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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)

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The ESCORT Vision Central Station is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring for a variable number of ESCORT II Bedside Monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.

The ST algorithm has been tested for accuracy of the ST segment measurement data. The significance of the ST segment changes must be determined by a physician.

The modified ESCORT Vision Central Station is a central station monitor comprised of a standard VGA display, a standard personal computer base and an auxiliary base or receiver hub used to mount the network communications hardware. The modified Stickman telemetry transmitter is an RF physiological signal transmitter comprised of an ECG measurement system packaged with a UHF transmitter.

The modified ESCORT Vision Central Station provides centralized display, storage and recording (or printing) of patient vital sign and waveform data that are being monitored at ESCORT II, 100, 300 or 400 Series Bedside Monitors or UHF telemetry receivers. The modified Stickman telemetry transmitter provides ECG signal monitoring and RF signal transmission.

The modified ESCORT Vision Central Station with Stickman Telemetry Transmitters communicates in the new WMTS band, providing protection against interference.

This document describes the ESCORT Vision Central Station with Stickman Telemetry Transmitter. The information provided primarily focuses on substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study specifically proving the device meets those criteria for clinical performance.

Here's a breakdown of the available information based on your requested categories:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as typically seen for AI/ML device evaluations. The focus is on the device's technological characteristics being similar to the predicate and confirmation of testing for safety and accuracy of the ST algorithm.

2. Sample size used for the test set and the data provenance

The document does not provide details on the sample size for any test sets or the data provenance (e.g., country of origin, retrospective/prospective). It only states that the "ST algorithm has been tested for accuracy."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document mentions that "The significance of the ST segment changes must be determined by a physician," but this refers to clinical interpretation, not the establishment of ground truth for a device's performance study.

4. Adjudication method for the test set

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

This information is not explicitly provided. The summary focuses on the device's technical characteristics and substantial equivalence, not a comparative effectiveness study involving human readers with and without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document indicates that "The ST algorithm has been tested for accuracy." This suggests a standalone evaluation of the algorithm's performance without a human in the loop, but no specific results or study design for this are detailed.

7. The type of ground truth used

The type of ground truth used for the ST algorithm accuracy testing is not specified. It's implied to be related to clinical ST segment changes, but whether this was expert consensus, pathology, or another method is not stated.

8. The sample size for the training set

This information is not provided. The document predates common AI/ML terminology like "training set."

9. How the ground truth for the training set was established

This information is not provided, as the concept of a "training set" and its ground truth establishment in the context of advanced machine learning is not discussed in this 2001 document. The device's modifications are primarily around communication hardware and software for channel/identifier programming, not a major AI algorithm update requiring extensive new training data.

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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.

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.

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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:

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

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The ESCORT-LINK® Central Station Monitor is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia/ST monitoring for a variable number of ESCORT® II Bedside Monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.

The ST algorithm has been tested for accuracy of the ST segment measurement data. The significance of the ST segment changes must be determined by a physician.

The modified ESCORT-LINK® Central Station Monitor Model 20500 is a Central Station Monitor comprised of a standard VGA display, a standard Personal Computer Base and an auxiliary base used to mount the network communications hardware.

The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide centralized display, storage and recording (or printing) of patient vital sign and waveform data that are being monitored at ESCORT® II, 100, 300 or 400 Series Bedside Monitors or UHF Telemetry Receivers.

Data accumulated at ESCORT® II Bedside Monitors is sent via a proprietary Spread Spectrum Local Area Network to the modified ESCORT-LINK® Central Station Model 20500 for display and storage. Data accumulated from any of Medical Data Electronics' analog or digital telemetry transmitters is sent directly to the central station on standard UHF telemetry frequencies. Telemetry transmitter communication may include patient data similar to that described for the ESCORT® II Bedside Monitors. The modified ESCORT-LINK® Central Station Monitor Model 20500 oversees all communications activity, allowing each system component to pass information without interrupting patient monitoring.

The modified ESCORT-LINK® Central Station Monitor Model 20500 can provide alarm detection and reporting for all vital sign parameters available to the central station. This alarm response is in addition to alarms available at the ESCORT® II 100. 300 or 400 Series Bedside Monitors. Also, arrhythmia monitoring, with ST reporting, is available for up to 16 patients at the Central Station to provide the configurable ability to detect and report certain cardiac abnormalities, including ST abnormalities. Parameter alarms, arrhythmia alarms and ST alarms are independently configurable to accommodate the wide range of patients encountered in the hospital environment.

