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The K.E.P. Connector and Clip is intended to secure the position of the outlet tubing of single-use peritoneal dialysis sets on any solid surface.

The K.E.P. Connector and Clip comprises three major components: (1) the rightangle barbed tubing connector (outlet), (2) the wire frame, and (3) the suction cup. This device is provided to the user as an assembled device. The K.E.P Connector and Clip enables free flow of waste dialysate in a safe and hygienic manner. The suction cup is designed to adhere to ceramic or any other non-porous surface, unless intentionally released by the "A tab." The K.E.P. Connector and Clip has been designed with an air gap between the distal end of the connector and the discharge site (drain), thereby making it impossible for any fluid to back flow or to be restricted; this air gap is consistent with ASME designs for plumbing fixtures.

The provided text describes a medical device called the "K.E.P. Connector and Clip" and its 510(k) submission to the FDA. However, the document does not contain specific details about acceptance criteria or a study that proves the device meets such criteria.

The text states: "Testing of the K.E.P. Connector and Clip demonstrates that it complies with design and performance specifications." This is a general statement and does not provide quantifiable acceptance criteria, specific performance metrics, or details of how these were tested or achieved.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary information is not present in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information (and why):

• Specific Acceptance Criteria: The document mentions "design and performance specifications" but does not define what those specifications are (e.g., tensile strength, flow rate, retention force, material biocompatibility, duration of secure hold, etc.).
• Quantifiable Device Performance: Without specific criteria, there are no reported numerical or descriptive performance outcomes.

The information regarding the study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness is entirely absent from the provided 510(k) summary. This type of detail is often found in the full test reports that accompany a 510(k) submission, but it's not present in this high-level summary.

Summary of Missing Information for all other points:

• Sample size for test set and data provenance: Not mentioned.
• Number of experts and their qualifications: Not mentioned.
• Adjudication method: Not mentioned.
• MRMC comparative effectiveness study: Not mentioned. The device is a physical connector, not an AI/software device, so this type of study would be highly unlikely.
• Standalone (algorithm only) performance: Not applicable; this is a physical device.
• Type of ground truth used: Not mentioned.
• Sample size for training set: Not applicable and not mentioned.
• How ground truth for training set was established: Not applicable and not mentioned.

In conclusion, while the K.E.P. Connector and Clip received 510(k) clearance based on its submission, the provided summary document lacks the detailed performance testing information required to answer your specific questions about acceptance criteria, study design, and ground truth establishment. This document only states that testing was performed and that the device complies with its specifications.

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