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The Liberty Cycler Sets are designed to operate with the Liberty Cycler to perform acute and chronic peritoneal dialysis.

The Cycler Sets are sterile, single-use devices designed to operate with the Liberty Cycler to perform acute and chronic peritoneal dialysis. Each Cycler Set contains a cassette portion and seven (7) fluid lines. The cassette is composed of a rigid molded plastic body covered with a flexible film (membrane). The cassette contains molded features, such as fluid channels, valve domes, and pumping chambers. There are 7 fluid lines connected to the cassette body:

• One (1) drain line (yellow clamp)
• One (1) patient connection line with two (2) stay •safe® patient connectors (blue clamp)
• Five (5) Dialysate Solution Lines (with Safe-Lock® connectors):
• One (1) heater bag (red clamp)
• One (1) last dialysate bag/'last fill option' (green clamp)
• Three (3) additional solution bags (white clamps)
  The flow of peritoneal dialysate solution to and from the patient's peritoneal cavity is directed by interaction between the Liberty Cycler and the cassette.

The Fresenius Liberty Cycler Set is an accessory for the Liberty Cycler, used for acute and chronic peritoneal dialysis. The 510(k) summary provides performance data and acceptance criteria for various aspects of the device.

Here's an overview of the acceptance criteria and supporting studies:

Key Takeaways:

• No AI Component: The provided document is for a medical device accessory (cycler set) that does not contain software or electrical components, and therefore no AI. Consequently, many of the typical AI-related study components (like expert ground truth, MRMC studies, training set details) are not applicable here.
• Focus on Physical and Biocompatibility Performance: The studies conducted focus on the physical performance of the cycler set (e.g., fill/drain accuracy, structural integrity, leak tests) and its biological safety (biocompatibility).
• Comparison to Predicate Device: The primary method for proving substantial equivalence to a legally marketed predicate device (K043363) relies on demonstrating similar technological characteristics and meeting established performance and safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document generally states that testing "was conducted or leveraged to support the determination of substantial equivalence" and "implies meeting criteria" without providing specific numerical acceptance limits or raw performance results. This is common in 510(k) summaries where detailed results are part of the full submission but not always publicly accessible.

2. Sample size used for the test set and the data provenance

• The document does not specify the exact sample sizes for each test in the test set.
• The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature. However, these are performance tests and biocompatibility tests conducted on the physical device and its materials, typically under controlled laboratory conditions rather than with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This device is a cycler set (physical accessory), not an AI/software device that generates outputs requiring expert interpretation for ground truth. Ground truth for these tests would be established by objective measurements against engineering specifications and international standards (e.g., ISO, ASTM).

4. Adjudication method for the test set

• Not applicable for the same reasons as point 3.

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 applicable. This device does not have an AI component and therefore no MRMC study was performed in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The device does not contain a standalone algorithm.

7. The type of ground truth used

• The ground truth for the performance and structural integrity tests are quantitative engineering specifications and established material testing standards.
• For biocompatibility, the ground truth is based on established international standards (e.g., ISO 10993-1) for evaluating biological responses to medical device materials.

8. The sample size for the training set

• Not applicable. This device is a physical accessory and does not involve machine learning or a training set.

9. How the ground truth for the training set was established

• Not applicable for the same reasons as point 8.

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

The Liberty Select Cycler is an electro-mechanical medical device. Software controls the functions of the machine during peritoneal dialysis treatment, including fluid flow, heating, and alarms. The Liberty Select Cycler is designed as a table-top unit and is prescribed for use in both professional and home treatment settings. The Liberty Select Cycler is a software-controlled electro-mechanical medical device designed to deliver Automated Peritoneal Dialysis (APD) therapy for the treatment of end-stage renal disease (ESRD). The Liberty Select Cycler is used to perform continuous and intermittent peritoneal dialysis therapies. Treatment settings are programmed based on a physician's prescription. The Liberty Select Cycler accommodates three (3) accessory devices: Cassette and tubing set, IQdrive, Optional wireless modem.

This document describes the Fresenius Liberty Select Cycler, a peritoneal dialysis system. Since the device is a peritoneal dialysis cycler and not an AI/ML powered device, the provided information does not contain details about acceptance criteria, test sets, ground truth, or training sets in the context of AI/ML performance evaluation. These types of details are typically pertinent to the validation of AI/ML algorithms, which is not the subject of this 510(k) summary.

However, the document does list essential performance characteristics and outlines the performance data used to demonstrate substantial equivalence to predicate devices. Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance:

The document states "The Liberty Select Cycler has the same essential performance characteristics as the predicate device (K123630) as listed in Table 1." It then provides the following table:

Note: These specifications serve as the "acceptance criteria" for the device's essential performance characteristics. The document implies that the reported device performance (i.e., the performance of the Liberty Select Cycler) meets these specifications, as it concludes the device is substantially equivalent to the predicate. The document does not provide separate "reported device performance" values if they are identical to the specifications.

2. Sample size used for the test set and the data provenance:

• This information is not explicitly provided in the context of AI/ML algorithm evaluation, as the device is not an AI/ML product.
• For the described performance parameters (inflow, outflow, temperature, volume accuracy), testing would typically involve a certain number of device units and repeated measurements. However, the specific sample size (e.g., number of cycles tested, number of devices) is not detailed in this summary.
• The data provenance (e.g., country of origin, retrospective/prospective) is also not applicable or specified for this type of medical device validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable, as this device is not an AI/ML system requiring expert-established ground truth for algorithm performance.
• The "ground truth" for the performance characteristics would be established by validated measurement techniques and sensors inherent to the engineering and medical device testing processes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not applicable for the type of device and validation described. Adjudication methods are typically used in clinical studies or AI/ML evaluations where there is subjective interpretation involved.

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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or AI-assisted interpretation devices, which the Fresenius Liberty Select Cycler is not.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This is not applicable as the device is not an AI/ML algorithm. The "standalone" performance here refers to the device's functional performance in an automated manner, which is what the essential performance characteristics refer to.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the device's essential performance characteristics (Inflow, Outflow, Temperature, Volume Accuracy), the "ground truth" is based on engineering measurements and calibration standards. For example, volume accuracy would be measured against known, accurately measured volumes; temperature against calibrated thermometers; and flow rates against calibrated flow meters.

8. The sample size for the training set:

• This information is not applicable, as the device is not an AI/ML system that undergoes a "training set" phase.

9. How the ground truth for the training set was established:

• This information is not applicable, as the device is not an AI/ML system with a "training set."

Summary of Study/Testing Methods (as provided in the document):

The performance testing requirements were determined through:

• Application of a risk management process.
• Applicable FDA guidance documents.
• Performance standards (21 CFR 876.5630).

Testing included:

• Software Verification and Validation Testing: Unit, integration, and system-level software verification to demonstrate effectiveness of software modifications and confirm machine operation.
• Mechanical and Acoustic Testing: Verified that noise level does not exceed 40 dBA during treatment.
• Human Factors Testing: Performed on modifications impacting Human Factors, including:
  • Selectable drain exit criteria (70% or 85%).
  • Selectable additional drain option with alert.
  • STAT drain at the end of treatment.
  • Implement Soft Alarms.
  • The remaining essential and critical user tasks were determined to be equivalent to the predicate devices.

The conclusion states that the four new features tested are safe and effective for the intended users, uses, and use environments, and that the device is substantially equivalent to its predicate.

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