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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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These devices are intended for various non-permanent intravascular applications including pressure monitoring, fluid administration, and blood sampling.

The various SDM Central Venous Catheters consist of polyurethane bodies with zero to five polyurethane extension tubes. Except for the smallest French sizes of the single lumen devices, the catheters all contain an additional flexible polyurethane distal tip. The proximal end(s) of each catheter terminate in molded-on, fixed, female locking luers. Where present, the extension tubes are joined to the catheter body by insertmolded polyurethane and contain clamps for occluding the tubes. Many configurations are marked with centimeter markings to indicate insertion depth.

Catheters will be offered in "kits" which will include some or all of the following depending on configuration: Catheter, guidewire in dispenser, dilator, syringe, scalpel, suture wing, and introducer needle. The makeup of specific sets can be seen in the Appendix D of this 510(k) submission. These kits will be packaged in semi-rigid vacuum formed trays containing a heat-sealed, ethylene oxide permeable lids, or in standard Tyvek/Poly pouches, depending on the product configuration.

This document describes the Safe-Cath Single- and Multi-Lumen Intravascular Catheter. However, it is a 510(k) Summary of Safety and Effectiveness for a medical device and does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

A 510(k) premarket notification is submitted to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This typically involves demonstrating "substantial equivalence" rather than presenting original clinical studies with detailed acceptance criteria and performance data in the way an AI/ML device submission would.

Therefore, I cannot provide the requested information from this document. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance data for an algorithm.
7. Type of ground truth used (as it's not an AI/ML device).
8. Sample size for a training set (as it's not an AI/ML device).
9. How ground truth for a training set was established (as it's not an AI/ML device).

The document focuses on comparing the Safe-Cath catheter to predicate devices based on intended use, materials, dimensions, and mechanical properties, to argue for substantial equivalence, not to present a study demonstrating performance against specific acceptance criteria.

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