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The Faller stylet is a surgical tool used to create a subcutaneous tunnel for a peritoneal dialysis catheter, from the initial implantation site to the preferred exit-site. It separates the tissue as it leads the catheter through to the skin exit-site.

Faller Stylet

This document is an FDA 510(k) clearance letter for the "Faller Stylet," a surgical tool used to create a subcutaneous tunnel for peritoneal dialysis catheters. As such, it does not contain the kind of detailed performance study information, acceptance criteria, or clinical trial data you are requesting for an AI/ML device.

The questions you've asked (about acceptance criteria, sample sizes, ground truth, expert adjudication, MRMC studies, and standalone performance) are highly relevant for the evaluation of AI/ML-based medical devices. These types of devices require rigorous testing against predefined performance metrics, typically involving clinical validation studies.

This document is for a mechanical surgical tool. Its clearance is based on substantial equivalence to predicate devices, which generally means demonstrating that it has the same intended use, technological characteristics, and safety and effectiveness profiles as legally marketed devices, without introducing new risks or questions of effectiveness. This usually involves:

• Bench testing: To confirm physical properties, strength, etc.
• Biocompatibility testing: To ensure materials are safe for human contact.
• Sterilization validation: To ensure the device can be properly sterilized.
• Performance testing: To confirm it performs its intended mechanical function (e.g., smoothly separates tissue).

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes for test/training, expert details, adjudication, MRMC, standalone performance, ground truth types) from this specific document because it pertains to a different type of medical device and regulatory pathway.

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Peritoneal Dialysis Catheters and Adapters are access devices used for providing peritoneal dialysis treatment for patients suffering from End Stage Renal Disease (ESRD). Their main function is to allow the bi-directional flow of peritoneal dialysis solution in a consistent manner, without requiring extraordinary effort or causing discomfort.

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This document is a 510(k) clearance letter from the FDA for Peritoneal Dialysis Catheters and Adapters (K993149). It indicates that the device has been found substantially equivalent to legally marketed predicate devices. However, this document does not contain specific acceptance criteria, device performance data, details of a study proving the device meets acceptance criteria, sample sizes, ground truth information, expert qualifications, or details about comparative effectiveness studies.

Therefore, I cannot fulfill your request as the provided text lacks the necessary information.

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Easy Care and Tubing Sets are used to provide peritoneal dialysis fluid exchanges for patients suffering from End Stage Renal Disease (ESRD). Their main function is to allow the bi-directional flow of peritoneal dialysis solution in and out of the peritoneal cavity of the patient by means of gravity.

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This looks like a 510(k) clearance letter for a medical device (K994218 Easy Care and Tubing Sets), rather than a study report or clinical trial. Therefore, the document does not contain the detailed information required to describe acceptance criteria and associated study results. The letter confirms that the device is "substantially equivalent" to a legally marketed predicate device (K910173/C), implying that it meets the same safety and effectiveness standards, but it doesn't provide specific performance metrics or details of a study that would explicitly prove it.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria or Reported Performance: The letter only states substantial equivalence. It does not list specific performance metrics (e.g., accuracy, sensitivity, specificity, flow rates, durability) or the numerical results achieved by the device against such criteria.
• No Study Details: There is no mention of a specific study, clinical trial, or independent testing to demonstrate performance. The 510(k) process often relies on existing data or performance characteristics of a predicate device, rather than requiring a new, comprehensive clinical study for every submission, especially for Class II devices.
• No Sample Sizes, Data Provenance, Expert Qualifications, or Adjudication Methods: These are all details typically found in a study report, which is not provided here.
• No MRMC or Standalone Performance: Again, these are specific study types and performance measures that would be reported in a detailed study, not a regulatory clearance letter.
• No Ground Truth Information: Ground truth establishment, whether for a test or training set, is part of a study design and is not included in this type of regulatory document.
• No Training Set Sample Size or Ground Truth Establishment: These pertain to the development and validation of an algorithm or model, which is not applicable to the "Easy Care and Tubing Sets," as these appear to be physical medical devices (peritoneal dialysis tubing) rather than an AI/software device.

In summary, the provided document is a regulatory clearance letter, not a scientific study report. Therefore, it does not contain the specific information requested about acceptance criteria, study design, or performance metrics.

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