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The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.

The 2-Way 100% Silicone ClearTract Catheter is a standard single-use 2-way Foley catheter that is constructed of medical grade silicone with a surface modification. It incorporates two (2) lumens, one for inflation/deflation of the balloon and the other for drainage of the urinary tract. The drainage inlet is located distal to the catheter's balloon. The connection between the catheter and the urinary bag is accomplished by using a standard non- interconnector. Catheterization is accomplished by inserting the catheter through the urethra. Drainage can also be accomplished by suprapubic placement or nephrostomy tract placement of the catheter.

The provided text is an FDA 510(k) clearance letter for a medical device: the "2-Way 100% Silicone Cleartract Catheter." This type of document primarily focuses on establishing substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and study results for software-based medical devices (like AI algorithms).

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance for a software component.
• Sample sizes used for a test set or training set, or their provenance.
• Number of experts and their qualifications for ground truth establishment.
• Adjudication methods.
• MRMC comparative effectiveness study results or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for the training set was established.

The document states that "performance testing was conducted on the subject device," and "All pre-determined acceptance criteria were met" for various bench performance tests related to the physical catheter (flow rate, balloon integrity, etc.). These are physical and mechanical tests for the catheter itself, not a study evaluating software or AI performance.

In summary, this document describes the clearance of a physical medical device (a catheter) and not a software/AI-driven device, thus the specific information requested about acceptance criteria and study details for an AI/software component is not present in the provided text.

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The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is generally accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic placement or other placement of the catheter, such as nephrostomy tract. Intended population is adults and pediatrics.

The 2-Way 100% Silicone ClearTract Catheter is a standard single-use 2-way Foley catheter that is constructed of medical grade silicone with a surface modification. It incorporates two (2) lumens, one for inflation/deflation of the balloon and the other for drainage of the urinary tract. The drainage inlet is located distal to the catheter's balloon. The connection to the urinary bag is a standard noninterconnectable connector.

The provided document is a 510(k) Premarket Notification from the FDA for a 2-Way 100% Silicone Cleartract Catheter. This document describes the device, its intended use, a comparison to predicate devices, and the non-clinical testing performed to support its substantial equivalence.

Crucially, this document is for a medical device (a catheter) and not for an AI/ML-based diagnostic or prognostic device. Therefore, many of the requested criteria related to AI/ML device performance (such as sensitivity, specificity, MRMC studies, human reader improvement, and ground truth establishment for training/test sets) are not applicable to this type of submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the regulatory requirements for medical device clearance (specifically, demonstrating substantial equivalence to a legally marketed predicate device) rather than performance metrics for an AI algorithm.

Here's a breakdown of the information that is applicable or inferred from the document, and why other points are not relevant:

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

For this medical device, "acceptance criteria" relate to demonstrating substantial equivalence to a predicate device in terms of indications for use, technological characteristics, and performance. The "performance" is assessed through non-clinical testing to ensure safety and effectiveness for the expanded indications.

• Type: Same as Predicate (2-Way Foley Catheter with inflation and drainage lumens)
• Size/Balloon: Same as Predicate (14Fr/10cc, 16Fr/5cc, 18Fr/10cc)
• Materials of Construction: Same as Predicate (Silicone, Medical Grade)
• Zwitterionic Polymer Surface Modification: Same as Predicate (Yes)
• Performance Standard: Same as Predicate (ASTM F623)
• Indwelling Time: Same as Predicate (Up to 30 days)
• Single Use? Same as Predicate (Yes)
• Prescription Use? Same as Predicate (Yes)
• Sterile? Same as Predicate (Yes)
• Sterilization Method: Same as Predicate (Ethylene Oxide Gas)

Conclusion: Technologically identical to the predicate device. |
| Safety and Biocompatibility (for new indications) | Non-Clinical Testing Performed:

• Biocompatibility: Genotoxicity Study per ISO 10993-3:2014, Biological Evaluation of Medical Devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
• Bacterial Endotoxins Test (BET) / LAL Test: per USP .

Conclusion: "All testing was successfully completed and provided objective evidence to demonstrate the ClearTract catheter is substantially equivalent to the predicate device." The submission states "the proposed additions to the indications for use do not change or add new risks to the ClearTract catheter." |
| Compliance with Design Control Regulations | "All changes [the updated IFU] were made in compliance with 21 CFR 820.30 for design controls." |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable in the context of this 510(k) submission. There is no "test set" of patient data in the sense of an AI/ML algorithm evaluation. The testing involved controlled laboratory studies for biocompatibility and endotoxins, not clinical sample data.

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)

Not applicable. There is no "test set" requiring ground truth establishment by clinical experts, as this is a physical medical device, not an AI diagnostic.

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

Not applicable. No clinical test set requiring adjudication was used.

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 pertains to AI-assisted diagnostic devices. This submission is for a physical medical catheter.

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

Not applicable. This pertains to AI diagnostic algorithms.

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

Not applicable. There is no "ground truth" in the clinical data sense required for this type of device. The "ground truth" for device performance is established through adherence to quality standards (e.g., ASTM F623), biocompatibility testing (ISO 10993-3), and endotoxin testing (USP ).

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning.

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

Not applicable. This device does not have a "training set" or "ground truth" in the machine learning sense.

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The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics.

The 2-Way 100% Silicone ClearTract Catheter (previously known as the HDX 100% Silicone 2-Way Foley Catheter) is a standard single-use 2-way Foley catheter that is constructed of medical grade silicone with a surface modification. It incorporates two (2) lumens, one for inflation/deflation of the balloon and the other for drainage of the urinary tract. The drainage inlet is located distal to the catheter's balloon. The connection to the urinary bag is a standard non-interconnectable connector.

This document is a 510(k) premarket notification for a medical device called the "2-Way 100% Silicone ClearTract Catheter." It is not for an AI/ML medical device, and therefore does not contain information about acceptance criteria or studies pertaining to AI/ML device performance.

The document states:

• "The renamed 2-Way 100% Silicone ClearTract Catheter has not been modified in any way. It is exactly the same as the HDX 100% Silicone 2-Way Catheter cleared under 510(k) premarket notification K192034."
• "This special 510(k) premarket notification only proposes an update to the product labeling."
• "No physical changes or modifications are proposed to the cleared device."

Instead, it discusses bench testing (friction testing based on ASTM D1894-14) to support the addition of information about a "surface modification that reduces surface friction" to the device's labeling. This is a physical characteristic of the catheter itself, not a performance metric of an AI/ML algorithm.

Therefore, I cannot provide the requested information about acceptance criteria or studies for an AI/ML device based on this document. The document describes a traditional medical device (a catheter) and a regulatory submission for a labeling change, not an AI/ML product.

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