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Intel-GE Care Innovations Connect RCM is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in videoconferences with caregivers and answer the caregivers' questions by participating in surveys.

Care Innovations Connect RCM is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.

Care Innovations Connect RCM is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

Care Innovations Connect RCM will be available for over the counter use.

Care Innovations™ Connect RCM is a software application for use with measurement devices commercially available for home use. The software executes on a web server and is accessed via a browser from the patient's COTS personal computing device. A small validated software application known as Device Connector runs on patients' home COTS platforms. Off the Shelf (OTS) software is also used with the internally developed software to provide functionality such as: setting & receiving email and text-based notifications, creating & editing calendar entries, playing Learn More videos, and holding a video conference with a clinician.

Care Innovations™ Connect RCM is a software application for use with measurement devices commercially available for home use. Connect RCM provides the same client capabilities of collecting and transmitting patient data to the clinician database system as the predicate devices, and uses the existing clinician database system in the Intel-GE Care Innovations 10 Guide (K130290). No changes were required to the existing clinician database system to support the new client software.

Patients can also enter measurement data manually entered data is stored in the backend clinician database as well as the Personal Health Data Record. It is flagged as manually entered data.

The provided document, K130821, states that the "Connect RCM does not rely on an assessment of clinical performance data." It asserts that "The device will conform to FDA 's recognized consensus standards and relies on its conformity to demonstrate the safety and efficacy." Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices and conformity to recognized consensus standards for safety and efficacy.

Given this, I cannot fill out the requested table or answer most of the follow-up questions because the submission explicitly states that clinical performance data was not used.

Here's what I can provide based on the document:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical studies. The "acceptance criteria" for this device appear to be its conformity to FDA recognized consensus standards and its substantial equivalence to predicate devices.

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

Not applicable. The device does not rely on clinical performance data for its 510(k) submission.

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

Not applicable. No clinical test set described.

4. Adjudication method

Not applicable. No clinical test set 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

Not applicable. The device is a remote patient monitoring system, not an AI-assisted diagnostic tool, and no such study was performed or described.

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

Not applicable. The device is software for collecting and displaying patient data, not an algorithm for standalone performance evaluation in a clinical sense.

7. The type of ground truth used

Not applicable. No clinical performance data was used for the 510(k) submission. The "ground truth" for regulatory approval appears to be the documented functionality of the predicate device and the adherence to safety standards.

8. The sample size for the training set

Not applicable. No machine learning model or training set is described in the context of clinical performance for this 510(k).

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

Not applicable. No training set is described.

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The Intel® Health Guide Express is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.

The Intel® Health Care Management Suite allows the caregiver to review patient data and initiate video conferencing with patients, or select and send educational and motivational content to patients.

The Intel® Health Guide Express is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.

The Intel® Health Guide Express is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

The Intel® Health Guide Express is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. The Intel® Health Guide Express is a software application running on a Commercial Off The Shelf (COTS) Personal Computer (PC). It collects measurements captured on commercially available wireless or tethered medical devices which are designed for home use and connection to a COTS PC. It displays the collected measurement on the PC, and securely stores the collected information locally on a memory device installed in the PC. The Intel® Health Guide Express also stores the information remotely on a host server, where the caregiver can view the measurement via the host server once synchronization between the host server and Intel® Health Guide Express has been completed. The Intel® Health Guide Express can be used to display educational and motivational content from the caregiver and can facilitate communication between the caregiver and patient via health wellness surveys and optional video conferencing.

The Intel® Health Guide Express is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. It is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

The Intel® Health Guide PHS Express system consists of the:

• Intel® Health Guide Express software application: (1)
  The software application captures, stores, displays and transmits information to a secure database on a host server running the Intel® Health Care Management Suite software via a standard telephone line or internet connection. The Intel® Health Guide Express software runs on a Commercial Off The Shelf (COTS) Personal Computer (PC).

Intel® Health Care Management Suite software application: (2)

The software application runs on a host server and allows caregivers to review patient vital signs on the secure website. The Intel® Health Care Management Suite allows for predefining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver.

The Intel® Health Guide Express is a remote patient monitoring system. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting them in the way clinical studies for diagnostic accuracy often do.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy or a specific performance study. Instead, it demonstrates substantial equivalence to a predicate device (Intel® Health Guide PHS6000) based on technological characteristics and functional similarities. The key performance aspect is the ability to collect, store, display, and transmit vital sign measurements, and this is compared to the predicate device's capabilities and compatibility with various peripherals.

