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The HomMed Genesis Patient Monitor with Options is a system designed to monitor patient vital signs at home and/or in healthcare facilities. Vital signs include pulse oximetry (optional), noninvasive blood pressure, pulse rate, and weight. Data from optional commercial stand-alone products including glucose meter, spirometer, and prothrombin time can be exported via the Genesis communication module. Vital signs data is transmitted via modem to a central viewing station for display, analysis and monitoring by healthcare professionals. All patient data is collected, stored, forwarded and displayed in a retrospective manner, and is not intended to provide real-time critical care monitoring of patients, nor any local alarms or alerts of patient status.

The HomMed Genesis Patient Monitor System with Options (HomMed Genesis) is a portable patient vital signs monitoring system. The system measures pulse oximetry (optional), noninvasive blood pressure, pulse rate, and weight. HomMed Genesis will have four serial ports available for external options. The Genesis acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel or PageNet Pager Network to a central station for storage with retrospective display and analysis.

The provided text is a 510(k) summary for the HomMed Genesis Patient Monitor System. It outlines the device description, intended use, and a comparison with a predicate device. However, it does not contain acceptance criteria for device performance or a detailed study proving the device meets specific performance criteria beyond general compliance with voluntary standards.

The summary states:

• "The HomMed Genesis employs the same technologies as the predicate Technology: device, HomMed Sentry III Patient Monitor System with Card Reader."
• "The Genesis monitor complies with the following voluntary standards: Medical Electrical Safety EN 60601-1, EMC Compliance IEC 601-1-2, Biocompatibility ISO 10993-5,10-11."
• "It is the HomMed position that the results of these measures demonstrate Conclusion: HomMed Genesis is as safe, as effective and performs as well as the leqally marketed predicate device, HomMed Sentry III Patient Monitor System with Card Reader."

This indicates that the device's acceptance is primarily based on substantial equivalence to a predicate device and compliance with general safety and EMC standards, rather than specific performance metrics (like accuracy, sensitivity, specificity, etc.) for its vital sign measurements as would be expected for a diagnostic AI/ML device.

Therefore, many of the requested details about acceptance criteria and a study proving device performance cannot be extracted directly from this document.

Here's an attempt to answer based on the available information, noting the missing details:

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

Comment: The document focuses on regulatory compliance and equivalence rather than specific performance metrics for the vital sign measurements themselves. For a device measuring vital signs like blood pressure, pulse oximetry, and pulse rate, one would typically expect to see performance criteria related to accuracy, bias, and precision against a reference standard. These are absent here, likely because the 510(k) process in this instance relies heavily on the predicate device's established performance.

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

• Sample Size (Test Set): Not specified. The document does not describe a clinical performance study with a test set.
• Data Provenance: Not applicable, as no specific performance study with a test set is detailed.

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

• Not applicable, as no specific performance study with a ground truth-established test set is detailed.

4. Adjudication method for the test set

• Not applicable, as no specific performance study with a test set requiring adjudication is detailed.

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. The device is a vital signs monitor, not an AI-assisted diagnostic imaging tool with human-in-the-loop performance.

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

• The device itself is a standalone vital signs monitor. Its performance is compared to a predicate device, and it complies with voluntary standards. However, the document does not detail specific standalone performance studies for accuracy of the vital sign measurements against a gold standard as one might see for an AI algorithm. Its function is to acquire and transmit data, not to perform complex algorithmic interpretations that require "human-in-the-loop" interaction in the typical AI/ML sense.

7. The type of ground truth used

• Not applicable, as no specific performance study with a ground truth is detailed. Performance is asserted based on technological equivalence to a predicate device and compliance with general safety standards.

8. The sample size for the training set

• Not applicable, as this device does not appear to involve AI/ML that would require a "training set" in the conventional sense (e.g., for image recognition or predictive modeling). It is a hardware system for measuring physiological parameters.

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

• Not applicable.

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The HomMed Sentry IIIB-F Patient Monitor System is designed to measure Patient Vital Signs in the home by patients or in clinical environments by health care providers. The HomMed Sentry IIIB-F Patient Monitor System is available with physicians' orders only.

The HomMed Sentry IIIB-F Patient Monitor System measures the following parameters: Non-Invasive Blood Pressures (Systolic and Mean Arterial Pressure), Functional Oxygen Saturation (%SpO₂), Peripheral Pulse Rate (PPR), Pulse Strength, Oral Temperature and Patient Weight via an external scale. The HomMed Sentry IIIB-F Patient Monitor System's optional, compatible devices extend those measurements to glucometer, spirometer, electrocardiogram (ECG) and prothrombin time (PT/INR) monitoring and digital image acquisition. The patient parameter data is collected and displayed by the HornMed Sentry IIIB-F Patient Monitor System. Data can be transmitted via the communication module to a central station where the patient data can be viewed and analyzed.

