(88 days)
ResScan-Pro is intended to augment the standard follow-up care of patients by providing transfer of machine and therapeutic information, including the ability to remotely change settings. It is intended to be used by Clinicians in conjunction with ResMed compatible flow generators.
The performance and functional characteristics of ResScan-Pro includes all the user friendly features of the predicate device.
ResScan-Pro allows the clinician to:
- Download, view and store patient and machine details from a ResMed Flow Generator
- Create and print reports on patient and machine details
- Transfer treatment parameters to a ResMed Flow Generator
The ResScan-Pro 510(k) summary does not contain sufficient information to answer your request.
Here's why and what information is missing:
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Acceptance Criteria and Reported Device Performance: The document states, "All tests confirmed the product met the predetermined acceptance criteria," but it does not list what those acceptance criteria were or what the specific performance metrics were that met them. Without these criteria and corresponding performance data, the table cannot be created.
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Sample Size for Test Set and Data Provenance: The document mentions "Design and Verification activities were performed," but it does not specify the sample size of any test set used for these activities, nor does it provide details about the data's origin (country, retrospective/prospective). This information is crucial for understanding the rigor of the testing.
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Number of Experts and Qualifications: There is no mention of experts being used to establish ground truth for a test set. The device appears to be data management software, not a diagnostic AI device requiring expert consensus for ground truth.
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Adjudication Method: Since there's no indication of experts or complex diagnostic interpretations, an adjudication method is not applicable or mentioned.
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MRMC Comparative Effectiveness Study: The document does not describe any Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device's function is to transfer and manage data/settings, not to assist human readers in interpretation.
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Standalone Performance: The 510(k) summary focuses on the device's functionality in transferring and managing data/settings. While "performance" is mentioned in a general sense, there's no specific "standalone" performance study detailed in the way one would expect for an AI diagnostic algorithm (e.g., sensitivity, specificity for a particular condition). The device's performance is tied to its ability to correctly transfer information, which is a functional test, not a diagnostic one.
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Type of Ground Truth: Given the device's nature (data transfer and settings management), the concept of "ground truth" as typically applied to diagnostic algorithms (expert consensus, pathology, outcomes data) is not directly relevant or discussed. The performance would likely be validated against successful data transfer and accurate setting changes.
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Sample Size for Training Set and Ground Truth Establishment for Training Set: The document does not refer to a "training set" because this device is not an AI/ML algorithm that learns from data in that manner. It's software for managing and transferring existing machine and therapeutic information.
In summary, the provided 510(k) summary for ResScan-Pro describes a device for data transfer and settings management for non-continuous ventilators, not a diagnostic AI/ML device. Therefore, many of the typical questions regarding acceptance criteria, study design, and ground truth for AI algorithms are not applicable or the information is not present in this type of submission.
§ 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).