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The Liberty Cycler is indicated for acute and chronic peritoneal dialysis.

The Liberty Cycler is the first model in the next generation of Fresenius peritoneal dialysis cyclers. It incorporates features found on other Fresenius cvclers and also utilizes a cassette design similar to the cassette for Baxter HomeChoice Pro.

The provided document is a 510(k) Premarket Notification for the Fresenius Liberty Cycler and Disposable Cycler Set. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel acceptance criteria or a comprehensive study proving a device meets specific performance metrics against an established ground truth.

Therefore, the document does not contain the information requested in the prompt regarding:

• A table of acceptance criteria and reported device performance: The submission states that "The Fresenius Liberty Cycler Functional and Software validation and release testing rigorously tested the features of the cycler. The results of this testing indicate that the Liberty Cycler is safe and effective for its intended use." However, specific quantitative acceptance criteria or detailed performance data are not provided.
• Sample size used for the test set and data provenance: No information is available about the sample size or the origin of any test data.
• Number of experts used to establish ground truth and qualifications: No ground truth establishment process or experts are mentioned.
• Adjudication method for the test set: Not applicable as no ground truth establishment is described.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This type of study is not mentioned as the device is a medical cycler, not an AI diagnostic tool.
• Standalone (algorithm-only) performance: Not applicable as the device is a physical cycler.
• Type of ground truth used: Not applicable as no ground truth is described.
• Sample size for the training set: Not applicable as the device is not an AI algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

The document primarily focuses on establishing substantial equivalence to predicate devices. It states:

• Intended Use: "The intended use for the Liberty Cycler is identical to that for the Fresenius PD* IQcard Cycler" and "The Liberty Cycler is indicated for acute and chronic peritoneal dialysis."
• Technological Characteristics: "The features included in the Liberty Cycler are equivalent to those present on other commercially available peritoneal dialysis cyclers and raise no new types of safety or effectiveness questions."
• Functional and Software Validation: It mentions that "The Fresenius Liberty Cycler Functional and Software validation and release testing rigorously tested the features of the cycler." and "The results of this testing indicate that the Liberty Cycler is safe and effective for its intended use." However, these are general statements and do not include specific performance data against acceptance criteria.

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