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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 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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