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The Fresenius StaySafe Patient Connectors are intended for use with a peritoneal cycler for drainage and infusion of PD solution during a peritoneal dialysis exchanges. The Fresenius StaySafe Patient Connectors are indicated for use in acute and chronic peritoneal dialysis.

The Fresenius StaySafe Patient Connectors are designed for use during cycler assisted peritoneal dialysis. The device incorporates a pin and push button/plunger mechanism that provides a closed system after patient disconnection. The pin engages the patient's catheter during a PAUSE or at then end of the treatment. The device also has several accessories associated with its use: StaySafe adaptors. Multiple tubing sets, and extension sets. The device is provided sterile and is for single use only.

The provided 510(k) summary for the Fresenius STAYSAFE Patient Connectors does not include specific acceptance criteria or performance data from a study as one would typically find for a new device requiring detailed performance evaluation against stated metrics. Instead, the document focuses on demonstrating substantial equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given document. The submission hinges on the device being "substantially equivalent" to predicate devices, implying that its performance is presumed to be similar to those already on the market without needing entirely new, quantifiable acceptance criteria or performance metrics in a table.

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

This information is not provided. The submission states that substantial equivalence is supported by "information, materials data, device description, and performance testing submitted and/or described within this 510K." However, no details about specific test sets, sample sizes, or data provenance (e.g., country of origin, retrospective/prospective) for any studies are given.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. Given that the submission focuses on substantial equivalence to predicate devices rather than a de novo performance study requiring expert ground truth establishment, this detail would likely not be relevant or present in such a summary.

4. Adjudication Method for the Test Set

This information is not provided. As no specific test sets or ground truth establishment methods are described, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done according to the provided text. The submission relies on demonstrating substantial equivalence to predicate devices, not on showing human reader improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done according to the provided text. The device described is a physical medical connector, not an algorithm or AI system.

7. The Type of Ground Truth Used

This information is not explicitly provided. Since the device is a physical connector, "ground truth" as typically understood in data-driven AI/software contexts (pathology, outcomes data, expert consensus) is not directly applicable in the same way. The "truth" would be its adherence to design specifications, material properties, and functional performance, likely assessed through engineering and biocompatibility testing, but these details are not provided in this summary. The summary states that "materials data" and "performance testing" were submitted, implying these types of evaluations were conducted.

8. The Sample Size for the Training Set

This information is not provided. "Training set" is not relevant here as the device is a physical medical device, not an AI or machine learning algorithm.

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

This information is not provided. "Training set" is not relevant here.

Summary of what is present:

The submission focuses primarily on establishing substantial equivalence by stating that the subject device (Fresenius STAYSAFE Patient Connectors) has:

• Identical indications for use to predicate devices.
• Identical technological characteristics to predicate devices.
• Identical design features to predicate devices.
• Identical materials to predicate devices.

The document lists several predicate devices from Fresenius Medical Care itself, implying a direct comparison to previously cleared products. The performance testing and materials data mentioned are likely standard engineering and biocompatibility tests to ensure the device functions as intended and safely, consistent with its identical characteristics to predicate devices, rather than a novel study with specific acceptance criteria that are quantitatively reported in this summary.

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