The HomMed Sentry IIIB-F Patient Monitor System (Sentry IIIB-F) is a portable patient vital signs monitoring system. The system measures noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. In addition, the system has optional glucometer, spirometer, electrocardiogram (ECG) and prothrombin time (PT/INR) measuring, and digital image acquisition capabilities. The Sentry IIIB-F acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel or PageNet Pager Network to a central station for storage with retrospective display and analysis.

Sentry IIIB-F provides a noninvasive blood pressure (NIBP) monitor for measurements of a patient's systolic, diastolic, and mean arterial (MAP) blood pressures; pulse oximeter, acquires a pulse rate using an oximeter; oral temperature via an electronic thermometer; weight from an electronic scale. All data collected from these functions as well as optional glucometry, ECG devices, PT/INR monitor and acquired digital images are sent through an internal communication module.

The provided 510(k) summary for the HomMed Sentry IIIB-F Patient Monitor System states that the device's performance has been confirmed to be equivalent to its predicate device (HomMed Sentry III Patient Monitor System with Card Reader, K014025). The summary also mentions compliance with various national and international standards. However, it does not provide a detailed list of specific acceptance criteria or the reported device performance in a numerical or quantitative format. Instead, it offers a general statement regarding compliance and consistency with guidelines.

Therefore, the requested table of acceptance criteria and reported device performance, as well as several other detailed study parameters, cannot be fully extracted from the provided text. The document focuses on regulatory compliance and equivalence to a predicate device rather than presenting a standalone clinical or performance study with detailed statistical results.

Here's a breakdown of what can and cannot be extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not specified. The document mentions "testing done on the Sentry III IIIB-F" but does not provide details on sample size (e.g., number of patients, number of measurements), data provenance, or whether the study was retrospective or prospective.

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 specified. The nature of the device (vital signs monitor) suggests that ground truth would typically be established by validated reference devices rather than human experts interpreting complex data. The document does not mention any expert involvement in establishing ground truth for testing.

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

• Not applicable/Not specified. This type of adjudication is typically used for subjective interpretations by multiple human readers (e.g., in imaging studies). For a vital signs monitor, performance is usually assessed against a known standard or reference device, not via subjective adjudication.

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. This is not an AI-assisted device, nor is it a device that involves human readers interpreting complex cases in the way that an MRMC study would apply. Therefore, no such study was conducted or reported.

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

• Yes, implicitly. The "Performance Data" section describes "testing done on the Sentry III IIIB-F" to assure compliance with standards and to demonstrate it "performed within its specifications and functional requirements." This refers to the device's inherent performance. Since this is a direct vital signs measurement device, its "standalone" performance is its primary mode of operation. There is no "algorithm only" in the sense of an AI model being evaluated separately from the device's physical sensors and processing.

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

• Implicitly, reference standards or validated measurement methods. For vital signs, ground truth would be established by highly accurate, often invasive or gold-standard, reference devices (e.g., intra-arterial blood pressure for NIBP, co-oximetry for SpO2, calibrated scales for weight, etc.). The document does not explicitly state the specific reference devices used but implies comparison to established and validated measurement techniques.

8. The sample size for the training set

• Not applicable/Not specified. This device is not an AI/machine learning device that requires a training set in the conventional sense. Its performance is based on traditional signal processing and sensor technology, not a learned model.

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

• Not applicable/Not specified. As mentioned above, there is no "training set" for this type of device.

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The HomMed Central Station intended use is to retrospectively receive, display, and store certain monitored physiological parameters received from adult and pediatric (over 12 years of age) patients within healthcare and home environments. Central Station, Version 3.3H includes a HL7 interface to transfer data from HomMed Central Station to vendor systems and storage media. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, SpO2, temperature, and weight. Additionally monitoring device data from optional commercial stand-alone products including glucometry, spirometry, prothrombin time, ECG and digital camera images can also be received, displayed and stored. The Central Station displays patient data and system alerts for review and interpretation by physicians and/or physician supervised nurses. Central Station is a retrospective data monitor system and is not intended for emergency use or real-time monitoring.

The HomMed Central Station is a software system that operates on a commercially available PC system with the minimum performance specifications consistent with typical PC hardware and equipment specifications. The HomMed Central Station is a software system that accepts data from the HomMed Sentry Patient Monitors.

