Search Results

The Diacap Ultra Dialysis Fluid Filter is intended to filter bacteria and endotoxins from dialysate used for hemodialysis treatments.

The Diacap Ultra dialysis fluid filter is sterile, non-pyrogenic dialysis fluid filter for use with machines providing hemodialysis treatments. The device is composed of a hollow core polysulfone and polyvinylpyrrolidone membrane, polycarbonate housing and headers (end-caps) with Hansen type connectors, silicone O-rings, and polyethylene port caps.

This is a 510(k) summary for the Diacap Ultra Dialysis Fluid Filter and does not contain specific details about acceptance criteria or a study proving device performance as typically understood for AI/ML-based medical devices. The document is for a medical device that filters bacteria and endotoxins from dialysate. It's a submission to the FDA seeking clearance based on substantial equivalence to existing predicate devices.

Therefore, most of the requested information regarding acceptance criteria and performance study specifics cannot be extracted directly from the provided text.

However, I can extract the information that is present:

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

This information is not provided in the document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than presenting specific performance data against defined acceptance criteria. For devices like filters, the "performance" would typically refer to filtration efficiency for bacteria and endotoxins, and flow rates; these are not detailed here.

2. Sample size 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 this is a physical filter, "test set" would likely refer to physical testing of filters, not a data set in the AI/ML sense. No details about such testing are included.

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 information is not applicable/provided. This type of information is relevant for AI/ML devices where human experts establish ground truth for image interpretation, for example. For a physical filter, "ground truth" would be established through laboratory testing and measurement of filtration efficacy, not expert consensus in the typical sense.

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

This information is not applicable/provided. This is a method used for establishing ground truth in AI/ML studies involving human interpretation.

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 information is not applicable/provided. An MRMC study is relevant for AI/ML devices that assist human readers in tasks like medical image interpretation. This document describes a physical medical filter.

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

This information is not applicable/provided. This is relevant for AI/ML algorithms.

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

This information is not provided. For a filter, ground truth would likely be established through quantitative measurements of bacterial and endotoxin removal in a laboratory setting, rather than expert consensus or pathology.

8. The sample size for the training set:

This information is not applicable/provided. This is relevant for AI/ML devices.

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

This information is not applicable/provided. This is relevant for AI/ML devices.

Summary based on available information:

The provided document is a 510(k) summary for a physical medical device (dialysis fluid filter) seeking clearance based on substantial equivalence to predicate devices. It does not contain details about specific performance studies with acceptance criteria, test sets, ground truth establishment, or human expert involvement in the way these questions apply to AI/ML or diagnostic devices.

The key information from the document related to "acceptance" is the FDA's determination of Substantial Equivalence (K052764) to predicate devices:

• K993806 Clarigen, Inc., DialGuard™
• K003957 GAMBRO® Renal Products, Dialclear™ Ultrafilter
• K983126 Minntech FibreFlo

This substantial equivalence determination means the FDA believes the Diacap Ultra Dialysis Fluid Filter is as safe and effective as the legally marketed predicate devices, and therefore "meets the acceptance criteria" in the regulatory sense for market clearance.

Ask a specific question about this device