Search Results

The Commander III device is for use by patients to collect and transmit general health questions and patient vital sign data (such as weight, blood pressure, glucose, pulse oximetry, peak flow) between the patient, typically at home, and a health care professional at a remote site.

Commander III is similar to a simple personal computer with a modem that stores and transmits data. Commender III connects to a user's telephone line at home. It has a display that asks health related questions to which the user can respond 'Yes', 'No', or select from a list. It contains an integrated blood pressure meter. It also has inputs for devices such as weight scales, glucometers, peak flow meters and pulse oximeters. These devices download data through a RS232 connection. The functionality of these devices has not been modified; they are used as supplied from the manufacturer.

Here's the analysis of the provided text regarding the Cardiocom Commander III device, focusing on its acceptance criteria and the study used to prove it meets them:

Disclaimer: The provided document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. It is not generally a detailed clinical study report and thus may not contain all the specific metrics and methodologies typically found in such a report. Many of the requested details (like specific statistical measures for performance, sample sizes for training data, expert qualifications, etc.) are not explicitly stated in this type of regulatory submission and would be found in the actual studies conducted by the manufacturer, which are summarized or referenced here.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the Cardiocom Commander III does not define explicit, quantitative acceptance criteria for its performance. Instead, the core of this submission is a demonstration of substantial equivalence to a predicate device (Cardiocom LLC Commander II). This means the acceptance criterion is implicitly that the new device is "as safe and effective" as the predicate device.

The reported device performance, in this context, is that the new device maintains the same functionalities and performance characteristics as the predicate, especially regarding its core function of oscillometric automated blood pressure monitoring.

Study Details

The submission refers to "bench, laboratory, and clinical testing data" to support its claim of substantial equivalence. However, the details of these studies are very brief, which is typical for a 510(k) summary.

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

   • Test Set Sample Size: Not explicitly stated. The document simply mentions "clinical testing data."
   • Data Provenance: Not specified (e.g., country of origin). The document does not indicate if the data was retrospective or prospective.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not mentioned.
   • Qualifications of Experts: Not mentioned.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not mentioned.

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:

   • This is not applicable to this device. The Cardiocom Commander III is a non-invasive automated blood pressure monitor and a data collection/transmission system. It does not involve human "readers" interpreting medical images or data in a way that an AI would assist.

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

   • Yes, for the blood pressure measurement component, the device would have undergone standalone performance testing against reference standards, as required for blood pressure devices. The submission states, "The Commander III has a built in NIBP meter," and this component's accuracy would have been validated. However, the specific results of this standalone performance (e.g., mean difference, standard deviation compared to a reference sphygmomanometer as per ISO standards) are not provided in this summary. The summary broadly states "bench, laboratory, and clinical testing data."

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

   • For the blood pressure meter component, the ground truth would typically be a simultaneous measurement by a trained observer using a calibrated mercury sphygmomanometer or an equivalent reference standard, adhering to recognized protocols for blood pressure device validation (e.g., ANSI/AAMI/ISO 81060-2). For the other vital sign inputs (glucometers, pulse oximeters, peak flow meters), the ground truth would be established by the respective reference devices' measurements, as the Commander III acts as a data collector and transmitter for these, not the primary measurement device (except for the built-in NIBP).

7. The sample size for the training set:

   • Not applicable/Not mentioned. This device does not appear to employ a machine learning or AI model that requires a "training set" in the conventional sense of AI algorithms that learn from data. It's a hardware device with embedded firmware for data collection and transmission.

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

   • Not applicable. As above, there's no indication of a machine learning "training set" being used for this device.

Ask a specific question about this device