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The HomeChoice APD Set with Lineo Connector is intended for use with the HomeChoice Automated Personal Cycler.

The HomeChoice Integrated APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.

The HomeChoice Low Recirculation Volume APD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy in pediatric and adult renal failure patients requiring fill volumes of 60 - 1000 ml, using only the HomeChoice Automated Personal Cycler with Low Fill Mode Drain Logic.

The Lineo OptiCap is for protection of the Lineo Connector (patient line) of APD Disposable Sets with Lineo Connector that are intended for delivery of peritoneal dialysis therapy.

The HomeChoice Automated PD Set with Lineo Connector is intended for delivery of peritoneal dialysis therapy and is compatible with the HomeChoice Automated PD System only, and is to be used with the MiniCap Extended Life PD Transfer Set, Easy-Lock Extended Life PD Transfer Set, or Easy-Lock Transfer Set.

HomeChoice APD Set with Lineo Connector is a disposable tubing administration set used in automated peritoneal dialysis therapies. It provides for connection of the patient and the peritoneal dialysis solutions to the automated cycler.

The provided 510(k) summary (K031676) for the HomeChoice APD Set with Lineo Connector and related products (HomeChoice Integrated APD Set with Lineo Connector, HomeChoice Low Recirculation Volume APD Set with Lineo Connector, and Lineo Opticap) does not contain information about acceptance criteria or a study proving device performance in the context of diagnostic accuracy, sensitivity, specificity, or similar metrics typically associated with AI/ML devices.

This submission is for a medical device that is a disposable tubing administration set used in automated peritoneal dialysis therapies. The evaluation of this type of device primarily relies on biocompatibility, sterilization, and functional/physical testing to ensure safety and effectiveness, rather than clinical performance metrics like those found in AI/ML products.

Therefore, many of the requested categories for AI/ML device studies are not applicable to the information provided in this 510(k) summary.

Here's an breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify sample sizes for biocompatibility, sterilization, or functional testing. Data provenance (country of origin, retrospective/prospective) is not applicable or specified for these types of engineering and materials tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML devices (e.g., expert labels on medical images) is not relevant for the biocompatibility, sterility, or functional testing of a disposable tubing set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are not relevant for the biocompatibility, sterility, or functional testing of a disposable tubing set.

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, a MRMC comparative effectiveness study was not done. This is a disposable medical device, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the types of tests described (biocompatibility, sterilization, functional/physical), the "ground truth" would be established by:

• Biocompatibility: Standardized laboratory tests according to ISO 10993-1 guidelines, with 'truth' being the measured biological response against established thresholds for safety.
• Sterilization: Microbiological testing and validation processes to confirm an SAL of ≥ 10⁻⁶.
• Functional/Physical Testing: Engineering specifications and performance standards for mechanical integrity, flow rates, leak resistance, etc.

8. The sample size for the training set
Not applicable. This device does not use an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm.

Summary of Device and Performance Evaluation Approach:

This submission uses the "Substantial Equivalence" pathway (510(k)) based on comparison to predicate devices (HomeChoice APD Sets and disconnect caps with povidone iodine). The primary argument for safety and effectiveness is that the "technological characteristics of the HomeChoice APD Set with Lineo Connector do not raise any new types of safety and effectiveness issues, when compared to the predicate product."

The evaluation focuses on:

• Similar Design and Materials: The new device incorporates disinfectant features of existing disconnect caps into the patient connector of the set, maintaining the general design and materials similar to predicate devices.
• Biocompatibility: Conformance to ISO 10993-1.
• Sterilization: Validated to an SAL of ≥ 10⁻⁶.
• Functional and Physical Testing: Routine testing performed before release (details not provided in the summary).

The clinical data section explicitly states "N/A," reinforcing that a clinical study with human subjects, or any study measuring diagnostic performance outcomes, was not required or submitted for this type of device and submission.

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