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The V Series Monitoring System is intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters:

• . ECG waveform derived from 3, 5, 6 and 12 Lead measurements
• . Heart Rate
• . Pulse Oximetry (SpO2)
• ST Segment Analysis ●
• . Arrhythmia Detection
• . Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP) .
• Cardiac Output (CO) .
• . Respiratory Gasses
• . Respiration Rate
• . Temperature

The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

The V Series Monitoring System is a multi physiological parameter patient monitor. It is a modular system that allows the user to customize monitored parameters based on a patient's need or acuity level.

The Mindray V Series Monitoring System is a multi-physiological parameter patient monitor. The summary provided does not include specific acceptance criteria values or detailed study results for each parameter. Instead, it states that the device has been tested and found to be in compliance with recognized performance, safety, and electromagnetic compatibility standards.

However, based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not list specific numerical acceptance criteria (e.g., accuracy ranges for SpO2, NIBP, etc.) or quantitative performance results for each physiological parameter. Instead, it states that the device was found "to be in compliance with the following recognized performance, safety and electromagnetic compatibility standards." The listed standards implicitly define the acceptance criteria for each measurement type. For instance, ISO 9919:2005 for pulse oximetry, ANSPAAMI SP10:2002 + A1:2003 + A2:2006 for sphygmomanometers, and EC57:1998/(R)2003 for cardiac rhythm and ST-segment measurement algorithms would each contain detailed performance requirements.

Since specific performance values are not given, a table like the one requested cannot be fully constructed directly from the provided text. The "reported device performance" is implicitly that the device meets the requirements of the cited standards.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No clinical testing was required to confirm the safety and performance of the new features and non significant modification subject to this 510(k) submission." This implies that performance was likely evaluated through engineering bench testing and adherence to recognized standards, rather than through extensive clinical trials with a specific "test set" of patient data. Therefore, details about sample size for a test set and data provenance (country of origin, retrospective/prospective) are not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Given that no clinical testing was required, there is no mention of experts being used to establish a ground truth for a test set. The validation relies on compliance with established technical standards.

4. Adjudication Method for the Test Set

As no clinical testing with a specific test set was conducted that would require ground truth establishment by experts, there is no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was reported. This device is a physiological monitoring system, not typically an imaging interpretation device where MRMC studies are common for evaluating AI assistance.

6. Standalone Performance Study

The summary focuses on compliance with recognized performance, safety, and electromagnetic compatibility standards (e.g., IEC 60601 series, ISO 9919). This indicates that the device's performance was evaluated independently against these standards without human intervention in the loop for the core measurements. Therefore, a standalone performance study was implicitly done by demonstrating compliance with these technical standards, which outline specific test methods and performance requirements for the algorithm and hardware.

7. Type of Ground Truth Used

The ground truth used for performance validation is the reference methods and specifications defined within the recognized performance standards (e.g., calibrated instruments for NIBP accuracy, known signal generators for ECG parameters, etc.). It's not based on expert consensus, pathology, or outcomes data from a clinical trial in this context.

8. Sample Size for the Training Set

This device is a hardware-based physiological monitoring system. The concept of a "training set" is primarily relevant to machine learning or AI algorithms that "learn" from data. While the device may employ algorithms for signal processing (e.g., arrhythmia detection, ST-segment analysis), the 510(k) summary does not indicate that these algorithms were developed using a specific machine learning "training set" in the modern AI sense. Therefore, no information on training set sample size is provided.

9. How Ground Truth for the Training Set Was Established

As no "training set" in the machine learning context is mentioned or implied, the method for establishing its ground truth is not applicable and not provided. Algorithm development for such devices typically relies on established signal processing techniques validated against known physiological models or benchmark databases, rather than a "training set" with expert-labeled ground truth as seen in diagnostic AI.

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The AS3700 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

The AS3700 is intended for use by licensed clinicians, for patients requiring anesthesia within a health care facility, and can be used in both adult and pediatric populations.

The AS3700 Anesthesia Delivery System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation.

The provided text describes a 510(k) summary for the AS3700 Anesthesia Delivery System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and performance metrics for a diagnostic or AI-driven device.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) are not applicable or cannot be extracted from this document.

However, I can extract the information relevant to how the device's performance was evaluated for its 510(k) clearance, which is primarily through compliance with recognized standards.

