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The stay safe catheter extension set with Safe-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay safe catheter extension set with Safe-Lock is used to connect a PD catheter with Safe-Lock compatible catheter adapter to PD systems that use stay safe PIN technology.

The stay safe catheter extension set with Luer-Lock is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay safe with Luer-Lock is used to connect a PD catheter with a Luer-Lock catheter adapter to PD systems that use stay safe PIN technology.

The stay safe to Luer-Lock adapter is indicated for use in patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The stay safe to Luer-Lock adapter is used to connect a stay safe catheter extension set to medical devices with a Luer-Lock connection.

The stay safe® catheter extension set with Safe-Lock (hereinafter referred to as "Safe-Lock extension set") is a single-use device designed to connect a PD catheter to PD systems that use staysafe PIN technology. The Safe-Lock extension set is provided sterile and non-pyrogenic. The Safe-Lock extension set is sterilized using ethylene oxide (EO).

The stay safe® catheter extension sets with Luer-Lock (hereinafter referred to as "Luer-Lock extension sets") are single-use devices designed to connect a PD catheter to PD systems that use stay safe PIN technology. The Luer-Lock extension sets are provided sterile and non-pyrogenic. The Luer-Lock extension sets are sterilized using EO.

The stay safe® to Luer-Lock adapter (hereinafter referred to as "Luer-Lock adapter") is a single-use device designed to connect a stay safe catheter extension set to a medical device with a Luer lock connector. The Luer-Lock adapter is provided sterile and non-pyrogenic. The Luer-Lock adapter is sterilized using EO.

The provided document is a 510(k) premarket notification for several medical devices: "stay safe® catheter extension set with Safe-Lock," "stay safe® catheter extension set with Luer-Lock," and "stay safe® to Luer-Lock adapter." These are accessories for peritoneal dialysis systems.

The document describes the acceptance criteria and the studies performed to demonstrate that the devices meet these criteria. However, it is important to note that the type of acceptance criteria and studies are not based on AI/ML performance, but rather on the safety and effectiveness of the physical medical devices. Therefore, many of the typical questions for AI/ML device evaluations (e.g., sample size for test/training set, expert ground truth, MRMC studies, effect size of human improvement with AI) are not applicable here.

Here's a breakdown of the requested information based on the provided text, with explanations for non-applicable points:

Acceptance Criteria and Device Performance for Physical Medical Devices

The acceptance criteria for these devices are primarily focused on their physical and biological properties to demonstrate substantial equivalence to predicate devices, ensuring safety and effectiveness for their intended use in peritoneal dialysis.

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

The document lists performance data categories rather than specific quantitative acceptance criteria or numerical reported performance values. The overarching acceptance criterion is demonstrating "substantial equivalence" to predicate devices, implying that the new devices perform safely and effectively for their intended use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document, as the studies are primarily about physical and biological testing of the device for manufacturing and material safety and performance, not data-driven algorithmic performance or clinical trial data. These tests would involve specific numbers of physical units of the device.

• Sample Size: Not specified for the performance and biocompatibility tests.
• Data Provenance: Not applicable in the context of AI/ML. The tests are laboratory-based and conducted on the manufactured device units.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a physical medical accessory, not an AI/ML algorithm requiring expert interpretation to establish ground truth for image or diagnostic data. Ground truth here refers to the validated physical and biological properties of the device, established through standardized testing methodologies.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or AI/ML evaluations to resolve disagreements among human readers or experts in establishing ground truth. For these physical devices, the "ground truth" is determined by meeting engineering and biocompatibility standards.

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

This is not applicable. MRMC studies are specific to AI/ML devices where the performance of human readers, with and without AI assistance, is compared. This document concerns a physical medical accessory, not an AI-powered device. No human-in-the-loop study involving AI was conducted.

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

This is not applicable. This refers to the performance of an AI algorithm on its own. The devices are physical medical accessories, not software algorithms.

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

The "ground truth" for these physical devices is established through compliance with recognized standards and validated test methods for material properties, mechanical integrity, sterility, and biocompatibility. These involve:

• Engineering specifications and design requirements.
• ISO standards (e.g., ISO 10993-1 for biocompatibility, ISO 594-2 for Luer connections).
• Laboratory testing results (e.g., tensile strength measurements, bacterial cultures for sterility, chemical analysis for leachables).
• Demonstration of functional performance (e.g., proper connection, fluid flow).
• Toxicological risk assessment.

There is no "expert consensus" on imaging or diagnostic outcomes, nor pathology or outcomes data in the context of an AI/ML device.

