Search Results

BP 700-WF is a non-invasive blood pressure measurement device intended to measure systolic, diastolic BP 700-Wr is a non-invasive blood pressure modult individual over age 18, at home by using a non-invasive blood pressure and puise rate of an addit managed around the upper arm. The cuff circumference is limited to 9"-13" for Arm type.

The device can transmit the readings through wireless communication for record archiving and review.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the Carematix Inc. Blip model bp-700wf, a non-invasive blood pressure measurement system. As such, it does not contain the detailed study information required to answer your questions about acceptance criteria, study design, expert qualifications, or ground truth establishment.

This type of FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics, and raises no new questions of safety and effectiveness. The actual performance data and study details would be found in the manufacturer's 510(k) submission document, which is typically much more extensive than this clearance letter.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need access to the full 510(k) submission document for K123020, or a summary of its performance data and clinical study details.

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 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

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) and pulse rate using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an in-home coagulation measurement system; Body temperature measurement using a digital thermometry device or 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 (CWS) provides easy monitoring of the basic wellness parameters via a wireless connection between the monitoring device and a hub (receiving station) located in the home. The hub transmits the information to the Carematix Internet server where the data is added to the patient's chart. Using a web-browser, the caregiver can track the patient's data, graph the results, monitor trends, annotate variances, set alert criteria, and send reminders and receive alerts via e-mail or pager. The following monitoring devices are currently available from Carematix: Blood pressure unit (Arm cuff and Wrist cuff), Weight Scale, Blood Glucose Meter adaptors, Pulse Oximeter adaptors, Coagulation Measurement System adaptors, Digital Thermometer adaptors, Peak Flow Meter adaptors.

The Carematix Wellness System is a telemedicine system that collects, accumulates, and transmits patient vital signs and other physiological data from a patient at home to a healthcare practitioner. The device being cleared in K040966 is a modified version of the Carematix Wellness System (K031840). The modification is primarily related to the connectivity method between the hub and the sensor devices, changing from wired to wireless (RF protocol). The acceptance criteria and the study that proves the device meets these criteria are outlined below:

1. Acceptance Criteria and Reported Device Performance

The submission relies on a substantial equivalence comparison to predicate devices, rather than predefined quantitative performance acceptance criteria for the overall system. The implicit acceptance criteria are that the modified device remains "as safe and effective" as the predicate devices, despite the technological differences.

2. Sample Size for the Test Set and Data Provenance

The document describes "bench and user testing" as methods used to demonstrate safety and effectiveness. However, no specific sample size (number of participants or tests) for these "user testing" or "bench testing" activities is provided in the document.

The data provenance is not explicitly stated. Given the context of a 510(k) submission for a medical device aiming for the US market, it can be inferred that the testing would typically adhere to US regulatory standards. However, details like country of origin for user data or whether the studies were retrospective or prospective are not mentioned.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set in the traditional sense of clinical studies (e.g., radiologists interpreting images). The system relies on measurements from existing 510(k) cleared sensor devices. These sensor devices themselves would have undergone validation against established references or expert diagnoses during their own clearance processes.

For the Carematix Wellness System, the "ground truth" for the collected vital signs is implicitly assumed to be the accurate readings from the 510(k) cleared sensor devices. The system's role is to collect, store, and transmit these readings accurately, not to interpret or diagnose. Therefore, expert consensus or qualification of experts on the Carematix system's data collection and transmission wouldn't typically involve medical diagnostic experts but rather technical experts validating data integrity, security, and functionality.

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing focuses on the accurate collection, storage, and transmission of data from existing cleared sensors, rather than diagnostic interpretation requiring expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The device is a data collection and transmission system, not an AI-assisted diagnostic tool that would typically involve human readers. Therefore, there is no discussion of human readers improving with or without AI assistance.

6. Standalone Performance Study

A standalone performance evaluation of the system's ability to collect, store, and transmit data was conducted through "bench and user testing." The key outcomes verified were:

• Meeting product requirements and functional specifications.
• Proper storage of physiologic data received.
• Secure and integral transmission of data.