The provided text describes the HomMed Central Station, Version 3.3H, a device intended to retrospectively receive, display, and store physiological parameters. However, the document does not contain information regarding specific acceptance criteria, a detailed study proving performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies, or how ground truth was established beyond a general statement of "software validation results."

The "Performance Data" section states that "The software validation results demonstrated that the HomMed Central Station 3.3H System was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements." This is a high-level summary and does not provide the specific details requested in the prompt.

Therefore, I can only provide limited information based on the text.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria. The performance is stated generally:

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

• Sample size for the test set: Not specified in the provided document.
• Data provenance: Not specified in the provided document. The device itself retrospectively receives data, but the provenance of data used for validation is not mentioned.

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 specified in the provided document.

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

• Not specified in the provided 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

• No MRMC comparative effectiveness study is mentioned or implied. The device is a data display and storage system, not an AI-powered diagnostic tool for human reader improvement.

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

• The document implies a standalone software validation was performed ("The HomMed Central Station is a software system... The software validation results demonstrated..."), but specific details on the methodology (e.g., comparison to a reference standard without human involvement) are not provided. The phrase "algorithm only" might not be fully applicable as it's a data management system, not a diagnostic algorithm.

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

• Not specified. The statement "performed within its specifications and functional requirements" suggests validation against predetermined software requirements and potentially functional testing, but the nature of the "ground truth" for the physiological parameters themselves is not detailed.

8. The sample size for the training set

• Not specified in the provided document.

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

• Not specified in the provided document.

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The HomMed Central Station is intended to be used to retrospectively receive, display, evaluate, analyze and store certain monitored physiological parameters of patients within healthcare and home environments. The physiologic patient parameters available for retrospective display and evaluation include NIBP, pulse rate, SpO2, temperature and weight. The Central Station will be the device used by the healthcare professional to display and evaluate the monitored patient data, and the healthcare professional is responsible for the interpretation of the monitored data made available by the Observer. The Central Station data will be a utilized by the healthcare professional health including physicians and/or physician supervised nurses. Physiological data, system alerts and patient data analysis will be available to the health care provider from Central Station that may be considered as a retrospective data monitor system.

The HomMed Central Station is a software system that operates on a commercially available PC system with the minimum performance specifications consistent with typical PC hardware and equipment specifications. The HomMed Central Station is a software system that is an accessory to the HomMed Sentry Patient Monitors.

Here's a breakdown of the acceptance criteria and study information for the HomMed Central Station, based on the provided text:

Summary of Acceptance Criteria and Reported Device Performance

Study Information

Based on the provided text, the submission is a 510(k) Premarket Notification for the HomMed Central Station. This type of submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting extensive clinical efficacy trials typically seen for PMA applications.

Here's what can be inferred about the "study" mentioned for this device:

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

   • The document states: "The software validation results demonstrated that the HomMed Central Station System was in compliance with the guidelines and standards referenced in the FDA reviewer's guides and that it performed within its specifications and functional requirements."
   • This indicates a software validation study was performed. However, no specific sample size for a "test set" of patient data is provided. The validation would likely involve testing various scenarios and inputs to ensure the software (Central Station) accurately receives, displays, evaluates, analyzes, and stores the physiological parameters from the HomMed Sentry Patient Monitors.
   • Data provenance is not specified. Given the nature of a software validation, it would likely involve simulated or representative data, potentially from a variety of sources but not explicitly stated. The intent is to process data acquired "within healthcare and home environments."

2. 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):

   • The document does not mention the use of experts to establish ground truth for a test set in the context of validating algorithmic performance. The validation appears to be centered on the software's functional correctness and adherence to technical specifications. The "healthcare professional is responsible for the interpretation of the monitored data."

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

   • Not applicable/Not mentioned. The study described is a software validation, not a clinical study involving adjudication of interpretations.

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, an MRMC comparative effectiveness study was not done. The HomMed Central Station is described as "a retrospective data view and analysis system" and an "accessory device used by the healthcare professional to display and evaluate the monitored patient data." It does not claim to incorporate AI or provide interpretations that would necessitate an MRMC study comparing human performance with and without AI assistance. The healthcare professional is explicitly stated to be "responsible for the interpretation of the monitored data."

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

   • Yes, in essence, the "software validation" serves as a standalone performance assessment of the algorithm/software's functionality. The validation assesses if the software, in isolation, correctly receives, processes, stores, and displays data according to its specifications. However, it's crucial to note that this "standalone" performance is within the context of a retrospective display and analysis system, where final interpretation remains with the human professional. The device is not making diagnostic decisions on its own.

