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

The Liberty Cycler is a computer-controlled electro-mechanical medical device designed for use in Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Liberty Cycler design incorporates software-controlled pumping action for fluid movement. The Liberty Cycler heats the peritoneal dialysate solution prior to user infusion, measures and delivers a pre-determined amount of fluid to the user and monitors the drained volume from the user. The Liberty Cycler is designed as a table-top unit and is prescribed in both professional and home treatment settings. Modifications to the predicate Liberty Cycler include changes to the performance specifications to allow use of a 6-liter dialysate solution bag. The Liberty Cycler can now accommodate a 1 to 6-liter dialysate solution bag configuration. Additional modifications are included in this submission which are intended to enhance performance and data management within predicate specifications.

The provided text describes modifications to an existing medical device, the Fresenius Liberty Cycler, and the testing conducted to ensure its continued safety and effectiveness. It is not an AI/ML device, therefore, some of the information requested in the prompt is not available in the given text.

Here's an analysis of the acceptance criteria and study information available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "Test results demonstrated that all modifications functioned as intended and met predetermined acceptance criteria" and that "The essential performance of the Liberty Cycler is not affected by the modifications." However, specific numerical acceptance criteria for each test and their corresponding reported performance values are not detailed in the provided text.

The text mentions several types of tests, implying that acceptance criteria were established for each. Here's a general table based on the information provided, noting the lack of specific numerical criteria:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: The document does not specify the sample size for any of the tests. For example, it doesn't mention how many units were tested for electrical safety or how many participants were involved in human factors testing.
• Data Provenance: The testing was conducted by Fresenius Medical Care North America according to their internal procedures, protocols, and quality system regulations (21 CFR 820). The country of origin of the data is implicitly the United States (Fresenius Medical Care North America is located in Waltham, MA) and is prospective for the modified device, as the testing was done to verify the modifications.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable and not provided in the document. The device is a medical cycler, not an AI/ML diagnostic tool that requires expert consensus for ground truth establishment. The "ground truth" here is compliance with engineering and safety standards.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of images or data to establish a ground truth, which is not relevant to the performance testing of a peritoneal dialysis cycler.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable and not provided in the document. An MRMC study is relevant for evaluating the impact of AI on human reader performance, which doesn't apply to this electromechanical device.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

This information is not applicable to this device in the context of an AI algorithm. The device has software control for pumping and other functions, but it's not an AI/ML algorithm being evaluated in isolation. The "standalone performance" of the device refers to its ability to function according to specifications.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance testing is:

• Compliance with established engineering standards and regulations: UL 60601-1, IEC 62366, IEC 60601-2-39, IEC 60601-1-2.
• Meeting pre-determined internal Fresenius Medical Care acceptance criteria for system validation, software functionality, and functional performance (e.g., fluid measurement accuracy, heating capabilities, ability to accommodate a 6-liter bag).

8. Sample Size for the Training Set:

This information is not applicable and not provided in the document, as the device is not an AI/ML model that undergoes a "training set." The software within the device is validated, not trained in the machine learning sense.

9. How Ground Truth for the Training Set Was Established:

This information is not applicable and not provided. As explained above, there is no "training set" in the context of an AI/ML model for this device. The software's functionality is verified against design specifications and industry standards.

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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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