These tests would represent the standalone (algorithm/system only, without human interpretation of the system's core function) performance of the Carematix Wellness System in its defined role.

7. Type of Ground Truth Used

The "ground truth" for the performance claims rests on the accurate readings provided by the integrated, pre-cleared sensor devices. The Carematix system's function is to relay these existing "truths" reliably. The testing verified the integrity of handling these known values rather than establishing new diagnostic ground truths. Specifically, the "ground truth" for the system's function is:

• The known output from the 510(k)-cleared biometric devices.
• The expected functional behavior as defined in product specifications.
• Normative standards for electrical safety and FCC compliance.

8. Sample Size for the Training Set

This submission does not discuss a training set. The device is a system for collecting and transmitting physiological data, not an AI/machine learning algorithm that requires a training set for model development. The focus is on the functional performance and equivalence to predicate devices, using established engineering and verification methods rather than algorithm training.

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

As there is no training set mentioned for an AI/ML algorithm, this question is not applicable.

Ask a specific question about this device

The Carematix Wellness System is intended for patient home use for the following: Non-invasive blood pressure measurement; Measurement of blood glucose; 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. Prescription Device. Federal law (US) restricts this device to sale by or on the order of a physician.

The Carematix Wellness System (CWS) provides easy monitoring of the basic wellness parameters via a wireless connection between the monitoring device and a hub (receiving station) located in the home. The hub transmits the information to the Carematix Internet server where the data is added to the patient's chart. Using a web-browser, the caregiver can track the patient's data, graph the results, monitor trends, annotate variances, set alert criteria, and send receive alerts via e-mail or pager. The following monitoring devices are currently available from Carematix: Blood pressure unit (Arm cuff and Wrist cuff), Weight Scale, Blood Glucose Meter adaptors.

The provided text describes the Carematix Wellness System and its 510(k) summary for substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria with quantitative performance metrics.

However, based on the provided information, we can infer some aspects and highlight what is not present.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. Instead, it relies on a comparison to predicate devices, claiming "substantial equivalence." The "performance" is implicitly defined by the functions of the predicate devices.

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

The document mentions "bench and user testing" but does not specify:

• The sample size of devices or users for any test set.
• The data provenance (e.g., country of origin of the data, retrospective or prospective).

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

This information is not provided in the document. The document refers to "user testing," but there's no mention of how "ground truth" for the performance of the system (e.g., accuracy of measurements) was established or by whom. The system transmits data from already cleared sensors, so the accuracy of those sensors themselves would have been established previously, but the system's performance in transmitting and displaying that data isn't detailed.

4. Adjudication Method:

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This study type is not mentioned or implied. The Carematix Wellness System facilitates data collection and transmission, not interpretation by human readers. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not applicable to the description of this device.

6. Standalone Performance Study:

A standalone performance study of the system's components (e.g., accuracy of the blood pressure unit, blood glucose meter, or weight scale) would have been conducted as part of their initial 510(k) clearances. However, for the Carematix Wellness System itself (the hub, transmission, and software functionality), the document mentions "bench and user testing." It does not provide specific data from a standalone study for the Carematix system's performance (e.g., data transmission accuracy, reliability of data display). The submission relies on the fact that it uses "sensor devices already cleared with 510(k) clearance" or provides "external adaptors for Blood glucose monitors having existing 510(k) clearances."

7. Type of Ground Truth Used:

For the Carematix system (as opposed to the individual sensors it connects to), the document does not explicitly state the type of ground truth used. "User testing" suggests qualitative feedback or verification of function, but no objective ground truth (like pathology, outcomes data, or expert consensus on system data accuracy) is specified. For the measurements themselves, the ground truth would have been established by the original 510(k) clearances of the individual sensor devices (e.g., comparison to a reference standard for blood pressure, glucose, or weight).

8. Sample Size for the Training Set:

This information is not applicable or provided. The Carematix Wellness System, as described, is a data collection and transmission system, not an AI/ML device that requires a training set.

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

This information is not applicable as the device is not described as using AI/ML requiring a training set.

Ask a specific question about this device