(116 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance (Integrated Digital Stethoscope) | Performance exceeds that of the predicate device (CareTone II Telephonic Stethoscope (#K963678)). | Performance testing of the integrated digital stethoscope functions was performed to show that the performance exceeds and thus meets substantial equivalency of the predicate device. |
| Functional Performance (External Vital Signs Devices) | Operate equivalently when used with the CareStation as when operated as independent devices. | Testing was performed with each vital signs measurement device to show that they operate equivalently when used with the CareStation as when operated as independent devices. |
| Safety | Compliance with applicable safety standards. | The CareStation has been subjected to performance testing to applicable safety standards. All specifications were met. |
| Mechanical | Compliance with applicable mechanical standards. | The CareStation has been subjected to performance testing to applicable mechanical standards. All specifications were met. |
| Electrical | Compliance with applicable electrical standards. | The CareStation has been subjected to performance testing to applicable electrical standards. All specifications were met. |
| Electromagnetic Compatibility (EMC) | Compliance with applicable EMC standards. | The CareStation has been subjected to performance testing to applicable EMC standards. All specifications were met. |
| Environmental | Compliance with applicable environmental standards. | The CareStation has been subjected to performance testing to applicable environmental standards. All specifications were met. |
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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).