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

   • For a software validation of this nature, the "ground truth" would likely be derived from:
     • Expected system behavior: Comparison of the software's output against predefined functional and performance requirements.
     • Input data accuracy: Ensuring that known input physiological data is accurately processed and displayed by the system.
     • Compliance with standards: Verifying that the software adheres to established software development and medical device standards.
   • There is no mention of pathology, expert consensus on patient conditions, or outcomes data being used as ground truth for this software validation.

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device is not described as an "AI" or machine learning device that requires a training set in the typical sense. It is a data management and display software system.

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

   • Not applicable, as there is no indication of a "training set" for AI/ML processes.

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The HomMed Sentry III Patient Monitor System with Card Reader is intended for in home and/or healthcare facility applications under physician orders. The Card Reader with the HomMed Sentry III Patient Monitor System allows patients to use multiple Sentry III monitors or multiple patients to use the same Sentry III monitor. The use of the system is to allow retrospective review of certain patient physiological functions. The HomMed Sentry III Patient Monitor System with Card Reader can measure and display patient data including noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. Additionally, the patient vital signs data can be communicated to a central review station via a pager network with a backup landline telephone modem for telephone communication with the central pager network if necessary.

The HomMed Sentry III Patient Monitor System with Card Reader is a portable patient vital signs monitoring system which allows patients to use multiple Sentry III monitors or multiple patients to use the same Sentry III monitor. The system measures noninvasive blood pressure, pulse rate, oral temperature, oximetry, and weight. In addition, the system has optional glucometry and spirometer measuring capabilities. The Sentry III Patient Monitor with Card Reader acquires the patient vital signs data and displays it. The data can also be transmitted via the communication system through the Skytel Pager Network to a central station for storage with retrospective display and analysis. The Card Reader with the HomMed Sentry III Patient Monitor System allows patients to use multiple Sentry III monitors or multiple patients to use the same Sentry III monitor.

The provided text describes the HomMed Sentry III Patient Monitor System with Card Reader but does not contain the specific details required to fully address your request regarding acceptance criteria and a definitive study demonstrating direct device performance against those criteria.

The document is a 510(k) summary indicating substantial equivalence to a predicate device and compliance with general standards, rather than detailing a specific clinical performance study with clear acceptance criteria and resulting data.

Therefore, I can only provide information based on what is available in the text and indicate where information is missing.

Here's an attempt to answer your questions based on the provided text, highlighting what is present and what is not:

HomMed Sentry III Patient Monitor System with Card Reader

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria (e.g., accuracy ranges for NIBP, SpO2, etc.) and corresponding detailed device performance results are NOT explicitly stated in a table format. The document focuses on demonstrating substantial equivalence and compliance with general standards.

However, the text implies that the device performs:

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

The document does not specify a sample size for a test set or clinical study. It mentions "testing has been completed" to demonstrate compliance with standards and guidelines, but details about the nature of this testing (e.g., number of subjects, whether it was a clinical trial, or internal lab testing) and its provenance (e.g., country of origin, retrospective/prospective) are not provided.

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

This information is not provided in the document. Given that the document focuses on substantial equivalence and engineering/compliance testing rather than a de novo clinical validation study with expert-established ground truth, it's unlikely this type of detail would be present.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for a test set.

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

A MRMC comparative effectiveness study is not mentioned in the document. This type of study would typically assess the impact of AI assistance on human reader performance, which is not the focus of this 510(k) summary for a patient monitoring system.

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

The HomMed Sentry III Patient Monitor System is a device that provides measurements for human review. While it implicitly performs "standalone" measurement capture (e.g., NIBP, SpO2 algorithmically determine values from raw physiological signals), the document does not explicitly detail an "algorithm only" performance study in the context of an AI-driven standalone assessment. The focus is on the device's ability to capture and transmit vital signs.

7. The Type of Ground Truth Used

The document does not explicitly state the "type of ground truth" used for performance validation. Instead, it relies on:

• Comparison to a predicate device: The HomMed Sentry III Patient Monitor System.
• Compliance with established standards and guidelines: "FDA reviewer's guides for respiratory devices and electronic thermometers," EN 60601-1, IEC 601-1-2, ISO 10993-5, 10-11.

For individual measurements (e.g., blood pressure, SpO2), the implicit ground truth would be established using reference standard measurement devices during engineering and performance testing.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This device is a vital signs monitor, not typically an AI/machine learning device that requires a distinct "training set" for model development in the way an imaging AI algorithm would. Its underlying algorithms for vital sign extraction are likely well-established and pre-programmed, not "trained" in the modern ML sense.