Essentially, the "acceptance criteria" here are that the new device performs its intended functions (collecting and transmitting data) and is at least as safe and effective as the predicate device, given its specific use case as a communication tool and not a diagnostic device.

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

The document does not describe a specific "test set" or a study involving patient data for performance evaluation in the context of diagnostic accuracy or a similar clinical measurement. The device is a "Remote Patient Monitoring System" that collects data from other commercially available medical devices.

The assessment is primarily a technical comparison and declaration of substantial equivalence to a predicate, not a clinical trial evaluating the performance on a patient cohort or a specific dataset. There is no mention of data provenance (country of origin, retrospective/prospective).

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

This information is not applicable as there is no mention of a "test set" requiring ground truth established by experts for performance evaluation. The device's function is data capture and transmission, not interpretation or diagnosis.

4. Adjudication Method for the Test Set

This information is not applicable for the same reason as point 3. No test set requiring expert adjudication for ground truth establishing is described.

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

No, a MRMC comparative effectiveness study was not done. The device is a data collection and communication tool, and its primary purpose is not to assist human readers in interpretation or diagnosis. Therefore, a study of improved human reader performance with AI assistance is not relevant to this type of device.

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

No, a standalone study in the context of algorithmic performance for diagnosis/interpretation was not described. The device is a software application running on a COTS PC that interacts with other medical devices. Its performance is assessed in terms of its ability to correctly capture, store, transmit data, and its compatibility with hardware, rather than standalone diagnostic accuracy. The safety and efficacy claims "do not rely on an assessment of clinical performance data" but on conformity to recognized consensus standards.

7. The Type of Ground Truth Used

Not applicable. As stated earlier, the submission focuses on substantial equivalence based on technological characteristics and safety standards, not on evaluating diagnostic accuracy against a ground truth. The device itself is "not interpretive, nor is it intended for diagnosis."

8. The Sample Size for the Training Set

Not applicable. This device is a remote patient monitoring software system. There is no mention of a "training set" for an AI algorithm in the context of diagnosis or prediction.

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

Not applicable. For the same reasons as point 8, there is no mention of a training set or ground truth establishment relevant to an AI model's training.

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The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.
Contraindications, Precautions and Warnings: The Commander III device makes no interpretation, evaluation, medical judgments or recommendations for treatment. Clinical judgment and experience are required to check and interpret the information transmitted. The Commander III is not intended as a substitute for medical care.

Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commander III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It also has inputs for devices such as weight scales, blood pressure meters, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.

Here's an analysis of the provided text regarding the Cardiocom Commander III, broken down by your requested categories.

Important Note: The provided document is a 510(k) summary for a medical device seeking clearance based on substantial equivalence. This type of submission relies on showing that a new device is as safe and effective as a legally marketed predicate device (K982481 A&D Medical UA-767PC Digital Blood Pressure Monitor in this case), rather than requiring extensive de novo clinical trials to prove efficacy from scratch. Therefore, many of the typical acceptance criteria and study details for AI/ML devices, such as multi-reader multi-case studies or detailed ground truth establishment, are not present in this type of submission. The focus is on demonstrating comparability to the predicate device, particularly in areas like accuracy and safety standards.

Acceptance Criteria and Device Performance

Study Proving Acceptance Criteria:

The document states, "The results of bench, laboratory, and clinical testing indicates that the new device is as safe and effective as the predicate device." And in the conclusion: "After analyzing bench, test laboratory, and clinical testing data, it is the conclusion of Cardiocom that the Cardiocom Commander III is as safe and effective as the predicate device, has essentially no significant technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device."

This indicates that studies were performed to demonstrate that the Commander III meets the same performance and safety standards as the predicate device, specifically ANSI/AAMI SP10: 1992+A1 for blood pressure accuracy.

Additional Information Not Extensively Detailed in the Provided Text:

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

   • The document mentions "clinical testing data" but does not specify the sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective). As a 510(k) based on substantial equivalence, the clinical testing would likely be focused on demonstrating comparable performance to the predicate against established standards (like AAMI SP10), which often involves a specific number of subjects. However, these specifics are not in the provided summary.