The Central Station provides storage of patient data. Stored patient data includes waveform and vital sign information. Stored waveform and vital sign data can be retrieved for viewing or printing.

The provided 510(k) summary for the ESCORT-LINK® Central Station Monitor Model 20500 with ST Option offers limited details regarding specific acceptance criteria and a comprehensive study to prove those criteria. However, I can extract the available information and structure it according to your request.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria or a direct comparison to reported device performance in a table format. It generally mentions the device was "designed and tested to functional standards developed by independent and regulatory agencies."

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated. The document mentions validation against "the European ST-T (ESC) database." The size of this database for the specific testing performed is not provided.
• Data Provenance: "European ST-T (ESC) database." This indicates the data is from Europe. It is not specified whether the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not mentioned in the document.

4. Adjudication method for the test set

Not mentioned in the 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done based on the provided text. The device is a central station monitor with an ST option, not an AI interpretation tool for human readers. Its primary function is to provide automated ST analysis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, implied. The algorithm comprising the modification (the ST analysis) was "validated against the European ST-T (ESC) database," suggesting a standalone performance evaluation of the algorithm. The device itself operates "without human-in-the-loop performance" for the ST analysis function. The physician's role is to interpret the significance of the changes detected by the device.

7. The type of ground truth used

The ground truth for the ST analysis algorithm's validation was established from "the European ST-T (ESC) database." This database is typically a collection of annotated ECG recordings where ST-T changes (and often associated clinical events like ischemia) are validated, often by expert cardiologists or based on clinical outcomes. However, the specific method of ground truth establishment within that database (e.g., expert consensus, angiography results, pathology) is not detailed in this 510(k) summary.

8. The sample size for the training set

Not mentioned in the document. The document only refers to validation data.

9. How the ground truth for the training set was established

Not mentioned in the document, as no information on a training set is provided.

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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.

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The primary use of the CIM, as an intermittent themmeter, is to take a patient's temperature at a single point in time. However, the instrument's Monitor mode also allows continuous monitoring of the patient's temperature. The CIM is a clinical grade thermometer. It is intended for use by healthcare practitioners only; typically in a hospital, clinic or mobile environment. It is not intended for lay or home use.

The Clinical Themometry Module is intended to be used for the intermittent determination of temperature in hypothermic normothermic of ebrildren or adults, In the Normal mode, oral use in compliant patients allowing maintenance of the sublingual picket for the temperature-taking cycle, enables the predictive algorithm to determine an accurate temperature in approximately 4 seconds. Rectal use results in a predictive temperature in approximately 10 seconds.

The CTM consists of an elongated metal heat-conductive probe connected to the multiparameter module (MPM) which may be used with the ESCORT® II Patient Monitor through a coiled cable. The probe contains a thermistor which conveys temperature information to the MPM for calculation of patient temperature which may be displayed on the ESCORT® II display panel.

Prior to use, the probe is inserted into a plastic probe cover. The cover offers no significant barrier to heat transfer from the patient to the probe body. The disposable nature of the probe cover prevents microbiological cross-contamination among patients such as might occur with a reusable probe.

Calculation of patient temperature may, in the normal mode, utilize algorithms which enable accurate temperature prediction within 3 to 10 seconds of probe placement.

Here's an analysis of the provided text regarding the K970011 Clinical Thermometry Module, focusing on acceptance criteria and supporting studies, formatted as requested:

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance

The document describes "bench testing methods" used for device testing. It does not specify a sample size in terms of number of patients, readings, or specific data points for the test set. Instead, it relies on statistical analysis of temperature measurements.

• Data Provenance: The bench testing involved "making temperature measurements at operational environmental extremes of temperature and humidity" and "using a constant temperature source." This indicates the data was generated in a laboratory setting rather than from human subjects. The provenance is therefore considered retrospective/simulation based on laboratory conditions and not derived from clinical patient data or specific geographical regions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts to establish ground truth for the test set. The ground truth for the bench testing appears to be established by the "constant temperature source" and the predicate devices themselves, as the CTM was validated "against the predicate devices incorporating Diatek technology."

4. Adjudication method for the test set

There is no mention of an adjudication method for the test set. Since the testing involved bench comparisons to known standards (constant temperature source) and predicate devices, a human adjudication method was not applicable or described.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a direct measurement instrument (thermometer), not an AI-assisted diagnostic tool that would involve human interpretation or "readers." Therefore, there is no discussion of human reader improvement with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a form of standalone performance evaluation was implicitly done. The "bench testing methods" evaluated the CTM's accuracy and repeatability in a lab setting, comparing its measurements to known standards and predicate devices without human intervention in the measurement process. The predictive algorithm's performance (determining accurate temperature in approximately 4 seconds orally, 10 seconds rectally) is described as an inherent function of the device itself.