8. The sample size for the training set

This is not applicable. A training set is used for machine learning models. These are physical medical devices, and the document explicitly states:

• "Software Verification and Validation Testing: Not applicable. The [device] does not contain software." (Applicable to all three device types).

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

This is not applicable due to the reason stated in point 8.

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Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors: The Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The MTS Set is placed during set-up to make additional connections to the cycler set when an interruption in treatment is necessary. This device is compatible with stay safe Peritoneal Dialysis (PD) connectology system and is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.

stay·safe® Drain Set: The stay safe Drain Set is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The staysafe Drain Set is used to connect directly to the stay safe catheter extension set to enable drainage and/or effluent sampling as needed. This device is compatible with Fresenius Medical Care (FMCNA) Peritoneal Dialysis (PD) stay safe catheter extension sets.

Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors: The MTS Set is a single-use device that provides additional connections/disconnections when used with a stay safe compatible cycler set during acute and chronic peritoneal dialysis (PD) treatment. The MTS Set is provided sterile and non-pyrogenic. The MTS Set is sterilized using ethylene oxide (EO). The MTS Set consists of two (2) stay safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end.

stay·safe® Drain Set: The Drain Set is a single-use device that connects directly to the patient's stay safe catheter extension set to enable effluent drainage as needed. The Drain Set is provided sterile and non-pyrogenic. The Drain Set is sterilized using ethylene oxide (EO). The Drain Set consists of an empty three (3) L drain bag, a stay safe PIN connector, a sample port, tubing, and a low force clamp.

The provided text describes two medical devices: the Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors and the stay safe® Drain Set. Both are accessories for peritoneal dialysis.

Here's an analysis of the acceptance criteria and supporting studies for both devices, structured as requested. Please note that the document focuses on performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical effectiveness study in the typical sense of AI/reader studies.

Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (Test Set)

• The document does not explicitly state exact sample sizes for each test (e.g., number of MTS Sets tested for tubing verification, bond strength, etc.).
• It describes "test samples" for bond/tensile strength, "cases (corrugated cartons) of MTS Sets" for weight verification, and a general reference to methods for tubing, connector, and packaging verification.
• Data provenance is not specified (e.g., country of origin). The studies appear to be performed internally by the manufacturer or a contract lab.
• The studies are retrospective in the sense that they are conducted on manufactured devices as part of the market clearance process.

3. Number of Experts and Qualifications (Ground Truth for Test Set)

• Not applicable. These are engineering and biological performance tests, not AI-based diagnostic studies requiring expert review for ground truth.

4. Adjudication Method (Test Set)

• Not applicable. The tests involve objective measurements and visual inspections against predefined criteria, not expert adjudication.

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

• No. This is not an AI-based diagnostic device.

6. Standalone Performance Study (Algorithm Only)

• No. This is not an AI-based diagnostic device.

7. Type of Ground Truth Used

• The ground truth for these tests is based on established engineering standards (e.g., ASTM, ISO), internal design specifications (e.g., tubing dimensions, vent count, force resistance), and standardized biological evaluation methods.

8. Sample Size for Training Set

• Not applicable. This is not an AI-based device requiring a training set.

9. How Ground Truth for Training Set was Established

• Not applicable.

stay safe® Drain Set

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (Test Set)

• The document does not explicitly state exact sample sizes for each test (e.g., number of Drain Sets tested for tubing verification, bond strength, etc.).
• It describes "test samples" for bond/tensile strength, "cases (corrugated cartons) of Drain Sets" for weight verification, and a general reference to methods for tubing, clamp, and packaging verification, and a single "Drain Set" for the drop test.
• Data provenance is not specified (e.g., country of origin). The studies appear to be performed internally by the manufacturer or a contract lab.
• The studies are retrospective as they are conducted on manufactured devices as part of the market clearance process.

3. Number of Experts and Qualifications (Ground Truth for Test Set)

• Not applicable. These are engineering and biological performance tests, not AI-based diagnostic studies requiring expert review for ground truth.

4. Adjudication Method (Test Set)

• Not applicable. The tests involve objective measurements and visual inspections against predefined criteria, not expert adjudication.

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

• No. This is not an AI-based diagnostic device.

6. Standalone Performance Study (Algorithm Only)

• No. This is not an AI-based diagnostic device.

7. Type of Ground Truth Used

• The ground truth for these tests is based on established engineering standards (e.g., ASTM, ISO), internal design specifications (e.g., tubing dimensions, vent count, force resistance, no-leak for drop test), and standardized biological evaluation methods.

8. Sample Size for Training Set

• Not applicable. This is not an AI-based device requiring a training set.

9. How Ground Truth for Training Set was Established

• Not applicable.

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