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

As there is no mention of a training set, there is no information on how its ground truth would have been established.

In summary: The provided text is a 510(k) summary for a patient monitor system, demonstrating substantial equivalence to a predicate device and compliance with relevant safety and performance standards. It successfully obtains FDA clearance based on these aspects. However, it does not detail specific acceptance criteria in a quantitative table or provide specifics about clinical study designs, sample sizes, expert ground truth establishment, or AI-specific performance metrics (like MRMC studies), which are more commonly found in submissions for diagnostic AI algorithms.

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The HomMed Model Sentry patient monitor system is for spot checking of adult or pediatric patient's systolic, diastolic and mean arterial (MAP) blood pressures, pulse rate, SpO2 oximetry and oral temperature. The device will provide fast, reliable NIBP measurements on patients when using the appropriate blood pressure cuff. The oximetry function operates with all OEM (BCI) oximetry sensors, providing SpO2 and pulse rate on all patients from pediatric to adult patients. The electronic thermometry is intended for oral temperature measurements and is only compatible with the Welch Allyn thermometry probes and probe covers. The device is intended for use in clinical environments by health care providers and for home use by patients with retrospective review by health care providers.

HomMed Model Sentry patient monitor provides a manually initiated sequence of automatic patient measurements. The Sentry patient monitor consists of a small tabletop NIBP monitor with a desktop Features include an NIBP cuff hose connection, an SpO2 sensor interface, a oral charger. temperature probe interface and holder, display of patient systolic, diastolic, and mean arterial pressure, interval timer, SpO2, pulse rate, pulse strength, temperature via an LED display.

The HomMed Model Sentry is the existing presently marketed BCI Mini-Torr Plus noninvasive blood pressure (NIBP) monitor with oximeter and electronic thermometer options with certain defeatures implemented via software toggle off/on function controls. The BCI Mini-Torr Plus monitor has a FDA 510(k) approval, Number K983796.

The provided text describes a 510(k) submission for the HomMed Model Sentry patient monitor. However, the document explicitly states that no additional performance testing was conducted for the HomMed Model Sentry. Instead, its performance is considered equivalent to its predicate device, the BCI Model 6004, which had already met applicable FDA requirements.

Therefore, the HomMed Model Sentry itself did not undergo a study to prove it meets specific acceptance criteria. Its acceptance is based on the substantial equivalence principle, drawing upon the pre-existing performance data of the BCI Model 6004.

Given this, I cannot provide an answer that fully addresses all points of your request as the specific performance study for the HomMed Model Sentry, and thus its unique acceptance criteria and study details, are not present in the provided text.

However, I can extract the relevant information regarding the basis for its acceptance:

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

Since no new performance testing was conducted for the HomMed Model Sentry, there are no specific new acceptance criteria or reported device performance metrics unique to this device in the provided text. The device's acceptance is based on the performance of its predicate device, the BCI Model 6004. The HomMed Model Sentry is stated to perform "within its specifications and functional requirements," which are implicitly those of the BCI 6004.

• Acceptance Criteria (Implicit, based on predicate): Compliance with guidelines and standards referenced in FDA reviewer's guides for respiratory devices and electronic EMC, electrical, mechanical durability, safety (operator and patient), and thermometers.
• Reported Device Performance (Implicit, based on predicate): The Sentry "performed within its specifications and functional requirements" and its performance "remains unchanged" from the BCI 6004.

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, as no new testing was performed for the HomMed Model Sentry. The predicate device's testing details are not provided.

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, as no new testing was performed for the HomMed Model Sentry.

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

Not applicable, as no new testing was performed for the HomMed Model Sentry.

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. The device is a patient monitor, not an AI-assisted diagnostic tool.

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

Not applicable, as no new testing was performed for the HomMed Model Sentry. The device is an integrated patient monitor with hardware and software elements, not a standalone algorithm.

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

Not applicable, as no new testing was performed for the HomMed Model Sentry. The predicate device's testing would have used established reference methods for vital sign measurements (e.g., direct arterial line for NIBP, calibrated temperature probes for temperature).

8. The sample size for the training set

Not applicable, as no new testing was performed for the HomMed Model Sentry, and the device is not described as having an AI component that would require a "training set" in the typical machine learning sense.

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

Not applicable, as no new testing was performed for the HomMed Model Sentry, and the concept of a "training set" is not relevant to the described device.

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