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

   • Not applicable/Not specified in this type of submission. For blood pressure monitors, accuracy is typically assessed against a reference standard (e.g., a mercury sphygmomanometer used by trained clinicians) rather than "expert consensus" in the way it applies to diagnostic image interpretation. The AAMI SP10 standard outlines the methodology for such validation tests.

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

   • Not applicable/Not specified. "Adjudication" typically refers to resolving discrepancies in expert interpretations, which isn't the primary method for validating blood pressure device accuracy.

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. This device is a measurement system, not an AI diagnostic tool that assists human readers/interpreters. There is no mention of AI or human-in-the-loop performance measurement in the provided text.

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

   • Yes, in the sense that the device's ability to measure blood pressure, pulse, etc., is evaluated as a standalone function primarily against established standards (like AAMI SP10). The device itself is a standalone measurement system for collecting vital signs.

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

   • For blood pressure accuracy, the ground truth would typically be established by a reference method, such as a mercury sphygmomanometer, performed by trained observers according to standard protocols (e.g., specified in AAMI SP10). The document refers to "clinical testing data" which would be based on this type of ground truth.

7. The sample size for the training set:

   • Not applicable/Not specified. This device is not described as using machine learning or AI that would require a distinct "training set." It is a hardware and software system for data collection and transmission.

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

   • Not applicable, as a training set, as typically understood for AI/ML, is not described for this device.

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The MedStar System is indicated for Out-of-Hospital Use with any patient requiring Out-of-Hospital monitoring. The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital-Type facility, Medical Clinic or Physician's Office.

The MedStar Monitoring System II comprises the MedStar Unit and the associated Collection Server. The MedStar Unit is a portable, battery-operated unit for controlling the transmission of data from a range of compatible patient monitors or measurement devices to a remote monitoring center. Data is transmitted via telephone lines to the associated data collection server at the remote site. The MedStar Unit is contained in a small plastic enclosure with an LCD screen mounted into the top of the case. The case is made of a strong impact resistant plastic material. A User push button control is located adjacent to the display. Four serial communication ports are located at the side of the unit for connection to the serial data ports of specific patient monitors. Two standard phone jacks are also located at the side of the unit for connection to standard phone outlets. Two recessed programming buttons are included on the opposite side of the enclosure to the phone jacks. The Collection Server comprises a Personal Computer-type Processor Unit incorporating an additional electronics board to control phone line transmission to and from the MedStar Unit.

The provided text lacks the detailed study information required to complete the table and answer all questions comprehensively. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria and specific statistical results.

Here's an attempt to extract the available information and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified, but the "bench testing" mentioned suggests internal testing, not necessarily human patient data.

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

• Not applicable. The device's function is data transfer, not diagnostic interpretation requiring expert ground truth.

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

• Not applicable. The device's function is data transfer, not diagnostic interpretation.

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 MedStar System II is a data transfer device, not an AI-powered diagnostic tool used by human readers.

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

• Yes, implicitly. The "bench testing" mentioned would be a standalone evaluation of the device's technical performance (e.g., successful data transmission, accuracy of data transfer) without human intervention in its core function. However, specific results are not provided.

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

• For a data transfer device, the 'ground truth' would likely involve verifying the integrity and accuracy of the transmitted data against the original source data (e.g., verifying that a blood glucose reading of 'X' from the monitor is correctly received as 'X' by the server). The document does not specify the method used for this verification.

8. The sample size for the training set:

• Not applicable. This device is not described as using machine learning or AI that would require a training set.

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

• Not applicable, as there's no mention of a training set.

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The BL Healthcare Remote Care Management system is for use by patients remotely in combination with a variety of monitoring devices such as blood pressure monitor, blood glucose monitor, and weight scale upon the prescription of a licensed physician or healthcare provider. The BL Healthcare Remote Care Management system serves as the communication link between the compatible devices and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center.

The purpose of the system is to collect and transmit medical information such as weight, blood pressure and pulse rate, and blood glucose from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.

This system is installed by or with support from trained professionals.

This device is not intended to provide time sensitive data or alarms. This system may not be used as a substitute for direct medical intervention or emergency care.

Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.