Here's the closest representation based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states that "The AS3700 Anesthesia Delivery System has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards." This implies a series of engineering verification and validation tests were conducted to ensure the device met the requirements of each listed standard. It also mentions a "risk analysis has been developed to identify potential hazards and document the mitigation of the hazards" and that "The device's software has been verified and validated in accordance with the appropriate test requirements."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided: This is an engineering safety and performance validation, not a clinical study involving human data or a machine learning evaluation. The "test set" would refer to the physical device and its components undergoing testing against engineering standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided: Ground truth in this context refers to the defined specifications within the listed industry standards, which are established by expert consensus within standards bodies, not by individual clinical experts for a specific test set. The engineers conducting the tests would be qualified in medical device testing and regulatory compliance.

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

• Not applicable/Not provided: This pertains to clinical diagnostic studies involving reader interpretations, not engineering compliance testing.

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 an anesthesia delivery system, not an AI-powered diagnostic or assistive tool.

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

• Not applicable: This device operates with human input (licensed clinicians) and is not a standalone algorithm.

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

• Engineering Standards and Specifications: The "ground truth" for this device's performance is adherence to the technical specifications outlined in the various IEC, ISO, CGA, and ASTM standards listed. These standards represent established best practices and safety requirements for anesthesia delivery systems.

8. The sample size for the training set

• Not applicable: This is not a machine learning or AI device that requires a training set.

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

• Not applicable: This is not a machine learning or AI device that requires a training set.

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The Endeavour Monitoring System is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters:

• ECG waveform derived from 3, 5, 6 and 12 lead measurements
• Heart Rate
• Pulse Oximetry (SpO2)
• ST Segment Analysis
• Arrhythmia Detection
• Non Invasive Blood Pressure (NIBP)
• Invasive Blood Pressure (IBP)
• Cardiac Output (CO)
• Respiratory Gasses
• Respiration Rate
• Temperature

The Endeavour Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices.

The target populations are adult, pediatric and neonate with the exception of:

• Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only,
• IV Drug Calculations for which the target population is adult only, and
• Cardiac Output for which the target population is adult and pediatric only.

The Endeavour Monitoring System is a multi physiological parameter patient monitor. It is a modular system that allows users to customize monitored parameters based on a patients monitoring need or acuity level.

Here's an analysis of the provided text regarding the Endeavour Monitoring System's acceptance criteria and study information:

Acceptance Criteria and Device Performance for Endeavour Monitoring System

This summary is based on the provided 510(k) submission for the Endeavour Monitoring System (K102004).

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on compliance with established medical device standards and a clinical study comparing Non-Invasive Blood Pressure (NIBP) measurement. Specific quantitative acceptance criteria for each physiological parameter were not explicitly detailed in the provided text, but compliance with relevant IEC, ISO, AAMI, and ASTM standards serves as the implicit acceptance criteria for most parameters.

For the NIBP module, the acceptance criterion was implicitly defined by demonstrating no statistically significant difference in mean readings compared to the predicate device.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for NIBP Clinical Study: The specific number of subjects in the clinical study for NIBP is not mentioned in the provided text. It is only referred to as a "non-significant risk study."
• Data Provenance: The document does not specify the country of origin of the data. The study was a "non-significant risk study," which implies it was a prospective study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

For the NIBP clinical study, the ground truth was established by comparison to the predicate device, the Accutorr Plus Monitor (K983575). The text does not mention the use of experts to establish a separate ground truth or their qualifications. The predicate device itself acts as the reference for comparison.

4. Adjudication Method for the Test Set

Since the NIBP study compared the device to a predicate device, there's no mention of an adjudication method in the traditional sense (e.g., 2+1 or 3+1 expert consensus) as would be seen in image interpretation or diagnostic studies. The comparison was likely a direct measurement comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. This device is a physiological monitoring system and not an AI-based diagnostic tool that would typically involve human readers interpreting output. The study focused on the performance of the NIBP module against a predicate device, not on how human readers' performance improved with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

The NIBP clinical study appears to evaluate the device's NIBP algorithm in a standalone manner, comparing its measurements directly to a predicate device. While a human uses the device, the study's focus was on the machine's measurement accuracy versus another machine, not on human interpretation of the machine's output. Therefore, for the NIBP component, this was essentially a standalone performance evaluation of the measurement capability. For other parameters, compliance with standards (e.g., for heart rate, SpO2, etc.) also implies standalone verification of their algorithms/measurement capabilities.

7. The Type of Ground Truth Used

For the NIBP clinical study, the ground truth was the measurements obtained from the legally marketed predicate device, the Accutorr Plus Monitor (K983575). This is a form of comparative ground truth against an established and accepted reference.

8. The Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. This is a physiological monitoring device, and the submission primarily focuses on compliance with established performance standards and validation against a predicate device, rather than the development and training of a machine learning algorithm.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned or implied for an AI/machine learning algorithm, this information is not applicable and not provided in the document. The device's performance is established through adherence to recognized standards and clinical comparison to a predicate.

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