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The Vital Concepts Irrigation Sets are intended for the delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures.

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The provided text is a 510(k) clearance letter from the FDA for "Irrigation Sets" manufactured by Vital Concepts, Inc. This type of document does not contain information about acceptance criteria or a study proving that a device meets those criteria.

510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, not on meeting specific performance criteria through a standalone study with defined endpoints.

Therefore, I cannot extract the information requested as it is not present in the provided document. The document primarily focuses on regulatory clearance, device classification, and indications for use.

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This device is intended for delivery of irrigation solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cyctoscopy, transurethral resection (TUR) and arthroscopic procedures. This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee.

The International Medsurg Connections Irrigation Sets.

This is a 510(k) premarket notification for a medical device (Irrigation Sets), not an AI/ML device. Therefore, the questions related to AI/ML performance, ground truth, expert adjudication, and training/test sets are not applicable.

The document describes the device's characteristics and its substantial equivalence to a predicate device based on intended use, configurations, and materials. It also outlines a summary of testing conducted to ensure the materials and components meet certain standards.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a list of evaluations performed on the "Joined Tubing 5" and 20"" and "Irrigation Sets*". These can be considered the acceptance criteria for material and component properties. The document states that "All materials used in the fabrication... were evaluated for" these characteristics, implying they met specified acceptance levels, although the specific performance values or pass/fail thresholds are not detailed in this summary.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study or a test set in the context of AI/ML evaluation. The "testing" refers to material and component evaluations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI/ML device, and no "ground truth" for diagnostic or predictive performance is being established.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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: Not applicable. This device is an irrigation set, not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be engineering specifications and material standards.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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Baxter's line of irrigation sets are intended for delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures.

Baxter's line of irrigation sets are intended for delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cystoscopy, transurethral resection (TUR) and arthroscopic procedures. The subject of this submission is a material change in the distal tubing segment of the irrigation set from natural rubber latex to styrene ethylene butadiene styrene (SEBS). This tubing segment is connected to the endoscope for delivery of solution to the irrigation site such as the bladder or knee joint. The change from latex to SEBS is being made to improve user safety by eliminating the potential for sensitivity reactions associated with natural rubber proteins.

The provided text describes a 510(k) Premarket Notification for Irrigation Sets with a modified tubing segment. The submission focuses on a material change from natural rubber latex to styrene ethylene butadiene styrene (SEBS) in the distal tubing segment to improve user safety by eliminating potential sensitivity reactions to natural rubber proteins.

However, the provided text does not contain information about:

1. Acceptance criteria and reported device performance in a specific table with quantitative metrics.
2. Sample size, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, ground truth type, training set size, or ground truth establishment for a study that proves the device meets specific acceptance criteria related to a diagnostic or AI-driven medical device.

The document is a 510(k) summary for a material change in a medical device (irrigation sets). The "studies" mentioned are non-clinical tests to verify the biocompatibility and functional performance of the new material, not a clinical study to assess diagnostic accuracy or the effectiveness of an AI algorithm in a healthcare setting.

Based only on the provided text, I can infer the following about the acceptance criteria and the "study" mentioned, though it does not fit the typical format for AI/diagnostic device evaluation:

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

2. Sample sized used for the test set and the data provenance:

• Sample Size: Not specified for any of the tests (kink, pull, pressure, biological).
• Data Provenance: Not specified. These are likely in-house laboratory tests conducted by Baxter Healthcare Corporation.

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

• Not applicable. This submitter is for a material change in a physical medical device. There is no "ground truth" in the diagnostic sense, nor clinical experts establishing diagnostic accuracy. The "truth" is established by adherence to physical and biological testing standards.

4. Adjudication method for the test set:

• Not applicable. This refers to diagnostic/AI studies. The tests mentioned are objective physical and biological assessments.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This is not a diagnostic device or an AI-assisted tool.

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

• No. This refers to AI algorithms.

7. The type of ground truth used:

• Not applicable in the diagnostic sense. The "ground truth" for the material and functional performance is based on established ISO and USP standards for biocompatibility and engineering specifications for functional requirements.

8. The sample size for the training set:

• Not applicable. There is no "training set" for an AI algorithm mentioned.

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

• Not applicable.

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