BL Healthcare Remote Care Management system serves as the communication link between FDA approved compatible devices such as Blood Pressure monitor, Blood Glucose Instrument and Weight Scale, and the server software at a compatible healthcare facility. The healthcare facility may include healthcare provider, other caregivers, or a disease management center. The system enables video conferencing over broadband and a TV Interface between the Healthcare provider and the patient. The Healthcare provider may also enable video clips, automatic medication reminders and other training materials for the user to view. The TV interface provides this information on a specific TV channel and the user is informed of new updates or videoconferencing request via audio-visual indicators on the TV Interface remote.

The purpose of the system is to collect and transmit measurement information such as weight, blood pressure and pulse rate, and blood glucose from the patients on completion of their testing and transmit these results to their healthcare provider at another facility.

The provided text is a 510(k) summary for the BL Healthcare Remote Care Management system, focusing on its substantial equivalence to predicate devices rather than a detailed performance study with specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, especially in the context of an AI/ML device, cannot be extracted directly from this document.

The device described is a telemedicine system that acts as a communication link to transmit data from FDA-approved medical devices (blood pressure monitor, blood glucose instrument, weight scale) to healthcare providers. It also offers video conferencing and medication reminders. It is not an AI/ML diagnostic device that would typically have performance metrics like sensitivity, specificity, or AUC a study design for AI.

Here's an attempt to answer the questions based on the available information, noting where information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit acceptance criteria or a performance table in the way one would for a diagnostic or AI/ML device. The "performance" being evaluated here is the functional equivalence of the communication system to predicate telemedicine devices.

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

• Sample Size: Not applicable. This submission describes substantial equivalence testing for a communication system, not a clinical trial with a "test set" of patient data or samples. The "testing" referred to is functional testing, not statistical evaluation with a patient cohort.
• Data Provenance: Not applicable for the reasons above. The document does not mention data from specific countries or whether it was retrospective or prospective.

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

• Number of Experts: Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant to this type of device submission. The device's function is data transmission, not interpretation or diagnosis.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. There is no "test set" in the context of clinical data requiring adjudication mentioned in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No, an MRMC study was not done.
• Effect Size: Not applicable. This device is a data transmission system, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable. This device is not an algorithm performing a standalone diagnostic function. It is a communication device; human interpretation is explicitly part of its intended use ("Interpretation of the information collected and transmitted requires clinical judgement by an experienced medical professional.").

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable. The concept of "ground truth" (e.g., pathology, outcomes data) is not relevant for demonstrating the substantial equivalence of a communication device for remote monitoring. The "truth" here relates to the reliable and accurate transmission of data from existing, FDA-cleared medical devices.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not employ machine learning that would require a "training set" of data.

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

• Ground Truth Establishment for Training Set: Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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The Telecare®D.R. is intended to be used in conjunction with 510(k) certified devices that upon prescription by an authorized healthcare provider for patients provides a means of receiving and storing audio, video, and patient biometric data including vital signs information received over standard phone lines or high speed connection between patients, typically at home, and health professionals at the health care provider's site.

The Telecare DR System consists of multiple software and hardware components. Utilizing this system of components, healthcare professionals are empowered with the ability to conduct real-time, secure audio/visual communication and measurement collection encounters from the patient's home to the healthcare facility and presented for secure Internet browser review.

Typically, the Telecare D.R. resides on a health facility's server and connects to the HCV NurseStation. Using the HCV NurseStation software component, the healthcare professional instantiates audio/visual communication with the patient using a standalone videophone system (i.e., CS-126S, CS-126, or CS-146 videophone devices) that is equipped with the capability to transmit and receive data from a variety of external vital signs and medical measurement devices. The CS 126S also includes an integrated digital stethoscope that provides for both local and remote auscultation functions and an optional accessory plug-in pulse oximetry sensor unit.

Upon connection with a standalone videophone, the HCV NurseStation, located at a healthcare professional's office or facility, identifies all the external vital signs and medical measurement devices (i.e., weight scale, glucometer, vital signs monitor, NIBP, pulse oximetry and spirometer) connected to the standalone videophone. Using the HCV NurseStation, the healthcare professional may proceed to communicate using standard phone line or high speed connection through internal modems and transmit real-time video, audio, and data between them. The real-time video and audio communications allow the patient and caregiver to view and speak with each other.

