(68 days)
The Commander III 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.
The Commander III is an FDA cleared device (K053303, K053304). It is similar to a simple personal computer with a modem that stores and transmits data to remote locations. The Commander III is cleared for use with a pulse oximeter, a weight scale, a glucose meter, a peak flow meter and a blood pressure cuff. This premarket submission seeks to add an additional pulse oximeter, the PO100, for use with the Commander III. The PO100 is a reusable pulse oximeter that connects to the Cardiocom Commander III via a cable in the same manner as the currently cleared pulse oximeter.
The provided text is a 510(k) summary for the Cardiocom Commander III, seeking to add an additional pulse oximeter (PO100) for use with the device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.
Therefore, much of the requested information cannot be extracted from this document, as it describes a regulatory submission focused on substantial equivalence rather than a detailed performance study with acceptance criteria.
However, based on the provided text, here's what can be gathered and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission states: "To verify that device design met its functional and performance requirements, representative samples of the device underwent electrical, mechanical and clinical testing in accordance with applicable industry standards." However, it does not specify the numerical acceptance criteria or the quantitative results of these tests for the Commander III or the PO100.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "representative samples of the device" were tested, but no details on the sample size or the nature of the data are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the document. The submission does not detail any expert-driven ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided and is not applicable. The device described (Commander III with PO100) is a medical device for collecting and transmitting vital sign data, not an AI or imaging diagnostic tool that would typically involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not explicitly detailed in the context of specific performance metrics. The submission focuses on the Commander III's ability to "store and transmit data to remote locations" and its use with various sensors, including the new PO100 pulse oximeter. The "functional and safety testing" mentioned implies testing the device's standalone performance in accordance with industry standards, but no specific results are given.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. Given the nature of the device (a data collection and transmission system), ground truth would typically refer to the accuracy of the vital sign measurements provided by the connected sensors (like the pulse oximeter) compared to a gold standard, but this is not discussed in the summary.
8. The sample size for the training set
This information is not applicable/provided. The device is not an AI/machine learning algorithm requiring a "training set" in the conventional sense. Its functionality is to collect and transmit data from established medical sensors.
9. How the ground truth for the training set was established
This information is not applicable/provided for the same reasons as point 8.
§ 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).