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The ResScan™ software is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResScan™ is used to download and view therapy data, as well as store therapy information and print reports. ResScan™ also provides functionality for setting flow generator parameters.

The performance and functional characteristics of ResScan includes all the user friendly features of the predicate device.

ResScan allows the clinician to,

• download and view data from a ResMed Flow Generator
• store patient details and downloaded treatment data
• create reports on patient details and downloaded treatment data
• transfer treatment parameters to a ResMed Flow Generator

The provided text does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets acceptance criteria in the format requested. The document is a 510(k) premarket notification summary for the ResScan™ software, focusing on substantial equivalence to a predicate device.

Here's what can be extracted and what is missing based on your request:

Acceptance Criteria and Study Information (Not Present in Text):

The document states: "Design and Validation activities were performed on the new version of ResScan as a result of the risk analysis and product requirement. All tests confirmed the product met the acceptance criteria." However, it does not provide any details on what those acceptance criteria were, what the reported device performance was, or any specifics about the validation activities (like study design, sample size, ground truth, etc.).

Therefore, I cannot fill in the requested table or answer most of your detailed questions.

Information Extracted from the Text:

• Device Name: ResScan™
• Intended Use: The ResScan™ software is intended to be used by clinicians with ResMed flow generators that have software incorporating ResMed's proprietary communication protocol. ResScan™ is used to download and view therapy data, as well as store therapy information and print reports. ResScan™ also provides functionality for setting flow generator parameters.
• Reason for Submission: Expanded indication; change in design.
• Predicate Device(s): ResScan™ (K034033), S8 Pioneer CPAP System (K041209)
• Nature of the Submission: 510(k) Premarket Notification for a software device.

Missing Information (Not provided in the document):

1. A table of acceptance criteria and the reported device performance: Not provided. The document only generally states that "All tests confirmed the product met the acceptance criteria."
2. Sample sized used for the test set and the data provenance: Not provided. No test set details are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. No ground truth establishment details are mentioned.
4. Adjudication method for the test set: Not provided.
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: Not provided. This is a software for data management and parameter setting, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. This device's function is centered around human-in-the-loop (clinician) interaction for data management.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

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