Using the HCV NurseStation component, the healthcare professional is capable of monitoring the data from the measurement devices in real-time during collection, as well as, storing these measurements to the centralized data repository using the Telecare D.R. server software. To terminate the encounter, the healthcare professional disconnects the video call via the HCV NurseStation software component. This event triggers the HCV Conduit software component, which completes remaining data inserts/updates, broadcasts notifications and prepares data for secure browser viewing via the secure HCV Rendezviewer software component.

With existing legally marketed vital signs measurement devices attached to the patient's system, the health professional and caregiver may monitor the patient's blood pressure. pulse rate, temperature, weight, blood oxygen saturation, blood glucose level, breath peak flow, images, and transmit this data to the caregiver's system. Vital signs measurement devices used with the HCV NurseStation and Telecare D.R. are FDA approved devices and are used for the same purposes which they received 510(k) approval or are devices that are exempt under applicable 21 CFR sections. The data may be captured, displayed, and/or saved on Telecare D.R.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Telecare D.R. device:

Based on the provided 510(k) summary, the Telecare D.R. is a software system intended as an accessory to existing 510(k) cleared medical devices for remote patient monitoring. Crucially, the document explicitly states that "Clinical study information was not submitted for the purpose of demonstrating substantial equivalence to the predicate devices." Therefore, there is no information about clinical acceptance criteria or studies to directly prove device performance in a clinical setting provided in this document.

The focus of the submission is to demonstrate substantial equivalence to predicate devices through non-clinical testing of the software's functional performance and its compatibility with approved vital signs measurement devices.

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

Acceptance Criteria and Reported Device Performance

"Further testing was performed with each vital signs measurement device to show that they operate equivalently when used with the Telecare D.R. as when operated as independent devices." |
| Data Transmission & Storage | Capability to receive and store audio, video, and patient biometric data (vital signs) over standard phone lines or high-speed connections. | "The Telecare D.R. is intended to be used...to provide a means of receiving and storing audio, video, and patient biometric data including vital signs information received over standard phone lines or high speed connection..."

"The main functional difference between the systems are the Telecare D.R. is the data server/Web server that permits the storage, retrieval, and presentation of patient-specific vital sign data using standard phone lines and high speed connections over the Internet." |
| Compatibility with Approved Devices | Device interfaces correctly with listed 510(k) cleared vital signs measurement devices (e.g., Criticare Vital Signs Monitor, NIBP Monitor UA-767PC, etc.). | "Further testing was performed with each vital signs measurement device to show that they operate equivalently when used with the Telecare D.R. as when operated as independent devices." (Implies successful integration and performance). |

Study Details (Based on Non-Clinical Testing Section)

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

   • Sample Size: Not specified. The document only mentions "performance testing of the software" and "testing was performed with each vital signs measurement device." This likely refers to a technical verification and validation activity rather than a clinical sample size.
   • Data Provenance: Not applicable in the context of a clinical test set, as no clinical studies were performed. For the functional testing, the data would be generated from the connected devices and the Telecare D.R. system itself.

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

   • Not applicable. As no clinical studies were conducted, there was no need for expert-established ground truth in a clinical sense. The ground truth for functional testing would be the expected outputs and behaviors of the system and connected devices as per their specifications.

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

   • Not applicable. No adjudication method for a test set is mentioned as no clinical studies were performed.

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 document explicitly states: "Clinical study information was not submitted for the purpose of demonstrating substantial equivalence to the predicate devices." This means no MRMC study was performed.

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

   • Yes, in a sense. The document describes "performance testing of the software" and testing to ensure connected devices "operate equivalently when used with the Telecare D.R. as when operated as independent devices." This suggests standalone functional testing of the software and its interaction with the devices, without necessarily involving interpretation by human readers in a diagnostic capacity. The device itself is not a diagnostic AI, but a communication and data management system.

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

   • For the non-clinical functional testing, the ground truth would be the expected functional behavior and data integrity as defined by the system's design specifications and the known outputs of the connected FDA-approved vital signs monitors. It's not clinical ground truth like pathology or expert consensus.

7. The sample size for the training set:

   • Not applicable. The Telecare D.R. is described as a software system for communication and data management, not an AI or machine learning algorithm requiring a "training set" in the conventional sense for diagnostic or predictive purposes.

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

   • Not applicable, as there is no mention of a training set or AI/ML components requiring one.

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The CareStation CS126S is intended to be used upon prescription of an authorized healthcare provider by patients to provide two-way video, audio, and data communications including patient vital signs information over standard telephone lines between the patient, typically at home, and a health care professional at the health care provider's site.

