Search Results

The Carematix™ Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as:

Non-invasive blood pressure measurement;

Pulse rate measurement;

Blood glucose level using a Glucometer;

Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter;

Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an inhome coagulation measurement system;

Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter;

Patient weight using a stand-on electronic scale

The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.

The Carematix™ Wellness System is intended to gather and transmit patient data from the home site or remote location to caregivers at a clinical facility where it provides supplemental information for the care of the patient.

The Carematix™ Wellness System consists of wireless radiofrequency transmitter adapters, a communication hub or receiving station, and an internet server:

• The radiofrequency transmitter adapter is connected, either wired directly or to . a serial port, of monitoring devices currently in distribution having capability to monitor patient parameters for blood pressure, pulse rate, blood sugar, blood oxygen saturation, PT/INR, and FEV/PEFR.
• The communications hub, or receiving station, collects and stores data transmitted from each of the radiofrequency transmitter adapters or wired device and transmits patient data to the internet server via PSTN. LAN. cellular, wireless etc.
• The internet server receives the patient data from the home setting or remote . location where it is made available to the caregiver to track, graph, note variances, set alert criteria, and receive notifications when parameters are outside the criteria set.

The provided text describes the Carematix™ Wellness System, a physiological monitoring system intended for home use to collect and transmit patient vital signs to caregivers.

However, the 510(k) summary does not contain the specific acceptance criteria or a detailed study proving the device meets them in the format requested. It only provides a general statement that "Verification and Validation tests were conducted for the Carematix Wellness System in accordance with Good Manufacturing Practices and the results met acceptable criteria." and that it conforms to IEC 60601-1.

Therefore, I cannot populate the table or answer most of the specific questions (2-9) about the study design, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided document.

Here's what I can extract and state based on the text:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (Not available in the provided text):

• Specific numerical acceptance criteria for each physiological measurement (e.g., accuracy, precision).
• Detailed performance metrics (e.g., sensitivity, specificity, accuracy, error margins) for each vital sign measurement handled by the system.

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

• Not specified. The document only states that "Verification and Validation tests were conducted." It does not provide any details on the sample size of patients or data points, nor the country of origin, 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:

• Not specified. The document does not mention the use of experts for establishing ground truth for any test set.

4. Adjudication method for the test set:

• Not specified. There is no mention of 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:

• Not applicable / Not specified. The Carematix™ Wellness System is a data collection and transmission system for physiological parameters. It is not an AI-assisted diagnostic device that would involve "human readers" or an "AI assistance" component in the typical sense this question implies. The document does not mention any MRMC study.

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

• Partially addressed indirectly, but not fully detailed. The device primarily acts as a data collection and transmission system. Its "performance" would likely be evaluated on the accuracy of data transmission and integration with monitoring devices, rather than a standalone a diagnostic algorithm. The document states "Verification and Validation tests were conducted," which would implicitly cover the standalone functionality of the data handling without human intervention in the loop of that specific function. However, no details on how this was evaluated are provided.

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

• Not specified. Given the nature of vital sign monitoring, the ground truth would typically be established by comparing the device's readings against a gold standard reference device for each physiological parameter (e.g., a clinically validated blood pressure monitor, glucometer, etc.). However, the document does not explicitly state the type of ground truth used.

8. The sample size for the training set:

• Not applicable / Not specified. This device is described as a system for collecting and transmitting physiological data, not an AI or machine learning model that typically requires a distinct "training set." Therefore, a training set in that context would not be relevant, and no such information is provided.

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

• Not applicable / Not specified. As there's no mention of a training set for an AI/ML model, this question is not relevant based on the provided text.

Ask a specific question about this device

The Carematix™ Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as: Non-invasive blood pressure measurement: Pulse rate measurement; Blood glucose level using a Glucometer; Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an inhome coagulation measurement system: Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter; Patient weight using a stand-on electronic scale The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.

The Carematix™ Wellness System is intended to gather and transmit patient data from the home site or remote location to caregivers at a clinical facility where it provides supplemental information for the care of the patient. The Carematix™ Wellness System consists of wireless radiofrequency transmitter adapters, a communication hub or receiving station, and an internet server: - The radiofrequency transmitter adapter is connected, either wired directly or . to a serial port, of monitoring devices currently in distribution having capability to monitor patient parameters for blood pressure, pulse rate, blood sugar, blood oxygen saturation, PT/INR, and FEVR/PEF. - The communications hub, or receiving station, collects and stores data . transmitted from each of the radiofrequency transmitter adapters and transmits patient data to the internet server at specified intervals. - . The internet server receives the patient data from the home setting or remote location where it is made available to the caregiver to track, graph, trend, note variances, set alert criteria, and receive alerts when parameters are outside . the criteria set.

The provided text describes the Carematix™ Wellness System, a device for gathering and transmitting patient data from home to caregivers. However, it does not contain specific details about acceptance criteria, device performance metrics, or the study design as requested.

The document states:

• "The Carematix™ Wellness System was tested and passed all required electrical and mechanical testing."
• "The Carematix™ Wellness System performance was tested with clinical data and the results met the acceptable criteria."

This is a general statement that the device met acceptable criteria, but it does not particularize what those criteria were or how the performance was measured.

Therefore, I cannot provide the detailed information requested in the prompt based solely on the given text. The text primarily focuses on regulatory approval (510(k) summary) and indications for use, rather than a detailed technical description of performance evaluation studies.

Ask a specific question about this device