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The Optilume® High Pressure Urological Balloon Dilation Catheter is indicated for dilation of the urinary tract.

The Optilume® High Pressure Urological Balloon Dilation Catheter is an 0.038" (0.97mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume® High Pressure Urological Balloon Dilation Catheter is used to exert radial force to dilate narrow urinary tract segments (strictures). The distal end of the catheter is a non-compliant inflatable balloon. The 75 cm long Optilume® High Pressure Urological Balloon Dilation Catheter is supplied in five balloon diameters ranging from 4-10mm and balloon lengths ranging from 20-80mm. The balloon catheter is supplied sterile for single use.

This document is an FDA clearance letter for a medical device called the "Optilume® High Pressure Urological Balloon Dilation Catheter." It details the regulatory review process, including the determination of substantial equivalence to a predicate device.

However, the provided text does not contain information about the acceptance criteria or a study that proves the device meets those acceptance criteria in the context of an AI/ML medical device.

The performance data mentioned in the document are solely related to engineering and material performance tests for a physical medical device (a balloon catheter), not an AI algorithm. These tests include:

• Biocompatibility Testing: Ensuring the materials are safe for use in the body.
• Performance Testing: Evaluating physical attributes like balloon diameter, length, inflation/deflation time, burst strength, and compatibility with other medical equipment.
• Sterilization: Validating the sterilization process.
• Packaging and Distribution: Ensuring the device remains sterile and functional during transport and storage.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving an AI/ML device's performance, as the provided input does not describe such a device or study.

The questions you've asked (about sample sizes for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training sets, etc.) are highly relevant for AI/ML medical device clearances but are not addressed in this particular FDA letter, as it's for a traditional hardware device.

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The Optilume Basic Urological Balloon Dilation Catheter is indicated for the dilation of urethral strictures.

The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038" (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon.

The device is sterilized using ethylene oxide in a Tyvek pouch. Post sterilization the pouched catheter is sealed in a foil pouch with desiccant and contained within a single unit carton.

The provided text describes the regulatory clearance of the Optilume Basic Urological Balloon Dilation Catheter (K191061) as substantially equivalent to a predicate device. It includes performance data for various engineering and biocompatibility tests, but it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of diagnostic accuracy, which would typically involve human readers and assessment of performance metrics like sensitivity, specificity, or AUC.

The document focuses on the physical and biological performance of the device itself, rather than evaluating an AI algorithm's diagnostic performance. Therefore, most of the requested information regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert involvement for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this text.

Here's a breakdown of what can and cannot be extracted based on the provided document:

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

The document lists performance tests but does not provide explicit acceptance criteria values (e.g., "burst pressure > X atm") alongside the reported results. It only states that the device "underwent extensive testing" and "performed as intended."

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

• Sample Size: Not applicable in the context of diagnostic "test set" as this is a medical device for dilation, not a diagnostic algorithm. For the GLP animal study, the sample size is not specified beyond "canines."
• Data Provenance: The GLP animal study was performed in "canines." No country of origin is mentioned for the animal study.

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. The performance data relates to the physical and biological characteristics of the device, not the interpretation of diagnostic images requiring expert ground truth.

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 is not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithm.

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

For the engineering tests (e.g., balloon burst, tensile testing), the "ground truth" would be the established engineering specifications and physical properties of the materials. For biocompatibility, the ground truth is compliance with ISO 10993-1 standards. For the animal study, the "ground truth" refers to observation of device performance and absence of adverse events in living subjects.

8. The sample size for the training set:

Not applicable. This is not a machine learning algorithm.

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

Not applicable. This is not a machine learning algorithm.

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