The information includes heart, lung, and bowel sounds, blood oxygen saturation, pulse rate, blood pressure, temperature, blood glucose, weight, and breath peak flow measurements. The information is collected upon the request and direction of the health care provider.

The device does not send any real-time alarms. The device is a diagnostic aid. Clinical judgment and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The CareStation 126S Videophone system is a standalone videophone system that is equipped with the capability to transmit and receive data from a variety of external vital signs and medical measurement devices. The CareStation 126S also includes an integrated electronic digital stethoscope that provides for both local and remote auscultation functions and an optional accessory plug-in pulse oximetry sensor unit.

Typically, the CareStation is deployed in a patient's home and another CareStation is installed in a healthcare provider or caregiver's office. Each is connected to a standard telephone network connection and the two systems communicate with each other through internal modems and transmit real-time video, audio, and data between them. The realtime video and audio communications allow the patient and caregiver to view and speak with each other.

Using a supplied stethoscope transducer attached to the patient's system, heart, breath, and bowel sounds may be transmitted to the caregiver's system where they may be listened to using a set of stethoscope earphones that are supplied with the system.

With existing legally marketed vital signs measurement devices attached to the patient's system, the caregiver may monitor the patient's blood pressure, pulse rate, temperature, weight, blood oxygen saturation, blood glucose level, breath peak flow, and transmit this data to the caregiver's system. Vital signs measurement devices used with the CareStation system are FDA approved devices and are used for the same purposes for which they received 510(K) approval or are devices that are exempt under applicable 21 CFR sections. The data may be captured, displayed, and/or saved on a computer using one or more of a variety of software packages including CareStation for Windows™. The CareStation may be configured for use with one to three external devices

This document describes the CareStation 126S Videophone, a tele homecare system. The acceptance criteria and the study proving it meets these criteria are outlined below:

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not specify the exact sample size for the test set used in the functional performance testing of the integrated digital stethoscope or the external vital signs devices.
• The document does not specify the data provenance (e.g., country of origin, retrospective or prospective).

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

• The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the functional performance tests. Given the nature of performance testing against predicate devices, "ground truth" would likely be the established performance characteristics of the predicate devices or calibrated measurement standards.

4. Adjudication method for the test set:

• The document does not specify any adjudication method.

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 was done. This device is a tele homecare system, not an AI-assisted diagnostic tool for image interpretation by clinicians.

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

• The testing described is essentially for standalone device performance, as it focuses on the functional operation of the CareStation's integrated stethoscope and its ability to work with external vital signs devices. There is no mention of a human-in-the-loop component in the validation process for the device's functional equivalence compared to predicate devices.

7. The type of ground truth used:

• For the integrated digital stethoscope, the ground truth was the established performance characteristics of the predicate device (CareTone II Telephonic Stethoscope). The study aimed to show the CareStation's stethoscope performance "exceeds" that of the predicate.
• For the external vital signs measurement devices, the ground truth was their operation as independent, FDA-approved devices. The study aimed to show "equivalent" operation when integrated with the CareStation.
• For safety, mechanical, electrical, EMC, and environmental aspects, the ground truth would be the specifications outlined in the applicable international standards.

8. The sample size for the training set:

• This information is not applicable as the CareStation 126S Videophone is not an AI/ML device that requires a training set in the conventional sense. The testing focuses on hardware functionality and equivalence to predicate devices.

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

• This information is not applicable as no training set was used for an AI/ML algorithm.

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The N2000 Base Station is intended to be used in conjunction with the N2001 Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.

The N2000 Base Station is intended to be used upon prescription of an authorized healthcare provider, by patients where regular monitoring of vital signs information is indicated.

The N2000 Base Station is intended to be used as a means to collect and transmit patient vital signs information over standard telephone lines between the patient, typically at home, and a health care professional at the health care provider's site. The information includes: blood pressure, pulse rate, blood oxygen saturation, blood glucose level, temperature, weight, and heart, lung and bowel sounds. The information is collected upon request of the healthcare provider.

The device is not indicated for diagnostic purposes. The device does not send any real-time alarms. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The HomeCare Information Network System (HINS) consists of two components: the N2000 Base Station installed typically in a patient's home; and the N2001 Nurse Station located in the provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.