7. The type of ground truth used

The ground truth used for the bench testing was:

• Known constant temperature sources: Implicit in "using a constant temperature source."
• Measurements from predicate devices: The CTM was validated "against the predicate devices incorporating Diatek technology." This means the predicate devices' measurements served as a reference for accuracy.

8. The sample size for the training set

The document describes a 510(k) submission for a medical device (thermometer), not an AI/machine learning model that typically requires a distinct "training set." Therefore, there is no mention of a training set sample size. The CTM's algorithms would have been developed and tested by the manufacturer during its design phase, but this is not referred to as a "training set" in the context of this submission.

9. How the ground truth for the training set was established

As there is no explicit mention of a "training set" in the context of this 510(k) submission, the method for establishing its ground truth is not provided. The device's underlying algorithms would have been designed based on established thermometry principles and validated through internal development testing, likely using similar methods to the bench tests described for the 510(k) submission.

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The ESCORT-LINK™ Central Station Monitor is intended to be used to provide, using a wireless LAN for communication, centralized surveillance and documentation of patient vital sign data and arrhythmia monitoring and alarms for a variable number of ESCORT II bedside monitors and a variable number of UHF telemetry transmitters in the hospital environment. It is intended for use by healthcare practitioners trained in the use of the equipment only.

The ESCORT LINK Central Station Monitor Model 20500 is a Central Station monitor comprised of a standard VGA Display, a standard Personal Computer Base, and an auxiliary base used to mount the Network communications hardware (i.e. Spread Spectrum transponders and UHF telements of the The ESCORT LINK Central Station Monitor Model 20500 can provide the centralized display, storage, and recording (or printing) of patient vital sign and waveform data that is being monitored at ESCORT II 100, 300, or 400 bedside monitors or UHF Telemetry Receivers.

Here's a breakdown of the acceptance criteria and study information for the ESCORT LINK Central Station Monitor Model 20500, based on the provided text:

Acceptance Criteria and Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria or a direct table comparing them to reported device performance. Instead, it indicates that the device was designed to "functional standards developed by independent and regulatory agencies" and its performance was evaluated against these.

However, based on the "Device Testing" and "Test Conclusions" sections, we can infer the key performance areas that were tested and deemed acceptable:

The document states that the device was shown to be "safe, effective Central Station Monitor" in these areas, and "substantially equivalent" to the predicate device (ESCORT LINK Central Station Monitor Model 3200).

Study Details

The provided document offers limited specific details about the study methodology in the typical research paper format. However, it does provide some insights into the testing conducted:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The document refers to "tests demonstrating consideration of and mitigation of hazards" and "application of system tests, reviews, and product verification and validation studies." This suggests comprehensive system-level testing rather than a specific patient-based test set with a defined sample size.
   • Data Provenance: Not specified. The context implies internal testing by Medical Data Electronics, Inc.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The document does not mention the use of external experts for establishing ground truth for a test set.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not specified. This level of detail regarding adjudication methods is not present in the document.

4. 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:

   • No. The device described is a central station monitor for vital signs and arrhythmia, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC comparative effectiveness study involving human readers would not be applicable or expected for this type of device.

5. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

   • Yes, implicitly. The "Device Testing" and "Test Conclusions" sections refer to "performance testing" of the "ESCORT LINK Central Station Monitor Model 20500" itself. This suggests testing the device's inherent functionality (alarm detection, arrhythmia detection, data accuracy) as a standalone system. The central station's role is to display, store, and report data, and its own algorithms for arrhythmia detection are specifically mentioned (Provided by Zymed Inc.).

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not explicitly stated. Given the nature of the device (monitoring vital signs and arrhythmia), the "ground truth" would likely involve known, controlled physiological signals or simulated data representing various cardiac events and vital sign parameters, allowing for verification of the device's detection and reporting accuracy against these known states. This would likely be established through engineering and physiological standards.

7. The sample size for the training set:

   • Not applicable. The document describes a central monitoring system with specific hardware and software, including a "Zymed Inc." arrhythmia algorithm. It does not indicate that the device's core functionality (especially arrhythmia detection) involved a machine learning model that required a specific "training set" in the modern sense. The "Zymed Inc." algorithm would have been developed and validated by its provider, and its integration into this system would have been tested for proper function.

8. How the ground truth for the training set was established:

   • Not applicable, as a "training set" in the machine learning context is not mentioned or implied for this device.

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