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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.

AI/ML Overview

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

Test Category	Specific Test	Acceptance Criteria	Reported Device Performance
Performance	Cycler Set fill and drain accuracy	Not explicitly stated, but implies meeting functional specifications for fluid delivery and removal.	Conducted (implies meeting criteria)
	Load to close tubing clamps test	Not explicitly stated, but implies meeting force requirements for secure clamping.	Conducted (implies meeting criteria)
	Load to push the stay•safe patient connector test	Not explicitly stated, but implies meeting force requirements for secure connection.	Conducted (implies meeting criteria)
	Compression tests on cassette ports	Implies meeting break-force limits to ensure structural integrity during use.	Conducted (implies meeting criteria)
Structural Integrity	Abrasion test	Not explicitly stated, but implies resistance to wear and tear.	Conducted (implies meeting criteria)
	Positive and negative pressure leak test (Cycler Set)	Not explicitly stated, but implies no leaks under specified pressure ranges.	Conducted (implies meeting criteria)
	Bond strength testing (Tensile test)	Not explicitly stated, but implies adequate strength of bonded components.	Conducted (implies meeting criteria)
	Positive pressure leak test (connectors/clamps)	Not explicitly stated, but implies no leaks from patient connectors and tubing clamps under pressure.	Conducted (implies meeting criteria)
	Film seal integrity test (Endurance test)	Not explicitly stated, but implies seals maintain integrity over device lifespan/during use.	Conducted (implies meeting criteria)
	Shipping and packaging test	Not explicitly stated, but implies device maintains integrity and sterility after shipping.	Conducted (implies meeting criteria)
Biological Safety	Simulated use Leachables	Implies that leachable substances are within safe limits.	Conducted (implies meeting criteria)
	Cytotoxicity, ISO Elution Method with MEM	Implies non-toxic to cells.	Conducted (implies meeting criteria)
	Sensitization, Guinea Pig Maximization	Implies a low risk of causing allergic sensitization.	Conducted (implies meeting criteria)
	Intracutaneous Irritation	Implies materials do not cause significant skin irritation.	Conducted (implies meeting criteria)
	Material-Mediated Pyrogenicity	Implies materials do not cause fever.	Conducted (implies meeting criteria)
	Hemocompatibility, ASTM Hemolysis (Indirect) Extract	Implies materials do not cause significant red blood cell lysis.	Conducted (implies meeting criteria)
Other	Human Factors (HF) validation	Not explicitly stated, but implies usability and safety are validated for intended users and environments.	Conducted (implies meeting criteria)
	Maintenance of sterility	Not explicitly stated, but implies sterility is maintained until point of use.	Conducted (implies meeting criteria)

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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