The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.

With existing legally marketed vital signs measurement devices integrated with the N2000 Base Station, the N2000 Base Station is designed to monitor the patient's blood pressure, pulse rate, blood oxygen saturation, blood glucose level, temperature, weight and/or heart, lung and bowel sounds, and transmit this data to the N2001 Nurse Station. The real-time data is displayed to the caregiver operating the N2001 Nurse Station and also automatically recorded in a patient information database. The heart, lung and bowel sounds are recorded from the electronic stethoscope supplied with the system.

Vital signs measurement devices integrated in the HINS are FDA approved devices and have received 510(k) approval. The N2000 may be configured for use with one to five devices.

The N2001 Nurse Station consists of two sub-components, the N2001 Nurse Station PC, which is a standard PC with supporting peripherals, and the N2001 Nurse Station Data Client, which provides the video and audio communications and monitoring functions for the Nurse Station. The N2001 Nurse Station PC can operate as a standalone device for patient data management and record keeping functions.

The provided text contains a 510(k) Summary for the Neptec Homecare Information Network System (HINS). This document predominantly focuses on regulatory compliance, outlining the device's description, intended use, and substantial equivalence to predicate devices, rather than a detailed performance study with specific acceptance criteria and their verification.

Therefore, many of the requested details, such as a table of acceptance criteria with reported device performance, sample sizes for test and training sets, expert qualifications, and adjudication methods, are not available in the provided text.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• IEC 601-1 (Medical Electrical Equipment)
• CAN/CSA-C22.2 (Medical Electrical Equipment)
• UL 2601-1 (Safety of Medical Electrical Equipment)
• FCC Part 15, Subpart C (FCC Rules and Regulations) |
  | Accuracy of collected vital signs data | Not explicitly stated. The document implies accuracy through the integration of FDA-approved vital signs devices, but no direct performance metrics for the HINS system itself are provided regarding data accuracy. |
  | Real-time video, audio, and data transmission | "The real-time video and audio communications allow the patient and the caregiver to view and speak with each other... transmit this data to the N2001 Nurse Station." |
  | Absence of real-time alarms | "The device does not send any real-time alarms." (This is a design feature, not directly a performance metric.) |
  | Not for diagnostic purposes | "The device is not intended to be used for diagnostic purposes." (This is an intended use/limitation, not a performance metric.) |
  | Not a substitute for medical care/emergency intervention | "The device is not intended as a substitute for medical care or emergency intervention." (This is an intended use/limitation, not a performance metric.) |

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

• Not Available. The document mentions "performance testing" and "testing was performed," but does not specify any sample sizes (e.g., number of patients, number of vital sign readings, duration of testing) or the nature of the data provenance.

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

• Not Applicable / Not Available. The primary purpose of this system is to transmit vital signs data from existing FDA-approved devices. The study described focuses on functional performance and regulatory compliance, not on clinical interpretation or diagnostic accuracy where expert ground truth would be established for the HINS itself. The document states: "Clinical judgement and experience are required to check and interpret the information transmitted." This implies that the interpretation is done by healthcare professionals, but they are not establishing ground truth for the device's performance.

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

• Not Applicable / Not Available. As no expert-based ground truth establishment for diagnostic or interpretative tasks is described for the HINS device, an adjudication method is not mentioned.

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. An MRMC study was not described. The HINS is a "Tele Homecare System" for transmitting vital signs and enabling communication, not an AI-assisted diagnostic tool.

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

• Partially Applicable, but not for "algorithm only" in the modern sense. The N2001 Nurse Station PC (part of the HINS) "may also operate as a standalone device for patient data management and record keeping functions." This refers to its ability to function without the N2000 Base Station for certain administrative tasks, not as an "algorithm only" performance evaluation similar to AI models. The HINS itself is designed as a system requiring human oversight and interaction.

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

• Implicitly established by integrated devices. The "ground truth" for the vital signs data transmitted by the HINS is implicitly established by the FDA-approved vital signs measurement devices that are integrated with the N2000 Base Station. The HINS system's performance is based on its ability to accurately and reliably transmit data from these already validated devices, not on generating its own diagnostic ground truth.

8. The sample size for the training set

• Not Available. The document does not describe any training set, as it is not a machine learning or AI-based device in the context of this 510(k) summary.

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

• Not Applicable. No training set is described.

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