(116 days)
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.
| Feature / Criteria (Implied) | Carematix Reported Performance (Implied) |
|---|---|
| Indications of Use | Enables healthcare providers to manage chronic conditions of patients remotely (Same as predicates) |
| Intended Use | Telemedicine System (Same as predicates) |
| Intended Users | Home users and Healthcare provider (Same as predicates) |
| Site of Use | Home; clinic (Same as predicates) |
| Software | Patient Database (Same as predicates) |
| Types of Sensors Supported | Blood Pressure, Weight, Glucose levels (Subset of predicates, but sufficient for claimed indications) |
| Power Source | Wall power plug for health monitor (hub) and Standard batteries in devices (Same as predicates) |
| Communication method with devices | Wireless RF protocol (Differs from one predicate's wired, but same as another's wireless) |
| Communication method with central server | Via modem over telephone line (Same as predicates) |
| Display | On devices, and monitors connected to central server (Same as predicates) |
| Safety and Effectiveness | As safe and effective as the predicate devices (Claimed via bench and user testing) |
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.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).