishing ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. As ground truth for these types of vital sign measurements is typically objective reference measurements, an adjudication method for expert consensus would not be relevant or described in this document.
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 document describes a patient monitor (hardware device for measuring vital signs), not an AI-powered diagnostic or decision support system that would involve human "readers" or an "AI assistance" component to evaluate. Therefore, an MRMC study is not relevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not explicitly stated in relevant terms. While the device itself operates "standalone" in terms of its algorithms for processing ECG and SpO2 signals, the term "standalone performance" is often used in the context of AI algorithms analyzing data to provide a diagnostic or predictive output. This document is about the physical monitor and its basic measurement capabilities. Its "performance testing" would be against reference standards, implying an "algorithm only" type of evaluation in that sense, but not in the context of complex AI interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Inferred: Reference Measurement Equipment/Standards. For vital signs monitoring, ground truth is typically established by highly accurate and calibrated reference devices or simulators that generate known physiological signals or concentrations. The mention of specific standards (ANSI/AAMI EC-13, ASTM F 1415) implies testing against established methods and reference values defined within those standards.
8. The sample size for the training set:
- Not applicable/Not provided. This is a hardware device for vital sign monitoring, not an AI model that requires a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model is described.
In summary of what can be extracted:
- Device Type: Portable Patient Monitor (ECG, SpO2).
- Intended Use: Monitoring vital signs of critically ill adult and pediatric patients in the hospital environment.
- Key "Study" Reference: "conformance to product development procedures and plans is assured by application of comprehensive bench testing and product verification and validation studies."
- Standards Met (Implicit Acceptance Criteria):
- Reviewer Guidance for Premarket Notification Submissions, Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory and Neurological Devices; November, 1993
- Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review; Office of Device Evaluation, August, 1991
- ANSI/AAMI EC-13: 1992, Cardiac monitors, heart rate meters, and alarms, 2nd edition
- ASTM F 1415 - 92, Standard Specification for Pulse Oximeters
- Conclusion: "The MTS Option for the ESCORT® II Monitor is shown by performance testing to be a safe, effective portable patient monitor. The MTS Monitor is substantially equivalent to the MDE ESCORT® II 300 Series and the MDE ESCORT® II+ 400 Series Monitors."
This document reflects a 510(k) submission from 1997, which had different requirements and expectations for demonstrating device safety and effectiveness, particularly for non-AI hardware devices. The level of detail you're requesting is more aligned with modern AI/ML device submissions.
§ 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).