Search Results

This set is used during Peritoneal Dialysis therapy to transfer peritoneal dialysis solution to the patient from the source solution container.

The MiniCap Extended Life PD Transfer Sets are single use, sterile, non-pyrogenic devices for use with Baxter peritoneal dialysis systems. A Transfer Set is connected to a Titanium Adapter that is at the end of an implanted peritoneal catheter. The Transfer Sets stay connected to the patient and allows for the exchange of peritoneal dialysis solution into and out of the peritoneal cavity as prescribed.

The provided document describes the K192705 premarket notification for the "MiniCap Extended Life PD Transfer Sets." The acceptance criteria and the study performed to prove the device meets these criteria are outlined in the "DISCUSSION OF NONCLINICAL TESTS" and "Performance Data" sections.

Here's a breakdown of the requested information:

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

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" with specific quantitative results. Instead, it states that "All results meet their acceptance criteria." The performance data is described as a list of functional tests performed to ensure proper design and function. The acceptance criteria for these tests are implied to be satisfactory performance without specific pass/fail values mentioned.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size for any of the functional or biocompatibility tests. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The document outlines non-clinical testing, which typically involves laboratory testing rather than expert-based ground truth establishment as seen in diagnostic device studies.

4. Adjudication method for the test set

This information is not applicable and is not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple experts are resolving discrepancies in observational data. This document describes non-clinical laboratory testing.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This document describes non-clinical testing of a medical device (transfer sets), not a diagnostic algorithm involving human readers or AI assistance.

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

This is not applicable. The device is a physical medical device (transfer sets), not an algorithm.

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

For the functional tests, the "ground truth" would be established by predefined engineering specifications and performance standards relative to the device's intended use. For biocompatibility, the ground truth is established by the accepted standards within ISO 10993 and FDA guidance documents, which define what constitutes a biologically safe material for medical device contact. It's based on objective laboratory measurements and analyses, not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable as there is no training set for this device.

Ask a specific question about this device