(109 days)
The TxControl™ is a software application intended to be used by clinicians with ResMed flow generators that incorporate ResMed's proprietary communication protocol. TxControl provides real-time data display directly from the flow generator or via ResControl II™.
TxControl can also provide flow generator setting changes, remotely within a clinical environment.
ResMed's TxControl™ is a PC-based software application that enables clinicians to monitor real-time patient and flow generator information and adjust flow generator settings as required from the control raom within the sleep lab clinical setting.
TxControl is also designed to transfer data from a CPAP or bilevel flow generator to a polysomnograph (PSG) display system such as Somnologica (K971813) when used in conjunction with a ResControl II device The performance and functional characteristics of the TxControl includes similar user friendly features of the predicate device, ResControl II (K040944).
This document provides a summary of the 510(k) premarket notification for TxControl, a software application developed by ResMed Ltd. However, it does not contain specific details about acceptance criteria or a study proving the device meets those criteria with numerical performance metrics. The document primarily focuses on establishing substantial equivalence to a predicate device (ResControl II) and lists general design and verification activities.
Therefore, I cannot provide a table of acceptance criteria with reported device performance, nor can I answer questions related to sample size for test sets, data provenance, ground truth establishment, expert involvement, MRMC studies, or standalone performance directly from the provided text.
The document states: "Design and Verification activities were performed on the TxControl as a result of the risk analysis and product requirements. All tests confirmed the product met the predetermined acceptance criteria." This is a general statement and does not include the details of those tests or acceptance criteria.
Based only on the provided text, the following information can be extracted:
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A table of acceptance criteria and the reported device performance:
The document states: "All tests confirmed the product met the predetermined acceptance criteria." However, no specific acceptance criteria or performance numbers are provided in the text. -
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 present in the provided text. -
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 present in the provided text. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not present in the provided text. -
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 present in the provided text. The device is described as a software application for clinicians to display data and adjust settings, not an AI or diagnostic tool that would typically involve MRMC studies for improved human reader performance. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document focuses on the software's functionality in a clinical environment with clinicians. It states TxControl "enables clinicians to monitor real-time patient and flow generator information and adjust flow generator settings." This implies a human-in-the-loop scenario. No standalone algorithm performance without human involvement is mentioned or described. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not present in the provided text. Given the device's function (real-time data display and setting changes for flow generators), "ground truth" in a diagnostic sense may not be directly applicable as it's not performing a diagnostic task. The "tests" mentioned likely relate to software functionality and accuracy of data display/setting implementation rather than diagnostic accuracy. -
The sample size for the training set:
This information is not present in the provided text. -
How the ground truth for the training set was established:
This information is not present in the provided text.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).