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The Rusch Brilliant Balloon Catheter is indicated for routine transurethral drainage of the bladder.

The Rusch Silicone Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The retention balloon is attached to the silicone two-lumen shaft. One lumen is used for drainage and the other lumen for inflation of the balloon. Sterile water is used to inflate and deflate the balloon. The distal end has two opposite eye holes which are used for drainage. On the opposing end of the shaft are a connective funnel and a Luer activated valve.

The provided document is a 510(k) Summary for the Rusch Silicone Foley Catheter, which is a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific efficacy or diagnostic performance acceptance criteria through clinical studies. Therefore, much of the information requested about acceptance criteria and detailed study design for diagnostic performance is not present in this document.

However, I can extract information related to the non-clinical performance testing which served to demonstrate substantial equivalence.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific numerical acceptance criteria (e.g., a specific peel strength in Newtons) or reported numerical performance data for the subject device. It states what was tested and the conclusion that the subject device is substantially equivalent.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified for any of the individual non-clinical performance tests.
• Data Provenance: The tests are "bench testing" which are conducted in a laboratory setting. No country of origin is specified for these tests, but the applicant is Teleflex Medical, Inc. in the USA. The data is retrospective in the sense that the tests were performed and analyzed to support this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to the non-clinical performance (bench testing) described. Bench tests do not involve expert interpretation or ground truth establishment in the way a clinical diagnostic study would.

4. Adjudication Method for the Test Set

This is not applicable as there were no expert interpretations requiring adjudication for these bench tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This document describes a medical device (catheter) for drainage, not an AI or diagnostic imaging device that would typically involve an MRMC study.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study of an algorithm was done. This is a physical medical device.

7. Type of Ground Truth Used

For the bench tests, the "ground truth" would be the engineering specifications and established test methods (e.g., ISO standards, internal company standards) for measuring properties like peel strength, security, and reliability. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense. For biocompatibility, the ground truth is established by the successful completion of tests adhering to ISO 10993.

8. Sample Size for the Training Set

No training set is mentioned or applicable. This is not a machine learning or AI device.

9. How the Ground Truth for the Training Set Was Established

Not applicable as there is no training set.

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The Rusch Silicone Foley is used to drain fluids to and from the urinary tract.
The Rusch Silicone Foley Balloon Catheter is used to drain fluids to and from the urinary tract.

The Rusch Silicone catheter is of the retention type, commonly called a Foley catheter. The device is a single use, disposable, sterile with retention balloon, which is attached to the silicone shaft. One lumen is for draining fluids to and from the urinary tract. The second lumen is to inflate and deflate the balloon with sterile water. On models with a third lumen, it is used in conjunction with the first lumen for flushing the urinary tract. Sterile water is used for inflation and deflation of the balloon. The distal end has two opposite eye holes, which are used for drainage. On the Tiemann tip there is one hole. Cylindrical, Coude and Tiemann tips are available versions of this product. On the opposing end of the shaft, are a connecting funnel and a Luer activated valve. Pediatric sizes are available with the same configurations as the adult with the additional feature of a stylet that is inserted prior to the catheter placement. This product is available in sizes 8 Fr to 26 Fr, smooth and profile shafts. Both shafts are available in coated form. Profile shafts provide drainage channels along the shaft length.

This document is a 510(k) summary for a medical device (Rüsch Silicone Foley Catheter) which primarily discusses its substantial equivalence to predicate devices based on technological characteristics and intended use. It does not contain information about acceptance criteria or a study proving device performance against such criteria.

The 510(k) notification process focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics as the predicate device, or, if it has different technological characteristics, the differences do not raise different questions of safety and effectiveness and the device is as safe and effective as the predicate device. This typically involves comparison to existing devices, rather than detailed performance studies with acceptance criteria in the way a clinical trial or performance study for a novel device would.

Therefore, for your request, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics or acceptance criteria for the Rüsch Silicone Foley Catheter beyond its intended use and technological equivalence.
2. Sample size used for the test set and the data provenance: No test set or performance study data is included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no test set or ground truth establishment is described.
4. Adjudication method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily states that the "Rusch Silicone catheter with silicone balloon, ported distal tip, and silicone funnel with and without coating, is equivalent to predicate devices" based on its technological characteristics. The performance is essentially inferred to be equivalent to the predicate devices (Bard, Bardex®, and Mentor, 4 Sure®).

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